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LAAO With the Amplatzer Amulet Device
Study Questions:
What is the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer Amulet occluder?
Methods:
The investigators recruited patients with atrial fibrillation (AF) eligible for LAAO to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transesophageal echocardiography (TEE) was undertaken 1-3 months post-LAAO. Implant and follow-up TEEs were evaluated by a CoreLab. The primary endpoint was a composite of ischemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. The Kaplan–Meier method was used to calculate event rates at 2 years post-procedure for mortality, the composite of ischemic stroke, systemic embolism, and cardiovascular death, and device-related thrombus (DRT).
Results:
A total of 1,088 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 (OACs). 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 TEE. DRT was seen in 1.6% of cases. Cardiovascular death or ischemic stroke occurred in 8.7% of patients at 2 years. The ischemic 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).
Conclusions:
The authors concluded that the ischemic stroke rate was reduced by 67% compared to the predicted risk with the Amplatzer Amulet device.
Perspective:
This observational cohort study reports that among patients with AF at high risk for both ischemic stroke and major bleeding, with a left atrial appendage occlusion (LAAO) with the Amplatzer occluder, the Clinical Events Committee-adjudicated ischemic stroke rate was 67% lower than for AF patients without OACs predicted by the baseline CHA2DS2-VASc score. The data suggest that Amulet occluder may allow for prevention of AF-related thromboembolic events without the need for long-term OAC. Additional prospective validation studies are indicated.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Noninvasive Imaging, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Echocardiography/Ultrasound
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Appendage, Atrial Fibrillation, Brain Ischemia, Echocardiography, Transesophageal, Embolism, Geriatrics, Hemorrhage, Platelet Aggregation Inhibitors, Secondary Prevention, Septal Occluder Device, Stroke, Thromboembolism, Thrombosis, Vascular Diseases
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