title: Comparative study of the failure rates among 3 implantable defibrillator leads.
abstract: After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed.
  
  
  
  The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads.
  
  
  
  We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads. Lead failure was defined by low- or high-voltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference.
  
  
  
  During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%), and 5 Durata (1.5%) leads failed. At 5-year follow-up, the cumulative failure rate of Linox leads (6.4%) was higher than that of Endotak (0.4%; P < .0001) and Durata (2.0%; P = .003) leads. The incidence rate was higher in Linox leads (1.3 per 100 patient-years) than in Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P < .001). A log-log analysis of the cumulative hazard for Linox leads functioning at 3-year follow-up revealed a stable failure rate of 3% per year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%).
  
  
  
  This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure.
authors: Departments of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
authors: Sophie C H
authors: SC
authors: van Malderen
authors: Departments of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
authors: Tamas
authors: T
authors: Szili-Torok
authors: Departments of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
authors: Sing C
authors: SC
authors: Yap
authors: Anesthesiology, Erasmus MC, Rotterdam, The Netherlands.
authors: Sanne E
authors: SE
authors: Hoeks
authors: Departments of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
authors: Felix
authors: F
authors: Zijlstra
authors: Departments of Cardiology, Erasmus MC, Rotterdam, The Netherlands. Electronic address: d.theuns@erasmusmc.nl.
authors: Dominic A M J
authors: DA
authors: Theuns
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000145:classification; D042241:Early Diagnosis; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017097:Electric Impedance; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D009426:Netherlands; D012042:Registries / Q000706:statistics & numerical data; D058998:Remote Sensing Technology / Q000379:methods
keywords: Durata; Endotak; Implantable cardioverter-defibrillator; Lead failure; Linox