JACC. Clinical electrophysiology · 2026
Novel Approach to Lead Extraction, Utilizing Vibration Energy: From Bench Experiments to a First-in-Human Study.
СтатьяПоддержка исследования: вне правительства СШАНазвание 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.
Tomer Orr, Elitzur Yair, Przybylski Andrzej, Romanek Janusz, Stein Uri, Shafrir Roey, Shauer Ayelet, Love Charles J, Friedman Paul A, Deshmukh Abhishek J, Luria David
Аннотация
BACKGROUND: Lead extraction procedures typically use "over-the-lead" cutting tools (sheaths) to separate leads from the surrounding fibrotic, vascular, and cardiac tissue. These methods carry significant risks of collateral damage and major bleeding complications.
OBJECTIVES: The goal of this study was to evaluate the safety and efficacy of a novel vibration-based lead extraction technique that eliminates the need for cutting tools. The study included comprehensive preclinical testing and initial human experience.
METHODS: Development included 3 phases: 1) bench experiments; 2) animal studies (N = 13) with varying lead implant durations; and 3) a first-in-human study enrolling 10 consecutive patients requiring a total of 18 lead extractions. The primary endpoints were complete procedural success and absence of major complications. The secondary endpoint was successful extraction of all leads without conventional tools.
RESULTS: The bench experiments established optimal vibration parameters for lead extraction. The animal studies confirmed the safety of high-frequency vibration application to an implanted pacing lead. In 9 animals with long-term implants (up to 5 years), all leads (6 pacing and 3 implantable cardiac-defibrillator) were successfully extracted without significant tissue damage on anatomical and histologic examination. In the human study, complete extraction was achieved in all 10 cases (18 leads [12 pacing, 4 implantable cardiac-defibrillator, and 2 coronary sinus]) with a mean dwell time of 48.6 ± 21.74 months (21-78 months). Mean lead vibration time was 40 seconds (6-176 seconds). No device-related complications occurred during the procedure or at 1-month follow-up.
CONCLUSIONS: This novel vibration-based extraction technique exhibited excellent safety and efficiency profiles in preclinical and initial human study, potentially offering a simple, rapid, and safe alternative to conventional extraction methods.
OBJECTIVES: The goal of this study was to evaluate the safety and efficacy of a novel vibration-based lead extraction technique that eliminates the need for cutting tools. The study included comprehensive preclinical testing and initial human experience.
METHODS: Development included 3 phases: 1) bench experiments; 2) animal studies (N = 13) with varying lead implant durations; and 3) a first-in-human study enrolling 10 consecutive patients requiring a total of 18 lead extractions. The primary endpoints were complete procedural success and absence of major complications. The secondary endpoint was successful extraction of all leads without conventional tools.
RESULTS: The bench experiments established optimal vibration parameters for lead extraction. The animal studies confirmed the safety of high-frequency vibration application to an implanted pacing lead. In 9 animals with long-term implants (up to 5 years), all leads (6 pacing and 3 implantable cardiac-defibrillator) were successfully extracted without significant tissue damage on anatomical and histologic examination. In the human study, complete extraction was achieved in all 10 cases (18 leads [12 pacing, 4 implantable cardiac-defibrillator, and 2 coronary sinus]) with a mean dwell time of 48.6 ± 21.74 months (21-78 months). Mean lead vibration time was 40 seconds (6-176 seconds). No device-related complications occurred during the procedure or at 1-month follow-up.
CONCLUSIONS: This novel vibration-based extraction technique exhibited excellent safety and efficiency profiles in preclinical and initial human study, potentially offering a simple, rapid, and safe alternative to conventional extraction methods.