Document Detail

Initial worldwide experience with the WATCHMAN left atrial appendage system for stroke prevention in atrial fibrillation.
MedLine Citation:
PMID:  17397680     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: This study assessed the feasibility of implanting a device in the left atrial appendage (LAA) in patients with atrial fibrillation (AF) to prevent thromboembolic stroke. BACKGROUND: Meta-analyses confirmed that in cases of left atrial thrombus in nonrheumatic AF patients approximately 90% of them are in the LAA. METHODS: The WATCHMAN Left Atrial Appendage System (Atritech Inc., Plymouth, Minnesota) is a nitinol device implanted percutaneously to seal the LAA. Patients were followed by clinical and transesophageal echocardiography at 45 days and 6 months with annual clinical follow-up thereafter. RESULTS: Sixty-six patients underwent device implantation. Mean follow-up was 740 +/- 341 days. At 45 days, 93% (54 of 58) devices showed successful sealing of LAA according to protocol. Two patients experienced device embolization, both successfully retrieved percutaneously. No embolizations occurred in 53 patients enrolled after modification of fixation barbs. There were 2 cardiac tamponades, 1 air embolism, and 1 delivery wire fracture (first generation) with surgical explantation but no long-term sequelae for the patient. Four patients developed a flat thrombus layer on the device at 6 months that resolved with additional anticoagulation. Two patients experienced transient ischemic attack, 1 without visible thrombus. There were 2 deaths, neither device related. Autopsy documented a stable, fully endothelialized device 9 months after implantation. No strokes occurred during follow-up despite >90% of patients with discontinuation of anticoagulation. CONCLUSIONS: Preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible. A randomized study is ongoing comparing oral anticoagulation with percutaneous closure.
Peter B Sick; Gerhard Schuler; Karl Eugen Hauptmann; Eberhard Grube; Steve Yakubov; Zoltan G Turi; Gregory Mishkel; Steve Almany; David R Holmes
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2007-03-21
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  49     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-02     Completed Date:  2007-05-24     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1490-5     Citation Subset:  AIM; IM    
Krankenhaus der Barmherzigen Brüder, Regensburg, Germany.
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MeSH Terms
Aged, 80 and over
Atrial Appendage*
Atrial Fibrillation / complications*
Feasibility Studies
Follow-Up Studies
Middle Aged
Pilot Projects
Prostheses and Implants*
Prosthesis Design
Stroke / etiology*,  prevention & control*
World Health
Comment In:
J Am Coll Cardiol. 2007 Aug 28;50(9):914; author reply 914-5   [PMID:  17719480 ]
J Am Coll Cardiol. 2007 Apr 3;49(13):1496-7   [PMID:  17397681 ]

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