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This complaint is from a literature source.The following literature cite has been reviewed: keegan r, garmendia f, gregorietti f, urruti r, onetto l.Very high-power and short-duration radiofrequency ablation for atrial fibrillation in a latin american low-volume private center.J interv card electrophysiol.2024 jan 23.Doi: 10.1007/s10840-024-01756-4.Epub ahead of print.Pmid: 38261105.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).
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This complaint is from a literature source.The following literature cite has been reviewed: keegan r, garmendia f, gregorietti f, urruti r, onetto l.Very high-power and short-duration radiofrequency ablation for atrial fibrillation in a latin american low-volume private center.J interv card electrophysiol.2024 jan 23.Doi: 10.1007/s10840-024-01756-4.Epub ahead of print.Pmid: 38261105.Objective/methods/study data: background: center volume and operator experience/training are important factors impacting outcomes in afib ca.Setting for rf delivery (power, duration, and contact force) associated with better outcomes remains to be determined.Methods: this is an observational, longitudinal, and retrospective study.All consecutive procedures performed between december 12, 2013, and march 9, 2023, in a low-volume private center in latin america were analyzed.Procedure characteristics and outcomes were compared between std and vhpsd.Results: two hundred ten procedures were performed on 194 patients.Median annual number of procedures was 19 (7-29).Median age was 62 (52-68), and majority were male (71%).Median procedure duration was 155 (125-195) min, mean fluoroscopy time 32.8 ± 15 min and mean fluoroscopy dose 373.5 ± 208.9 mgray.Median follow-up was 27 months, significantly longer in std compared with vhpsd group (43 [31-68] vs.13 [8-19], respectively; p = 0.001).The recurrence rate was 33.2% and major complications 8.6%.Compared with std, vhpsd resulted in a significantly shorter procedure duration (125 vs.180 min, p = 0.001), shorter fluoroscopy time (22.7 ± 9.5 vs.39.2 ± 14.3 min, p = 0.001), and lower fluoroscopy dose (283.8 ± 161.1 vs.438.3 ± 216.1 mgray, p = 0.001).No long-term recurrence difference was observed when the follow-up periods were comparable.No difference in complication rate was observed (8.5% vs.8.6%, p = 0.988).Conclusions: outcomes in afib ca in a latin american low-volume private center can be considered acceptable, with efficacy and safety similar to those reported in the literature.Compared with std ablation, vhpsd showed higher efficiency with similar efficacy and safety.Biosense webster devices that were used in this study: decapolar cs catheter, lasso mapping catheter non biosense webster devices that were used in this study: livewire cs catheter (abbott), viewflex xtra ice probe (abbott), agilis nxt sheath (abbott), ensite precision mapping system (abbott), ensite velocity mapping system (abbott), reflexion mapping catheter (abbott), advisor hd grid mapping catheter (abbott), tacticath ablation catheter (abbott), flexibility ablation catheter (abbott).The literature article does not provide sufficient information to associated specific adverse events with specific device manufacturers.Additionally, exact quantities of products cannot be accurately determined as patients can experience more than adverse event and the data is summarized.The femoral av fistula/pseudoaneurysm (1 av fistula required vascular surgery and 1 pseudoaneurym required surgical femoral artery ligation) is associated with the sheath for femoral access (non biosense webster).Open chest cardiac surgery was not needed in any patient.No clinical cerebral (tia/stroke) or systemic embolic event was observed.No death occurred.Adverse event(s) and provided interventions cannot be associated with a specific device manufacturer due to insufficient information: qty (b)(4) atelectasis, qty (b)(4) chest pain, qty (b)(4) pv stenosis, qty (b)(4) pericardial effusion, qty (b)(4) tamponade treated with percutaneous drainage.
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