Micra™无导线起搏器临床应用的前瞻性研究

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目的:观察Micra? Transcatheter Pacing System无导线起搏器(Micra无导线起搏器)的植入背景和术中、术后并发症发生情况及其影响因素。方法:前瞻性、观察性研究,入选中国澳门镜湖医院2016年1月至2019年6月植入Micra无线起搏器患者80例,其中男性42例,女性38例,平均年龄81.6岁,最大102岁。分别在出院前、植入后1、3、6、12、24个月进行随访,收集起搏器电学参数和不良事件。结果:实施Micra植入术患者手术时间(49.0±15.1)min,X线光曝光时间(8.3±4.0)min。植入时电学参数:阻抗(803.2±233.8)Ω、感知(9.1±4.4)mV、阈值(0.6±0.3)V/0.24 ms,住院天数3~5 d。围术期内,早期并发症(植入术后3个月内)术后穿刺点血肿(3.8%,3/80)、心包填塞(2.5%,2/80)、穿刺点动静脉瘘(1.3%,1/80)、起搏器感知不良/阈值过高(2.5%,2/80)、起搏器综合征(1.3%,1/80),平均随访1.48年,无中远期并发症。结论:与传统起搏器相比,Micra无导线起搏器操作简单、微创,避免导线和囊袋相关并发症,手术时间短、术后恢复快,为符合单腔起搏器植入适应证的患者带来新的选择。“,”Objective:To analyze the background, intra-and post-operative complications and the influencing factors in patients implanted with leadless pacemakers using the Micra? transcatheter pacing system(Micra TPS).Methods:A total of 80 patients implanted with the Micra leadless transcatheter pacemaker(42 males and 38 females, mean age=81.6 years, with a maximum age of 102 years)in China Kiang Wu Hospital between January 2016 and June 2019 were enrolled in this prospective, observational study.Follow-up was conducted at pre-hospital discharge, 1, 3, 6, 12, 24 months after implantation, and the pacing parameters and adverse events were collected.Results:The average operation time was 49.0±15.1 minutes, and the average X-ray exposure time was (8.3±4.0) minutes.Electrical parameters including impedance, sensing amplitude and threshold at implantation were (803.2±233.8)Ω, (9.1±4.4) mV and (0.6±0.3) V/0.24 ms, respectively.The length of hospital stay was 3-5 days.The incidences of early complications(within 3 months after implantation), postoperative local hematoma at puncture point, intraoperative cardiac tamponade, arteriovenous fistula at puncture point, poor pacemaker capture/high threshold, and pacemaker syndrome were 3.8%(3/80), 2.5%(2/80), 1.3%(1/80), 2.5%(2/80), and 1.3%(1/80), respectively.The mean follow-up was 1.48 years, and no mid-or long-term complications were found.Conclusions:Compared with traditional pacemakers, the Micra leadless transcatheter pacemaker is easy to operate, minimally invasive, and capable of preventing complications associated with wires and bags, with a short operation time and quick postoperative recovery, and may be a new alternative for patients in need of single-chamber ventricular pacing.
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