Clinical impact of peri-device leaks following percutaneous left atrial appendage occlusion: a systematic review and meta-analysis

Abstract

Abstract Background Peri-device leaks (PDL) are quite common after left-atrial appendage occlusion (LAAO) given the complex anatomy of LAA and surrounding structures. However, there is uncertainty regarding the prognostic implications of PDL. Material and methods Literature search was conducted in MEDLINE (PubMed), EMBASE, Scopus by ELSEVIER and Cochrane Central Register of Controlled Trials (CENTRAL) databases until 12 October 2021. A random-effects meta-analysis was performed to assess the effect of PDL presence on thromboembolism, all-cause mortality and major bleeding occurrence. Sensitivity analyses accounted for: i. the combined AF ablation performance, ii. the anticoagulation strategy followed after LAAO, iii. mean PDL size, and iv. mean female percentage. Results Of 699 articles initially retrieved, 46 were deemed eligible for this analysis (9,184 AF patients undergoing LAAO out of whom 1,446 had PDL). PDL presence was significantly associated with elevated odds of thromboembolism (FIgure 1) [pooled odds ratio (pOR) 3.05, 95% confidence interval (CI) 1.94–4.81; I2=37%]; yet PDL was not significantly linked with mortality (pOR=0.86, 95% CI: 0.25–2.95; I2=69%) and major bleeding rates (0.95, 95% CI: 0.27–3.35; I2=72%). AF-ablation did not significantly interact with the prognostic impact of PDL when performed in conjunction with LAAO (p for subgroup= 0.17). Antiplatelet discharge medication affected the prognostic value of PDL (p for subgroup <0.01 and =0.04, respectively). The prognostic significance of mean PDL size [peri-procedural or at 1–3 months or D(mean size)/D(time of follow-up)] on the risk of thromboembolism did not yield any significant association (p values >0.05). Meta-regression analysis of the mean female percentage demonstrated a non-significant trend towards a positive linear correlation between female percentage and risk of thromboembolism (p=0.10) (FIgure 2). Conclusions This is the first meta-analysis on the prognostic impact of PDL after LAAO. The findings highlighted a significant association between PDL and thromboembolic events, warranting careful post-LAAO device surveillance. Funding Acknowledgement Type of funding sources: None.