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心脏手术同期行左心耳封堵术预防卒中
Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke


Richard P. Whitlock ... 心脑血管疾病 • 2021.06.03
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• 左心耳封堵装置获批后来自美国的数据 • 更新版心房颤动指南:聚焦抗凝策略

NEJM-ACC2021:LAAOS 为手术同期左心耳闭合降低卒中风险正名

 

徐旖炜,朱云鹏,赵强*

上海交通大学医学院附属瑞金医院心血管外科

*通讯作者

 

北京时间5月15日晚,在美国心脏病学会(American College of Cardiology,ACC)2021年年会上,心脏外科房颤治疗领域具有里程碑意义的前瞻性随机对照研究(RCT)——LAAOS Ⅲ(Left Atrial Appendage Occlusion Study Ⅲ)公布结果,并同步在线发表于《新英格兰医学杂志》(NEJM)。LAAOS Ⅲ结果为外科同期左心耳闭合降低缺血性卒中或体循环栓塞风险提供了强有力的支持。

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摘要


背景

左心耳封堵术被认为可预防心房颤动患者的缺血性卒中,但这一假设尚未得到证实。左心耳封堵术可在患者因其他原因接受心脏手术同期实施。

 

方法

我们开展了一项多中心随机试验,该试验纳入的是患心房颤动、CHA2DS2-VASc评分至少为2分(评分范围为0~9分,评分较高表明卒中风险较大),且因其他适应证而计划接受心脏手术的参与者。参与者被随机分成两组,分别在手术同期行或不行左心耳封堵术;随访期间,所有参与者都将接受包括口服抗凝剂在内的常规治疗。主要结局是发生缺血性卒中(包括神经影像学阳性的短暂性脑缺血发作)或体循环栓塞。参与者、研究人员和初级保健医师(手术医师除外)均不知晓分组结果。

 

结果

主要分析人群包括行封堵术组2,379例参与者和不行封堵术组2,391例参与者,平均年龄为71岁,平均CHA2DS2-VASc评分为4.2分。本试验对参与者进行了平均3.8年随访。共计92.1%的参与者接受了分配的操作,3年时,有76.8%的参与者继续接受口服抗凝剂治疗。行封堵术组114例参与者(4.8%)和不行封堵术组168例参与者(7.0%)发生了卒中或体循环栓塞(风险比,0.67;95%置信区间[CI],0.53~0.85;P=0.001)。两组的围手术期出血、心力衰竭或死亡发生率无显著差异。

 

结论

在接受心脏手术的心房颤动参与者中,大多数人继续接受持续抗血栓治疗;手术同期行左心耳封堵术的情况下,缺血性卒中或体循环栓塞的风险低于不行封堵术的情况(由加拿大健康研究所[Canadian Institutes of Health Research]等资助;LAAOS Ⅲ在ClinicalTrials.gov注册号为NCT01561651)。





作者信息

Richard P. Whitlock, M.D., Ph.D., Emilie P. Belley-Cote, M.D., Ph.D., Domenico Paparella, M.D., Jeff S. Healey, M.D., Katheryn Brady, B.Sc., Mukul Sharma, M.D., Wilko Reents, M.D., Petr Budera, M.D., Ph.D., Andony J. Baddour, M.D., Ph.D., Petr Fila, M.D., Ph.D., P.J. Devereaux, M.D., Ph.D., Alexander Bogachev-Prokophiev, M.D., Ph.D., Andreas Boening, M.D., Kevin H.T. Teoh, M.D., Georgios I. Tagarakis, M.D., Ph.D., Mark S. Slaughter, M.D., Alistair G. Royse, M.D., Shay McGuinness, M.B., Ch.B., Marco Alings, M.D., Ph.D., Prakash P. Punjabi, F.R.C.S., C. David Mazer, M.D., Richard J. Folkeringa, M.D., Ph.D., Andrea Colli, M.D., Álvaro Avezum, M.D., Ph.D., Juliet Nakamya, Ph.D., Kumar Balasubramanian, M.Sc., Jessica Vincent, M.Sc., Pierre Voisine, M.D., Andre Lamy, M.D., Salim Yusuf, F.R.S.C., D.Phil., and Stuart J. Connolly, M.D. for the LAAOS III Investigators*
From McMaster University (R.P.W., E.P.B.-C., J.S.H., M.S., P.J.D., J.N., K. Balasubramanian, A.L., S.Y., S.J.C.), Hamilton Health Sciences (R.P.W., E.P.B.-C., J.S.H., K. Brady, M.S., P.J.D., J.V., A.L., S.Y., S.J.C.), and the Population Health Research Institute (R.P.W., E.P.B.-C., J.S.H., K. Brady, M.S., P.J.D., J.N., K. Balasubramanian, J.V., A.L., S.Y., S.J.C.), Hamilton, ON, Southlake Regional Health Centre, Newmarket, ON (K.H.T.T.), the University of Toronto and Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto (C.D.M.), and Quebec Heart and Lung Institute, Quebec, QC (P.V.) — all in Canada; University of Foggia, Foggia (D.P.), Santa Maria Hospital, Gruppo Villa Maria Care and Research, Bari (D.P.), and the University of Pisa, Pisa (A.C.) — all in Italy; Rhön-Klinikum Campus Bad Neustadt, Bad Neustadt (W.R.), and University Hospital Giessen, Giessen (A.B.) — both in Germany; the Institute for Clinical and Experimental Medicine, Prague (P.B.), and the Center of Cardiovascular Surgery and Transplantation, Brno (P.F.) — both in the Czech Republic; “G. Papanikolaou” Hospital (A.J.B.) and Aristotle University of Thessaloniki (G.I.T.) — both in Thessaloniki, Greece; E. Meshalkin National Medical Research Center, Novosibirsk, Russia (A.B.-P.); the University of Louisville, Louisville, KY (M.S.S.); the University of Melbourne and Royal Melbourne Hospital, Melbourne, VIC, Australia (A.G.R.); Auckland City Hospital, Auckland, New Zealand (S.M.); Amphia Ziekenhuis, Breda (M.A.), and Medical Center Leeuwarden, Leeuwarden (R.J.F.) — both in the Netherlands; the National Heart and Lung Institute, Imperial College London, London (P.P.P.); and the International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo (Á.A.). Address reprint requests to Dr. Whitlock at the David Braley Research Institute, Hamilton General Hospital, 237 Barton St. E, Hamilton, ON L8L 2X2, Canada, or at richard.whitlock@phri.ca. *A full list of the LAAOS III Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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