Safety and performance outcomes by sex of a novel defibrillation lead used for left bundle branch area placement: LEADR LBBAP primary results analysis

Background Despite evidence demonstrating the benefit of ICDs, women are implanted at a lower rate than men. With the recent findings regarding left bundle branch area pacing (LBBAP) in ICD and CRT-D indicated patients and the advent of newer defibrillation technologies, it is important to demonstrate continued benefit in women and men. Purpose To assess the safety and performance outcomes of the LEADR LBBAP trial by sex. Methods The LEADR LBBAP trial enrolled de novo ICD/CRT-D indicated patients. The primary efficacy endpoint was defibrillation efficacy at implant in at least 160 patients. The primary safety endpoint was freedom from OmniaSecure lead-related major complication rate at 3 months of follow-up in 150 patients. LBBAP implant success was physician-reported ECG characterization of LBBA capture or confirmation of deep septal placement by imaging. Results A total of 88 females and 218 males underwent an implant attempt with the OmniaSecure lead. Implantation was successful in 87 female and 205 males. Defibrillation testing at implant was 100% successful with 84.6% of females and 81.8% of males successfully defibrillated with a single 18J shock (p=0.68). The estimate of the rate of freedom from OmniaSecure lead-related major complications at 3 months in all patients was 97.9% with a rate of 98.2% for females and 97.7% in males (p=0.58). Conclusion These results demonstrate the high defibrillation efficacy and low lead-related major complication rate of the OmniaSecure lead when intended for LBBAP in males and females.Figure.Safety endpoint LEADR LBBAP