The WATCHMAN device for stroke prophylaxis in atrial fibrillation: an evolving niche.

Atrial fibrillation is associated with a markedly increased risk of thromboembolic stroke. At present, lifelong antithrombotic therapy with warfarin or a novel oral anticoagulant is indicated for prophylaxis in the majority of patients. Left atrial appendage occlusion devices have been developed as an alternative to these agents, aiming to avoid issues around consistency of anticoagulation, bleeding risk, and drug-related side effects. The best evidence is available for Boston Scientific's WATCHMAN device. The safety and efficacy of WATCHMAN and other similar devices have been questioned, although the increasing body of evidence supports a role in selected settings. A recently updated randomized controlled trial of WATCHMAN (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients with Atrial Fibrillation [PROTECT-AF]) demonstrates its noninferiority to warfarin and suggests an advantage in terms of functional outcome for patients, with superior net clinical benefit 6 to 9 months after starting treatment. The procedural risk associated with device implantation remains substantial, although improving device design and increasing operator experience means that this should decrease in the future. As the body of data and overall experience around WATCHMAN grow, it may come to be recognized as the best option in selected patients.