Failure rate and conductor externalization in the Biotronik Linox/Sorin Vigila implantable cardioverter-defibrillator lead

Heart Rhythm. 2016 May;13(5):1075-1082. doi: 10.1016/j.hrthm.2015.12.038. Epub 2015 Dec 29.

Abstract

Background: We observed a case of conductor externalization in a Biotronik Linox lead.

Objective: The purpose of this study was to investigate lead performance of the Linox lead and the identical Sorin Vigila lead and prevalence of conductor externalization.

Methods: We compared lead performance of all Linox and Vigila leads implanted at our center (BL group; n = 93) with that of all Boston Scientific Endotak Reliance leads (ER group; n = 190) and Medtronic Sprint Quattro leads (SQ group; n = 202) implanted during the same period. We screened all patients in the BL group for conductor externalization.

Results: We identified 8 cases of lead failures in the BL group (index case of conductor externalization, 6 cases of nonphysiological high-rate sensing, and 1 case of high-voltage conductor fracture). Prospective fluoroscopic screening of 98% of all active BL group cases revealed 1 additional case of conductor externalization. The median follow-up was 41, 27, and 29 months for the BL group, ER group, and SQ group, respectively; lead survival was 94.9%, 99.2%, and 100% at 3 years and 88%, 97.5%, and 100% at 5 years (P = .038 for BL group vs ER group and P = .007 for BL group vs SQ group using the log-rank test). Younger age at implant was an independent predictor of lead failure in the BL group (adjusted hazard ratio 0.85; 95% confidence interval 0.77-0.94; P = .001).

Conclusion: At our center, survival of the Linox lead is 88% at 5 years and significantly worse than that of other leads. Conductor externalization is present in a minority of failed Linox leads. Younger age at implant is an independent predictor of Linox lead failure.

Keywords: Conductor externalization; Defibrillator lead; Endotak Reliance; Lead failure; Linox; Sprint Quattro.

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Death, Sudden, Cardiac / etiology
  • Death, Sudden, Cardiac / prevention & control*
  • Defibrillators, Implantable / adverse effects*
  • Defibrillators, Implantable / classification
  • Electrodes, Implanted / adverse effects*
  • Equipment Design
  • Equipment Failure Analysis / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prosthesis Failure*
  • Risk Assessment
  • Risk Factors
  • Switzerland
  • Tachycardia, Ventricular / therapy*