Abstract 15909: Pacemaker and Implantable Defibrillator Lead Survival and Malfunction Study: Long-term Follow-up of the Sprint Fidelis Lead
Introduction: The Sprint Fidelis lead is the largest defibrillator lead ever recalled. Multiple independent studies have suggested that the manufacturer's lead failure data significantly underestimates actual lead failure rates observed in clinical practice.
Hypothesis: The purpose of this study was to test the hypothesis that manufacturer reported data underestimates actual lead failure rates observed at a large implanting center.
Methods: This study was approved by the Winthrop University Hospital's IRB. All implanted Sprint Fidelis leads were retrospectively analyzed with respect to age, gender, ejection fraction, and implant approach. Lead failure included failure to capture/sense, abnormal impedance, fracture/insulation defect, dislodgement and/or perforation. Each suspected failure was independently confirmed by an individual who was blinded to the operator and patient identifiers. Kaplan-Meier survival curves were computed and a Cox regression was used to determine the relationship between survival and the continuous variable of age. Results were considered significant when p<0.05.
Results: A total of 795 leads were implanted by 5 physicians through October 2007 (595 men: 200 women) with a mean age of 70.8±12.7 years. The mean follow-up was 31.1±5.3 months with a total of 24 lead failures (3.02% failure rate). The first year lead survival was 99.9%, second year was 98.7%, third year was 96.1%, fourth year was 94.7% and the fifth year was 94.7%. 63.1% were implanted via cephalic venous and 36.9% via subclavian venous approach. There were no lead failure differences observed in our study based on age, gender, ejection fraction, or implant approach.
Conclusions: This study used identical lead failure criteria as employed by the manufacturer and came up with more favorable lead survival results when compared to other independent studies. Manufacturer reported Sprint Fidelis lead failure rates do not underestimate real world clinical experience.
- © 2010 by American Heart Association, Inc.