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Observational Study
. 2020 Aug 7;41(30):2894-2901.
doi: 10.1093/eurheartj/ehaa169.

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

David Hildick-Smith  1 , Ulf Landmesser  2 , A John Camm  3 , Hans-Christoph Diener  4 , Vince Paul  5 , Boris Schmidt  6 , Magnus Settergren  7 , Emmanuel Teiger  8 , Jens Erik Nielsen-Kudsk  9 , Claudio Tondo  10
Affiliations
Observational Study

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

David Hildick-Smith et al. Eur Heart J. .

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 of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 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%.

Keywords: Antithrombotic treatment; Bleeding; Death; LAA closure; Stroke.

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Figures

Figure 1
Figure 1
Flow chart of patient follow-up. Patients were considered enrolled when an Amulet occluder implant was attempted. The follow-up rate at 2 years was 94.2%.
Figure 2
Figure 2
Utilization of antithrombotic therapy through 2 years. Patients were often discharged on dual (57.7%) or single (22.4%) antiplatelet therapy. Oral anticoagulation was prescribed in 11.2% of patients at discharge. Patients often received single antiplatelet therapy or no antithrombotic medications beginning 1–3 months post-implant and were maintained on this regimen over long-term follow-up.
Take home figure
Take home figure
Patients were prospectively enrolled and followed for 2 years, with clinical events independently adjudicated by a clinical events committee. In a population of atrial fibrillation patients mostly on antiplatelet therapy alone, the observed ischaemic stroke rate of 2.2%/year (95% confidence interval 1.6–2.9%) was reduced 67% (95% confidence interval 57–76%) compared to the 6.7%/year predicted by baseline CHA2DS2-VASc score for atrial fibrillation patients without anticoagulants.
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