Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion.
Amulet
Atrial fibrillation
Cardioembolic event
Left atrial appendage
Stroke
Stroke prevention
Journal
Heart rhythm O2
ISSN: 2666-5018
Titre abrégé: Heart Rhythm O2
Pays: United States
ID NLM: 101768511
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
29
06
2022
revised:
12
07
2022
accepted:
13
07
2022
entrez:
7
11
2022
pubmed:
8
11
2022
medline:
8
11
2022
Statut:
epublish
Résumé
Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF. The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort. At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days. A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%). Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.
Sections du résumé
Background
UNASSIGNED
Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.
Objective
UNASSIGNED
The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort.
Methods
UNASSIGNED
At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days.
Results
UNASSIGNED
A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%).
Conclusions
UNASSIGNED
Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.
Identifiants
pubmed: 36340489
doi: 10.1016/j.hroo.2022.07.004
pii: S2666-5018(22)00160-X
pmc: PMC9626886
doi:
Types de publication
Journal Article
Langues
eng
Pagination
493-500Informations de copyright
© 2022 Heart Rhythm Society. Published by Elsevier Inc.
Références
Int J Cardiol. 2013 Sep 1;167(5):1807-24
pubmed: 23380698
Circulation. 2021 Nov 9;144(19):1543-1552
pubmed: 34459659
Europace. 2017 Jan;19(1):4-15
pubmed: 27540038
Am Heart J. 2019 May;211:45-53
pubmed: 30831333
Circulation. 2011 Jun 14;123(23):2736-47
pubmed: 21670242
JACC Cardiovasc Interv. 2009 Sep;2(9):834-42
pubmed: 19778771
Catheter Cardiovasc Interv. 1999 Oct;48(2):162-6
pubmed: 10506771
Circulation. 2013 Feb 12;127(6):720-9
pubmed: 23325525
JACC Cardiovasc Interv. 2012 Jan;5(1):82-9
pubmed: 22230153
Catheter Cardiovasc Interv. 2014 Mar 1;83(4):642-6
pubmed: 24214580
Best Pract Res Clin Haematol. 2013 Jun;26(2):103-14
pubmed: 23953899