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In the PROTECT AF trial, left atrial appendage (LAA) occlusion with the Watchman® device has been proven to be non-inferior to Warfarin in preventing ischemic stroke in patients with atrial fibrillation (AF) and risk of thromboembolic events and to be superior in preventing hemorrhagic stroke. The data suggest that LAA occlusion is especially helpful in AF patients with both a high risk for thromboembolic events and for bleeding events with contraindications for oral anticoagulation. However in the PROTECT AF trial, the postimplant anticoagulation protocol was aggressive: all patients get Warfarin combined with ASS for 45 days. At 45 days follow-up, patients were put on ASS plus Clopidogrel until completion of 6 months follow-up. Afterwards a lifelong ASS therapy was recommended. Patients with contraindications for oral anticoagulation were excluded from the PROTECT AF trial. For this study the postimplant anticoagulation was attenuated in such way that patients received ASS lifelong and LMWH for 2 months.
It was the aim of this analysis to investigate whether an attenuated postimplant anticoagulation regime is safe in AF patients with high risk for thromboembolic and hemorrhagic events undergoing LAA occlusion with the Watchman device.
Patients with chronic paroxysmal or persistent AF and a CHA2DS2-VASc score (CVS) ≥3 and a HAS-BLED score (HBS) ≥3 were eligible for this study. All patients received 100mg ASS lifelong and bodyweight adapted LMWH once a day for 2 months. Follow-up visits at 2 and 6 months included TEE.
69 patients were included (mean age: 74+7y; 46 male), all of them had undergone 2 months and 66/69 6 months follow-up visit so far. The mean CVS was 4.9±1.3, the mean CHADS2-Score was 3,2±0,9, the mean HBS was 4.3±1.0. 36 patients had history of ischemic strokes and 57 patients of major bleeding events.
LAA occlusion was feasible in 68/69 patients. Periprocedural complications were a stroke without residual neurological deficit in 1 patient, a mild pericardial effusion not requiring treatment in 3 patients, and groin hematoma in 6 pat.
At 2 months follow-up, the LAA was completely sealed (leakage ≤3 mm) in all patients. One Patient showed a ball-shaped thrombus inside the LAA, LMWH was discontinued in all patients than this one. No stroke or TIA had occurred. Neurological examination did not reveal any new abnormal findings. One patient died from endocarditis, one patient from intestinal ischemia.
At 6 months, 1 patient had experienced a TIA No other patient had any sign of stroke or peripheral embolism. One patient died from noncardiac reason. So, the incidence of TIA, stroke or peripheral embolism during the first 6 months post implantation was very low (2/68).
These results suggest that in AF patients with high risk for thromboembolic and bleeding events implantation of the Watchman LAA occlusion device can be performed safely with an attenuated postimplant anticoag. protocol.