Safety and Efficacy of the Novel OmniaSecure Defibrillation Lead Through Long-term Follow-up: Final Results from the LEADR Trial

Background: The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the small-diameter (4.7Fr), 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 ICD/CRT-D were implanted with the OmniaSecure lead in standard right ventricle (RV) 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, i.e., shock and/or anti-tachycardia pacing (ATP), with a 75.4% ATP 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.