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Left atrial appendage closure: First in man with the 4th generation watchman device
Author(s) -
Ledwoch Jakob,
Franke Jennifer,
Gonzaga Maik,
Bertog Stefan,
Braut Annkathrin,
Hofmann Ilona,
Vaskelyte Laura,
Gafoor Sameer,
Reddy Vivek,
Sievert Horst
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26238
Subject(s) - medicine , atrial fibrillation , thrombus , warfarin , stroke (engine) , cardiology , surgery , pericardial effusion , prospective cohort study , mechanical engineering , engineering
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 CHADS 2 and CHA 2 DS 2 ‐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. © 2015 Wiley Periodicals, Inc.