Key result
Pooled registry data of 1047 patients showed the Amplatzer Cardiac Plug achieved a 97.3% procedural success rate and a 0.9% stroke rate at 13 months for stroke prophylaxis in atrial fibrillation.
Why the study?
Does percutaneous left atrial appendage occlusion using Amplatzer devices prevent stroke in patients with non-valvular atrial fibrillation who are high risk for anticoagulation?
Does percutaneous left atrial appendage occlusion using Amplatzer devices prevent stroke in patients with non-valvular atrial fibrillation who are high risk for anticoagulation?
The Amplatzer Cardiac Plug 1 and Amulet devices offer a promising, effective, and safe alternative for stroke prophylaxis in patients with non-valvular atrial fibrillation who are ineligible for oral anticoagulation, though randomized controlled trial data are still needed.
High procedural success observed with Amplatzer LAAO; leaves open comparative efficacy versus anticoagulation in high-risk AF.
Percutaneous left atrial appendage (LAA) occlusion has emerged as an exciting and effective modality for stroke prophylaxis in patients with non-valvular atrial fibrillation who are deemed too high risk for anticoagulation with warfarin or newer anticoagulants. The Amplatzer devices have been used in LAA occlusion for more than a decade, starting with off label use of an atrial septal occluder device for LAA occlusion. This was followed by introduction of a dedicated Amplatzer cardiac plug (ACP) 1 for LAA occlusion, and more recently, the second generation Amulet device, with reported better stability enhancing features, has been introduced. Both these devices are widely used outside the United States, however in the US only the WATCHMAN device has been FDA approved. Unlike the WATCHMAN device, where the evidence is continuously building as the data from two pivotal randomized controlled trials are emerging, most of the evidence for ACP devices is from pooled multicenter registry data. In this article, we review the device design, implantation techniques and the most recently published evidence for both the Amplatzer cardiac plug 1 and the newer Amulet device. Our goal is to summarize the most recent literature and discuss the current role of the Amplatzer devices in the exciting and rapidly growing field of percutaneous LAA occlusion.
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Parashar et al. (2015) conducted a review in Non-valvular atrial fibrillation. Amplatzer Cardiac Plug 1 and Amulet devices was evaluated. Pooled registry data of 1047 patients showed the Amplatzer Cardiac Plug achieved a 97.3% procedural success rate and a 0.9% stroke rate at 13 months for stroke prophylaxis in atrial fibrillation.
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