Device-Related Thrombus After Left Atrial Appendage Occlusion With the Amulet Device.
Heart Lung Circ
; 28(11): 1683-1688, 2019 Nov.
Article
em En
| MEDLINE
| ID: mdl-30301672
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) CHA2DS2-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 DAPT 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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Complicações Pós-Operatórias
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Trombose
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Acidente Vascular Cerebral
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Dispositivo para Oclusão Septal
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Átrios do Coração
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Cardiopatias
Tipo de estudo:
Diagnostic_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article