Time-dependent risk of Fidelis lead failure

The Medtronic Sprint Fidelis leads (models 6930, 6931, 6948, 6949) are 6.6-F bipolar high-voltage implantable cardioverter-defibrillator electrodes that were first introduced in September 2004. In October 2007, Fidelis leads were removed from the market. We sought to determine the time-dependent hazard of the Fidelis failure rate to date. A retrospective chart review was conducted in all patients who underwent implantation of a Sprint Fidelis lead (426 leads) at our center. We primarily implanted models 6931 and 6949. With 1,056 years of combined follow-up (average 2.3 +/- 1), 38 of 426 (8.92%) Sprint Fidelis leads failed (3.6%/year). The hazard of fracture increased exponentially over time by a power of 2.13 (95% confidence interval [CI] 1.98 to 2.27, p <0.001) and the 3-year survival was 90.8% (95% CI 87.4 to 94.3). If a Fidelis lead was functioning normally at 1 year, the chance it would survive another year was 97.4% (95% CI 95.7 to 99.1); if functioning at 2 years, the chance of surviving another year was 94.7% (95% CI 91.8 to 97.7); and if functioning at 3 years, the chance of surviving 1 more year was 86.7% (95% CI 78.8 to 95.5). Other commonly used implantable cardioverter-defibrillator leads showed no evidence of increased failure rates. In conclusion, to date, the hazard of Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer's performance update. Further accumulative data are needed because it remains unknown if the fracture rate will level off or continue to increase.