Left atrial appendage occlusion with the Amplatzer Amulet device: full results of the prospective global observational study.

AIMS: To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer Amulet occluder. METHODS AND RESULTS: Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 +/- 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 +/- 1.6 and 3.3 +/- 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events ( /= 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). CONCLUSION: Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.