|
Unique complaint id number,event date,date entered,manufacturer aware date,brand name,generic name,model number,lot number,catalog number,serial number,udi number,pma / 510k number,date returned to manufacturer,type of reportable event,event description,manufacturer narrative,medical history,patient age,patient gender,patient weight,date implanted,date explanted,health effect clinical code,health effect impact code,device problem code,device component code,investigation type code,investigation findings code,investigation conclusion code,remedial action type,latest line item version
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred at discharge or within 7 days of implant.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 45 days after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
19870445,01/01/2015,06/05/2025,03/18/2025,watchman flx,"system, appendage closure, left atrial",unknown,unknown,unknown,na,unknown,p130013 ,03/18/2025,d,"it was reported that a death occurred 1 year after procedure.
type of procedure: left atrial appendage closure
boston scientific performed a retrospective data analysis using the aggregate electronic health record database from truveta.This analysis aimed to evaluate adverse event rates related to the watchman flx device in real-world use.The implant procedures were performed from january 2015 to april 2024.Patient events were identified as event terms with rates.Data obtained from truveta for this study is de-identified before being accessed by boston scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint.The study data does not provide a causality relationship for each reported event to the device.No further information is available to bsc.","time frame of event date collection: patients in truveta health systems implanted with watchman flx device between jan 2015 and april 2024.
summary of adverse events: patients had an average follow-up duration of 15.4 ± 10.8 days between watchman flx implant and data snapshot.Adverse events were assessed at discharge (or within 7 days of implant, whichever is later), 45 days, and 1 year.These events include the occurrence of all-cause mortality, any stroke, ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, and pericardial effusion requiring intervention.
total number of patients: 11618
device evaluation: under the terms and conditions of the study, anonymized data was provided.No products were returned as part of the study.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the ""potential adverse events"" list in the fda-approved instructions for use (ifu).
contextual analysis of study data:
publications of 1-year event rates from similar nationwide, retrospective analyses looking at data from 2016-2018(1) and 2020-2022(2) have reported rates of all-cause death from 8.2%(2) - 8.5%(1), all stroke from 1.5%(2) - 2.1%(1), ischemic stroke from 1.2%(2) - 1.5%(1), hemorrhagic stroke from 0.26%(2) - 0.46%(1), major bleeding from 6.4%(2) - 6.9%(1), and systemic embolism from 0.10%(2) - 0.68%(1).Pericardial effusion was reported at 45-days with a rate of 0.50%.(2)
overall, 1-year clinical outcomes after watchman flx implantation from truveta align with expectations derived from published literature.The 1-year event rates found in this analysis for death (5.9%), all stroke (2.0%), hemorrhagic stroke (0.41%), systemic embolism (0.10%), and major bleeding (3.0%) are within or lower than reported rates from analyses of similar nationwide registries of published watchman literature.The 45-day rate for pericardial effusion requiring intervention (0.31%) as well as the 1-year rate (0.41%) are lower than the published 45-day rate and thus are in-line with expectations.The 1-year ischemic stroke rate (1.7%) is within the 95% confidence interval for the upper bound of the range reported in the literature (1.4% - 1.7%)(1).A similar japanese nationwide registry published an ischemic event rate of 2.6%(3) for watchman flx and single center watchman studies have reported rates of 2.0%.(4,5) as such, the rate found in this analysis aligns with expectations from published literature.Thus, all rates found in this analysis align with expectations derived from similar published literature.
references
1.Price mj, slotwiner d, du c, et al.Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the united states.Jacc cardiovasc interv.Apr 11 2022;15(7):741-750.Doi:10.1016/j.Jcin.2022.02.009
2.Kapadia sr, yeh rw, price mj, et al.Outcomes with the watchman flx in everyday clinical practice from the ncdr left atrial appendage occlusion registry.Circ cardiovasc interv.Sep 2024;17(9):e013750.Doi:10.1161/circinterventions.123.013750
3.Nakashima m, yamamoto m, sago m, et al.Comparative data of procedural and midterm outcomes in patients who underwent percutaneous left atrial appendage closure between the watchman flx and watchman 2.5 devices?- insight from the ocean-laac registry.Circ j.Jun 25 2024;88(7):1187-1197.Doi:10.1253/circj.Cj-24-0062
4.Huang wp, zhang yh, he l, su x, yang xw, guo zx.Efficacy and safety of the watchman left atrial appendage system for stroke prevention in chinese patients with nonvalvular atrial fibrillation: a single-center, prospective, observational study.Chin med j (engl).Feb 20 2017;130(4):434-438.Doi:10.4103/0366-6999.199832
5.Hana d, miller t, chaker z, et al.Evaluating gender-based differences in clinical outcomes for patients undergoing left atrial appendage occlusion: a single centre experience.Curr probl cardiol.Mar 2023;48(3):101532.Doi:10.1016/j.Cpcardiol.2022.101532
race: american indian or alaska native 29(0.2 %), asian 165(1.4 %), black 401(3.5 %), other pacific islander 5(0.0 %), other race 142(1.2 %), unknown 676(5.8 %), and white 10200(87.8 %).
ethnicity: hispanic or latino 162(1.6 %), and not hispanic or latino 10128(98.4 %).
detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.",,average 76 years,"female 4740 (40.8 %)
male 6878 (59.2%)",,,,e2403,f02,a24,g07001,b17,c19,d12,,0
.
|
