Objectives To evaluate the feasibility and safety of the fourth generation WATCHMAN device. Background The WATCHMAN left atrial appendage (LAA) closure device has been shown to be non-inferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with non-valvular atrial fibrillation. A new (fourth) generation of the WATCHMAN device was designed to facilitate easier delivery and improve safety. Methods We conducted a prospective, non-randomized study of LAA closure with use of the 4th generation WATCHMAN device in 36 patients with non-valvular atrial fibrillation. Follow-up was performed at 45 days, 6 months and 12 months following implantation. Results The mean age of the population was 73 ± 6 years and 67% were male. The mean CHADS2 and CHA2DS2-VASc Score were 2.5 and 4.5, respectively. The device was implanted successfully in 34/36 (94%). No serious hospital complications related to the device or procedure occurred. During 12 month follow-up, three ischemic strokes (8%), one hemorrhagic stroke (3%), one TIA (3%) and three deaths (9%) occurred. Device-associated thrombus formation was detected in one patient (3%) during six-month follow-up and was treated successfully with low molecular weight heparin. Conclusions LAA closure with the 4th generation WATCHMAN device is feasible and safe. New technical features may contribute to a better performance of the occluder, particularly regarding the risk of pericardial effusions.
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© 2015 Wiley Periodicals, Inc.
- atrial fibrillation
- left atrial appendage closure
- stroke prevention