NEJM:皮下 vs 经静脉除颤器植入的疗效及安全性差异研究

2020-08-06 MedSci原创 MedSci原创

对于需接受心脏复律除颤器植入的患者,接受皮下植入方式造成的设备相关并发症和异常电击风险与经静脉植入相当

心脏复律除颤器(ICD)皮下植入的目的是避免经静脉ICD植入相关的并发症,但这种采用完全胸外放置手段的效果尚未得到随机对照试验的证实。近日研究人员开展一项非劣效性对照研究,比较ICD皮下植入与静脉植入的疗效和安全性差异。
 
满足ICD指征患者参与本次非劣效性对照研究,随机接受皮下ICD或经静脉ICD。研究的主要终点为与设备相关的并发症和异常电击的复合终点,次要终点为死亡和正常的电击干预。
 
共有849例患者参与研究,其中皮下ICD组426例,经静脉ICD组423例。在平均49.1个月的随访期间,皮下ICD组68例患者发生主要终点事件,经静脉ICD组68例患者发生主要终点事件,48个月Kaplan-Meier主要终点事件累积发生率分别为15.1%和15.7%,危险比为0.99,达到非劣性终点。皮下ICD组31例患者出现器械相关并发症,经静脉ICD组44例(危险比0.69),皮下ICD组41例出现异常电击,经静脉ICD组29例 (危险比1.43)。皮下ICD组83例患者死亡,经静脉ICD组68例 (危险比1.23);皮下ICD组经历正常电击干预的比率高于经静脉ICD组(83 vs 57例,比值比1.52)。
 
研究认为,对于需接受心脏复律除颤器植入的患者,接受皮下植入方式造成的设备相关并发症和异常电击风险与经静脉植入相当。
 
原始出处:
 
Reinoud E. Knops et al. Subcutaneous or Transvenous Defibrillator Therapy. N Engl J Med, August 6, 2020.

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    2021-03-23 fusion
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    2020-08-08 zhouqu_8
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    2020-08-08 jiyangfei
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    2020-08-06 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2020-08-06 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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