Focus of the Report: Oral anticoagulation (OAC) is standard care to reduce the risk of stroke in patients with atrial fibrillation (AF) and risk factors for stroke. Limitations of OAC therapy have spurred the development of nonpharmaceutical approaches to prevent stroke in patients with AF by occluding the left atrial appendage (LAA). LAA occlusion is achieved by either surgical excision or via the insertion of occlusion devices. This health technology assessment focuses on the AtriClip LAA Exclusion System.
Technology Description: The AtriClip LAA Exclusion System comprises a clip and a deployment device. The clip is placed at the base of the LAA during cardiac surgical procedures to exclude it from the left atrium. Exclusion of the LAA is thought to prevent formation of LAA thrombus, and cause electrical isolation of the LAA. AtriClip occlusion of the LAA is carried out via sternotomy, thoracotomy, thoracoscopy, or robotic assistance during concomitant cardiac surgery or an ablation procedure, or as a stand-alone thoracoscopic procedure—although this is an off-label use of the system.
Controversy: Some methods for LAA occlusion (e.g., stapled exclusion, excision with epicardial closure, and endocardial suture) may be technically demanding and carry a risk for bleeding, incomplete exclusion of the LAA, or residual blood flow. Percutaneous devices are the least invasive method, but they have a risk of incomplete closure, residual blood flow, and may require lifelong antiplatelet therapy (Romano and Bergquist, 2019). Controversial issues related to the clinical application of the AtriClip system include device placement safety, effectiveness in stroke prevention, and long-term safety.
Key Questions:
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Is the AtriClip LAA Exclusion System effective in excluding the left atrial appendage (LAA) and preventing stroke?
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How does the AtriClip System compare with other methods for LAA exclusion or removal?
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Is the AtriClip System safe?
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Have definitive patient selection criteria been identified for the AtriClip System?
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