Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke
Richard Whitlock, Emilie P. Belley‐Côté, Domenico Paparella, Jeff S. Healey, Katheryn Brady, Mukul Sharma, Wilko Reents, Petr Budera, Andony J Baddour, Petr Fila, P.J. Devereaux, Alexander Bogachev‐Prokophiev, Andreas Boening, Kevin Teoh, Georgios Tagarakis, Mark S. Slaughter, Alistair Royse, Shay McGuinness, Marco Alings, Prakash P Punjabi, C. David Mazer, Richard Folkeringa, Andrea Colli, Álvaro Avezum, Juliet Nakamya, Kumar Balasubramanian, Jessica Vincent, Pierre Voisine, André Lamy, Salim Yusuf, Stuart J. Connolly
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: -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: -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.).