Beyar Rafael, Schatzberger Rachel, Darawsha Wisam, Shofti Rona, Dagan Amir, Palti Yoram
Rambam Health Care Campus and Technion, Israel Institute of Technology, Haifa, Israel.
CardoAid, Haifa, Israel.
Sci Rep. 2025 May 21;15(1):17565. doi: 10.1038/s41598-025-00692-1.
Cardiac pacing using long leads has inherent complications of adhesions, fractures and infection. Current leadless pacemakers include battery-operated devices that are relatively large in size. We present here the initial design and animal experiments with a new ultrathin leadless device, activated by subcutaneous application of short trains of high frequency (250 kHz) alternating electrical fields (HFAF). The myocardial 40 × 0.5 mm rectifying device, implanted in the right ventricle and in epicardial veins, converts the HFAF sinusoidal transients to unidirectional current pulses which stimulate the myocardium. The method was tested in a swine model under open and closed chest conditions for both endocardial and cardiac venous approaches. We demonstrated pacing under all these conditions and measured the thresholds of current, voltage and pulse duration. This method allows for leadless stimulation at multiple points. It may be applied to various pacing needs and has an interesting appeal for CRT Therapy, where multiple electrodes can be implanted, overcoming the limitations of current long pacing leads.
使用长导线进行心脏起搏存在粘连、断裂和感染等固有并发症。目前的无导线起搏器包括尺寸相对较大的电池供电设备。我们在此展示了一种新型超薄无导线设备的初始设计和动物实验,该设备通过皮下施加短串高频(250kHz)交变电场(HFAF)来激活。植入右心室和心外膜静脉的40×0.5mm心肌整流装置将HFAF正弦瞬变转换为单向电流脉冲,从而刺激心肌。该方法在猪模型中进行了测试,包括开胸和闭胸条件下的心内膜和心脏静脉途径。我们在所有这些条件下都证明了起搏,并测量了电流、电压和脉冲持续时间的阈值。这种方法允许在多个点进行无导线刺激。它可应用于各种起搏需求,对于心脏再同步治疗(CRT)具有有趣的吸引力,在CRT中可以植入多个电极,克服了当前长起搏导线的局限性。