This review provides a critical appraisal of percutaneous left atrial appendage occlusion therapy, focusing on the FDA-approved WATCHMAN device for stroke prevention in atrial fibrillation.
Does percutaneous left atrial appendage occlusion prevent stroke and systemic embolism in patients with atrial fibrillation?
This review highlights the complex clinical trial history and FDA approval process of the WATCHMAN device, emphasizing that while procedural safety has improved, its efficacy compared to modern anticoagulation remains debated.
The authors review the current status of percutaneous left atrial appendage (LAA) occlusion therapy in patients with atrial fibrillation with the goal to prevent ischemic stroke and systemic embolism and to reduce oral anticoagulation associated bleeding. While we cover the historical and also surgical background, and all tested devices, the main focus rests on the single currently U.S. Food and Drug Administration (FDA) approved LAA occluder, the WATCHMAN device, and its approval process. The authors also give a critical appraisal beyond the review of mere facts, trying to put the current data into perspective.
Schellinger et al. (Sun,) conducted a review in Atrial fibrillation. Percutaneous left atrial appendage (LAA) occlusion (WATCHMAN device) was evaluated. This review provides a critical appraisal of percutaneous left atrial appendage occlusion therapy, focusing on the FDA-approved WATCHMAN device for stroke prevention in atrial fibrillation.