Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion
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Background: 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: The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort. Methods: 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: 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: 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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Heart Rhythm O2 |
| Vol/bind | 3 |
| Udgave nummer | 5 |
| Sider (fra-til) | 493-500 |
| Antal sider | 8 |
| ISSN | 2666-5018 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
The Amulet IDE trial was funded by Abbott . No additional funding was provided for this analysis.
Funding Information:
The Amulet IDE trial was funded by Abbott. No additional funding was provided for this analysis. Dr Lakkireddy reports research grants from Abbott, AtriCure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; speaker honoraria from Abbott, Medtronic, Biotronik, and Boston Scientific; and is the principal investigator of the Amulet IDE. Dr Thaler reports consulting fees from Abbott and Occlutech; and research grants from Abbott and the National Institutes of Health (NIH). Dr Ellis reports research grants from Boehringer-Ingelheim, Medtronic, and Boston Scientific; and serves as a consultant to Medtronic, Abbott, and Boston Scientific. Dr Swarup reports consulting fees Biosense Webster, Boston Scientific, and Abbott. Dr Sondergaard reports consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Dr Carroll reports consulting fees from Abbott; and research grants from Abbott, Medtronic, Edwards Lifesciences, and Philips. Dr Gold reports consultant fees and research grants from Abbott, Boston Scientific, Medtronic, and EBR; and consulting fees with CVRx. Dr Hermiller reports being a consultant to Abbott, Edwards, and Medtronic. Dr Diener received honoraria from Abbott, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Novo-Nordisk, Pfizer, Portola, and WebMD Global; financial support for research projects provided by Boehringer Ingelheim; research grants from the German Research Council, German Ministry of Education and Research, European Union, NIH, Bertelsmann Foundation, and Heinz-Nixdorf Foundation. Dr Schmidt reports serving on the advisory board and being a proctor for Abbott and Boston Scientific; and has received speaker fees from Lifetech. Drs MacDonald, Mansour, and Maini received consultant fees from Abbott. Dr Anderson and Mr Gage are employees of Abbott. Dr Windecker reports research and educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave. All authors attest they meet the current ICMJE criteria for authorship. Patient consent was obtained. The authors attest that the research reported has adhered to relevant ethical guidelines and that the authors are in compliance with the regulations of their institutional review boards on human studies and animal care and use committees. Please see our information on Ethics in publishing.
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© 2022 Heart Rhythm Society
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