Natural history of the Sprint Fidelis lead: survival analysis from a large single-center study

Abstract

This study presents a single-center experience on the natural history of the Fidelis lead. In our experience, lead survival declines at a lower rate when compared to prior reports. The risk of lead failure demonstrated a double peaked pattern at approximately 3 and 5 years. No identified variable was predictive of lead failure. LIA was effective in reducing the incidence and number of IS.

Trends in Fidelis Lead Survival

“…Our 3-year Fidelis survival rate of 93.5% is higher than what was seen in initial studies with shorter follow-up but is comparable to the 93% to 95.3% rates reported in 3 recent large studies with comparable follow-up time to ours. 9,10,12 In any case, our Fidelis survival rates are still lower than those that have been published by the manufacturer from the SLS and CareLink PLUS cohorts. 2 We found that female sex was the only significant clinical predictor of Fidelis lead failure and was associated with a doubling of the risk of lead failure.…”

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study

“…A relatively low lead failure rate was achieved with implantations which involved only double-coil lead in all patients. Tzogias et al [17] presented similar 9.7% failure rate in 971 patients with 6949 lead (double-coil) in a 5-year follow-up. Piot et al [15] found that singlecoil lead had over 3-times higher risk of fracture compared with double-coil lead.…”

Very Late Follow‐Up of a Passive Defibrillator Lead Under Recall: Do Failure Rates Increase during Long‐Term Observation

“…In the majority of papers published on SFL, only cumulative lead survival rate after 5 years is reported, the definition of failure is not consistent, and the lead type is mostly active. Reported lead survival ranges between 90% and 83%, mean/median follow‐up is less than 4 years, and the number of leads “at risk” at the time point 5 and 6 years is very low (e.g., less than 20% and 5%, respectively, in the paper by Cheung et al…”

“…Some of the current definitions of lead failure might overestimate true failure rate, as, for example, a continuous increase in low‐voltage impedance, a decrease in sensing values, and an increase in pacing thresholds were taken as “failure.” However, these changes might not be due to true lead failure, but due to normal lead degeneration or local tissue factors. We therefore decided to present both failure rates, a stricter as well as a more lenient one.…”

“…More than 250,000 Sprint Fidelis® leads (SFL; Medtronic Inc., Minneapolis, MN, USA) have been implanted worldwide up to its withdrawal in 2007 after reports on elevated failure rates. Since then, many studies on the “long‐term” performance of the lead have been published. All of them showed a seriously impaired lead survival rate compared to other regularly used leads.…”