Randomized Trial of Surgical Left Atrial Appendage Closure: Protection Against Cerebrovascular Events
Following open-heart surgery, atrial fibrillation and stroke occur frequently. Left atrial appendage closure added to elective open-heart surgery could reduce the risk of ischemic stroke. We aim to examine if routine closure of the left atrial appendage in patients undergoing open-heart surgery provides long-term protection against cerebrovascular events independently of atrial fibrillation history, stroke risk, and oral anticoagulation use. Long-term follow-up of patients enrolled in the prospective, randomized, open-label, blinded evaluation trial entitled left atrial appendage closure by surgery (NCT02378116). Patients were stratified by oral anticoagulation status and randomized (1:1) to left atrial appendage closure in addition to elective open-heart surgery vs standard care. The primary composite endpoint was ischemic stroke events, transient ischemic attacks, and imaging findings of silent cerebral ischemic lesions. Two neurologists blinded for treatment assignment adjudicated cerebrovascular events. In total, 186 patients (82% males) were reviewed. At baseline, mean (standard deviation (SD)) age was 68 (9) years and 13.4% (n = 25/186) had been diagnosed with atrial fibrillation. Median [interquartile range (IQR)] CHA2DS2-VASc was 3 [2,4] and 25.9% (n = 48/186) were receiving oral anticoagulants. Mean follow-up was 6.2 (2.5) years. The left atrial appendage closure group experienced fewer cerebrovascular events; intention-to-treat 11 vs 19 (P = 0.033, n = 186) and per-protocol 9 vs 17 (P = 0.186, n = 141). Left atrial appendage closure as an add-on open-heart surgery, regardless of pre-surgery atrial fibrillation and oral anticoagulation status, seems safe and may reduce cerebrovascular events in long-term follow-up. More extensive randomized clinical trials investigating left atrial appendage closure in patients without atrial fibrillation and high stroke risk are warranted. Following open-heart surgery, atrial fibrillation and stroke occur frequently. Left atrial appendage closure added to elective open-heart surgery could reduce the risk of ischemic stroke. We aim to examine if routine closure of the left atrial appendage in patients undergoing open-heart surgery provides long-term protection against cerebrovascular events independently of atrial fibrillation history, stroke risk, and oral anticoagulation use. Long-term follow-up of patients enrolled in the prospective, randomized, open-label, blinded evaluation trial entitled left atrial appendage closure by surgery (NCT02378116). Patients were stratified by oral anticoagulation status and randomized (1:1) to left atrial appendage closure in addition to elective open-heart surgery vs standard care. The primary composite endpoint was ischemic stroke events, transient ischemic attacks, and imaging findings of silent cerebral ischemic lesions. Two neurologists blinded for treatment assignment adjudicated cerebrovascular events. In total, 186 patients (82% males) were reviewed. At baseline, mean (standard deviation (SD)) age was 68 (9) years and 13.4% (n = 25/186) had been diagnosed with atrial fibrillation. Median [interquartile range (IQR)] CHA2DS2-VASc was 3 [2,4] and 25.9% (n = 48/186) were receiving oral anticoagulants. Mean follow-up was 6.2 (2.5) years. The left atrial appendage closure group experienced fewer cerebrovascular events; intention-to-treat 11 vs 19 (P = 0.033, n = 186) and per-protocol 9 vs 17 (P = 0.186, n = 141). Left atrial appendage closure as an add-on open-heart surgery, regardless of pre-surgery atrial fibrillation and oral anticoagulation status, seems safe and may reduce cerebrovascular events in long-term follow-up. More extensive randomized clinical trials investigating left atrial appendage closure in patients without atrial fibrillation and high stroke risk are warranted. Central MessageRandomized add-on surgical left atrial appendage closure seems safe and may prevent cerebrovascular events independently of atrial fibrillation and stroke risk in long-term follow-up.Perspective StatementOur findings add to the evolving evidence that surgical closure of the left atrial appendage seems safe and may prevent cerebrovascular events, even in patients without a history of atrial fibrillation or high stroke risk. Results from ongoing, larger RCTs are needed before guidelines – and clinical practice – can be changed. Randomized add-on surgical left atrial appendage closure seems safe and may prevent cerebrovascular events independently of atrial fibrillation and stroke risk in long-term follow-up. Our findings add to the evolving evidence that surgical closure of the left atrial appendage seems safe and may prevent cerebrovascular events, even in patients without a history of atrial fibrillation or high stroke risk. Results from ongoing, larger RCTs are needed before guidelines – and clinical practice – can be changed. Patients frequently experience atrial fibrillation (AF) after open-heart surgery, ranging from 35% after coronary artery bypass grafting (CABG) to 50% after mitral valve surgery, and have an increased risk of ischemic stroke in the range of 1-5% per year.1Ahlsson A Fengsrud E Bodin L et al.Postoperative atrial fibrillation in patients undergoing aortocoronary bypass surgery carries an eightfold risk of future atrial fibrillation and a doubled cardiovascular mortality.Eur J Cardiothorac Surg. 2010; 37: 1353-1359https://doi.org/10.1016/j.ejcts.2009.12.033Crossref PubMed Scopus (150) Google Scholar, 2Healey JS Connolly SJ Gold MR et al.Subclinical atrial fibrillation and the risk of stroke.N Engl J Med. 2012; 366: 120-129https://doi.org/10.1056/NEJMoa1105575Crossref PubMed Scopus (1387) Google Scholar, 3Pillarisetti J Patel A Bommana S et al.Atrial fibrillation following open heart surgery: Long-term incidence and prognosis.J Interv Card Electrophysiol. 2014; 39: 69-75https://doi.org/10.1007/s10840-013-9830-6Crossref PubMed Scopus (16) Google Scholar, 4Lee SH Kang DR Uhm JS et al.New-onset atrial fibrillation predicts long-term newly developed atrial fibrillation after coronary artery bypass graft.Am Hear J. 2014; 167 (e1): 593-600https://doi.org/10.1016/j.ahj.2013.12.010Crossref PubMed Scopus (77) Google Scholar, 5Pernigo M Benfari G Geremia G et al.Atrial function as an independent predictor of postoperative atrial fibrillation in patients undergoing aortic valve surgery for severe aortic stenosis.J Am Soc Echocardiogr. 2017; 30 (e1): 956-965https://doi.org/10.1016/j.echo.2017.07.001Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar, 6Reddy VY Doshi SK Kar S et al.5-Year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials.J Am Coll Cardiol. 2017; 70: 2964-2975https://doi.org/10.1016/j.jacc.2017.10.021Crossref PubMed Scopus (441) Google Scholar, 7Mahajan R Perera T Elliott AD et al.Subclinical device-detected atrial fibrillation and stroke risk: A systematic review and meta-analysis.Eur Heart J. 2018; 39: 1407-1415https://doi.org/10.1093/eurheartj/ehx731Crossref PubMed Scopus (0) Google Scholar An estimated 90% of strokes occurring in patients with AF are due to thromboembolisms from the highly trabeculated left atrial appendage (LAA).2Healey JS Connolly SJ Gold MR et al.Subclinical atrial fibrillation and the risk of stroke.N Engl J Med. 2012; 366: 120-129https://doi.org/10.1056/NEJMoa1105575Crossref PubMed Scopus (1387) Google Scholar,8Dawson AG Asopa S Dunning J Should patients undergoing cardiac surgery with atrial fibrillation have left atrial appendage exclusion?.Interact Cardiovasc Thorac Surg. 2010; 10: 306-311https://doi.org/10.1510/icvts.2009.227991Crossref PubMed Scopus (116) Google Scholar Oral anticoagulants (OACs) can efficiently reduce the risk of stroke in the general population diagnosed with AF, but the diagnosis of AF can be challenging to detect, and compliance to long-term OAC treatment is limited.2Healey JS Connolly SJ Gold MR et al.Subclinical atrial fibrillation and the risk of stroke.N Engl J Med. 2012; 366: 120-129https://doi.org/10.1056/NEJMoa1105575Crossref PubMed Scopus (1387) Google Scholar,9Aguilar MI Hart R Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks.Cochrane Database Syst Rev. 2005; CD001927https://doi.org/10.1002/14651858.CD001927.pub2Crossref Scopus (124) Google Scholar,10Ogilvie IM Newton N Welner SA et al.Underuse of oral anticoagulants in atrial fibrillation: A systematic review.Am J Med. 2010; 123 (e4): 638-645https://doi.org/10.1016/j.amjmed.2009.11.025Abstract Full Text Full Text PDF PubMed Scopus (742) Google Scholar AF that occurs during a self-limiting concomitant medical condition such as surgery has previously been considered a phenomenon rather than a clear-cut AF diagnosis. 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Scopus Google Scholar In addition to stroke, silent cerebral ischemic are of ischemic that are after cardiac surgery, with a of in patients after and after mitral valve G F A et imaging following cardiac 2005; PubMed Scopus (16) Google Scholar, N M et ischemic after cardiac valve by to J Cardiothorac Surg. 2005; 28: PubMed Scopus Google Scholar, J L et and risk for silent infarction after cardiac surgery: A and of PubMed Scopus Google Scholar are associated with AF and of future S H et atrial fibrillation and silent cerebral A systematic review and Med. 2014; PubMed Scopus Google Scholar are for in the after cardiac surgery, but in the AF and are to new J L et and risk for silent infarction after cardiac surgery: A and of PubMed Scopus Google S et and of silent cerebral in the 39: PubMed Scopus Google G et of stroke in patients with silent cerebrovascular A for from the heart stroke 2017; PubMed Scopus (0) Google Scholar patients undergoing open-heart surgery are high risk of AF, and an be to the during AG Asopa S Dunning J Should patients undergoing cardiac surgery with atrial fibrillation have left atrial appendage exclusion?.Interact Cardiovasc Thorac Surg. 2010; 10: 306-311https://doi.org/10.1510/icvts.2009.227991Crossref PubMed Scopus (116) Google to reduce stroke in cardiac surgical patients with atrial Thorac Surg. Full Text PDF PubMed Scopus Google Scholar and European guidelines recommend that may be considered in patients with AF undergoing heart surgery, that evidence is CT Wann LS Calkins H et al.2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation ACC/AHA TASK FORCE MEMBERS.Hear Rhythm. 2019; (Published online)https://doi.org/10.1161/CIR.0000000000000665Crossref PubMed Scopus (1087) Google Scholar,20Hindricks G Potpara T Dagres N et al.2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European for surgery Heart J. Scopus Google Scholar from the randomized clinical trial to a risk of in patients with AF and CHA2DS2-VASc receiving concomitant et atrial appendage during cardiac surgery to prevent stroke.N Engl J Med. 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