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日本可穿戴式心脏复律除颤器(WCD)实际使用情况及真实世界数据积累的重新评估——J-WCDR研究的设计文件

Reassessment of practical usage and accumulation of real-world data of wearable cardioverter defibrillator (WCD) in Japan-Design paper for J-WCDR study.

作者信息

Niwano Shinichi, Abe Haruhiko, Takagi Masahiko, Sekiguchi Yukio, Iwasaki Yu-Ki, Kato Ritsushi, Kondo Yusuke, Kurita Takashi, Nitta Takashi, Nogami Akihiko

机构信息

Department of Cardiovascular Medicine Kitasato University School of Medicine Sagamihara Japan.

Department of Heart Rhythm Management University of Occupational and Environmental Health Kitakyushu Japan.

出版信息

J Arrhythm. 2020 Nov 20;37(1):226-230. doi: 10.1002/joa3.12456. eCollection 2021 Feb.

DOI:10.1002/joa3.12456
PMID:33664907
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7896442/
Abstract

Although implantable cardioverter defibrillators (ICDs) are a powerful preventive therapy for cardiac sudden death, there are some populations in whom ICDs cannot be applied because of a lack of a definitive indication (grey-zone patients), such as in patients during the acute phase of cardiac injury with a susceptible risk for lethal arrhythmias. In such patients, wearable cardioverter defibrillators (WCDs) provide safer bridging period during the acute phase until the final decision-making for the ICD use and it may eliminate any inappropriate overuse of ICDs in the subacute phase. The JCS/JHRS practical guidelines provide the criteria for WCD use in Japan. Nevertheless, the evidence for that is totally limited in Japan and is dependent on the accumulation of actual real-world data from other countries in order to be able to discuss the appropriate criteria for WCD use. This study will be conducted retrospectively and/or prospectively, and is an observational and multicenter study among Japanese institutions (J-WCDR, Japan WCD Registry). This will provide evidence for WCD use in our own country and contribute to upcoming updates for the future guideline revisions.

摘要

尽管植入式心脏复律除颤器(ICD)是预防心脏性猝死的有力疗法,但仍有一些人群因缺乏明确指征而无法应用ICD(灰色地带患者),例如处于心脏损伤急性期且有发生致死性心律失常易感性风险的患者。在此类患者中,可穿戴式心脏复律除颤器(WCD)在急性期提供了更安全的过渡期,直至最终决定是否使用ICD,并且可以避免在亚急性期对ICD的任何不适当过度使用。日本循环学会/日本心律学会实用指南提供了日本使用WCD的标准。然而,在日本,这方面的证据非常有限,并且依赖于其他国家实际真实世界数据的积累,以便能够讨论WCD使用的适当标准。本研究将进行回顾性和/或前瞻性研究,是一项在日本机构中开展的观察性多中心研究(J-WCDR,日本WCD注册研究)。这将为我国WCD的使用提供证据,并为未来指南修订的更新做出贡献。

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本文引用的文献

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Clinical Usefulness of Wearable Cardioverter Defibrillator (WCD) and Current Understanding of Its Clinical Indication in Japan.可穿戴式除颤器(WCD)的临床应用及在日本的临床适应证认识现状。
Circ J. 2018 May 25;82(6):1481-1486. doi: 10.1253/circj.CJ-17-1336. Epub 2018 Feb 14.
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