Trends in Fidelis Lead Survival
| Autor: | David J. Slotwiner, Apoor Patel, Aviva Tobin-Hess, Bruce G. Goldner, Jim W. Cheung |
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| Rok vydání: | 2012 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Operations research medicine.medical_treatment New York Sex Factors Physiology (medical) Internal medicine Heart rate Lead failure medicine Humans Lead (electronics) Aged Proportional Hazards Models Retrospective Studies Chi-Square Distribution business.industry Female sex Arrhythmias Cardiac Failure rate Equipment Design Middle Aged Implantable cardioverter-defibrillator Defibrillators Implantable Equipment Failure Analysis Survival Rate Linear Models Cardiology Equipment Failure Female Cumulative hazard Cardiology and Cardiovascular Medicine business |
| Zdroj: | Circulation: Arrhythmia and Electrophysiology. 5:906-912 |
| ISSN: | 1941-3084 1941-3149 |
| DOI: | 10.1161/circep.112.972000 |
| Popis: | 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 P 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. |
| Databáze: | OpenAIRE |
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