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Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry.

Landmesser, U; Tondo, C; Camm, J; Diener, H-C; Paul, V; Schmidt, B; Settergren, M; Teiger, E; Nielsen-Kudsk, JE; Hildick-Smith, D (2018) Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry. EuroIntervention, 14 (5). e590-e597. ISSN 1969-6213 https://doi.org/10.4244/EIJ-D-18-00344
SGUL Authors: Camm, Alan John

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Abstract

AIMS: Left atrial appendage occlusion (LAAO) is a stroke prevention therapy for patients with non-valvular atrial fibrillation (AF). This study reports one-year outcomes from patients enrolled in the prospective global Amulet registry. METHODS AND RESULTS: A total of 1,088 patients were recruited, aged 75±9 years; 65% of patients were male. The CHA2DS2-VASc and HAS-BLED scores were 4.2±1.6 and 3.3±1.1, respectively. Eighty-three percent (83%) of patients had contraindications to anticoagulation (OAC); 72% had a history of major bleeding. An AMPLATZER Amulet LAA occluder was successfully implanted in 99% of cases. Transoesophageal echocardiography one to three months after implant showed no residual flow or flow <3 mm in 98.4%. The observed ischaemic stroke rate was 2.9%/year. Device-related thrombus was noted in 1.7% of patients. There were ten cases between 0 and 90 days and eight cases between 91 and 365 days. Patients discharged without OAC (>80%), in particular those on single aspirin therapy, did not appear to have a higher risk of device-related thrombus. In the first year, major bleeding occurred at an annualised rate of 10.3%. All-cause mortality was 8.4% at one year. CONCLUSIONS: In the global prospective Amulet registry of patients at high risk of stroke and bleeding, the annualised ischaemic stroke rate was 2.9%. The LAA was sealed in 98.4% after one to three months and device-related thrombus was observed in 1.7% of cases with only a minority of all patients on anticoagulation treatment.

Item Type: Article
Keywords: antithrombotic treatment, bleeding, death, LAA closure, stroke
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: EuroIntervention
ISSN: 1969-6213
Language: eng
Dates:
DateEvent
3 August 2018Published
PubMed ID: 29806820
Web of Science ID: WOS:000440694800019
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/110512
Publisher's version: https://doi.org/10.4244/EIJ-D-18-00344

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