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. 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. 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. 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%). Of course, those rates are very low overall, as more and more centers gain experience with the device. The Watchman implant is not a treatment for A-fib. A meta-analysis revealed that WATCHMAN reduced relative risk of hemorrhagic stroke by 80%, which are often disabling or fatal. • High non-adherence rates • Complicates surgical procedures • Lack of reversal agents • High cost 1. New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). Advertising: Rebecca Djaic rebecca@bibamedical.com, United Kingdom: ... a … 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. 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. The procedure took around 50 minutes on average. 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. 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. Post-procedure therapy includes … 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. 1. Email: info@bibamedical.com Today, peri-procedural safety rates of 2-3% are already achievable and have been shown for the Watchman device (EWOLUTION registry, Boersma et al, EHJ 2016 and the AMPLATZER: The AMULET Study, Hildick-Smith, TCT 2016). These findings were independent of implanting physicians’ experience, thus confirming the safety of the device. Three-month data for Watchman show high success rate. 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%. ... 0.078 percent, 0.24 percent and 0.078 percent, respectively. 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. 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. The rate of fluid build up around the heart was 1% and of that 1% one-third required emergency surgery. Diamondback 360 atherectomy system gains CE mark, Elixir Medical announces treatment of first patient in BIOADAPTOR trial, Abbott receives expanded Medicare reimbursement for MitraClip, The Foundry announces first-in-human procedure in study of Half Moon TMVR device, InnovHeart announces first-in-human use of its Saturn mitral valve, “This is the tip of the iceberg” warns BHF as cardiothoracic surgeries cancelled. New data from the EWOLUTION registry, presented at EuroPCR 2016, confirms safety of the Boston Scientific left atrial appendage closure system (Watchman). 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 peri-device leakage. I also agree that, like other cardiac procedures, the Watchman procedure is not risk-free. The heart beat spreads throughout both the right atrium 6 In the PREVAIL trial, the rate of major complications, such as major bleeding around the heart requiring urgent surgery, dislodgment of the watchman device, and procedure related strokes were all less then 1%. Dr. Dilip Mathew is board certified in Cardiology & Cardiac Electrophysiology and has been serving patients in Sarasota and surrounding … WATCHMAN. Invasive Cardiovascular Angiography and Intervention. By understanding the differences between the two procedures and when each is used, you can become better educated on heart health. However, in the rare case this device cannot be applied at the base of the LAA, for example in redo procedure with firm adhesions, the risk of stroke remains unaltered [ 11 ]. 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.”. The results of the study showed that implantation was successful in 3,653 patients (95.6 percent) with a median procedure time of 50 minutes. 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