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日本机械辅助循环支持注册研究(J-MACS)的第二份官方报告:桥接至桥接策略的初步结果

The second official report from Japanese registry for mechanical assisted circulatory support (J-MACS): first results of bridge to bridge strategy.

作者信息

Kinugawa Koichiro, Nishimura Takashi, Toda Koichi, Saiki Yoshikatsu, Niinami Hiroshi, Nunoda Shinichi, Matsumiya Goro, Nishimura Motonobu, Arai Hirokuni, Morita Shigeki, Yanase Masanobu, Fukushima Norihide, Nakatani Takeshi, Sakata Yasushi, Ono Minoru

机构信息

Second Department of Internal Medicine, University of Toyama, Toyama, Japan.

Department of Cardiovascular and Thoracic Surgery, Ehime University, Matsuyama, Japan.

出版信息

Gen Thorac Cardiovasc Surg. 2020 Feb;68(2):102-111. doi: 10.1007/s11748-019-01227-y. Epub 2019 Oct 23.

Abstract

BACKGROUND

The Japanese registry for mechanical assisted circulatory support (J-MACS) is a prospective registry to collect all data of implantable left ventricular assist device (LVAD) (and part of paracorporeal VAD) established in 2010. The first analytical report was published in 2017. The organization running J-MACS was used to be the pharmaceuticals and medical devices agency (PMDA), but has been changed to the council for clinical use of ventricular assist device related academic societies in 2017.

METHODS

Since 2018, we changed the analytical methods as follows: first, we eliminated paracorporeal VAD from the analysis. Second, we included not only primary implantation but bridge to bridge (BTB) implantation of LVAD. Third, we added the analyses of adverse events that were not included in the previous analysis.

RESULTS

As of Oct 2018, 711 primary LVAD implants and 168 BTB implants were enrolled. Survival rate of primary LVAD was 93% at 360 days and 91% at 720 days, and that of BTB was 86% at 360 days and 82% at 720 days.

CONCLUSION

We first reported the results of BTB in the second official report of J-MACS. The prognosis after LVAD implantation has been kept good in Japanese circumstances.

摘要

背景

日本机械辅助循环支持注册研究(J-MACS)是一项前瞻性注册研究,旨在收集2010年建立的植入式左心室辅助装置(LVAD)(以及部分体外膜肺氧合装置)的所有数据。首份分析报告于2017年发表。运营J-MACS的组织曾是药品和医疗器械局(PMDA),但在2017年已变更为心室辅助装置相关学术团体临床应用委员会。

方法

自2018年起,我们对分析方法做了如下改变:首先,我们在分析中剔除了体外膜肺氧合装置。其次,我们不仅纳入了LVAD的初次植入,还纳入了LVAD的桥接至桥接(BTB)植入。第三,我们增加了先前分析未涵盖的不良事件分析。

结果

截至2018年10月,纳入了711例LVAD初次植入和168例BTB植入。LVAD初次植入的360天生存率为93%,720天生存率为91%;BTB植入的360天生存率为86%,720天生存率为82%。

结论

我们在J-MACS的第二份官方报告中首次报告了BTB的结果。在日本的情况下,LVAD植入后的预后一直良好。

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