Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III

Richard Whitlock; Jeff Healey; Jessica Vincent; Kate Brady; Kevin Teoh; Alistair Royse; Pallav Shah; Yingqiang Guo; Marco Alings; Richard J Folkeringa; Domenico Paparella; Andrea Colli; Steven R Meyer; Jean-François Legare; François Lamontagne; Wilko Reents; Andreas Böning; Stuart Connolly

doi:10.3978/j.issn.2225-319X.2013.12.06

Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III

Richard Whitlock, Jeff Healey, Jessica Vincent, Kate Brady, Kevin Teoh, Alistair Royse, Pallav Shah, Yingqiang Guo, Marco Alings, Richard J Folkeringa, Domenico Paparella, Andrea Colli, Steven R Meyer, Jean-François Legare, François Lamontagne, Wilko Reents, Andreas Böning, Stuart Connolly

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	45-54
Number of pages	10
Journal	Annals of Cardiothoracic Surgery
Volume	3
Issue number	1
DOIs	https://doi.org/10.3978/j.issn.2225-319X.2013.12.06
Publication status	Published - Jan 2014
Externally published	Yes

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Whitlock, R., Healey, J., Vincent, J., Brady, K., Teoh, K., Royse, A., Shah, P., Guo, Y., Alings, M., Folkeringa, R. J., Paparella, D., Colli, A., Meyer, S. R., Legare, J.-F., Lamontagne, F., Reents, W., Böning, A., & Connolly, S. (2014). Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III. Annals of Cardiothoracic Surgery, 3(1), 45-54. https://doi.org/10.3978/j.issn.2225-319X.2013.12.06

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title = "Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III",

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.",

author = "Richard Whitlock and Jeff Healey and Jessica Vincent and Kate Brady and Kevin Teoh and Alistair Royse and Pallav Shah and Yingqiang Guo and Marco Alings and Folkeringa, {Richard J} and Domenico Paparella and Andrea Colli and Meyer, {Steven R} and Jean-Fran{\c c}ois Legare and Fran{\c c}ois Lamontagne and Wilko Reents and Andreas B{\"o}ning and Stuart Connolly",

year = "2014",

month = jan,

doi = "10.3978/j.issn.2225-319X.2013.12.06",

language = "English",

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journal = "Annals of Cardiothoracic Surgery",

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Whitlock, R, Healey, J, Vincent, J, Brady, K, Teoh, K, Royse, A, Shah, P, Guo, Y, Alings, M, Folkeringa, RJ, Paparella, D, Colli, A, Meyer, SR, Legare, J-F, Lamontagne, F, Reents, W, Böning, A & Connolly, S 2014, 'Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III', Annals of Cardiothoracic Surgery, vol. 3, no. 1, pp. 45-54. https://doi.org/10.3978/j.issn.2225-319X.2013.12.06

TY - JOUR

T1 - Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III

AU - Whitlock, Richard

AU - Healey, Jeff

AU - Vincent, Jessica

AU - Brady, Kate

AU - Teoh, Kevin

AU - Royse, Alistair

AU - Shah, Pallav

AU - Guo, Yingqiang

AU - Alings, Marco

AU - Folkeringa, Richard J

AU - Paparella, Domenico

AU - Colli, Andrea

AU - Meyer, Steven R

AU - Legare, Jean-François

AU - Lamontagne, François

AU - Reents, Wilko

AU - Böning, Andreas

AU - Connolly, Stuart

PY - 2014/1

Y1 - 2014/1

N2 - 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.

AB - 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.

U2 - 10.3978/j.issn.2225-319X.2013.12.06

DO - 10.3978/j.issn.2225-319X.2013.12.06

M3 - Article

C2 - 24516797

SN - 2225-319X

VL - 3

SP - 45

EP - 54

JO - Annals of Cardiothoracic Surgery

JF - Annals of Cardiothoracic Surgery

IS - 1

ER -

Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III

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