Heart rhythm · 2025
A leadless pericardial pacemaker.
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.
Bar-Cohen Yaniv, Silka Michael J, Hill Allison C, Shwayder Mark, Pruetz Jay D, Stevey-Rindenow Lynlee, Peck Raymond, Kohan Samuel, Loeb Gerald E
Аннотация
BACKGROUND: Cardiac pacemakers have complications related to long pacemaker leads, subcutaneous pockets, and endovascular hardware.
OBJECTIVE: We report on the development of a leadless micropacemaker for percutaneous implantation into the pericardial space.
METHODS: Percutaneous implantations of a micropacemaker system were performed in 15 pigs through subxiphoid access to the pericardial space. In our concept phase, 10 implants were performed with iterative changes to the design and implantation techniques until a design was reached for a viable device. In the study phase, a viable device was implanted in 5 pigs and observed during 8 weeks.
RESULTS: At the completion of the concept phase, a prototype micropacemaker device was fabricated that met 3 mandatory system requirements: can be safely and reproducibly implanted percutaneously into the pericardial space; does not migrate after implantation; and successfully captures the myocardium at implantation and during long-term follow-up (up to 8 weeks). The prototype device was successfully and safely implanted into all 5 pigs in the study phase. These 5 animals survived to the 8-week end point without complications. Ventricular capture threshold calculations at implantation were a median 0.43 V at 0.4 ms (range, 0.05-0.75 V at 0.4 ms). At 8 weeks of follow-up, median capture thresholds were 2.8 V at 0.4 ms (total range, 2.2-7.1 V).
CONCLUSION: A novel pericardial micropacemaker system allows minimally invasive implantation of a leadless cardiac pacemaker without entering the vascular space. We provide proof of concept of this design with encouraging follow-up data.
OBJECTIVE: We report on the development of a leadless micropacemaker for percutaneous implantation into the pericardial space.
METHODS: Percutaneous implantations of a micropacemaker system were performed in 15 pigs through subxiphoid access to the pericardial space. In our concept phase, 10 implants were performed with iterative changes to the design and implantation techniques until a design was reached for a viable device. In the study phase, a viable device was implanted in 5 pigs and observed during 8 weeks.
RESULTS: At the completion of the concept phase, a prototype micropacemaker device was fabricated that met 3 mandatory system requirements: can be safely and reproducibly implanted percutaneously into the pericardial space; does not migrate after implantation; and successfully captures the myocardium at implantation and during long-term follow-up (up to 8 weeks). The prototype device was successfully and safely implanted into all 5 pigs in the study phase. These 5 animals survived to the 8-week end point without complications. Ventricular capture threshold calculations at implantation were a median 0.43 V at 0.4 ms (range, 0.05-0.75 V at 0.4 ms). At 8 weeks of follow-up, median capture thresholds were 2.8 V at 0.4 ms (total range, 2.2-7.1 V).
CONCLUSION: A novel pericardial micropacemaker system allows minimally invasive implantation of a leadless cardiac pacemaker without entering the vascular space. We provide proof of concept of this design with encouraging follow-up data.