家庭监测功能的心血管植入型电子器械的临床应用--多中心注册研究结果

The clinical application of cardiovascular implantable electronic devices in China：a multi-center regis-try study

目的：了解具有家庭监测功能的心血管植入型电子器械（CIED）在国内的临床应用现状。方法本研究为前瞻性、多中心的注册研究,连续入选植入具有家庭监测功能的起搏器、植入型心律转复除颤器以及心脏再同步治疗起搏器和除颤器患者。所有患者均程控打开远程监测功能,每日收集其远程监测信息。由第三方公司负责数据收集和监测。结果2009年2月10日至2014年12月31日,323家医院参与注册研究,共5378例患者植入了具有家庭监测功能的 CIED。植入量逐年增加,至2012年趋稳定。家庭监测无信息传输比例为7.8％。植入总量按地区分布,北京占首位。按居住地分布情况,在植入家庭监测功能的 CIED 患者中,北京地区患者仍然占据首位,40％接受家庭监测功能CIED 患者远离植入中心。平均随访时间（711.6±486.0） d,死亡445例,死亡率为8.3％（445/5378）。结论家庭监测功能 CIED 已广泛应用于国内临床,但存在明显地区差异。植入器械类型中,起搏器仍占据绝大部分。通过第三方公司负责网络监测和数据管理方式可提高家庭监测信息传输比例。

Objective To investigate the clinical application of cardiovascular implantable electronic devices（CIED）with home monitoring（HM） function in China. Methods This study was a multi-center, pro-spective, registry study to enroll patients who underwent implantion of a pacemaker or an implantable cardioverter debrillator （including cardiac resynchronization therapy devices） with HM function. HM function was activated in all patients to allow daily remote monitoring.The third party was authorized to monitor HM data. Results From February 2009 to October 2014,a total of 5 378 patients were implanted with HM devices. Pacemaker was the most common type among HM device implantations, accounting for 68. 0%.The number of HM implantation was increasing with year, but was stable after 2012. The majority of HM devices were implanted in Beijing. Patients who lived in Beijing were also underwent insertion of the majority HM devices. 40% patients with HM devices lived in remote areas. Over a follow-up period of （711. 6 ± 486. 0） days, 445 patients were died. The mortality of all causes was 8. 3%. Conclusion CIED with HM have been widely used in domestic clinical, but still with obvi-ous regional differences. Pacemaker was the most common type among HM device implant. A new model of HM data management has been established by authorizing a third party, which can improve the information transmission ratio.