Comparison of longevity and clinical outcomes of implantable cardioverter-defibrillator leads among manufacturers

Heart Rhythm. 2017 Oct;14(10):1496-1503. doi: 10.1016/j.hrthm.2017.05.020. Epub 2017 May 11.

Abstract

Background: An early failure of the Biotronik Linox S/SD implantable cardioverter-defibrillator (ICD) lead has been reported. We have also experienced several cases with early failure of Linox leads.

Objective: Our aim was to assess the longevity of Linox S/SD (Biotronik, Berlin, Germany) compared with Sprint Fidelis (Medtronic, Minneapolis, MN), Sprint Quattro (Medtronic), and Endotak Reliance (Boston Scientific, Natick, Massachusetts) leads.

Methods: We retrospectively reviewed patients who had undergone implantation of Linox S/SD (n = 90), Sprint Fidelis (n = 37), Sprint Quattro (n = 27), or Endotak Reliance (n = 50) leads between June 2000 and December 2013 at our hospital. Variables associated with lead failure were assessed by the Kaplan-Meier method and Cox survival modeling.

Results: Failure rates of Linox, Sprint Fidelis, and Endotak leads were 3.2%/year (7-year survival rate, 81.0%), 3.4%/year (7-year survival rate, 77.2%), and 0.61%/year (7-year survival rate, 95.8%), respectively. No lead failure was found with Sprint Quattro leads. The survival probability of Linox leads was significantly lower than that of Endotak leads (P = .049) and comparable to that of Sprint Fidelis leads (P = .69). In univariate analysis, age was the only predictor of Linox lead failure. Patients <58 years old were at significantly increased risk of lead failure compared with patients ≥58 years old (hazard ratio, 9.0; 95% confidence interval, 1.13-71.3; P = .037).

Conclusion: In our single-center experience, the survival rate of Linox leads was unacceptably low. The only predictor of Linox lead failure was age at implantation. This is the first description of a lower survival rate for Linox leads in an Asian population.

Keywords: Endotak Reliance; Implantable cardioverter-defibrillator; Linox; Longevity of ICD lead; Sprint Fidelis; Sprint Quattro.

MeSH terms

  • Adult
  • Aged
  • Defibrillators, Implantable*
  • Electrodes, Implanted / standards*
  • Equipment Design
  • Equipment Failure Analysis / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Materials Testing*
  • Middle Aged
  • Retrospective Studies
  • Risk Factors
  • Tachycardia, Ventricular / therapy