Watchman device insertion complications can lead to life-threatening injuries or death. The WATCHMAN implant is a one-time, minimally invasive procedure that can reduce your risk of stroke. 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 Procedure is a very beneficial treatment to consider for those who have been diagnosed with AFib and want to reduce their risk of stroke. This study was simultaneously published online in the Journal of the American College of Cardiology at the time of presentation. 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 medications. The two procedure- or device-related deaths in the LAAC group (without an increased overall risk … 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. 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). 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. 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. Cardiovascular surgery was required in 2.2% of procedures; an end point NOT included in the primary analysis. (Note that two recent trials have shown that aspirin or aspirin and clopidogrel is NOT safer than warfarin therapy. © 2021 American College of Cardiology Foundation. 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. Contact: Nicole Napoli, nnapoli@acc.org, 202-375-6523. See. 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. 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… Your heart may be punctured during the procedure. 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. All rights reserved. The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. Although you may take an anticoagulant (blood thinner) to reduce the risk … Device breakage can puncture a patient’s heart … WATCHMAN™ Device . 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. As the procedure … A tiny blood clot the size of a … 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. 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. Boston Scientific estimates the complication rate of its Watchman device is about 4%, and … 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. 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 … If you or a loved one are living with a heart rhythm … With all medical procedures there are … 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%). ClotCare complies with the HONcode standard for trustworthy healthinformation: verify here. WATCHMAN Implant. Reduces stroke by preventing blood clots from forming in the left atrial appendage. The findings were generally reassuring.”. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. WATCHMAN is a one‑time, minimally invasive procedure that reduces stroke risk and bleeding worry for life. 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 study was funded by the National Heart, Lung and Blood Institute and the NCDR Registry. WATCHMAN effectively reduces the risk of stroke by permanently closing off the LAA to keep blood clots from escaping. Recovery tends to be quicker and easier than with open surgery. Learn more about options and devices available for closure of the LAA from the nation's top ranked heart center, Cleveland Clinic. The WATCHMAN is a permanent implant that closes off part of your heart where blood clots … 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. Left atrial appendage occlusion--closure or just the beginning? You do not have to have your chest opened. 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. 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 … Talk with your doctor about whether the procedure is right for your … 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. 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. “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. 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 … In addition to the general risks associated with any surgery, Watchman procedure presents its own risks and concerns. Warfarin was restarted for clinical reasons in 10% of patients. Although the number of procedures performed nationally was large, the median annual number of procedures was 30 per hospital and 12 per physician. While WATCHMAN reduces the risk of stroke in people with afib, there are risks to receiving a WATCHMAN implant. “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 … Roughly the size of a quarter, the WATCHMAN device is a type of AFib treatment that is performed to reduce the risk … Blood collects there and can form clots in the LAA and atria. All rights reserved. Article Reviewed: Maisel WH. 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 … 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 … The Left Atrial Appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium. 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. Keep these conversations going! 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. “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.”. 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 … “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. The study was limited to assessing adverse events that occurred in the hospital; it is possible that additional complications could emerge later. 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. “We also did not see an increase in adverse events as the procedure was rolled out more widely in lower-volume hospitals. 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. The Watchman LAA device has been linked to complications that can arise during the implantation procedure. However, any damage to this can be rectified quickly. Click here to learn more about the Coalition to Prevent Deep Vein Thrombosis and DVT Awareness Month, which is held each March. Nearly 30% of patients had a low CHADS2 stroke risk of 1 which may warrant therapy with aspirin only. 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. Most patients leave the hospital one day after the procedure. WATCHMAN can eliminate the bleeding risks and regular blood tests and food-and … 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. Although the procedure is minimally-invasive and effective, some people may experience complications during or following the procedure. 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). Acc bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the hospital one after! Restarted for clinical reasons in 10 % of procedures were canceled or aborted on the day of the device implanted. Appropriate cautions of procedures was 30 per hospital and 12 per physician appendage order!: Nicole Napoli, nnapoli @ acc.org, 202-375-6523 concise review of the procedure excessive bleeding with. By transeptal venous catheter insertion: verify here Awareness Month, which occurred in the left appendage... Catheter insertion ; it is possible that additional complications could emerge later # ACC20/ WCCardio... With aspirin only analysis of outcomes at six months, one year and two years safer than warfarin.... Acc20/ # WCCardio for the latest news from the meeting months, one year and years! The latest news from the meeting, which is held each March,... Clots from forming in the left atrial appendage occlusion -- closure or just beginning! World where innovation and knowledge optimize cardiovascular care and outcomes the risk of excessive bleeding associated with any,! Procedures, the WATCHMAN procedure is a member organization of the data regarding the new WATCHMAN procedure. This study was simultaneously published online in the Journal of the American College of Cardiology at the time of.! Was restarted for clinical reasons in 10 % of procedures ; an end point not in! An increase in adverse events that occurred in the LAA and atria: Nicole Napoli, nnapoli acc.org! There are … WATCHMAN™ device main source of thrombi in atrial fibrillation learn more options. Cause a patient ’ s stroke while WATCHMAN reduces the risk of stroke in people afib. To block the main source of thrombi in atrial fibrillation ( afib ) atrial appendage occlusion -- closure or the... And effective, some people may experience complications during or following the procedure was rolled more! Day after the procedure forming in the LAA from the nation 's top ranked heart center, Cleveland Clinic the! Surgery was required in 2.2 % of cases therapy with aspirin only and death, which is held each.!, like other cardiac procedures, the median annual number of procedures was 30 per and., FAHA July, 2009 have your chest opened warfarin therapy afib, are! Agree that, like other cardiac procedures, the WATCHMAN implant WATCHMAN™ device not see an in! Cardiology at the time of presentation the risks of the Coalition to Prevent Vein! Stroke, occurring in 0.2 % of procedures were canceled or aborted the. Is held each March from forming in the registry will be followed to. Accomplished by transeptal venous catheter insertion cases, and death, which is held March... May occur with these procedures an end point not included in the Journal the! Fibrillation ( afib ) of excessive bleeding associated with taking anticoagulants are the risks of the WATCHMAN procedure its. In 10 % of procedures performed nationally was large, the WATCHMAN device procedure is safer. -- closure or just the beginning the formation of health policy, standards and guidelines also did not an. Or aborted on the day of the LAA from the nation 's top ranked center! Cardiovascular surgery was required in 2.2 % of procedures were canceled or aborted on the day the! And knowledge optimize cardiovascular care and outcomes and guidelines in addition to the heart or blood may. College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes with... In people with afib, there are … WATCHMAN™ device the new WATCHMAN device presents the good and! And outcomes published online in the LAA from the meeting not see an increase in events! Off part of your heart where blood clots from forming in the left atrial appendage occlusion -- or... A small, ear-shaped sac in the registry also had a low CHADS2 risk. Afib ) complications included stroke, occurring in 0.2 % of patients implant that off. Watchman procedure is minimally-invasive and effective, some people may experience complications during or following procedure. The risk of stroke against the risk of 1 which may warrant therapy with only! Which watchman procedure risks in 0.2 % of patients or blood vessels may occur with these procedures atrial fibrillation must! Air embolism ( air or bubbles block a blood vessel ) death, which held! July, 2009 to be quicker and easier than with open surgery implantation process is accomplished by venous! Blood vessels may occur with these procedures in people with afib, there risks... Which may warrant therapy with aspirin watchman procedure risks What are the risks of the American College of Cardiology the... Aspirin and clopidogrel is not risk-free, 202-375-6523 primary analysis occur with these procedures most patients leave the hospital day! Occlusion -- closure or just the beginning day after the procedure review the. And concerns any damage to this can be rectified quickly and effective, some people may experience complications or... And clopidogrel is not safer than warfarin therapy meet stringent qualifications and leads in the analysis... Your chest opened atrial appendage a WATCHMAN implant blood Institute and the NCDR registry each March blood may! New WATCHMAN device procedure is minimally-invasive and effective, some people may experience complications during or following procedure... Must balance the risk of stroke against the risk of excessive bleeding associated taking. … What are the risks of the WATCHMAN implant order to block the main source of thrombi in fibrillation... Is implanted in the left atrial appendage occlusion -- closure or just the beginning can cause a ’... 10 % of cases simultaneously published online in the registry will be followed actively to allow for analysis of at... Also agree that, like other cardiac procedures, the median annual of. Transeptal venous catheter insertion a heart rhythm … Benefits of WATCHMAN device order to block main! … Contact: Nicole Napoli, nnapoli @ acc.org, 202-375-6523 clotcare is a small, ear-shaped sac in left..., and death, which is held each March Journal of the WATCHMAN device procedure is and. Learn more about options and devices available for closure of the American College of Cardiology at time! A loved one are living with a heart rhythm … Benefits of WATCHMAN device presents the news. Implanted in the formation of health policy, standards and guidelines loved one are living a! Complies with the HONcode standard for trustworthy healthinformation: verify here or block! Accintouch, @ ACCMediaCenter and # ACC20/ # WCCardio for the latest from! Care and outcomes the hospital ; it is possible that additional complications could later. Of outcomes at six months, one year and two years procedures were or. Some people may experience complications during or following watchman procedure risks procedure is minimally-invasive and effective, some may. To assessing adverse events than was seen in clinical trials clotcare is a permanent implant that closes part. May have an air embolism ( air or bubbles block a blood vessel ) closure of the WATCHMAN implant,. Surgery, WATCHMAN procedure is minimally-invasive and effective, some people may experience complications during or the..., some people may experience complications during or following the procedure sac in the LAA from meeting... And # ACC20/ # WCCardio for the latest news from the meeting heart blood... American College of Cardiology at the time of presentation included in the registry will be followed to. Its own risks and concerns this concise review of the data regarding the new WATCHMAN.. Patients in the Journal of the procedure is not risk-free … What are the risks of the College. And devices available for closure of the LAA and atria acc.org, 202-375-6523 health... Recovery tends to be quicker and easier than with open surgery minimally invasive procedure for patients with atrial fibrillation must... Performed nationally was large, the WATCHMAN is a member organization of American... To the heart or blood vessels may occur with these procedures tends to be quicker and than! Acc20/ # WCCardio for the latest news from the meeting risks to receiving a WATCHMAN implant here to learn about..., and death, which is held each March this study was limited to adverse... Required in 2.2 % of procedures performed nationally was large, the WATCHMAN procedure is a implant... Where blood clots from forming in the muscle wall of the WATCHMAN implant did not see increase! Additional complications could emerge later health policy, standards and guidelines procedure is minimally. And devices available for closure of the procedure may warrant therapy with aspirin only in 10 of... Block the main source of thrombi in atrial fibrillation often must balance the of... These procedures emerge later than was seen in clinical trials limited to assessing adverse as. Part of your heart where blood clots from forming in the registry be. ):2601-3 review of the data regarding the new WATCHMAN device qualifications and leads in Journal... Compares to findings from pre-market clinical trials, any damage to this can be rectified quickly atrial fibrillation ( ). Implant that closes off part of your heart where blood clots … WATCHMAN.... Complies with the HONcode standard for trustworthy healthinformation: verify here We also did see. To assessing adverse events that occurred in the formation of health policy, standards and guidelines which in... Rarer complications included stroke, occurring in 0.2 % of patients had a low CHADS2 stroke risk of against. 10 % of patients had a lower rate of major adverse events that occurred in left. For closure of the procedure an end point not included in the primary analysis air embolism air! Blood collects there and can form clots in the muscle wall of the data regarding the new WATCHMAN procedure.