Richard P Whitlock1, Emilie P Belley-Cote1, Domenico Paparella1, Jeff S Healey1, Katheryn Brady1, Mukul Sharma1, Wilko Reents1, Petr Budera1, Andony J Baddour1, Petr Fila1, P J Devereaux1, Alexander Bogachev-Prokophiev1, Andreas Boening1, Kevin H T Teoh1, Georgios I Tagarakis1, Mark S Slaughter1, Alistair G Royse1, Shay McGuinness1, Marco Alings1, Prakash P Punjabi1, C David Mazer1, Richard J Folkeringa1, Andrea Colli1, Álvaro Avezum1, Juliet Nakamya1, Kumar Balasubramanian1, Jessica Vincent1, Pierre Voisine1, Andre Lamy1, Salim Yusuf1, Stuart J Connolly1. 1. 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.).
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 CHA2DS2-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 CHA2DS2-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.).
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 CHA2DS2-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 CHA2DS2-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.).
Authors: Jurij M Kalisnik; Giuseppe Santarpino; Andrea I Balbierer; Janez Zibert; Ferdinand A Vogt; Matthias Fittkau; Theodor Fischlein Journal: J Clin Med Date: 2022-06-14 Impact factor: 4.964