Abstract 3257: Electrical Performance of GORE-Covered Defibrillation Leads is Equivalent to Non-GORE Leads
Introduction: In the event of infection, erosion, or failure fibrosis of an ICD lead can make extraction difficult. The ENDOTAK RELIANCE G defibrillation lead has electrode coils covered with GORE expanded polytetrafluoroethylene (ePTFE) to prevent tissue ingrowth around and between the shocking coils. However, lead electrical performance between GORE and non-GORE leads has not been evaluated.
Methods: Patients in the REFLEx Study received either an ICD or CRT-D and were randomized in a 1:1 ratio to type of defibrillation lead -Guidant ENDOTAK RELIANCE G lead or a non-GORE covered lead of choice manufactured by Guidant, Medtronic, or St. Jude (comparative leads). Performance success was defined as meeting all minimum performance standards as specified in the appropriate manufacturer’s manual. A non-inferiority margin of 5% was pre-specified.
Results: Performance success at 12 months was 93.0% (280/301) for RELIANCE G and 94.5 (291/308) for comparative leads. The success rate of GORE covered leads was statistically non-inferior to comparative leads (p=0.04). Success rates for the RELIANCE G and comparative lead groups were 93.8% vs. 94.9% for intrinsic RV amplitude, 99.1% vs. 99.7% for pacing threshold, 99.7% vs. 100% for pacing impedance, and 100% vs. 100% for shock impedance. Lead migration/dislodgements occurred in 1.25% (7/560) of patients receiving RELIANCE G leads and 0.90% (5/555) of patients receiving comparative leads.
Conclusion: GORE ePTFE-covered coils are as good as comparative leads with respect to electrical performance and have the added benefit of prevention of tissue ingrowth.