Affiliation:
1. Sektion Kardiologie‐Rhythmologie Klinikum Traunstein Traunstein Germany
2. Klinik für Innere Medizin III, Universitätsklinikum Homburg Universität des Saarlandes Saarbrücken Saarland Germany
Abstract
AbstractBackgroundLead 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 MethodsAll 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.ResultsWe 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).ConclusionThis 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.
Subject
Physiology (medical),Cardiology and Cardiovascular Medicine
Reference19 articles.
1. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death
2. Early Failure of the Biotronik Linox Implantable Cardioverter Defibrillator Lead
3. Biotronik SE & Co. KG. Product performance report 2nd edition. Cardiac rhythm management cumulative survival probability; 2020 pp. 93‐112.
4. Biotronik. Biotronik product performance. Linox smart ICD leads—high performance with safety in mind. June 21 2017.http://www.biotronik.com/en-gb/products/crm/tachycardia/linox
5. Comparative study of the failure rates among 3 implantable defibrillator leads