Only two primary safety events—both ischemic strokes—were seen early after procedure, for a rate of 0.5%.
2 5 WATCHMAN U.S. NESTed Post Approval Study
In a post FDA approval analysis, major complications occurred in 1.5% of cases from time of implant to 7 days post-implantation or hospital discharge, which is a similar rate to an ablation procedure. 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%). 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 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. A press release reports that the three-month results from the EWOLUTION registry indicate that the Watchman device is associated with a high success rate in complete left atrial appendage closure with a low periprocedural risk. 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. Further, there were 39 pericardial tamponades, three procedure-related strokes, nine device embolizations and three procedure-related deaths. … The implant procedure was successful in 98.5% of cases Independent of centre experience, 99% of implanted devices presented no or minimal (≤5mm) peri-device leakage at the first follow-up, assessed by periprocedural transesophageal echocardiogram (TEE) Take-home #2 : The tricky part of the selective reporting of Watchman began with the PREVAIL trial. If you have an increased risk for stroke and have nonvalvular afib, but you aren’t able to take blood thinners because of side effects, compliance, or bleeding problems, your doctor may recommend mechanical LAA closure. Of course, those rates are very low overall, as more and more centers gain experience with the device. https://www.acc.org/.../10/27/11/12/wed-920am-watchman-us-post-tct-2016
In contrast, in a recent published reviewof nearly 4,000 U.S. implantations, rates of these intraprocedural complications were 1.02 percent, 0.078 percent, 0.24 percent and 0.078 percent, respectively. At 1 – 3 month follow-up of 1073 patients, the majority of patients were on antiplatelet therapy only and the CoreLab analyzed© 2020 American College of Cardiology Foundation. WATCHMAN Demonstrates Low Major Complication Rate in Real-World Setting The WATCHMAN procedure has proven safety, with a 1.5% major complication rate in the highest-risk patients studied to date. New, non-clinical trial implanters accounted for 71 percent of the implanting physicians, performing 50 percent of the procedures. Successful device implantation (median procedure time: 50 minutes) was performed in 95.5% of all patients, with 1.38 devices used, on average, per case. Here, the authors of PREVAIL published the paper (2014) with incomplete results–only 28% of patients had reached the 1.5 years of follow-up. With almost 20 years of clinical trial and real world experience - including 10 clinical trials - WATCHMAN has a proven safety record. After the nonsurgical WATCHMAN procedure, the device replaces the need for prescription blood thinners in most patients. Why is a WATCHMAN implantation performed? All rights reserved.
These findings were independent of implanting physicians’ experience, thus confirming the safety of the device. Highlights of the data, which were presented at EuroPCR 2016 by Martin W Bergmann (Cardiologicum Hamburg, Germany), include:The implant procedure was successful in 98.5% of casesIndependent of centre experience, 99% of implanted devices presented no or minimal (≤5mm) peri-device leakage at the first follow-up, assessed by periprocedural transesophageal echocardiogram (TEE)Device or procedure related serious adverse events (SAE) rates at 92 days were similar if patients were treated with warfarin or DAPT (2.6% vs. 4.8%, respectively).Rates for bleeding SAE were also similar if warfarin or DAPT was used post-implantation (4.8% vs. 3.6%, respectively)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.Stroke (0.4%) and bleeding (4.1%) rates were low overall and did not vary by post-implantation medications. A partial recapture of the final device was needed in 23% of cases, with 1.49 average recaptures per procedure.
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