Failure Rates of Single | 合法醫療器材資訊網

2016年11月30日—PatientsimplantedwiththerecalledMedtronicFidelislead(Medtronic...Thedual​-coilSprintQuattromodel6947wasapprovedforuseinthe ...

Electrical failure is more common in single-coil compared with dual-coil implantable cardioverter defibrillator (ICD) leads in the case of the recalled Riata lead. Single-coil leads are however favored in most patients given their lower risk of extraction. We therefore evaluated the failure-free survival of single- versus dual-coil ICD leads not included in Food and Drug Administration recalls. All patients receiving a Medtronic transvenous Sprint Quattro single- or dual-coil ICD lead were included in this analysis. Leads were followed to the end point of electrical failure. A total of 1,020 dual-coil and 631 single-coil ICD leads were implanted at our institution from November 2000 to March 2014. As expected, dual-coil leads had a longer follow-up time (3.4 ± 2.6 years vs 1.3 ± 1.0 years, p <0.001) because they were approved many years earlier by the Food a...