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Impact of Risk Scores on Outcomes in Amplatzer Amulet Study
Quick Takes
- The Amplatzer Amulet left atrial appendage occluder significantly reduces stroke risk for patients with AF.
- The Amplatzer Amulet device reduces stroke risk similarly to oral anticoagulant therapy for patients with AF.
- Unlike anticoagulant use, the Amplatzer Amulet device was not associated with increased major bleeding risk.
Study Questions:
What is the impact of the CHA2DS2-VASc and HAS-BLED scores on ischemic and bleeding event risk among patients in the Amplatzer Amulet observational study?
Methods:
The authors used 2-year follow-up data from the prospective Amplatzer Amulet observational study of patients with atrial fibrillation (AF) undergoing implantation of the Amplatzer Amulet left atrial appendage occluder device. Patients were stratified by baseline risk according to the CHA2DS2-VASc (low risk <3, moderate risk 3-5, high risk >5) and HAS-BLED (low risk ≤3, high risk >3) scores. Patients were treated with aspirin for a minimum of 6 months along with clopidogrel as directed by the local site leads. The primary outcomes of interest were stroke and major bleeding (Bleeding Academic Research Consortium [BARC] ≥3).
Results:
The study consisted of 156 patients at low stroke risk, 715 at moderate stroke risk, and 215 at high stroke risk according to the CHA2DS2-VASc score. The annual rate of ischemic stroke was 1.1%, 2.0%, and 3.5%, respectively. As compared to the predicted rate without anticoagulation or other intervention, the Amulet device was associated with a relative stroke risk reduction of 56%, 69%, and 68%, respectively. Device-related thrombosis occurred in 0.7%, 1.5%, and 3.0% of patients at low, moderate, and high stroke risk, respectively. When stratified by bleeding risk, 619 were considered low risk, while 456 were high risk. Annual rates of major bleeding were 6.1% and 9.0%, respectively.
Conclusions:
The authors concluded that the Amplatzer Amulet left atrial appendage occluder device significantly reduced the risk of ischemic stroke compared to predicted, with a greater reduction among patients at higher risk of stroke.
Perspective:
The past few years have seen a growth in the use of left atrial appendage occluder device use for stroke prevention in AF. Appropriate patient selection has remained somewhat challenging. This observational study suggests that the Amplatzer Amulet device (currently not approved for use in the United States) is effective at reducing stroke risk in a similar magnitude as oral anticoagulant therapy (~60-70% relative risk reduction) without significantly elevated bleeding risk. While promising, enthusiasm should remain somewhat tempered until robust prospective, randomized data are available. Currently, most patients referred for left atrial appendage occluder placement have high bleeding risk that prevents anticoagulant use. Broadening the use of these devices will require further prospective studies in a broader population of patients.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Appendage, Atrial Fibrillation, Brain Ischemia, Hemorrhage, Risk, Secondary Prevention, Septal Occluder Device, Stroke, Thrombosis, Vascular Diseases
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