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Individuals with atrial fibrillation often must balance the risk of stroke against the risk of excessive bleeding associated with taking anticoagulants. An air embolism can … ClotCare is a member organization of the Coalition to Prevent Deep Vein Thrombosis. Among procedures in which the WATCHMAN device was introduced into the heart, 98.1% were implanted successfully, with little to no leakage around the device, a rate of success higher than those reported in the pivotal trials and comparable to or better than smaller prior registry studies. Good news: When compared to warfarin therapy, the primary end point (absence of ischemic and hemorrhagic stroke, cardiovascular and unexplained death, and systemic embolism) was 32% lower in the Watchman group than in the warfarin-treated group; an outcome that met the non-inferiority criteria. Procedures to implant the WATCHMAN left atrial occlusion device had a high implant success rate and a low rate of in-hospital complications in an analysis of more than 38,000 procedures presented at the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC). Cardiovascular surgery was required in 2.2% of procedures; an end point NOT included in the primary analysis. Left atrial appendage occlusion--closure or just the beginning? The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. Most patients leave the hospital one day after the procedure. Follow @ACCinTouch, @ACCMediaCenter and #ACC20/#WCCardio for the latest news from the meeting. A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to … The Watchman LAA device has been linked to complications that can arise during the implantation procedure. Nearly 30% of patients had a low CHADS2 stroke risk of 1 which may warrant therapy with aspirin only. Although the number of procedures performed nationally was large, the median annual number of procedures was 30 per hospital and 12 per physician. The U.S. Food and Drug Administration (FDA) approved it in 2015 for reducing the risk of stroke in patients with the heart rhythm disorder atrial fibrillation. The Watchman Procedure is a very beneficial treatment to consider for those who have been diagnosed with AFib and want to reduce their risk of stroke. Left Atrial Appendage Closure devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) for that device’s FDA-approved indication and meet all of the conditions spe… Article Reviewed: Maisel WH. Benefits of WATCHMAN Device. Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism, CardioSource Plus for Institutions and Practices, Nuclear Cardiology and Cardiac CT Meeting on Demand, Annual Scientific Session and Related Events, ACC Quality Improvement for Institutions Program, National Cardiovascular Data Registry (NCDR), Congenital Heart Disease and     Pediatric Cardiology, Invasive Cardiovascular Angiography    and Intervention, Pulmonary Hypertension and Venous     Thromboembolism. A tiny blood clot the size of a … Warfarin therapy in the control group was not ideal in that more than 25% of patients never took or discontinued warfarin, and INRs were in range only 55% of the time (below target 29.6% and above target 15.4%). Rarer complications included stroke, occurring in 0.2% of cases, and death, which occurred in 0.2% of cases. Procedures in the registry also had a lower rate of major adverse events than was seen in clinical trials. The WATCHMAN device procedure is a minimally invasive procedure for patients with atrial fibrillation (AFib). Left atrial appendage occlusion--closure or just the beginning? The Centers for Medicare & Medicaid Services (CMS) covers percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development (CED) under 1862(a)(1)(E) of the Social Security Act with the following conditions:A. The most common complications were pericardial effusion (fluid buildup around the heart) requiring intervention, which occurred in 1.4% of cases, and major bleeding, which occurred in 1.3% of cases. WATCHMAN™ Device . Tr… “Any time you’re dealing with older and sicker patients, there’s always going to be concern and the risk of procedures is going to be higher,” Freeman said. WATCHMAN is a one‑time, minimally invasive procedure that reduces stroke risk and bleeding worry for life. “Patients getting this procedure in the real world are generally older and sicker than the patients who were in clinical trials, and it is reassuring to see that the procedural safety profile looks good.”. Your doctor has recommended or prescribed the WATCHMAN Implant for you because you have atrial fibrillation without significant heart valve disease, but with other risk factors that put you at an increased risk of stroke. 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