A meta-analysis for efficacy and safety evaluation of transcatheter left atrial appendage occlusion in patients with nonvalvular atrial fibrillation.

OBJECTIVES

This meta-analysis was conducted to evaluate the efficacy and safety of transcatheter left atrial appendage (LAA) occlusion in patients with nonvalvular atrial fibrillation.

METHODS

The randomized controlled trials (RCT) or observational studies with any transcatheter LAA occlusion devices were searched in PubMed, Embase, and Cochrane library from inception to November 2015. The incidence rates from individual studies were combined to evaluate the procedural efficacy and safety, including all-cause death, cardiac/neurological death, stroke, transient ischemic attack (TIA), thrombosis, hemorrhagic complications, and pericardial effusion/tamponade.

RESULTS

Thirty-eight studies involving 3585 patients and 6 different occlusion devices were eligible for our inclusion criteria. The procedural failure rate for LAA closure was 0.02 (95% CI: 0.02-0.03). The all-cause mortality was 0.03 (95% CI: 0.02-0.03) and cardiac/neurological mortality was 0 (95% CI: 0.00-0.01). The stroke/TIA rate was estimated only 0.01 (95% CI: 0.01-0.01). The incidence of thrombus on devices was 0.01 (95% CI: 0.01-0.02). The major hemorrhagic complication rate was estimated 0.01 (95% CI: 0.00-0.01). Pericardial effusion/tamponade was estimated 0.02 (95% CI: 0.02-0.03). No heterogeneity was observed for above pooled estimates (I = 0). In devices subgroups analysis, the all-cause mortality and cardiac/neurological mortality of PLAATO group were the highest (P = 0.01 and P < 0.01 respectively), whereas the incidence of thrombus on devices in the ACP group was the highest (P < 0.01). In follow-up period subgroups analysis, there were significant differences in all-cause death, stroke/TIA, major hemorrhage, and pericardial effusion/tamponade events between the shorter and longer follow-up period subgroups (P < 0.05). However, the differences among the subgroups were numerically small.

CONCLUSIONS

the pooled data demonstrated that transcatheter LAA occlusion was effective and safe in the patients with nonvalvular atrial fibrillation who were not suitable for lifelong antithrombotic therapy.