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The Medtronic Sprint Fidelis® lead history revisited-Extended follow-up of passive leads

Simon Martin Frey, Christian Sticherling, David Altmann, Roman Brenner, Michael Kühne, Peter Ammann, Michael Coslovsky, Stefan Osswald & Beat Schaer

abstract

BACKGROUND
Due to high failure rates, Medtronic withdrew the Sprint Fidelis lead (SFL) from the market. Passive fixation lead models exhibited better survival than active models, but most studies have limited follow-up. Aim of this study was to give insights into passive lead survival with a follow-up of 10 years.

METHODS
In two large Swiss centers, patients with passive SFLs were identified and data from routine implantable cardioverter defibrillator (ICD) follow-ups were collected. Patients were censored at time of death, last device interrogation (if lost to follow-up), time of lead revision (in non-SFL-related problems), or at database closure (31th December 2017). We defined lead failure as any of the following: lead fracture with inappropriate discharge; sudden increase in low-voltage impedance to >1500 or high-voltage impedance to >100 Ω; >300 nonphysiological short VV-intervals.

RESULTS
We identified 145 patients. Age at implant was 60 ± 12 years with a median follow-up of 10.2 (interquartile range [IQR]: 5.0-11.2) years. Thirty-five percent of patients died after 5.4 ± 2.7 years. A total of 19 leads (13%) failed after 6.7 ± 3.2 years (range: 1.2-12.0). Overt malfunction with shocks existed in four patients (3%). Cumulative lead survival was 93.1% at 6, 88.2% at 8, 83.8% at 10, and 77.6% at 11 years, respectively, with 35% of implanted leads under monitoring at 10 years. Lead survival fits best a Weibull distribution with accelerating failure rates (k = 1.95, 95% CI 1.32-2.87, P < 0.001).

CONCLUSIONS
During very long-term follow-up, failure rate of the passive SFL shows an increase resulting in an impaired lead survival of 84% at 10 years.
   
citation Frey S M, Sticherling C, Altmann D, Brenner R, Kühne M, Ammann P, Coslovsky M, Osswald S, Schaer B. The Medtronic Sprint Fidelis® lead history revisited-Extended follow-up of passive leads. Pacing Clin Electrophysiol 2019;.
   
type journal paper/review (English)
date of publishing 18-10-2019
journal title Pacing Clin Electrophysiol
ISSN electronic 1540-8159
PubMed 31625613
DOI 10.1111/pace.13820