Heart rhythm · 2025
Safety and performance of a novel defibrillation lead for left bundle branch area placement: Primary results of the LEADR LBBAP clinical trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Vijayaraman Pugazhendhi, Liu Xingbin, Denman Russell, Schloss Edward J, Whinnett Zachary I, Kron Jordana, Jastrzębski Marek, Zakaib John S, Abhayaratna Walter P, Philippon François, Afzal Muhammad R, Pokharel Parash, Burrell James, Tanner Jocelyn, Geelen Tessa, Platner Megan L, Butler Kiah, Mason Pamela K, Crossley George H, LEADR LBBAP Trial Investigators
Аннотация
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.
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.