Impact of left atrial appendage closure on events after severe bleeding in anticoagulated patients with atrial fibrillation: real life data from the PERSEO registry

Abstract Background There are paucity of "real world" data on the actual impact of percutaneous left atrial appendage closure (LAAC) in event prevention after a severe bleeding in anticoagulated patients with atrial fibrillation (AF). Purpose Our main objective was to investigate the impact of a LAAC strategy on events in follow-up in anticoagulated AF patients surviving a severe bleeding event versus those medically managed in Andalusia (South of Spain). Methods The PERSEO registry (Prevention of embolic events after a severe hemorrhage in anticoagulated patients with atrial fibrillation -in Spanish, Prevención de eventos Embólicos tras una hemoRragia SEvera en pacientes anticoagulados con fibrilaciOn auricular) was an observational, retrospective, multicentre study that included all consecutive patients discharged alive from January 1st, 2021 to December 31st, 2022, after an intracranial or gastrointestinal severe haemorrhage, who were previously anticoagulated for AF, in all public Andalusian hospitals with LAAC program, and who could be eligible either for LAAC or direct anticoagulant treatment. The main end-point was a composite of stroke/transient ischemic attack, systemic embolism, major or clinically relevant non-major bleeding or all-cause mortality in follow-up. The secondary outcome was all-cause mortality. Associations of the treatment strategy (LAAC versus usual medical management) with events in follow up were investigated by univariate and multivariate analysis. Results Among a reference population of 7119044 inhabitants in 15 hospitals, 1403 patients were included in the study. Median age was 81 years p25-75, 76-87 years with 51.6% male patients. A LAAC procedure was performed in 114 patients (8.13%) at a median time of 5 2-10 months after discharge. After the procedure, the 114 patients treated with the LAAC strategy had a significantly better survival free from the combined event (66% versus 49%, p=0.016) and overall survival (82% versus 64%, p=0.002) at 24 months of follow-up in Kaplan-Meier analysis (Figure 1, panels A and B, respectively). After multivariate adjusting in Cox proportional hazards models including all unbalanced variables between the two management strategies and all independent predictors of events, this benefit was maintained for the LAAC strategy, with HR 0.65 0.46-0.92, p=0.016 for the combined event and HR 0.52 0.32-0.86, p=0.011 for mortality (Figure 2, panels A and B, respectively). Conclusions In anticoagulated patients with AF who survived a severe bleeding event in all public hospitals with LAAC program in a large European region in 2021-2022, and who were also eligible for anticoagulation with DOAC, only 8.13% of them were managed with a LAAC strategy. The LAAC strategy was associated with a significantly lower incidence of the combined event and all cause death in univariate and multivariate analysis compared with medical management.Figure 1.Kaplan Meier analysis Figure 2.Cox multivariate analysis