Left atrial appendage closure: First in man with the 4th generation WATCHMAN device.

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 4(th) 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 CHA2 DS2-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 4(th) 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.