Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman

• Published in: Journal of the American College of Cardiology Vol. 70; no. 24; pp. 2976 - 2978
• Main Author: Saw, Jacqueline
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 19.12.2017; Elsevier Limited
• Subjects: Age; Anticoagulants; Atrial Appendage; Atrial Fibrillation; Cardiac arrhythmia; Cardiology; Diabetes; Enrollments; Heart failure; Humans; Hypertension; left atrial appendage; left atrial appendage closure; oral anticoagulation; Patients; Prevention; Stroke; stroke prevention; Studies; Warfarin; Watchman; United States > US; atrial fibrillation; Watchman; left atrial appendage; left atrial appendage closure; oral anticoagulation; stroke prevention; warfarin
• ISSN: 0735-1097; 1558-3597; 1558-3597
• DOI: 10.1016/j.jacc.2017.10.056

Amongst these, the most noteworthy criticism relates to the uncertain evidence supporting the safety and efficacy of LAAC for stroke prevention; this concern led to 3 extensive panel deliberations by the U.S. Food and Drug Administration (FDA) prior to final approval of the device in March 2015. [...]an in-depth discussion of this best-available clinical evidence is explored here. Furthermore, the robustness of PROTECT AF results was limited by the enrollment of patients with a CHADS2 score of 1, the number of subjects who did not receive protocol treatment per randomization, and a higher than expected hemorrhagic stroke rate in the warfarin group. [...]the FDA requested a second RCT to primarily confirm the safety and effectiveness of Watchman in a higher-risk cohort. [...]the safety and efficacy of stroke prevention with non-Watchman devices have not been established in RCT, and the proof-of-concept of LAAC may not extend to these devices due to differences in device design, safety and success of implant, residual device leak, and device-associated thrombosis. [...]large, prospective, real-world registries will need to confirm the long-term procedural safety and efficacy of these devices in commercial use.