Richard Whitlock1, Jeff Healey2, Jessica Vincent3, Kate Brady3, Kevin Teoh4, Alistair Royse5, Pallav Shah6, Yingqiang Guo7, Marco Alings8, Richard J Folkeringa9, Domenico Paparella10, Andrea Colli11, Steven R Meyer12, Jean-François Legare13, François Lamontagne14, Wilko Reents15, Andreas Böning16, Stuart Connolly2. 1. Department of Surgery, McMaster University, Hamilton, Canada ; ; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada ; 2. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada ; ; Department of Medicine, McMaster University, Hamilton, Canada ; 3. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada ; 4. Department of Surgery, McMaster University, Hamilton, Canada ; ; Department of Surgery, Southlake Regional Health Centre, Newmarket, Canada ; 5. Department of Surgery, Royal Melbourne Hospital, The University of Melbourne, Melbourne, Australia ; 6. Department of Cardiothoracic Surgery, Princess Alexandra Hospital, University of Queensland, Brisbane, Australia ; 7. Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, China ; 8. Department of Cardiology and Electrophysiology, Amphia Ziekenhuis, Breda, the Netherlands ; 9. Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, the Netherlands ; 10. Division of Cardiac Surgery, Department of Emergency and Organ Transplant (DETO), University of Bari Aldo Moro, Bari, Italy ; 11. Department of Cardiology, Thoracic and Vascular Sciences, University of Padova, Padova, Italy ; 12. Department of Surgery, University of Alberta, Edmonton, Canada ; 13. Division of Cardiac Surgery, Dalhousie University, Halifax, Canada ; 14. Centre de recherché Clinique Étienne-Lebel and Faculté de Médecine et des Sciences de la Santé, Univesité de Sherbrooke, Sherbrooke, Canada ; 15. Department of Cardiac Surgery, Cardiovascular Clinic Bad Neustadt, Bad Neustadt, Germany ; 16. Department of Cardiovascular Surgery, University of Giessen, Giessen, Germany.
Abstract
BACKGROUND: Occlusion of the left atrial appendage (LAA) is a promising approach to stroke prevention in atrial fibrillation (AF). However, evidence of its efficacy and safety to date is lacking. We herein describe the rationale and design of a definitive LAA occlusion trial in cardiac surgical patients with AF. METHODS: We plan to randomize 4,700 patients with AF in whom on-pump cardiac surgical procedure is planned to undergo LAA occlusion or no LAA occlusion. The primary outcome is the first occurrence of stroke or systemic arterial embolism over a mean follow-up of four years. Other outcomes include total mortality, operative safety outcomes (chest tube output in the first post-operative 24 hours, rate of post-operative re-exploration for bleeding in the first 48 hours post-surgery and 30-day mortality), re-hospitalization for heart failure, major bleed, and myocardial infarction. RESULTS: Left Atrial Appendage Occlusion Study (LAAOS) III is funded in a vanguard phase by the Canadian Institutes for Health Research (CIHR), the Canadian Network and Centre for Trials Internationally, and the McMaster University Surgical Associates. As of September 9, 2013, 162 patients have been recruited into the study. CONCLUSIONS: LAAOS III will be the largest trial to explore the efficacy of LAA occlusion for stroke prevention. Its results will lead to a better understanding of stroke in AF and the safety and efficacy of surgical LAA occlusion.
BACKGROUND: Occlusion of the left atrial appendage (LAA) is a promising approach to stroke prevention in atrial fibrillation (AF). However, evidence of its efficacy and safety to date is lacking. We herein describe the rationale and design of a definitive LAA occlusion trial in cardiac surgical patients with AF. METHODS: We plan to randomize 4,700 patients with AF in whom on-pump cardiac surgical procedure is planned to undergo LAA occlusion or no LAA occlusion. The primary outcome is the first occurrence of stroke or systemic arterial embolism over a mean follow-up of four years. Other outcomes include total mortality, operative safety outcomes (chest tube output in the first post-operative 24 hours, rate of post-operative re-exploration for bleeding in the first 48 hours post-surgery and 30-day mortality), re-hospitalization for heart failure, major bleed, and myocardial infarction. RESULTS:Left Atrial Appendage Occlusion Study (LAAOS) III is funded in a vanguard phase by the Canadian Institutes for Health Research (CIHR), the Canadian Network and Centre for Trials Internationally, and the McMaster University Surgical Associates. As of September 9, 2013, 162 patients have been recruited into the study. CONCLUSIONS: LAAOS III will be the largest trial to explore the efficacy of LAA occlusion for stroke prevention. Its results will lead to a better understanding of stroke in AF and the safety and efficacy of surgical LAA occlusion.
Entities:
Keywords:
Left atrial appendage (LAA); occlusion; randomized trial; stroke
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