Surgical left atrial appendage occlusion in valvular heart disease without atrial fibrillation: the OPINION trial

Clinical Snapshot

Key Findings

• P Value: P = 0.25

• Effect Size: 6.9% vs 8.2% event rate (1.3% absolute risk reduction)

• Primary Outcome: Composite of ischaemic stroke, TIA, or cardiovascular mortality at 1 year

• Nnt Or Sensitivity: NNT = 77 (not statistically significant)

• Confidence Interval: HR 0.83 (95% CI 0.61-1.14)

Clinical Application

Technically feasible during valve surgery but adds operative complexity without proven benefit Results suggest prophylactic SLAAO should not be routinely performed in Australian practice. Current CSANZ guidelines do not recommend prophylactic SLAAO in non-AF patients. Valvular surgery patients with CHA₂DS₂-VASc ≥2 without pre-operative AF, though generalisability to non-Chinese populations uncertain

Abstract

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.

References

1. 1.Yuan, X., Ju, F., Wu, H., Zhao, Y., Wang, X., Liu, S., Wang, X., Zhu, J., Su, P., Xu, F., Feng, W., Yang, Y., Wang, Y., & Sun, H. (2026). Surgical left atrial appendage occlusion in valvular heart disease without atrial fibrillation: the OPINION trial. European Heart Journal. https://doi.org/10.1093/eurheartj/ehaf674