[Safety and efficacy of Laager left atrial appendage occlusion system in patients with nonvalvular atrial fibrillation: a prospective, multicenter clinical study].

Objective

To investigate the safety and efficacy of the Laager left atrial appendage occlusion system in stroke prevention in patients with atrial fibrillation.

Methods

This was a prospective, multicenter, non-randomized, single-arm cohort study with prespecified performance goal. Patients with nonvalvular atrial fibrillation were enrolled at 12 centers nationwide from November 2017 to April 2019. All enrolled patients had CHA2DS2-VASc scores of ≥2 for males and ≥3 for females, and were not suitable for long-term warfarin anticoagulation therapy. All patients underwent left atrial appendage occlusion with the Laager occlusion system and were followed up. The primary efficacy endpoint was the rate of successful left atrial appendage occlusion, defined as a residual shunt ≤3 mm on transesophageal echocardiography at 12 months postoperatively. The primary safety endpoint was the incidence of ischemic stroke.

Results

A total of 212 patients with nonvalvular atrial fibrillation were enrolled, with an age of (65.9±8.5) years, including 86 females (40.6%). Immediate procedural success was achieved in 210 patients (99.1%), and residual shunt >3 mm was observed in 2 patients post-procedure. At 12 months postoperatively, 187 patients completed transesophageal echocardiography (including 2 patients with residual shunt >3 mm post-procedure), and the success rate of left atrial appendage occlusion was 96.8% (181/187). The incidence of ischemic stroke was 0.5% (1/212).

Conclusion

The Laager left atrial appendage occlusion system demonstrates favorable safety and efficacy for stroke prevention in patients with nonvalvular atrial fibrillation.