Background: Left atrial appendage (LAA) closure is an alternative approach to chronic oral anticoagulation for the prevention of thromboembolism in patients with atrial fibrillation (AF).
Objectives: The purpose of this observational, prospective, multicenter clinical study is to compile real-world clinical outcome data for LAA closure in a nationwide and population-based registry.
Methods: 367 subjects at 8 institutions in Israel were included. Patients were followed after implantation, according to standard medical practice. Primary endpoints included procedural and long-term data including stroke/embolism, bleeding, and death.
Results: A total of 367 patients were included, with a mean age of 76 years and male predominance (63.2%). Leading indications for implant were history of gastrointestinal bleeding in 150 (40.8%) of patients, history intracranial bleeding in 115 (27.4%) of patients and high risk of bleeding in 112 (30.5%) of patients. Watchman (Boston Scientific) was implanted in 53.9% of patients, and Amplatzer (St Jude Medical) was implanted in 46.1% of patients. The overall rate of success was 95.3%. During one year follow up, the subsequent outcomes were found: ischemic stroke – 1(0.4%), peripheral emboli – 1(0.4%), major bleeding – 2 (0.7%), minor bleeding – 8 (2.8%). The one year mortality rate was 12.2% (41 patients).
Conclusions: Within the limitations of the present study, it can be concluded that LAA closure is safe and effective. The favorable effect of LAA closure on long-term bleeding should be considered when selecting a stroke prevention strategy for patients with nonvalvular AF.