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According to the notification, the publication titled "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" reports the results of a retrospective chart review (n=11 patients) between january 2012 to june 2013 "all were dependent on a tunneled femoral dialysis catheter due to central venous occlusion (cvo).The iocva [inside out central venous access] technique was used in each case.This technique was used as last resort for patients who had no other dialysis access option." regarding the patients, "average age was 54.4 y (sd 16.4 y).Six were caucasian and five were african american.Seven had diabetes.Eight had coronary artery disease.Etiologies for renal failure besides diabetes included lithium toxicity, focal segmental glomerulosclerosis (fsgs), polycystic kidney disease (pckd), lupus, and hypertension." three grafts were ligated due to steal syndrome.Two grafts were lost due to thrombosis.Five of 11 patients experienced a 30-day complication.Three patients died within the follow-up period; however, none were directly related to the graft placement.Three grafts were ligated for steal syndrome at 2, 35, and 97 days after placement.Before ligation, angiograms were performed in two grafts to evaluate for treatable stenosis.Angioplasty of one subclavian and one radial artery stenosis failed to adequately treat the ischemia.None were deemed appropriate for further revision.Two were diabetic and had previously undergone lower extremity amputation.None of these patients had a stent in the svc.This investigation is relegated to the first of three incidents of steal syndrome.
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According to the notification, the publication titled "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" reports the results of a retrospective chart review (n=11 patients) between january 2012 to june 2013 "all were dependent on a tunneled femoral dialysis catheter due to central venous occlusion (cvo).The iocva [inside out central venous access] technique was used in each case.This technique was used as last resort for patients who had no other dialysis access option." regarding the patients, "average age was 54.4 y (sd 16.4 y).Six were caucasian and five were african american.Seven had diabetes.Eight had coronary artery disease.Etiologies for renal failure besides diabetes included lithium toxicity, focal segmental glomerulosclerosis (fsgs), polycystic kidney disease (pckd), lupus, and hypertension." three grafts were ligated due to steal syndrome.Two grafts were lost due to thrombosis.Five of 11 patients experienced a 30-day complication.Three patients died within the follow-up period; however, none were directly related to the graft placement.This investigation is relegated to the first of three incidents of steal syndrome.Regarding the patients, "average age was 54.4 y (sd 16.4 y).Six were caucasian and five were african american.Seven had diabetes.Eight had coronary artery disease.Etiologies for renal failure besides diabetes included lithium toxicity, focal segmental glomerulosclerosis (fsgs), polycystic kidney disease (pckd), lupus, and hypertension." three grafts were ligated for steal syndrome at 2, 35, and 97 days after placement.Before ligation, angiograms were performed in two grafts to evaluate for treatable stenosis.Angioplasty of one subclavian and one radial artery stenosis failed to adequately treat the ischemia.None were deemed appropriate for further revision.Two were diabetic and had previously undergone lower extremity amputation.None of these patients had a stent in the svc.Multiple attempts to obtain additional clarifying information from the corresponding author of the publication were made without success.Emails were sent on 02/23/2016 and 03/09/2016 and a letter was sent on 03/09/2016 without response.Manufacturing records were not reviewed as definitive lot numbers are unavailable.The system could not be queried for potential lots shipped to the hospital as dates of implant are unknown.Davis et al.Published the article entitled, "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" online in january of 2016.The retrospective review documents the following adverse events in a set of 11 patients with superior vena cava (svc) occlusion: steal, thrombosis, death (unrelated to the hero graft), acute ischemic stroke, pneumonia, wound dehiscence, pacemaker wire dislodgement, bleeding requiring transfusion, acute psychosis, and bacteremia.The surgeons implanted the hero graft using the inside-out central venous access technique (iocva) to traverse the occluded vena cava.The description of the technique can be found in the publication.Additionally, the hero graft was placed in a two-step process for five of the eleven patients.The known medical history reported for the sample included previous dependency on a tunneled femoral catheter, history of multiple failed accesses, 8 patients with coronary artery disease (cad) and 7 patients with diabetes.Three patients were reported to have steal syndrome, which required ligation.The cases occurred 2, 35, and 97 days post implant.Attempts at an intervention were made prior to ligation but they ultimately failed; the patients were not considered candidates for distal revision with interval ligation (dril) or revision with distal inflow (rudi) due to multiple comorbidities, calcified arteries, diseased runoff, and severity of tissue loss.Two of the three patients were reported to be diabetic and had previously undergone lower extremity amputation.All three patients had a history of peripheral vascular disease (pvd).It was also documented that the patients did not have a stent in the svc.No additional medical history was documented in the three patients relating to this event.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges from 2.6% to 3.8% with hero and 3.8% in avg.Steal syndrome is not unique to hero graft and is a well-known complication of arteriovenous (av) access conduits (fistula, prosthetic, biologic and xenograft inclusive).The relationship between the hero graft and the cases of steal cannot be determined without additional, patient-specific information.The patients reported here had a procedure modification, as the surgeons chose to implant with the iocva approach.The hero graft ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft implanted with the iocva technique have not been evaluated by cryolife and therefore there is no data on anticipated adverse events.The following complications were reported with limited additional information within the publication, but were not documented to be directly related to the hero graft: pneumonia, wound dehiscence, pacemaker wire dislodgement, bleeding, and psychosis.One patient had pneumonia requiring hospitalization within 30 days of hero placement.This patient was documented to have frequent lung infections and chronic pleural effusion.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.The patient's pertinent medical history of lung infections would increase the risk of pneumonia.One patient had wound dehiscence, which was noted in a follow-up appointment within 30 days of hero placement.There was no exposed graft documented and the tissue was re-approximated after washout in the operating room.The patient was treated with a 3-week course of iv antibiotics.The graft was reported to be operational at the time of the publication.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.One patient had a case of pacemaker wire dislodgement within 30 days of hero placement.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.One patient had a case of bleeding requiring transfusion within 30 days of hero placement.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.The source of the bleeding was not reported.One patient had a case of acute psychosis within 30 days of hero placement.The following information is not available for consideration in the reported event: additional patient medical history, implant/intervention notes, and dialysis information.
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According to the notification, the publication titled "the use of hero catheter in catheter-dependent dialysis patients with superior vena cava occlusion" reports the results of a retrospective chart review (n=11 patients) between january 2012 to june 2013 "all were dependent on a tunneled femoral dialysis catheter due to central venous occlusion (cvo).The iocva [inside out central venous access] technique was used in each case.This technique was used as last resort for patients who had no other dialysis access option." regarding the patients, "average age was 54.4 y (sd 16.4 y).Six were caucasian and five were african american.Seven had diabetes.Eight had coronary artery disease.Etiologies for renal failure besides diabetes included lithium toxicity, focal segmental glomerulosclerosis (fsgs), polycystic kidney disease (pckd), lupus, and hypertension." three grafts were ligated due to steal syndrome.Two grafts were lost due to thrombosis.Five of 11 patients experienced a 30-day complication.Three patients died within the follow-up period; however, none were directly related to the graft placement.Three grafts were ligated for steal syndrome at 2, 35, and 97 days after placement.Before ligation, angiograms were performed in two grafts to evaluate for treatable stenosis.Angioplasty of one subclavian and one radial artery stenosis failed to adequately treat the ischemia.None were deemed appropriate for further revision.Two were diabetic and had previously undergone lower extremity amputation.None of these patients had a stent in the svc.This investigation is relegated to the first of three incidents of steal syndrome.
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