Key result
Prophylactic surgical left atrial appendage occlusion did not significantly reduce ischaemic stroke, TIA, or cardiovascular mortality compared to no SLAAO (HR 0.83; 95% CI 0.61-1.14; P=0.25).
Why the study?
Does surgical left atrial appendage occlusion reduce ischaemic stroke, TIA, or cardiovascular mortality in non-AF patients with CHA₂DS₂-VASc ≥2 undergoing valve surgery?
RCT (n=2,118)
Open-label
1:1
Yes
Does surgical left atrial appendage occlusion reduce ischaemic stroke, TIA, or cardiovascular mortality in non-AF patients with CHA₂DS₂-VASc ≥2 undergoing valve surgery?
Prophylactic surgical left atrial appendage occlusion during valve surgery in patients without pre-operative AF does not significantly reduce the 1-year risk of ischaemic stroke, TIA, or cardiovascular mortality.
Background and Aims While surgical left atrial appendage occlusion (SLAAO) reduces stroke in atrial fibrillation (AF) patients, its efficacy in patients without pre-operative AF but with CHA₂DS₂-VASc ≥2 remains uncertain despite their high post-operative AF risk (15–54%). The aim of this study was to evaluate whether prophylactic SLAAO reduces post-operative thrombo-embolic events in valvular surgery patients. Methods The OPINION was a multicentre, open-label, randomized, superiority trial conducted at three cardiac surgery centres in China. Eligible non-AF patients with CHA₂DS₂-VASc ≥2 and an indication for valve repair or replacement due to mitral or aortic valve lesions were randomly assigned (1:1) to undergo SLAAO (intervention arm) or not undergo SLAAO (control arm) during surgery. The primary outcome was a composite of ischaemic stroke, transient ischaemic attack (TIA), or cardiovascular mortality assessed at 1 year. The primary analysis was done in the intention-to-treat population. Results Between April 2021 and June 2024, a total of 2157 patients were enrolled and randomized. After exclusion of 39 patients who withdrew informed consent, 2118 participants were included in the intention-to-treat population (1062 in the SLAAO group and 1056 in the control group). Baseline characteristics were well-balanced between the SLAAO group and control group (mean age 55.5 [11.4] vs 55.6 [11.5] years, P = .65; female 32.9% vs 32.3%, P = .78; CHA2DS2-VASc score 2.88 [0.98] vs 2.87 [0.96], P = .83; median EuroSCORE II 1.58% [1.42%] vs 1.56% [1.28%], P = .74). The 1-year primary endpoint occurred in 73 (6.9%) patients in the SLAAO group and in 87 (8.2%) patients in the control group (hazard ratio 0.83; 95% confidence interval 0.61–1.14; P = .25). Conclusions For valvular surgery patients with CHA₂DS₂-VASc scores ≥2 but no pre-operative AF, routine prophylactic left atrial appendage closure did not significantly reduce the incidence of the primary composite endpoint (ischaemic stroke, TIA, and cardiovascular mortality) at 1-year follow-up. Trial Registration ChiCTR.org registry ChiCTR2100042238
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Yuan et al. (2025) conducted an RCT in Valvular heart disease without atrial fibrillation (n=2,118). Surgical left atrial appendage occlusion (SLAAO) vs. No SLAAO was evaluated on Composite of ischaemic stroke, transient ischaemic attack (TIA), or cardiovascular mortality (HR 0.83, 95% CI 0.61-1.14, p=0.25). Prophylactic surgical left atrial appendage occlusion did not significantly reduce ischaemic stroke, TIA, or cardiovascular mortality compared to no SLAAO (HR 0.83; 95% CI 0.61-1.14; P=0.25).
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