Clinical and electrical performance of expanded polytetrafluoroethylene-covered defibrillator leads in comparison to traditional leads

Pacing and Clinical Electrophysiology : PACE
Bruce A KoplanREFLEx Study Investigators

Abstract

In the event of infection, erosion, or failure, fibrosis of a defibrillation lead can make extraction difficult. In the ENDOTAK RELIANCE G defibrillation lead, coils are covered with expanded polytetrafluoroethylene (ePTFE) to prevent tissue ingrowth. The objective of the REFLEx Study was to evaluate if RELIANCE G defibrillation leads with ePTFE-covered coils are as good as comparative defibrillation leads with respect to electrical performance and termination of spontaneous tachyarrhythmias. Patients were randomized to type of defibrillation lead--Guidant RELIANCE G lead or a non-ePTFE-covered lead of choice. Electrical performance success was defined as meeting all minimum standards in the respective manufacturer's manual for amplitude, threshold, and impedance. A noninferiority margin of 5% was prespecified. Electrical performance success at 12 months was 93.0% (280/301) for RELIANCE G and 94.5% (291/308) for comparative leads. The performance success rate for RELIANCE G did not differ significantly from study comparative (P = 0.04, noninferiority). For spontaneous episodes, first shock conversion success rate was 90% for RELIANCE G and 95% for study comparative (P = 0.89, noninferiority). Implant conversion testing was succ...Continue Reading

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Citations

Apr 28, 2010·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Joseph W HacklerMina K Chung
Oct 3, 2009·Pacing and Clinical Electrophysiology : PACE·Haris M Haqqani, Harry G Mond
Mar 11, 2015·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Seah Nisam, Shantanu Reddy
Jan 22, 2013·Pacing and Clinical Electrophysiology : PACE·Andrew R KohutSteven P Kutalek

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