Safety and performance of a novel defibrillation lead for left bundle branch area placement: Primary results of the LEADR LBBAP clinical trial

作者：Pugazhendhi Vijayaraman, Xingbin Liu, R. Denman, Edward J. Schloss, Zachary I. Whinnett, Jordana Kron, Marek Jastrzębski, John S. Zakaib, Walter P. Abhayaratna, François Philippon, Muhammad R. Afzal, Parash Pokharel, James Burrell, Jocelyn Tanner, Tessa Geelen, Megan L Platner, Kiah Butler, Pamela Mason, George H. Crossley · 发表于：Heart Rhythm · 年份：2025 · DOI：10.1016/j.hrthm.2025.10.028 · 被引用次数：7 · 研究领域：Cardiac pacing and defibrillation studies、Cardiac Structural Anomalies and Repair、Cardiac Valve Diseases and Treatments

BACKGROUND: Right ventricular placement of the OmniaSecure defibrillation lead has demonstrated high defibrillation success and low occurrence of lead-related major complications. With the advent of left bundle branch area pacing (LBBAP) as a physiological pacing option, the use of the OmniaSecure lead may be a viable alternative for LBBAP in the implantable cardioverter-defibrillator population. OBJECTIVE: This study aimed to understand the defibrillation efficacy at implant and the safety of the OmniaSecure lead for LBBAP. METHODS: The global Lead Evaluation for Defibrillation and Reliability LBBAP trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy with a defibrillator. Per study protocol, LBBAP includes electrocardiographic characterization of left bundle branch pacing and deep septal pacing. The primary efficacy objective was defibrillation efficacy at implant exceeding a prespecified threshold of 88% in ≥160 patients. The primary safety endpoint was to demonstrate the OmniaSecure lead-related major complication rate at 3 months after implant. RESULTS: ). A total of 293 patients were successfully implanted per protocol (95.4%). The primary efficacy objective was met with 100% of patients defibrillated to protocol. The observed freedom from OmniaSecure lead-related major complications at 3 months was 97.9% (95% confidence interval 95.8-100). There were z...