Efficacy and safety results of a novel small-diameter defibrillation lead by race and age: lead evaluation for defibrillation and reliability (LEADR) trial analysis

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.

To assess the safety and efficacy of the OmniaSecure lead by race and age groups.

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.

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.

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.