心脏手术中的左心耳封堵术预防中风。

Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke.

机构信息

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.).

出版信息

N Engl J Med. 2021 Jun 3;384(22):2081-2091. doi: 10.1056/NEJMoa2101897. Epub 2021 May 15.

DOI:10.1056/NEJMoa2101897

PMID:33999547

Abstract

BACKGROUND

Surgical occlusion of the left atrial appendage has been hypothesized to prevent ischemic stroke in patients with atrial fibrillation, but this has not been proved. The procedure can be performed during cardiac surgery undertaken for other reasons.

METHODS

We conducted a multicenter, randomized trial involving participants with atrial fibrillation and a CHADS-VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating greater risk of stroke) who were scheduled to undergo cardiac surgery for another indication. The participants were randomly assigned to undergo or not undergo occlusion of the left atrial appendage during surgery; all the participants were expected to receive usual care, including oral anticoagulation, during follow-up. The primary outcome was the occurrence of ischemic stroke (including transient ischemic attack with positive neuroimaging) or systemic embolism. The participants, research personnel, and primary care physicians (other than the surgeons) were unaware of the trial-group assignments.

RESULTS

The primary analysis population included 2379 participants in the occlusion group and 2391 in the no-occlusion group, with a mean age of 71 years and a mean CHADS-VASc score of 4.2. The participants were followed for a mean of 3.8 years. A total of 92.1% of the participants received the assigned procedure, and at 3 years, 76.8% of the participants continued to receive oral anticoagulation. Stroke or systemic embolism occurred in 114 participants (4.8%) in the occlusion group and in 168 (7.0%) in the no-occlusion group (hazard ratio, 0.67; 95% confidence interval, 0.53 to 0.85; P = 0.001). The incidence of perioperative bleeding, heart failure, or death did not differ significantly between the trial groups.

CONCLUSIONS

Among participants with atrial fibrillation who had undergone cardiac surgery, most of whom continued to receive ongoing antithrombotic therapy, the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it. (Funded by the Canadian Institutes of Health Research and others; LAAOS III ClinicalTrials.gov number, NCT01561651.).

摘要

背景

外科手术闭合左心耳已被假设可预防有房颤病史的患者发生缺血性卒中，但这一假设尚未得到证实。该手术可在因其他原因进行的心脏手术中同时进行。

方法

我们开展了一项多中心、随机临床试验，纳入了因其他指征接受心脏手术且 CHADS-VASc 评分至少为 2 分（评分范围为 0 至 9 分，分数越高表示卒中风险越高）的房颤患者。参与者被随机分配到术中进行或不进行左心耳闭合；所有参与者在随访期间都预计会接受常规治疗，包括口服抗凝药物。主要结局是缺血性卒中和（或）全身性栓塞的发生。参与者、研究人员和初级保健医生（除外科医生外）均不知道试验组的分配情况。

结果

主要分析人群包括闭合组 2379 名参与者和未闭合组 2391 名参与者，平均年龄为 71 岁，平均 CHADS-VASc 评分为 4.2。参与者平均随访 3.8 年。92.1%的参与者接受了分配的手术，3 年后，76.8%的参与者继续接受口服抗凝药物治疗。闭合组中有 114 名（4.8%）参与者发生卒中或全身性栓塞，未闭合组中有 168 名（7.0%）参与者发生卒中或全身性栓塞（风险比，0.67；95%置信区间，0.53 至 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。