Article
作者: Zakaib, John S ; Vijayaraman, Pugazhendhi ; Afzal, Muhammad R ; Schloss, Edward J ; Geelen, Tessa ; Mason, Pamela K ; Denman, Russell ; Whinnett, Zachary I ; Platner, Megan L ; Pokharel, Parash ; Tanner, Jocelyn ; Burrell, James ; Jastrzębski, Marek ; Liu, Xingbin ; Crossley, George H ; Abhayaratna, Walter P ; Philippon, François ; Kron, Jordana ; Butler, Kiah
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 307 patients underwent an LBBAP implant attempt (age 64.9 ± 12.2 years; 28.7% female; body mass index 28.4 ± 6.1 kg/m2). 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 zero study lead fractures, no oversensing adverse events, and stable electrical parameters through 2.6 ± 2.5 months' follow-up.
CONCLUSION:These results demonstrate that implantation of OmniaSecure lead when intended for LBBAP results in high defibrillation success at implant, stable short-term electrical parameters, and a low rate of OmniaSecure lead-related major complications at 3 months.