Performance of an implantable cardioverter-defibrillator lead family

Abstract

Background: Lead failure is the major limitation in implantable cardioverter‐ defibrillator (ICD) therapy. Long‐term follow‐up data for Biotronik Linox ICD leads are limited. Therefore, we analyzed the performance of all these leads implanted at our institution. Materials and Methods: All Linox and Linox Smart ICD leads implanted between 2006 and 2015 were identified. Lead failure was defined as electrical dysfunction (oversensing, abnormal impedance, exit block). Lead survival was described, according to Kaplan–Meier. Associations between lead failure and specific variables were examined. p < .05 was considered significant. Results: We included 417 ICD leads. The median follow‐up time for Linox (n = 205) was 81 months and for Linox Smart (n = 212) 75 months. During that follow‐up time, 30 Linox (14.6%) and 16 Linox Smart leads (7.6%) showed a malfunction. The 5‐year lead survival probability was 97.4% for Linox and 95.2% for Linox Smart (log‐rank test, p = .19). The 6‐ and 8‐year lead survival probability for Linox was 93.6% and 84.6%, and for Linox Smart 93% and 91.9%. The only factor significantly associated with lead failure was younger patient age at implantation (hazard ratio/year: 0.97, 95% CI: 0.94–0.99, p = .002). Conclusion: This relatively large study with a long follow‐up period highlights a relevant failure rate of Biotronik Linox leads. The performance of Linox versus Linox Smart ICD leads was comparable. Although we show an acceptable 5‐year lead survival probability, we observed a marked drop after just 1 more year of follow‐up. In an era of improving heart failure survival probability, a prolonged follow‐up of ICD leads is increasingly clinically relevant.