Atrial fibrillation (AF) in patients who experience a major bleeding event represents a complex clinical scenario in which percutaneous left atrial appendage closure (LAAC) has emerged as a therapeutic alternative. At present, population-based data on the actual frequency of use of this procedure and its prognostic impact following hospitalization for bleeding are limited. The aim of this study was to investigate the frequency of use, associated factors, and prognostic impact of LAAC in anticoagulated patients with AF after hospitalization for intracranial or gastrointestinal hemorrhage.
The PERSEO registry was conducted as a multicenter, observational, retrospective study including patients treated at 15 public hospitals in Andalusia (Spain), all of which had active LAAC programs. Adult patients with AF who were previously anticoagulated and discharged alive between January 2021 and December 2022 after non-traumatic intracranial hemorrhage or gastrointestinal bleeding requiring hospital treatment were included.
The primary endpoint was event-free survival from the composite outcome of death, embolic events (stroke, transient ischemic attack, or systemic embolism), or major or clinically relevant non-major bleeding. Secondary endpoints included the individual components of the composite outcome and factors associated with the indication for LAAC.
A total of 1,403 patients were included, with a median age of 81 years (IQR 76–87); 51.6% were male. Gastrointestinal bleeding was the index event in 1,041 patients (74.2%), while intracranial hemorrhage occurred in 364 patients (25.9%). Baseline thrombotic and bleeding risk was high, with median CHA₂DS₂-VASc and HAS-BLED scores of 5 (IQR 4–6) and 3 (IQR 2–4), respectively. At the time of bleeding, most patients were receiving anticoagulation therapy: direct oral anticoagulants in 69.1%, vitamin K antagonists in 26.2%, and heparins in 3.3%.
Clinical outcomes of left atrial appendage closure after major bleeding in patients with atrial fibrillation
During follow-up, LAAC was performed in 114 patients (8.13%; 95% CI 6.70–9.56), at a median of 5 months after hospital discharge. The devices used were Watchman in 56 cases, Amplatzer/Amulet in 41, Lambre in 13, and others in 4 cases, with a high procedural success rate and a very low incidence of periprocedural complications. Among patients who did not undergo left atrial appendage closure, discharge antithrombotic therapy was heterogeneous: 39% received direct oral anticoagulants, 39% low-molecular-weight heparin, 6% aspirin, 3.9% vitamin K antagonists, and 17% received no antithrombotic therapy at discharge.
Over a maximum follow-up of 40 months (median 19 months), all-cause mortality was 32.8%, and the composite endpoint occurred in 49.8% of the cohort. Compared with medical therapy, LAAC was associated with better clinical outcomes: at 24 months, event-free survival from the composite endpoint was 66% versus 49% (p=0.016), and overall survival was 82% versus 64% (p=0.002). In adjusted analyses, LAAC was associated with a lower risk of the composite endpoint (HR 0.68; 95% CI 0.48–0.97; p=0.034) and lower mortality (HR 0.52; 95% CI 0.32–0.86; p=0.011).
Regarding hard clinical outcomes, mortality was 15.7% in the LAAC group compared with 34.3% in the medical management group. Rates of embolic events were similar between groups, and no significant differences were observed in major bleeding events. In the propensity-matched analysis, 24-month event-free survival was 68% versus 46% (p=0.014), and overall survival was 85% versus 66% (p=0.011), confirming the consistency of the findings.
In multivariable analysis, percutaneous left atrial appendage closure was less frequently performed in patients older than 80 years (OR 0.31; 95% CI 0.20–0.49), those with dementia (OR 0.35; 95% CI 0.16–0.77), uncontrolled hypertension at admission (OR 0.11; 95% CI 0.02–0.84), use of vitamin K antagonists (OR 0.53; 95% CI 0.31–0.90), or when the index bleeding event required interventional treatment (OR 0.52; 95% CI 0.27–0.99).
Conclusion: Prognostic benefit of left atrial appendage closure versus medical management after major bleeding in atrial fibrillation
In anticoagulated patients with atrial fibrillation who survive a severe bleeding event, percutaneous left atrial appendage closure was performed in a relatively small proportion (8.13%), even in centers with active programs. Nevertheless, it was associated with a significant reduction in the composite endpoint and mortality compared with conventional medical management, suggesting a potential prognostic benefit that should be confirmed in randomized clinical trials.
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