Trends in Fidelis lead survival: transition from an exponential to linear pattern of lead failure over time.

Background: The Sprint Fidelis implantable cardioverter-defibrillator lead was recalled in 2007 because of an levated risk of lead fracture. Several studies have demonstrated an accelerating risk of lead failure over time. We sought to identify predictors and characterize trends of Fidelis lead failure.

Methods And Results: We evaluated 604 Fidelis leads with ≥ 90 days of follow-up implanted at our institution. Fidelis lead survival was analyzed by the Kaplan-Meier method. Analysis of log-log plots of cumulative hazard plots was performed to assess changes in lead failure rate over time. During follow-up of 3.3 ± 1.7 years, 51 (8.4%) Fidelis lead failures were identified. The 3-year and 5-year Fidelis lead survival rates were 93.5% and 85.3%, respectively. Female sex was the only significant predictor of lead failure (heart rate, 2.1; 95% CI, 1.1-3.9; P<0.0001). The rate of lead failure initially increased exponentially with a power of 2.3 (95% CI, 2.22-2.43; P<0.0001). However, log-log analysis of cumulative hazard for leads functioning at 2 and 4 years revealed a stable rate of failure of 4.5%/year. Mathematical modeling of the Fidelis lead failure demonstrated a transition from an exponential to linear pattern of lead failure at 2.9 years.

Conclusions: After 3 years, failure rates of Fidelis leads stabilize but at a significantly elevated rate. Female sex is associated with a doubling of the risk of Fidelis lead failure. These findings have implications for Fidelis lead management decisions that are based on the prediction of lead failure risk.