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.