Evaluation of the WATCHMAN left atrial appendage closure device

Abstract

Left atrial appendage device occlusion for the preventions of systemic thromboembolism and stroke represents a major breakthrough in the field of cardiovascular disease. The wide prevalence of atrial fibrillation with devastating consequences of thromboembolic stroke as a result of thrombus arising from the left atrial appendage has led to the development of transcatheter and surgical based occlusion devices. Though this device is yet to be formally approved for a clinical indication in the USA, the WATCHMAN appendage occlusion device remains the most rigorously examined and studied of all transcatheter-based devices in this space. This review will focus on the needs assessment in this space, the technology of the current WATCHMAN device, trials and studies looking at safety and efficacy, specific patient populations who might benefit as well as future perspectives.

Keywords::

• atrial fibrillation
• left atrial appendage
• left atrial appendage occlusion
• oral anticoagulant
• PROTECT AF
• WATCHMAN

Financial & competing interests disclosure

D Holmes and the Mayo clinic have a financial interest in the technology related to the WATCHMAN device which has been licensed to Atritech. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Atrial fibrillation is the most common arrhythmia encountered in clinical practice and thromboembolism leading to stroke is its most devastating consequence.

• Oral anticoagulants have been the mainstay of stroke prophylaxis but are limited by bleeding issues, cost and compliance.

• Left atrial appendage (LAA) has been shown to be the source of clot formation in patients with atrial fibrillation.

• The WATCHMAN LAA occlusion device is the only device in this space that has randomized data supporting its efficacy and noninferiority when compared to medical therapy for closure of the LAA in patients with atrial fibrillation.

• The PROTECT atrial fibrillation trial, the only randomized trial of LAA occlusion devices, has shown noninferiority of the WATCHMAN device compared to oral anticoagulation.

Notes