Comparison of lead failure manifestation of Biotronik Linox with St. Jude Medical Riata and Medtronic Sprint Fidelis lead

J Interv Card Electrophysiol. 2019 Mar;54(2):161-170. doi: 10.1007/s10840-018-0486-0. Epub 2018 Nov 23.

Abstract

Purpose: To compare lead failure manifestation and lead performance of the Biotronik Linox/Sorin Vigila defibrillator lead (Linox group) with the St. Jude Medical Riata/Riata ST (Riata group) and Medtronic Sprint Fidelis defibrillator leads (Fidelis group).

Methods: We assessed the performance of all aforementioned leads implanted at our center and investigated the manifestation of lead failures.

Results: Of 93 Linox, 86 Riata, and 81 Fidelis leads implanted at our center, 11 (12%), 22 (26%), and 25 (31%) leads failed during a median follow-up of 46, 61, and 84 months, respectively. Inappropriate shocks were delivered in 64% (Linox), 5% (Riata), and 32% (Fidelis) of lead failures; a device alert was noted in none (Linox), 5% (Riata), and 52% (Fidelis); and lead failure was a coincidental finding in 36% (Linox), 91% (Riata), and 16% (Fidelis) of cases (p < 0.001). Non-physiological high rate signals were observed in 73% (Linox), 27% (Riata), and 80% (Fidelis) of lead failures (p = 0.001) and damaged lead integrity was found in 36% (Linox), 73% (Riata), and 24% (Fidelis) of cases (p = 0.064). Lead survival at 5 years was 88%, 92%, and 71% for Linox, Riata, and Fidelis group, respectively.

Conclusions: The most frequent clinical manifestation of lead failure was inappropriate shocks for Linox, coincidental finding for Riata and device alert for Fidelis leads. Non-physiological high rate signals were frequently observed in Linox and Fidelis lead failures whereas in Riata lead failures, a damaged lead integrity was the predominant finding.

Keywords: Defibrillator lead; Lead failure; Linox; Riata; Sprint fidelis.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Cardiac Resynchronization Therapy / adverse effects
  • Cardiac Resynchronization Therapy / methods
  • Cardiomyopathy, Dilated / therapy
  • Cohort Studies
  • Defibrillators, Implantable / adverse effects*
  • Electrodes, Implanted / adverse effects*
  • Equipment Design / methods*
  • Equipment Failure Analysis*
  • Equipment Safety / statistics & numerical data*
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myocardial Ischemia / therapy
  • Retrospective Studies
  • Risk Assessment
  • Sex Factors
  • United States