A trial fibrillation (AF) is the most prevalent cardiac arrhythmia-found in 1% to 2% of the general population.1 It is also a major cause of ischemic stroke. Patients with AF are 4 to 5 times more likely to have an ischemic stroke.2 Their annual rate of stroke is 5%, which accounts for 15% of all strokes in the United States.2,3 The left atrial appendage (LAA) is a trabeculated cul-de-sac that is responsible for more than 90% of thrombus formations in AF patients. 4 Because of these findings, LAA closure devices have been developed as an alternative to oral anticoagulant (OAC) therapy.The first generation of endocardial LAA occluders comprised 3 devices: the Percutaneous LAA Transcatheter Occlusion system (Plaato) (ev3 Inc.; Plymouth, Minn), the Watchman Left Atrial Appendage Closure Device (Boston Scientific Corporation; Natick, Mass), and the Amplatzer Cardiac Plug (ACP) device (St. Jude Medical, Inc.; Minneapolis, Minn). Plaato withdrew from the market in 2006, and the ACP is not yet available for commercial use in the U.S.
5The newer generation of endocardial LAA occluders comprises the WaveCrest ® LAA Occlusion System (Coherex Medical, Inc.; Salt Lake City, Utah), the LAmbre Left Atrial Appendage Occluder (Lifetech Scientific [Shenzhen] Co., Ltd.; Shenzhen, PRC), and the Ultrasept LAA Closure Device (Cardia Inc.; Eagan, Minn), none of which is available for commercial use in the U.S. 6 If you prefer to perform LAA closure through an epicardial approach, the Lariat ® Suture Delivery Device (SentreHeart, Inc.; Redwood City, Calif ) and the Aegis device (Aegis Medical Innovations Inc.; Vancouver, Canada) will permit that. But the Aegis device is available for investigational use only.
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The Watchman Clinical Trial ExperienceThe Watchman LAA Closure Technology for Embolic Protection in Patients with Atrial Fibrillation (Protect AF) clinical trial was designed to examine the safety and efficacy of the Watchman device in patients with nonvalvular AF who were eligible for warfarin therapy and had a CHADS 2 stroke-risk score of 1 or greater.7 From February 2005 through June 2008, 707 patients at 59 centers in the U.S. and Europe were enrolled in the Protect AF study. The patients were randomly assigned in a 2:1 ratio to percutaneous closure of the LAA and subsequent discontinuation of warfarin (n=463), or to warfarin treatment. All patients were monitored for 12 months. The Protect AF trial showed that the Watchman LAA Closure is noninferior to warfarin for the combined endpoint of stroke, systemic embolism, and death, and it is a safe and effective alternative to OAC therapy in decreasing the risk of AF-related stroke. 7,8 The Protect AF trial showed a high rate (8.7%) of implant device-related sequelae, including perforations and pericardial effusions, and had a procedural failure rate of around 9%. However, most of these events occurred during the early stages of the trial, and procedural failure rates declined as surgeons became more experienced with the operation. According to the Protect AF trial, the U.S....