David Hildick-Smith1, Ulf Landmesser2, A John Camm3, Hans-Christoph Diener4, Vince Paul5, Boris Schmidt6, Magnus Settergren7, Emmanuel Teiger8, Jens Erik Nielsen-Kudsk9, Claudio Tondo10. 1. Department of Cardiology, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, 177 Preston Rd, Brighton BN1 6AGE, UK. 2. Department of Cardiology, Charité - Universitätsmedizin Berlin, Charitépl. 1, Berlin 10117, Germany. 3. Cardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St. George's University of London, Cranmer Terrace, Tooting, London SW17 0RE, UK. 4. Universitätsklinikum Essen, , Hufelandstraße 55, Essen 45147, Germany. 5. Department of Cardiology, Fiona Stanley Hospital, 11 Robin Warren Dr 6150, Perth, Australia. 6. Cardioangiologisches Centrum Bethanien, Wilhelm-Epstein-Straße 4, Frankfurt 60431, Germany. 7. Department of Cardiology, Karolinska Universitetssjukhuset, Eugeniavägen 3, Solna 171 76, Stockholm, Sweden. 8. Department of Cardiology, University Hospital Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France. 9. Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark. 10. Heart Rhythm Centre at Monzino Cardiac Center, IRCCS, Department of Clinical Sciences and Community Health, University of Milan, Via Francesco Sforza 35, Milan 20122, Italy.
Abstract
AIMS: To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. METHODS AND RESULTS: Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). CONCLUSION: Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. METHODS AND RESULTS:Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). CONCLUSION: Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%. Published on behalf of the European Society of Cardiology. All rights reserved.
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