Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke

doi:10.1056/NEJMoa2101897

Randomized Controlled Trial

. 2021 Jun 3;384(22):2081-2091.

doi: 10.1056/NEJMoa2101897. Epub 2021 May 15.

Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke

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; LAAOS III Investigators

Collaborators, Affiliations

Collaborators

LAAOS III Investigators:
Stuart J Connolly, Richard P Whitlock, Marco Alings, Álvaro Avezum, Emilie P Belley-Côté, Katheryn Brady, Petr Budera, Andrea Colli, P J Devereaux, Richard J Folkeringa, Jeff S Healey, Shay McGuinness, Domenico Paparella, Prakash P Punjabi, Wilko Reents, Alistair G Royse, Mark S Slaughter, Georgios I Tagarakis, Kevin H Teoh, Jessica Vincent, Mukul Sharma, Jan P Bembenek, Luciana Catanese, Dionysia Dellaporta, Danielle de Sa Boasquevisque, Gregory Jacquin, João Pedro Marto, Robert Mikulik, Luis E Morillo, Wolfgang Müllges, Paul J Nederkoorn, Kelvin K H Ng, Antonia Nucera, André Peeters, Kanjana S Perera, Alexandre Pieri, Alexander Thiel, Anthoula C Tsolaki, Hans van Lieshout, Martin Šrámek, Ondrej Volny, Viktor Weiss, Paweł Wrona, Xiaomeng Yang, Vladimir Zakharov, John A Cairns, Martin J O'Donnell, Marc Ruel, John L Sapp, George A Wells, Amber Good, Tracy Miranda, Shirley Pettit, Lori Robinson, Kumar Balasubramanian, Marsella Bishop, Peggy Gao, Rutaba Khatun, Mark Molec, Juliet Nakamya, Lisa M Tittley, Hasib Hanif, Victor F Chu, Leah I Hayward, Courtney J Mullen, François Dagenais, Frédéric Jacques, Siamak Mohammadi, Éric Charbonneau, Éric Dumont, Wendy Wiley, Christi Darby, Heather Hobson, Alexis Wainwright, Angela Forbes, Nicolas Noiseux, Louis Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joe Helou, Michael H Yamashita, Rohit K Singal, Wendy Janz, Charissa Cepidoza, Steven Rhodes Meyer, Nasim Boroumand, Ismet Puhovac, Craig D Brown, Jean F Legare, Ansar Hassan, Ismail El-Hamamsy, Louis P Perrault, Denis Bouchard, Greg M Hirsch, Jean Francois Legare, Tarit K Saha, Darrin M Payne, Samson Moses, Shira Brodutch, Robert James Cusimano, Ganesh Shanmugam, William Kidd, John Bozinovski, Sheryll Sorensen, François Lamontagne, Étienne De Medicis, Hugues Jeanmart, Carole Sirois, Linrui Ray Guo, Stephen E Fremes, Buu-Khanh Lam, Anno Diegeler, Joerg Babin-Ebell, Fitsum Lakew, Aristidis Lenos, Xiaochun Zhan, Peter Roth, Bernd Niemann, Coskun Orhan, Raed Aser, Elisabeth Dominik, Bernhard C Danner, Katharina R Ort, Hassina Baraki, Martin Czerny, Nawras Diab, Clarence Pingpoh, Daniel Wendt, Strohschnitter Heike, Linda Vetešková, Petr Němec, Jiří Ondrášek, Vladimír Horváth, Tomáš Ostřížek, Petr Kacer, Aliaksandr Fedarau, Martin Jedlinsky, Jan Rocek, Karel Jirasek, Ondrej Szarszoi, Miroslav Konarik, Jan Harrer, Ales Mokracek, Jaroslav Lindner, Petr Jansky, Vít Jirásek, Athanasios A Madesis, George E Drossos, Vasileios Simopoulos, Fani Tsolaki, Nikolaos Tsilimingas, Sofia Xeromerisiou, Ioannis Alexiou, Christos Voucharas, Angeliki Vouchara, Dimitrios Bismpos, Georgios A Pitoulias, Szabolcs Miskolczi, Steven Livesey, Kim Evelyn de Courcy-Golder, Guiqing Liu, Panagiotis Grigorios Kyriazis, Inderpaul Birdi, Annaliza Sevillano, Ralph W White, Carmen Neave, Victoria Lake, Sarah Milgate, Hunaid Ahmed Vohra, Steven Hunter, Peter Charles Braidley, Joseph Zacharias, Ishtiaq M Ahmed, Aziz Momin, Francis Charles Wells, Kamran Baig, Ravil Sharifulin, Sergey Zheleznev, Sergey Budagaev, Anton Zalesov, Anastasiia Karadzha, John M Stulak, Spencer J Melby, Robert S Kramer, Lorraine D Cornwell, Peter A Knight, Anson M Lee, Wingchi Lo, Christopher Cole, Kelly Gaddes, Colin Forbes Royse, Lynda Jane Tivendale, Michael David O'Keefe, Jane Mack, Huan-Lei Huang, Ji-Mei Chen, Hui-Ming Guo, Li-Shang Zhong, Liang Yang, Jun Shi, Qiang Zhao, Crescenzia Rotunno, Micaela De Palo, Vito Margari, Adriano De Santis, Pietro Giorgio Malvindi, Andrea Cavicchiolo, Elena Rossi, Davide Schiavi, Marco Agostini, Adam El Gamel, Kelly Patrick Byrne, David John McCormack, Paul Joseph Conaglen, Rachael L Parke, Eileen Gilder, Magdalena Butler, Sean D Galvin, Jan Rogowski, Rafał Pawlaczyk, Barbara Brzeska, Wojciech Fil, Krzysztof Sanetra, Janusz Konstanty-Kalandyk, Radoslaw Cezary Zwolinski, Marek J Jasinski, Mohammed Bentala, Ineke Hunze, Hafid Amrane, Fabiano Porta, Niels J Verberkmoes, Jose Lopez-Menendez, Angela R Granda Bauza, Guillermo Reyes, Jose Miguel Borrego, Seyed Hesameddin Abbasi, Kyomars Abbasi, Renato A K Kalil, Carlos A Santos, Mário Issa, José Francisco Keerr Saraiva, Filip Rega, Peter Verbrugghe, Ricardo M Ferreira, Angelo L Nobre, Carlos Eduardo Obando López, Skarlet M Vásquez, Tonny A Sarquis, Eduardo Cadavid-Alvear, Ahmed Ouda, Jürg Grünenfelder, Shahrul A Hashim, Ilinca Damian, Mark L Da Costa, Hosam F Fawzy, Anil R Jain, Chandrasekar Padmanabhan, Moira J Alvarez, Yasushi Sakata

Affiliation

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.).

PMID: 33999547
DOI: 10.1056/NEJMoa2101897

Randomized Controlled Trial

Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke

Richard P Whitlock et al. N Engl J Med. 2021.

. 2021 Jun 3;384(22):2081-2091.

doi: 10.1056/NEJMoa2101897. Epub 2021 May 15.

Authors

Collaborators

LAAOS III Investigators:
Stuart J Connolly, Richard P Whitlock, Marco Alings, Álvaro Avezum, Emilie P Belley-Côté, Katheryn Brady, Petr Budera, Andrea Colli, P J Devereaux, Richard J Folkeringa, Jeff S Healey, Shay McGuinness, Domenico Paparella, Prakash P Punjabi, Wilko Reents, Alistair G Royse, Mark S Slaughter, Georgios I Tagarakis, Kevin H Teoh, Jessica Vincent, Mukul Sharma, Jan P Bembenek, Luciana Catanese, Dionysia Dellaporta, Danielle de Sa Boasquevisque, Gregory Jacquin, João Pedro Marto, Robert Mikulik, Luis E Morillo, Wolfgang Müllges, Paul J Nederkoorn, Kelvin K H Ng, Antonia Nucera, André Peeters, Kanjana S Perera, Alexandre Pieri, Alexander Thiel, Anthoula C Tsolaki, Hans van Lieshout, Martin Šrámek, Ondrej Volny, Viktor Weiss, Paweł Wrona, Xiaomeng Yang, Vladimir Zakharov, John A Cairns, Martin J O'Donnell, Marc Ruel, John L Sapp, George A Wells, Amber Good, Tracy Miranda, Shirley Pettit, Lori Robinson, Kumar Balasubramanian, Marsella Bishop, Peggy Gao, Rutaba Khatun, Mark Molec, Juliet Nakamya, Lisa M Tittley, Hasib Hanif, Victor F Chu, Leah I Hayward, Courtney J Mullen, François Dagenais, Frédéric Jacques, Siamak Mohammadi, Éric Charbonneau, Éric Dumont, Wendy Wiley, Christi Darby, Heather Hobson, Alexis Wainwright, Angela Forbes, Nicolas Noiseux, Louis Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joe Helou, Michael H Yamashita, Rohit K Singal, Wendy Janz, Charissa Cepidoza, Steven Rhodes Meyer, Nasim Boroumand, Ismet Puhovac, Craig D Brown, Jean F Legare, Ansar Hassan, Ismail El-Hamamsy, Louis P Perrault, Denis Bouchard, Greg M Hirsch, Jean Francois Legare, Tarit K Saha, Darrin M Payne, Samson Moses, Shira Brodutch, Robert James Cusimano, Ganesh Shanmugam, William Kidd, John Bozinovski, Sheryll Sorensen, François Lamontagne, Étienne De Medicis, Hugues Jeanmart, Carole Sirois, Linrui Ray Guo, Stephen E Fremes, Buu-Khanh Lam, Anno Diegeler, Joerg Babin-Ebell, Fitsum Lakew, Aristidis Lenos, Xiaochun Zhan, Peter Roth, Bernd Niemann, Coskun Orhan, Raed Aser, Elisabeth Dominik, Bernhard C Danner, Katharina R Ort, Hassina Baraki, Martin Czerny, Nawras Diab, Clarence Pingpoh, Daniel Wendt, Strohschnitter Heike, Linda Vetešková, Petr Němec, Jiří Ondrášek, Vladimír Horváth, Tomáš Ostřížek, Petr Kacer, Aliaksandr Fedarau, Martin Jedlinsky, Jan Rocek, Karel Jirasek, Ondrej Szarszoi, Miroslav Konarik, Jan Harrer, Ales Mokracek, Jaroslav Lindner, Petr Jansky, Vít Jirásek, Athanasios A Madesis, George E Drossos, Vasileios Simopoulos, Fani Tsolaki, Nikolaos Tsilimingas, Sofia Xeromerisiou, Ioannis Alexiou, Christos Voucharas, Angeliki Vouchara, Dimitrios Bismpos, Georgios A Pitoulias, Szabolcs Miskolczi, Steven Livesey, Kim Evelyn de Courcy-Golder, Guiqing Liu, Panagiotis Grigorios Kyriazis, Inderpaul Birdi, Annaliza Sevillano, Ralph W White, Carmen Neave, Victoria Lake, Sarah Milgate, Hunaid Ahmed Vohra, Steven Hunter, Peter Charles Braidley, Joseph Zacharias, Ishtiaq M Ahmed, Aziz Momin, Francis Charles Wells, Kamran Baig, Ravil Sharifulin, Sergey Zheleznev, Sergey Budagaev, Anton Zalesov, Anastasiia Karadzha, John M Stulak, Spencer J Melby, Robert S Kramer, Lorraine D Cornwell, Peter A Knight, Anson M Lee, Wingchi Lo, Christopher Cole, Kelly Gaddes, Colin Forbes Royse, Lynda Jane Tivendale, Michael David O'Keefe, Jane Mack, Huan-Lei Huang, Ji-Mei Chen, Hui-Ming Guo, Li-Shang Zhong, Liang Yang, Jun Shi, Qiang Zhao, Crescenzia Rotunno, Micaela De Palo, Vito Margari, Adriano De Santis, Pietro Giorgio Malvindi, Andrea Cavicchiolo, Elena Rossi, Davide Schiavi, Marco Agostini, Adam El Gamel, Kelly Patrick Byrne, David John McCormack, Paul Joseph Conaglen, Rachael L Parke, Eileen Gilder, Magdalena Butler, Sean D Galvin, Jan Rogowski, Rafał Pawlaczyk, Barbara Brzeska, Wojciech Fil, Krzysztof Sanetra, Janusz Konstanty-Kalandyk, Radoslaw Cezary Zwolinski, Marek J Jasinski, Mohammed Bentala, Ineke Hunze, Hafid Amrane, Fabiano Porta, Niels J Verberkmoes, Jose Lopez-Menendez, Angela R Granda Bauza, Guillermo Reyes, Jose Miguel Borrego, Seyed Hesameddin Abbasi, Kyomars Abbasi, Renato A K Kalil, Carlos A Santos, Mário Issa, José Francisco Keerr Saraiva, Filip Rega, Peter Verbrugghe, Ricardo M Ferreira, Angelo L Nobre, Carlos Eduardo Obando López, Skarlet M Vásquez, Tonny A Sarquis, Eduardo Cadavid-Alvear, Ahmed Ouda, Jürg Grünenfelder, Shahrul A Hashim, Ilinca Damian, Mark L Da Costa, Hosam F Fawzy, Anil R Jain, Chandrasekar Padmanabhan, Moira J Alvarez, Yasushi Sakata

Affiliation

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.).

PMID: 33999547
DOI: 10.1056/NEJMoa2101897

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.).

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The Closing Argument for Surgical Left Atrial Appendage Occlusion.
Page RL. Page RL. N Engl J Med. 2021 Jun 3;384(22):2154-2155. doi: 10.1056/NEJMe2106069. Epub 2021 May 15. N Engl J Med. 2021. PMID: 33999543 No abstract available.
LAAO during cardiac surgery prevents stroke.
Robson A. Robson A. Nat Rev Cardiol. 2021 Aug;18(8):543. doi: 10.1038/s41569-021-00572-x. Nat Rev Cardiol. 2021. PMID: 34045729 No abstract available.
Patients with Atrial Fibrillation Undergoing Cardiac Surgery: No Left Atrial Appendage Shall Remain Untouched.
Whitlock RP, Belley-Cote EP. Whitlock RP, et al. Innovations (Phila). 2021 Jul-Aug;16(4):301-302. doi: 10.1177/15569845211032139. Epub 2021 Aug 1. Innovations (Phila). 2021. PMID: 34338069 Review.
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Caliskan E, Falk V, Emmert MY. Caliskan E, et al. N Engl J Med. 2021 Sep 9;385(11):1054. doi: 10.1056/NEJMc2111008. N Engl J Med. 2021. PMID: 34496184 No abstract available.
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Choudhury S, Gatherer R, Anwar S. Choudhury S, et al. N Engl J Med. 2021 Sep 9;385(11):1054. doi: 10.1056/NEJMc2111008. N Engl J Med. 2021. PMID: 34496185 No abstract available.
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Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke

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Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke

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