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Device-Related Thrombus After Left Atrial Appendage Occlusion With the Amulet Device

Abstract : Background Left atrial appendage occlusion (LAAO) is increasingly used for stroke prevention in patients with atrial fibrillation who are considered unsuitable for a lifelong oral anticoagulant regimen. Recently, a single-centre study reported device-related thrombus formation in 16.7% of patients treated with the second-generation Amulet device (St. Jude Medical, St. Paul, MN, USA), presenting a potential major safety concern. As "real-world" data on device-related thrombus formation following LAAO with the Amulet occluder are scarce, we aimed to evaluate this outcome in a retrospective registry. Methods Clinical and tranosesophageal echocardiography data after LAAO with the Amulet in consecutive patients from three centres were collated. Results Among 38 patients (mean age 75.8 years), mean (standard deviation) CHA(2)DS(2)-VASc and HAS-BLED scores were 4.4 (1.2) and 3.4 (0.9), respectively. All patients underwent successful device placement without procedure-related adverse events. The antithrombotic regimen at discharge consisted of dual antiplatelet therapy (DAPT) in 27 patients (71.1%), single antiplatelet therapy in 10 patients (26.3%), and no antithrombotic therapy in one patient (2.6%). Device-related thrombus was observed in one patient (2.6%) despite DAFT regimen. The outcome of this patient was uncomplicated after adjustment of oral anticoagulant therapy. No patients presented with a thromboembolic event following LAAO during a mean (standard deviation) follow-up of 15 (5) months. Conclusions In this retrospective study, device-related thrombus formation with the second-generation Amulet device was rare and occurred at a rate similar to that of the previous device. Importantly, no patient experienced a device-related thromboembolic event during follow-up. Larger real-life studies are required to confirm the safety profile of this increasingly used device.
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https://hal-amu.archives-ouvertes.fr/hal-02898974
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Submitted on : Tuesday, July 14, 2020 - 2:56:28 PM
Last modification on : Saturday, September 19, 2020 - 4:29:22 AM

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Michael Peyrol, Jennifer Cautela, Erwan Salaün, Charlène Miola, Frédéric Franceschi, et al.. Device-Related Thrombus After Left Atrial Appendage Occlusion With the Amulet Device. Heart, Lung and Circulation, Elsevier, 2019, 28 (11), pp.1683-1688. ⟨10.1016/j.hlc.2018.08.022⟩. ⟨hal-02898974⟩

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