Why the study?
Does left atrial appendage closure with the WATCHMAN device provide a safe alternative to oral anticoagulation in patients with atrial fibrillation and severe bleeding contraindications?
Does left atrial appendage closure with the WATCHMAN device provide a safe alternative to oral anticoagulation in patients with atrial fibrillation and severe bleeding contraindications?
Left atrial appendage closure with the WATCHMAN device followed by short-term dual antiplatelet therapy appears to be a safe alternative to long-term oral anticoagulation in high-risk atrial fibrillation patients with prior severe bleeding.
Caution against routine adoption; leaves open WATCHMAN role in high-bleeding-risk AF pending randomized trials.
Therapy with coumarin-derivates in patients with atrial fibrillation is often associated with a high risk of bleeding complications. The LAA-closure with the WATCHMAN™ device provides an alternative to lifetime anticoagulation. We evaluated success rate and safety of WATCHMAN™ implantation in patients with atrial fibrillation and contraindications to oral anticoagulation due to severe bleeding. In 26 patients (72 ± 11 years, 8 female) with contraindications to anticoagulation due to severe bleeding (19 patients with gastrointestinal bleeding and 7 patients with hemorrhagic strokes) we performed LAA-closure with the WATCHMAN™ device. After LAA-closure patients received a short time dual antiplatelet therapy with aspirin and clopidogrel (100 mg of aspirin and 75 mg clopidogrel per day) for 6 weeks, followed by a monotherapy with 100 mg of aspirin per day. We screened patients for ischemic or bleeding events and performed a transoesophageal echocardiography at 6 weeks, 6 and 12 months after the implantation of the WATCHMAN™ device. WATCHMAN™ device was positioned in a total of 25 patients (96%), 1 patient was excluded because of thrombus-detection in LAA. One pericardial effusion (4%) appeared after positioning and was successfully drained. In the follow-up at 6 weeks, 6 and 12 months 2 patients (8%) presented a severe bleeding event 8 weeks and 9 months after LAA-closure (1 patient with a bleeding of oesophageous varices, 1 patient with a bleeding of the hemorhoides). None of the patients got either an ischemic or hemorrhagic stroke or a systemic embolism. Transoesophageal echocardiography demonstrated a correct position of the device in each of the 25 patients, no device-attached thrombus or device embolization. The closure of the left atrial appendage with a WATCHMAN™ Device and a subsequent treatment with a short time dual antiplatelet therapy in high risk patients after bleeding complications due to oral anticoagulation with coumarin-derivates appears to be a save alternative treatment strategy to long-term oral anticoagulation.
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Schlundt et al. (2014) studied this question.
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