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. This is a well-designed trial with pragmatic features that lends support to consideration of LAAC in high-risk AF patients, particularly those who may have a contraindication to OAC. The study was limited to assessing adverse events that occurred in the hospital; it is possible that additional complications could emerge later. The Left Atrial Appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium. The study, which included data from nearly all procedures conducted in the U.S. between 2016-2018, revealed that procedural success and complications compared favorably with randomized trials as the use of WATCHMAN expanded across hundreds of hospitals. Copyright 2000-2018 by ClotCare. This device is approved by the FDA to reduce the risk … The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. As the procedure … 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 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 … If you or a loved one are living with a heart rhythm … © 2021 American College of Cardiology Foundation. This study was simultaneously published online in the Journal of the American College of Cardiology at the time of presentation. Contact: Nicole Napoli, nnapoli@acc.org, 202-375-6523. The WATCHMAN device procedure is a minimally invasive procedure for patients with atrial fibrillation (AFib). An air embolism can … You may have an air embolism (air or bubbles block a blood vessel). Watchman device insertion complications can lead to life-threatening injuries or death. With all medical procedures there are … 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… One procedure used to close the left atrial appendage is a self-expanding, parachute-shaped device with an attached woven plastic cap called the WATCHMAN™ device. The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. WATCHMAN effectively reduces the risk of stroke by permanently closing off the LAA to keep blood clots from escaping. Risk … Individuals with atrial fibrillation often must balance the risk of stroke against the risk of excessive bleeding associated with taking anticoagulants. Device breakage can puncture a patient’s heart … Risks of Watchman Device Like any other procedure, even the Watchman Device also has specific risks associated with it, namely Damage to vessels in the leg Since the procedure is done through the leg vessels, there is a small chance of injury or damage to the vessels. Rarer complications included stroke, occurring in 0.2% of cases, and death, which occurred in 0.2% of cases. Thrombosis was identified on the device in 15 (3.7%) of patients and ischemic stroke was 50% higher in the device group (3% vs 2%), The need for ongoing anticoagulation meant that device recipients received warfarin for at least 45 days followed by aspirin indefinitely and clopidogrel for 6 months. Fewer than 100 patients with the device were followed for 2 or more years and the relatively small size of the study resulted in a wide 95% confidence interval (relative risk of 0.68; 95% credible interval of 0.37 to 1.41). “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™ Device . Patients are eligible for a WATCHMAN device if they have atrial fibrillation that is not caused by valve problems, face a moderate or high risk of stroke and cannot take anticoagulant … SAN FRANCISCO, CA—In the 3-and-a-half years after the Watchman device (Boston Scientific) was approved for left atrial appendage (LAA) occlusion in high-risk patients with atrial fibrillation, … 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. 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. Procedures in the registry also had a lower rate of major adverse events than was seen in clinical trials. “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.”. Although the procedure is minimally-invasive and effective, some people may experience complications during or following the procedure. The WATCHMAN implant is a one-time, minimally invasive procedure that can reduce your risk of stroke. Warfarin was restarted for clinical reasons in 10% of patients. Although you may take an anticoagulant (blood thinner) to reduce the risk … In addition to the general risks associated with any surgery, Watchman procedure presents its own risks and concerns. Patients with atrial fibrillation (AFib) who cannot be treated with the blood thinner warfarin due to bleeding concerns can now receive a minimally invasive procedure called the Watchman™ implant to reduce their risk of stroke. While WATCHMAN reduces the risk of stroke in people with afib, there are risks to receiving a WATCHMAN implant. The research is based on data from the NCDR Left Atrial Appendage Occlusion (LAAO) Registry, a national database capturing data on WATCHMAN procedures that also serves as the FDA’s post-marketing surveillance study and meets the reimbursement requirements for the Centers for Medicare and Medicaid Services. Seven percent of procedures were canceled or aborted on the day of the procedure. 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. For more, visit acc.org. The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. Cautions: The reviewer points out several key considerations that argue for caution in adopting this approach for preventing stroke in atrial fibrillation: ClotCare is a 501(c)(3) non-profit organization generously supported by your tax-deductible donations and grants from our industry supporters. Learn more about options and devices available for closure of the LAA from the nation's top ranked heart center, Cleveland Clinic. ClotCare complies with the HONcode standard for trustworthy healthinformation: verify here. Overall the watchman procedure is a relatively safe procedure. Cardiovascular surgery was required in 2.2% of procedures; an end point NOT included in the primary analysis. However, any damage to this can be rectified quickly. Talk with your doctor about whether the procedure is right for your … The Watchman LAA device has been linked to complications that can arise during the implantation procedure. The procedure is minimally invasive. Although the number of procedures performed nationally was large, the median annual number of procedures was 30 per hospital and 12 per physician. N Engl J Med. They also had a higher risk of stroke (an average CHA2DS2-VASC score of 4.6), and 70% had previously experienced clinically relevant bleeding, putting them in a higher risk category than most patients in the pre-marketing trials. The device is implanted in the left atrial appendage in order to block the main source of thrombi in atrial fibrillation. No matter what treatment pathways you and your team decide to follow, the conversations you have together now and in the future are essential for protecting your health and ensuring you are feeling well and able to enjoy your life. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care and offers cardiovascular accreditation to hospitals and institutions. Left atrial appendage occlusion--closure or just the beginning? WATCHMAN Implant. At Orlando Health, our doctors are trained in the newest surgical techniques and treatments to offer our patients more options for improved health and quality of life. BOSTON, MA—Patients who develop thrombus on the Watchman left atrial appendage (LAA) closure device (Boston Scientific) carry a greater risk of stroke or systemic embolism, and there … ACC.20/WCC will take place March 28-30, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Left atrial appendage occlusion--closure or just the beginning? Implantation was associated with several complications and implantation was successful in 408 of 449 (90.9%) attempts but 12.3% of patients had serious complications (pericardial effusion in approximately 5%, acute ischemic stroke in 1.1%, surgical removal due to embolization or sepsis in 4 patients. Henry I. Bussey, Pharm.D., FCCP, FAHA During the Watchman clinical trials, a small percentage of people suffered stroke, clots around the device, or fluid buildup (pericardial effusion) in the membrane surrounding the heart. ClotCare is a member organization of the Coalition to Prevent Deep Vein Thrombosis. Implantation was associated with several complications and implantation was … The findings were generally reassuring.”. The good news is that the risk of complication is small, and has continued to decrease as the cardiologists performing and planning the procedure have continued to gain experience and make the procedure … This concise review of the data regarding the new Watchman device presents the good news and appropriate cautions. Bleeding, infection, or injury to the heart or blood vessels may occur with these procedures. Reduces stroke by preventing blood clots from forming in the left atrial appendage. Click here to learn more about the Coalition to Prevent Deep Vein Thrombosis and DVT Awareness Month, which is held each March. The WATCHMAN implant closes off an area of the heart called the left atrial appendage to keep harmful blood clots from the LAA from entering the blood stream and potentially causing a stroke. “We also did not see an increase in adverse events as the procedure was rolled out more widely in lower-volume hospitals. Boston Scientific estimates the complication rate of its Watchman device is about 4%, and … I also agree that, like other cardiac procedures, the Watchman procedure is not risk-free. Blood collects there and can form clots in the LAA and atria. With all of this information, its likely you have at least started discussing treatment options available for managing your Afib symptoms and for reducing your stroke risk. In my experience, the risks of the procedure are less than other types of common procedures for atrial fibrillation, such as a catheter … “The Watchman device, which has been implanted in more than 90,000 patients globally, continues to demonstrate a reduced risk of stroke and has shown reduced bleeding post-procedure … All rights reserved. What are the risks of the Watchman implant? Tr… 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. Article Reviewed: Maisel WH. A tiny blood clot the size of a … But … The WATCHMAN is a permanent implant that closes off part of your heart where blood clots … All rights reserved. The second trial of Watchman v warfarin, called the PREVAIL study, showed lower complication rates (good), but higher rates of ischemic stroke (the kind caused by clots) in the … WATCHMAN is a device that blocks a portion of the heart known as the left atrial appendage to prevent blood clots from forming there, where they can exit the heart and cause strokes. I recently recommended an operation for a 72-year-old man with atrial fibrillation, an irregular heart rhythm that leads to an increased risk of having a stroke. Cardiovascular surgery was required in 2.2% of procedures; an end point NOT included in the primary analysis. As the professional home for the entire cardiovascular care team, the mission of the College and its 54,000 members is to transform cardiovascular care and to improve heart health. Keep these conversations going! 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%). 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 two procedure- or device-related deaths in the LAAC group (without an increased overall risk … The researchers also plan to further investigate the relationship between procedural volume and outcomes, as well as the impact of different strategies for managing anticoagulant and antiplatelet medications around the time of surgery and during follow-up. “There’s clearly a lot of enthusiasm in the post-market setting in the U.S. to undertake this procedure as an alternative to blood thinners for these patients, who can be stuck between a rock and a hard place because they are at risk for atrial fibrillation-related stroke but have had prior bleeding or other problems with blood thinners,” said James V. Freeman, MD, a cardiac electrophysiologist and associate professor of medicine at Yale School of Medicine and the study’s lead author. 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. Roughly the size of a quarter, the WATCHMAN device is a type of AFib treatment that is performed to reduce the risk … Most patients leave the hospital one day after the procedure. clotcare.com/clotcare/aspirinclopidogrelwarfarinafib.aspx, clotcare.com/clotcare/warfarinvsaspirinforafib.aspx, Click here to view full list of new postings, Key topics discussed on ClotCare include: Blood Clots | Deep Vein Thrombosis (DVT) | Pulmonary Embolism (PE) | Atrial Fibrillation (A. Fib or AF) | Heart Attack | Stroke | Transient Ischemic Attack (TIA) | Mini Stroke | Bleeding Complications | Vascular Surgery | Surgical Blood Clot Removal | Warfarin | Coumadin | Lovenox | Low Molecular Weight Heparin (LMWH) | Heparin | Anticoagulants | Plavix | Aspirin | Antiplatelets | Blood Thinners. Patients in the registry will be followed actively to allow for analysis of outcomes at six months, one year and two years. I have studied the evidence—not the spin–for left atrial appendage occlusion and this much is clear: it is an invasive procedure with a high risk of complications, and when it was compared … The implantation process is accomplished by transeptal venous catheter insertion. 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 … (Note that two recent trials have shown that aspirin or aspirin and clopidogrel is NOT safer than warfarin therapy. Benefits of WATCHMAN Device. The study was funded by the National Heart, Lung and Blood Institute and the NCDR Registry. 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). The study offers insights into how real-world implementation of the device compares to findings from pre-market clinical trials. 2009 Jun 18;360(25):2601-3. Recovery tends to be quicker and easier than with open surgery. Risks of the Watchman Procedure As with any invasive procedure there are risks associated. Researchers analyzed data from 38,158 patients who underwent WATCHMAN implantation procedures performed by 1,318 physicians at 495 hospitals between 2016-2018 in the U.S. With an average age of 76 years, patients in the registry were, on average, two to five years older than those who had participated in WATCHMAN pivotal clinical trials that led to FDA approval of the device. The neurological team typically advises that Watchman implantation be delayed for a few months after the bleed, and they use MRI to ascertain whether some patients are at such high bleeding risk … Follow @ACCinTouch, @ACCMediaCenter and #ACC20/#WCCardio for the latest news from the meeting. WATCHMAN is a one‑time, minimally invasive procedure that reduces stroke risk and bleeding worry for life. You do not have to have your chest opened. 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