Prospective multicenter study demonstrates high procedural success and safety with the SeaLA device in nonvalvular atrial fibrillation, indicating its feasibility for stroke prevention.
Objectives The clinical efficacy and safety of a novel left atrial appendage (LAA) occluder of the SeaLA closure system in patients with nonvalvular atrial fibrillation (NVAF) were reported. Background Patients with NVAF are at a higher risk of stroke compared to healthy individuals. Left atrial appendage closure (LAAC) has emerged as a prominent strategy for reducing the risk of thrombosis in individuals with NVAF. Methods A prospective, multicenter study was conducted in NVAF patients with a high risk of stroke. Results The LAAC was successfully performed in 163 patients. The mean age was 66.93 ± 7.92 years, with a mean preoperative CHA2DS2‐VASc score of 4.17 ± 1.48. One patient with residual flow >3 mm was observed at the 6‐month follow‐up, confirmed by TEE. During the follow‐up, 2 severe pericardiac effusions were noted, and 2 ischemic strokes were observed. Four device‐related thromboses were resolved after anticoagulation treatment. There was no device embolism. Conclusions The LAAC with the SeaLA device demonstrates encouraging feasibility, safety, and efficacy outcomes.
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Wang et al. (2024) studied this question.
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