Trends in Fidelis Lead Survival: Transition From an Exponential to Linear Pattern of Lead Failure Over Time

• Published in: Circulation. Arrhythmia and electrophysiology Vol. 5; no. 5; pp. 906 - 912
• Main Authors: Cheung, Jim W, Tobin-Hess, Aviva, Patel, Apoor, Slotwiner, David J, Goldner, Bruce G
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD American Heart Association, Inc 01.10.2012; Lippincott Williams & Wilkins
• Subjects: Aged; Arrhythmias, Cardiac - mortality; Arrhythmias, Cardiac - therapy; Biological and medical sciences; Chi-Square Distribution; Defibrillators, Implantable; Equipment Design; Equipment Failure; Equipment Failure Analysis; Female; Humans; Linear Models; Male; Medical sciences; Middle Aged; New York - epidemiology; Proportional Hazards Models; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Retrospective Studies; Sex Factors; Survival Rate - trends; Time Factors; New York; lead advisory; Intensive cardiocirculatory care; Prognosis; Rate; Trend; Instrumentation therapy; Cardioversion; Time; Survival; Implanted; Lead; Transition; failure rate; lead failure; Defibrillation; Failure; implantable cardioverter-defibrillator; Defibrillator
• ISSN: 1941-3149; 1941-3084
• DOI: 10.1161/CIRCEP.112.972000

BACKGROUND—The Sprint Fidelis implantable cardioverter-defibrillator lead was recalled in 2007 because of an elevated 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.