1. Comparative study of the failure rates among 3 implantable defibrillator leads.
- Author
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van Malderen SC, Szili-Torok T, Yap SC, Hoeks SE, Zijlstra F, and Theuns DA
- Subjects
- Aged, Early Diagnosis, Electric Impedance, Equipment Design, Female, Follow-Up Studies, Humans, Male, Middle Aged, Monitoring, Physiologic methods, Netherlands, Registries statistics & numerical data, Remote Sensing Technology methods, Arrhythmias, Cardiac therapy, Defibrillators, Implantable adverse effects, Defibrillators, Implantable classification, Electric Countershock adverse effects, Electric Countershock instrumentation, Electric Countershock methods, Equipment Failure statistics & numerical data
- Abstract
Background: After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed., Objective: The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads., Methods: We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads. Lead failure was defined by low- or high-voltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference., Results: During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%), and 5 Durata (1.5%) leads failed. At 5-year follow-up, the cumulative failure rate of Linox leads (6.4%) was higher than that of Endotak (0.4%; P < .0001) and Durata (2.0%; P = .003) leads. The incidence rate was higher in Linox leads (1.3 per 100 patient-years) than in Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P < .001). A log-log analysis of the cumulative hazard for Linox leads functioning at 3-year follow-up revealed a stable failure rate of 3% per year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%)., Conclusion: This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure., (Copyright © 2016. Published by Elsevier Inc.)
- Published
- 2016
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