Efficacy and safety of left atrial appendage occlusion for atrial fibrillation in patients with a history of prior intracranial hemorrhage: a systematic review and meta-analysis of observational studies.

Background: Left atrial appendage occlusion (LAAO) is emerging as alternative to anticoagulation in patients with nonvalvular atrial fibrillation (AF) to reduce ischemic stroke risk, particularly in those at high bleeding risk.

Objective: Assess LAAO efficacy and safety in patients with prior intracranial hemorrhage (ICH).

Methods: Systematic review was performed using PubMed, Embase, and Cochrane Central Register of Controlled Trials. Observational studies reporting outcomes of percutaneous LAAO for AF thromboembolic stroke prophylaxis in patients with prior ICH were included. Classic meta-analysis with risk ratios (RR) for outcomes with control groups and proportions for outcomes without controls were conducted.

Results: A total of 19 observational studies (13 retrospective and 6 prospective) involving 1671 patients met the inclusion criteria. The mean CHA₂DS₂-VASc score was 4.59 ± 0.46, and the mean HAS-BLED score was 3.66 ± 0.56. The mean follow-up duration was 19.1 ± 10.2 months, with follow-up ranging from 6 months to 3.7 years. LAAO was successfully implanted in 99.3% of patients. Periprocedural complications included ICH (0.4%), ischemic stroke (0.3%), pericardial effusion/cardiac tamponade (1.3%), device embolization (0.5%), and device-related thrombosis (0.1%). During follow-up, the incidence of ICH was 1.9%, ischemic stroke/TIA 2.9%, device-related thrombosis 1.4%, and all-cause mortality 3.3%. Using the CHA₂DS₂-VASc score, LAAO significantly reduced ischemic stroke risk (RR = 0.28, 95% CI 0.21-0.39). Similarly, using the HAS-BLED score, bleeding events were reduced (RR = 0.61, 95% CI 0.44-0.84).

Conclusion: LAAO is effective and relatively safe treatment for reducing ischemic stroke risk in nonvalvular AF patients with history of ICH.