Device Embolization after Percutaneous Left Atrial Appendage Occlusion: A Systematic Review and Meta-analysis

Abstract Background Left atrial appendage occlusion (LAAO) is an established alternative for stroke prevention in patients with atrial fibrillation who are unsuitable for long-term anticoagulation. Although device embolization is rare, it represents a potentially catastrophic complication. Robust contemporary data on its incidence, timing, determinants, and clinical consequences are limited. Aims To provide contemporary, comprehensive estimates of device embolization after percutaneous LAAO and to identify factors associated with embolization risk and related mortality. Methods and Results We conducted a systematic review and meta-analysis of studies reporting device embolization after LAAO, as well as embolization-related mortality. Random-effects models were applied to estimate pooled embolization incidence and case-fatality rates. Subgroup analyses were performed by device type and device family. Exploratory meta-regression assessed sources of heterogeneity, including publication year and study sample size. Seventy-three studies, including seventy observational studies and three randomized controlled trials, involving 97,316 patients, were analysed. The pooled embolization incidence was 0.31% (95% confidence interval [CI] 0.19-0.50). Among studies reporting embolization timing, 80% of events occurred within 24 hours of implantation. Larger sample size and more recent publication year were independently associated with lower embolization risk. Device-specific incidence was lowest for Watchman FLX (0.02%) and Watchman 2.5 (0.12%), and higher for Amplatzer Cardiac Plug (1.02%) and Amulet (0.43%). Embolization-related mortality was 10.61% (95% CI 4.98-21.16), with no evidence of temporal improvement. Conclusions Device embolization after LAAO is infrequent and has declined substantially over time, likely reflecting technological advances and procedural experience. However, when embolization occurs, it remains associated with high mortality, underscoring the importance of careful device selection and optimized implantation strategies.