Safety and Efficacy of the Novel OmniaSecure Defibrillation Lead Through Long-Term Follow-Up: Final Results From the LEADR Trial.

Abstract

Background: The LEADR (Lead Evaluation for Defibrillation and Reliability) trial evaluated the small-diameter (4.7F), lumenless, integrated bipolar OmniaSecure defibrillation lead. The trial exceeded primary safety and efficacy objective thresholds, demonstrating favorable efficacy at implant and a low rate of complications. Three-year term outcomes of the LEADR trial assessing the OmniaSecure lead are reported here.

Methods: The LEADR trial is a prospective, multicenter, single-arm clinical trial. Patients with an indication for de novo implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator were implanted with the OmniaSecure lead in standard right ventricle locations and followed at prespecified intervals. The lead was evaluated for safety, efficacy, and reliability through final follow-up.

Results: There were 643/657 patients (97.9%) successfully implanted with the OmniaSecure lead with a mean follow-up of 32.4±9.1 months (26% female, 61.9±12.9 years). Pacing capture threshold, pacing impedance, and R-wave amplitudes remained stable throughout. There was a 96.5% freedom from major study lead-related complications at 3 years. At 3 years, 22.3% of patients received appropriate therapies, that is, shock and antitachycardia pacing, with a 75.4% antitachycardia pacing efficacy. Inappropriate shock rate was 2.7% and 5.9% at 1 and 3 years, respectively.

Conclusions: The final results of the LEADR trial demonstrated 3-year term safety, efficacy, and reliability of the OmniaSecure lead, emphasizing the potential utility of this lead in a wide variety of patients.