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

ABSTRACT:

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 o

SUBMITTER: Hildick-Smith D 

PROVIDER: S-EPMC7421773 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature