Health Problem: Atrial fibrillation (AF) is a supraventricular, accelerated heart rhythm (tachyarrhythmia) characterized by uncoordinated atrial activation that leads to inefficient, irregular atrial contraction. Oral anticoagulation (OAC) is standard care to reduce the risk of stroke in patients with AF and risk factors for stroke. The 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).
Technology Description: The rationale for occluding the LAA is based on findings that atrial thrombi are located within the LAA in 89% of patients with nonvalvular atrial fibrillation (NVAF), in 78% of non-anticoagulated patients with NVAF, and in 44% of patients with valvular AF. Percutaneous LAA closure or occlusion involves the use of a percutaneously inserted, permanently implanted device to close the LAA or of a temporarily inserted device to assist in the permanent ligation of the LAA.
Controversy: Controversial issues related to the clinical application of percutaneous LAA closure devices include optimal patient selection, LAA anatomical considerations, device and procedural safety, effectiveness in stroke prevention versus newer OACs, and long-term safety, efficacy under ideal conditions, and effectiveness in real-world conditions.
Key Questions:
- Is percutaneous LAA closure effective in reducing the risk of stroke in patients with AF compared with alternative treatment modalities?
- Are there any demonstrated differences in safety and efficacy among the currently available percutaneous LAA closure devices?
- Is percutaneous LAA closure a safe procedure?
- Have definitive patient selection criteria been established for percutaneous LAA closure in patients with AF and risk of stroke?
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