The OmniaSecure defibrillation lead achieved 97.5% defibrillation success and 97.1% freedom from lead-related major complications at 6 months, with consistent performance across race and age.
Does the novel small-diameter OmniaSecure defibrillation lead provide safe and effective defibrillation across different race and age groups in de novo ICD/CRT-D patients?
The novel small-diameter OmniaSecure defibrillation lead demonstrates high implant success and safety at 6 months, with consistent performance across age and race groups.
Abstract Background ICD/CRT-D patients are living longer, and interest in reliable leads with targeted placement is growing. Younger patients have higher activity levels that may confer a higher risk for lead failure. Thus, modern defibrillation leads that are safe, efficacious, and reliable are needed. The LEADR trial evaluated the novel, lumenless, integrated bipolar (12 mm tip-to-coil-spacing, 6.1 cm length), small-diameter (4.7 Fr) OmniaSecure defibrillation lead designed for reliability and targeted placement, based on the established SelectSecure SureScan MRI Model 3830 pacing lead. Purpose To assess the safety and efficacy of the OmniaSecure lead by race and age groups. Methods The LEADR trial enrolled de novo ICD/CRT-D indicated patients; primary efficacy endpoint was successful defibrillation at implant and primary safety endpoint was freedom from RV lead-related major complications at 6 months. Further, patients were stratified by race (Asian, Black, White, Other) and age (≤30 and 30 years) to evaluate the endpoints within these groups. Results In total, 97.9% (643/657) of patients were implanted with the OmniaSecure defibrillation lead in the standard RV location. The defibrillation success at implant was 97.5% (116/119), with no statistically significant difference by race or age (Table 1). The Kaplan-Meier estimate of the rate of freedom from RV lead-related major complications at 6-months in all patients with an implant attempt was 97.1%, with no statistically significant difference by race or age (Table 2). There were zero fractures observed through 17.8±6.0-month follow-up. Conclusion The LEADR trial demonstrated that the OmniaSecure lead exceeded safety and efficacy performance goals, exhibiting high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures. There were no significant differences observed by race or age, indicating consistent performance of the OmniaSecure lead across various populations.
Mason et al. (Sat,) conducted a other in ICD/CRT-D indication (n=657). OmniaSecure defibrillation lead was evaluated on Successful defibrillation at implant and freedom from RV lead-related major complications at 6 months. The OmniaSecure defibrillation lead achieved 97.5% defibrillation success and 97.1% freedom from lead-related major complications at 6 months, with consistent performance across race and age.