Key result
WATCHMAN followed by antiplatelets in high-risk NVAF shows a ~2% major safety event rate.
Why the study?
Many patients with non-valvular atrial fibrillation have contraindications to or inefficiency of oral anticoagulation, warranting evaluation of left atrial appendage closure followed by antiplatelet therapy in a high-risk population.
Does left atrial appendage closure followed by antiplatelet therapy provide safety and efficacy in high-risk patients with non-valvular atrial fibrillation?
Observational (n=91)
No
Does left atrial appendage closure followed by antiplatelet therapy provide safety and efficacy in high-risk patients with non-valvular atrial fibrillation?
Left atrial appendage closure followed by antiplatelet therapy appears to be a safe and effective strategy for stroke prevention in high-risk patients with non-valvular atrial fibrillation who have contraindications to or failure of oral anticoagulation.
May support LAA closure with antiplatelet therapy in high-risk nonvalvular AF; leaves open randomized confirmation of net benefit.
Introduction: In our everyday practice we encounter many patients with non-valvular atrial fibrillation with either a contraindication to oral anticoagulation or with its inefficiency. Aim: To investigate whether left atrial appendage closure (LAAC) followed by post-procedure antiplatelet therapy is safe and efficient in a high-risk population. Material and methods: Ninety-one (48 males) consecutive patients with non-valvular atrial fibrillation (NVAF) underwent an LAAC procedure using a first-generation WATCHMAN 2.5 device followed by antiplatelet therapy. Clinical and transesophageal echocardiography data were collected at baseline and at the follow-up visit. A bleeding history was observed in 89% of patients and 24.2% of patients had a history of stroke or transient ischemic attack (TIA). The procedure was successful in 98.9%. Post-procedure therapy was dual antiplatelet therapy in 85 patients; 3 patients received single antiplatelet therapy and the therapy was maintained until the follow-up visit. Peri-procedural complications were tamponade (3.3%), pericardial effusion (2.2%) and two deaths (2.2%) with no bleeding or vascular complications. The median follow-up was 67 (52.75-84.75) days. Primary safety endpoint (bleeding BARC type 3 or more, tamponade, pericardial effusion, and device embolization) and primary efficacy endpoint (stroke or TIA, hemorrhagic stroke, peripheral embolism, cardiovascular (CV) and non-CV death) were observed in 2 and 4 patients, respectively. Conclusions: The LAAC procedure followed by antiplatelet therapy seems to be safe and efficient in the high-risk population. Further studies in this field are required.
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Maksym et al. (2023) conducted an observational in Non-valvular atrial fibrillation (n=91). Left atrial appendage closure (LAAC) with WATCHMAN 2.5 device followed by antiplatelet therapy was evaluated on Primary safety endpoint (composite of bleeding BARC ≥3, tamponade, pericardial effusion, and device embolization). Left atrial appendage closure with a WATCHMAN device followed by antiplatelet therapy in high-risk patients with non-valvular atrial fibrillation resulted in a primary safety endpoint rate of 2.2% and a primary efficacy endpoint rate of 4.5%.
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