EnPulse起搏器自动化功能的临床研究

The clinical research of automatic function of EnPulse pacemaker

目的:通过对EnPulse起搏器安置患者的随访,了解心房及心室自动阈值管理、自动AV间期搜索等功能的安全性和有效性。方法:选取置入EnpluseE2D01起搏器患者15例,分别于起搏器置入后1个月及6个月时复查起搏器参数,包括起搏器最近1次自动测量的心房及心室起搏阈值,手动测量心房及心室起搏阈值,记录患者心室感知占心室总事件的比例,并记录由SearchAV+所设定AV间期基础上的心室感知事件所占心室总事件的比例。结果:1个月及6个月随访时,手动测量心房及心室阈值与自动测量心房及心室阈值差异无统计学意义。术后病态窦房结综合征患者大部分心室事件为感知事件,其中绝大多数由searchAV+功能参与。结论:EnPulse起搏器的自动AV搜索功能、心房及心室自动阈值管理是安全有效的。

Objective：To evaluate the safety and effectiveness of automatic function of EnPulse pacemaker, including auto atrial capture management, ventricular capture management and Search AV＋, and their clinical value. Methods： 15 patients who received EnPulse pacemaker were selected. The parameters of pacemakers were recorded 1 month and 6 months after operation. At pulse width 0.4 ms, the atrial pacing thresholds were tested using the auto amplitude decrease method, then the same way for ventricular pacing thresholds, while the pacing thresholds tested by pacemakers were recorded. The percentage of cumulative ventricular sensing events to the total ventricular events were recorded using collected and stored data by pacemaker, as well as the percentage of cumulative ventricular sensing events to the total ventricular events from Search AV＋. Result：The thresholds tested by pacemakers at 1st month and 6th month have no significant difference with the thresholds by manual test. The SSS patients＇ ventricular events were mostly sensing events, which mostly depended on Search AV＋ function. Conclusion：The Search AV＋, ACM and VCM function of EnPulse pacemaker are safe and effective.