Prophylactic Surgical Left Atrial Appendage Closure in Bioprosthetic Aortic Valve Replacement: Short‐Term Outcomes of Randomized Controlled LAA–CLOSURE Trial

Background Surgical closure of the left atrial appendage (LAA) reduces stroke risk in patients with atrial fibrillation (AF) undergoing cardiac surgery. We evaluated the safety and efficacy of prophylactic LAA closure during bioprosthetic surgical aortic valve replacement in patients without prior AF. Methods In this investigator‐initiated, academic, randomized, open‐label, multicenter LAA‐CLOSURE (Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery) trial, 921 patients without prior AF undergoing bioprosthetic surgical aortic valve replacement with or without concomitant surgery were randomized and 904 patients included in the modified intention‐to‐treat analysis (prophylactic LAA closure, n=445; or usual care, n=459). Median age was 73 years (interquartile range, 69–76), 34.8% were women, and 49% had concomitant coronary artery disease. The primary end point was a composite of cardiovascular death, stroke, or systemic embolism at 30 days. Results The primary end point occurred in 10 of 434 (2.2%) patients in the LAA closure group and 14 of 452 (3.1%) patients in the control group; however, the treatment effect changed direction at ≈7 days. In the time‐split Cox regression model, hazard ratios were 2.4 (95% CI, 0.62–9.4; P =0.20) between 0 and 7 days and 0.29 (95% CI, 0.080–1.0; P =0.056) between 7 and 30 days. No closure‐related serious complications or differences in bleeding were observed. Postoperative AF occurred in 205 of 445 (46.1%) versus 184 of 459 (40.1%) patients (relative risk, 1.1 [95% CI, 0.99–1.3]; P =0.07), and AF at discharge in 40 of 445 (9.2%) versus 34 of 459 (7.7%) patients (relative risk, 1.2 [95% CI, 0.77–1.8]; P =0.44), in the closure and control groups, respectively. Conclusions Prophylactic LAA closure during bioprosthetic surgical aortic valve replacement was safe and did not increase bleeding. Registration URL: clinicaltrials.gov ; Unique Identifier: NCT02321137.

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Journal of the American Heart Association
Published
2026-08-20
DOI
https://doi.org/10.1161/jaha.125.046654
Primary Topic
Atrial Fibrillation Management and Outcomes
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article
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article

Prophylactic Surgical Left Atrial Appendage Closure in Bioprosthetic Aortic Valve Replacement: Short‐Term Outcomes of Randomized Controlled LAA–CLOSURE Trial

Juha Lund, Juan Bustamante‐Munguira, M. Juonala, Piotr Suwalski et al.
Journal of the American Heart Association
Atrial Fibrillation Management and Outcomes
article

Prophylactic Surgical Left Atrial Appendage Closure in Bioprosthetic Aortic Valve Replacement: Short‐Term Outcomes of Randomized Controlled LAA–CLOSURE Trial

Juha Lund, Juan Bustamante‐Munguira, M. Juonala, Piotr Suwalski, Juhani Airaksinen, Juha E.K. Hartikainen, R G H Speekenbrink, Frank Ruben Halfwerk, Pauli Ylikotila, Igor Zindovic, Sofia Dahlberg, Gregory Y.H. Lip, Jarmo Gunn, Markus Bjurbom, Nicobert E. Wietsma, Markus Malmberg, Clara Erixon, Frank van Schaagen, Tuija Vasankari, Elena Bustamante Munguira, Anders Jeppsson, Bart Van de Putte, Christian Olsson, Tuomas Kiviniemi, Joonas Lehto, Guillermo Reyes, Thorsten Hanke, Sossio Perrotta, Elena Bustamante, Frank Halfwerk, Juhani Airaksinen, Frans B.S. Oei, Tuomas Kiviniemi, Guillermo Reyes Copa, Anders Jeppsson, Timo Savunen, Gregory Y. H. Lip, Fausto Biancari, Juha Hartikainen, Jarmo Gunn, Ron Speekenbrink, Tuija Vasankari, Piotr Suwalski, Nicobert Wietsma
article en

Abstract

Background Surgical closure of the left atrial appendage (LAA) reduces stroke risk in patients with atrial fibrillation (AF) undergoing cardiac surgery. We evaluated the safety and efficacy of prophylactic LAA closure during bioprosthetic surgical aortic valve replacement in patients without prior AF. Methods In this investigator‐initiated, academic, randomized, open‐label, multicenter LAA‐CLOSURE (Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery) trial, 921 patients without prior AF undergoing bioprosthetic surgical aortic valve replacement with or without concomitant surgery were randomized and 904 patients included in the modified intention‐to‐treat analysis (prophylactic LAA closure, n=445; or usual care, n=459). Median age was 73 years (interquartile range, 69–76), 34.8% were women, and 49% had concomitant coronary artery disease. The primary end point was a composite of cardiovascular death, stroke, or systemic embolism at 30 days. Results The primary end point occurred in 10 of 434 (2.2%) patients in the LAA closure group and 14 of 452 (3.1%) patients in the control group; however, the treatment effect changed direction at ≈7 days. In the time‐split Cox regression model, hazard ratios were 2.4 (95% CI, 0.62–9.4; P =0.20) between 0 and 7 days and 0.29 (95% CI, 0.080–1.0; P =0.056) between 7 and 30 days. No closure‐related serious complications or differences in bleeding were observed. Postoperative AF occurred in 205 of 445 (46.1%) versus 184 of 459 (40.1%) patients (relative risk, 1.1 [95% CI, 0.99–1.3]; P =0.07), and AF at discharge in 40 of 445 (9.2%) versus 34 of 459 (7.7%) patients (relative risk, 1.2 [95% CI, 0.77–1.8]; P =0.44), in the closure and control groups, respectively. Conclusions Prophylactic LAA closure during bioprosthetic surgical aortic valve replacement was safe and did not increase bleeding. Registration URL: clinicaltrials.gov ; Unique Identifier: NCT02321137.

Journal of the American Heart Association
Karolinska University Hospital (SE), University of Liverpool (GB), University of Turku (FI), University of Eastern Finland (FI), Lund University (SE), Sahlgrenska University Hospital (SE), Medisch Spectrum Twente (NL), Turku University Hospital (FI), University Medical Center (US), Liverpool Heart and Chest Hospital (GB), Kuopio University Hospital (FI), Institute for Postgraduate Medical Education (CZ), St. Antonius Ziekenhuis (NL), University Hospital and Clinics (US), Hospital Universitario de La Princesa (ES), Asklepios Klinikum Harburg (DE), Hospital Clínico Universitario de Valladolid (ES), Liverpool John Moores University (GB), University of Gothenburg (SE), Rotterdam University of Applied Sciences (NL), University of Twente (NL)
Good health and well-being
Openalex Percentile: Top 9%
Atrial Fibrillation Management and Outcomes
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