Despite the introduction of new drug therapies for stroke prevention, many patients and physicians continue to seek alternatives for a variety of reasons, including contraindications, medication side effects, and adherence and quality-of-life concerns. Use of the Watchman left atrial appendage closure (LAAC) device has been linked to high rates of success among cardiac patients with atrial non-valvular atrial fibrillation (AF), according to research 1 presented at the 2016 Transcatheter Cardiovascluar Theraputics (TCT) scientific symposium in Washington, DC.. Data were simultaneously published online in the Journal of the American College … Anticoagulation Management and Atrial Fibrillation. Editorial: Will Date will@bibamedical.com Implant success was achieved in 1004 of the 1019 patients in whom Watchman deployment was attempted, for an overall implant success rate of 98.5%. David R. Holmes Jr., MD, MACC, et al., evaluated the acute procedural performance and complication rates for all WATCHMAN cases (n=3822) performed in the U.S. since the device was approved by the U.S. Food and Drug Administration (FDA) in March 2015. At 5 years, WATCHMAN patients had a 55% lower relative risk of disabling or fatal strokes compared to patients treated with warfarin. The new-generation Watchman FLX device is available in 5 … Efficacy Issues: Two studies published in 2018, one from Watchman investigators, [2] and the other from independent French researchers, [3] found high rates of device-related thrombus on follow-up echocardiograms (Translation: clot stuck to the device). Due to thorough patient assessments and the focus of an experienced team, Virginia Mason has an over 95 percent success rate implanting the Watchman device and eliminating long-term blood thinner regimens for patients. 2031. BIBA Medical, North America At this point, the Watchman is still deflated, but it is then positioned carefully under X-ray guidance, and expanded as it leaves the catheter so it fits snugly in the atrial appendage. The registry includes data from 1021 patients enrolled between October 2013 and May 2015 at 47 hospitals in Europe, Russia, and the Middle East. In an accompanying editorial comment, Jacqueline W. L. Saw, MD, FACC, et al., note that these “results are remarkably favorable for the earliest phase of widespread dissemination of this technology,” but that “there are several concerns relating to the study design [ – that it is not a prospective registry with patient informed consent – which] should be considered when interpreting the findings.”. receive the WATCHMAN Implant or you have recently had a WATCHMAN Implant procedure in a part of your heart called the left atrial appendage (LAA). Dual antiplatelet therapy following the implantation also appears to be safe. The Watchman implant is not a treatment for A-fib. b Refinements were made to the WATCHMAN device and procedure in the early stages of the PROTECT AF trial. Piccini, et al.. ... WATCHMAN™ LAAC Procedure Implant Video. ... systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure. Specifically, WATCHMAN and ablation are two of the most effective procedures for AFib patients. The procedure took around 50 minutes on average. Conclusion: Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Sharing international insight to improve the cardiovascular treatment pathway, Optimising pharmacology after transcatheter aortic valve replacement: Lessons from the POPular TAVI trial. The WATCHMAN device is used to reduce the risk of stroke in patients living with AFib. If you or a loved one are living with a heart rhythm disorder such as atrial fibrillation, contact Heart Rhythm Consultants. Posted: July 16, 2019 - 8:27 AM . The rate of the device coming loose was very low at 0.25%. BIBA Medical, Europe526 Fulham Road, Fulham, London, SW6 5NR Stroke (0.4%) and bleeding (4.1%) rates were low overall and did not vary by post-implantation medications. To date, Dr. Kashani has had a 100% success rate in closing the left atrial appendage with the Watchman device. Kashani one of the country’s largest Watchman implant volumes. WATCHMAN™ device for atrial fibrillation (AFib) Cardiologists with the Cardiac Innovations & Structural Heart Center ® at the Heart Hospital of Edward-Elmhurst Health use the WATCHMAN™ device to treat atrial fibrillation (AFib) and reduce stroke risk without the need for medication:. See Editorial by Turagam et al Over the last decade, left atrial appendage occlusion (LAAO) has become an attractive alternative to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (AF), especially when long-term oral anticoagulation (OAC), either a vitamin K antagonist (VKA) or a novel agent (NOAC), is not suitable or hazardous. The results of the AMULET Trial, presented Nov. 2 at TCT 2016, also showed high implant success rate and low major adverse events for percutaneous transcatheter LAA closure with the Amplatzer Amulet device in the prevention of stroke in patients with non-valvular atrial fibrillation. After the nonsurgical WATCHMAN procedure, the device replaces the need for prescription blood thinners in most patients. https://www.acc.org/.../10/27/11/12/wed-920am-watchman-us-post-tct-2016 Bruce Klugherz is a cardiologist and director of the Abington Hospital catheterization lab. Advertising: Rebecca Djaic rebecca@bibamedical.com, United Kingdom: Post-procedure therapy includes … WATCHMAN has a 95% procedural success rate with a low 1.5% major complication rate. Only two primary safety events—both ischemic strokes—were seen early after procedure, for a rate of 0.5%. WATCHMAN Is Proven To Reduce Risk of Disabling Strokes. Watchman in the Real World: Reports on Use in High-Risk Patients and Overall Safety ... At Cleveland Clinic, we have performed more than 200 of those procedures, with excellent results. Watchman FLX device. It is the only device of its kind approved by the U.S. Food and Drug Administration. 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. The recent meta-analysis of the final 5-year outcome data of the randomized controlled trials PROTECT-AF (Percutaneous Closure of the Left Atrial Appendage Vers… New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). 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. Further, there were 39 pericardial tamponades, three procedure-related strokes, nine device embolizations and three procedure-related deaths. While procedural success is 90% in the hands of newly trained/certified physicians, it is greater than 95% nationwide in the hands of more experienced physicians. Of course, those rates are very low overall, as more and more centers gain experience with the device. All rights reserved. Bleeding, infection, or injury to the heart or blood vessels may occur with these procedures. The procedural/device-related safety events in the second half of PROTECT AF were 4.8% (vs 9.9% in the first half), a level of safety similar to that seen in later studies. Invasive cardiologists love putting these in, as they are challenging and help people. By understanding the differences between the two procedures and when each is used, you can become better educated on heart health. But keep in mind all the major benefits of a watchman device. Edward-Elmhurst is ranked No. The following information about the WATCHMAN Implant is important for you to know ... rate is controlled by the heart’s internal pacemaker that is located in the upper portion of the right atrium. The rate of fluid build up around the heart was 1% and of that 1% one-third required emergency surgery. At 1 – 3 month follow-up of 1073 patients, the majority of patients were on antiplatelet therapy only and the CoreLab analyzed results of transesophageal echocardiography showed a closure rate of 99 percent. 6 Email: info@bibamedical.com The WATCHMAN left atrial appendage (LAA) closure device has high procedural success and low rates of complications, according to the results of the WATCHMAN POST-FDA APPROVAL study presented Nov. 2 at TCT 2016 and simultaneously published in the Journal of the American College of Cardiology. The data are for more than 1,000 patients, from across Europe, who received the device and focus on post-procedural drug regimen, impact of centre experience and … Following WATCHMAN implantation, 6% of patients received no anticoagulation, 27% received oral anticoagulation (16% warfarin and 11% novel oral anticoagulants, NOACs), 60% received dual antiplatelet therapy (DAPT) and 7%of patients were on single antiplatelet therapy. Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Pericardial Disease, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Interventions and Imaging, Echocardiography/Ultrasound, Keywords: Transcatheter Cardiovascular Therapeutics, Atrial Appendage, Atrial Fibrillation, Cardiac Surgical Procedures, Registries, Stroke, Warfarin, Cardiac Tamponade, Echocardiography, Transesophageal, Prospective Studies, Research Design, United States Food and Drug Administration. WATCHMAN. SH-230609-AD JUN2015 Device Release Criteria: PASS ... – 95% implant success rate4 – >92% warfarin cessation after 45 days, >99% after 1 year4 • WATCHMAN™ therapy demonstrated comparable stroke risk reduction, and New, non-clinical trial implanters accounted for 71 percent of the implanting physicians, performing 50 percent of the procedures. The Watchman device has a proven record of safety, with more than 20,000 procedures performed worldwide and over 10 years of clinical studies in some 2,000 patients. TEL: +1 949 723 9309 ... a … WATCHMAN FLX is now FDA APPROVED for use in nonvalvular atrial fibrillation patients who are eligible for anticoagulation therapy. A complete seal—defined as no identifiable leak—was recorded in 89.5%, much higher than what was seen in the PROTECT-AF and PREVAIL trials (66%). Total out-of-pocket spending for WATCHMAN is lower than Warfarin by year two and half the cost by year five. 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