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http://dx.doi.org/10.4103/apc.APC_47_17 | DOI Listing |
J Am Coll Cardiol
November 2024
University Hospital of Bern, Bern, Switzerland.
Background: The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific).
View Article and Find Full Text PDFJACC Cardiovasc Interv
June 2024
Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address:
Background: Pericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood.
Objectives: This study sought to assess the frequency, timing, predictors and clinical impact of PE after LAAC.
Methods: Data on consecutive patients undergoing percutaneous LAAC between 2009 and 2022 were prospectively collected including the 1-year follow-up.
JACC Cardiovasc Interv
August 2023
Inselspital, University of Bern, Bern, Switzerland.
Background: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years.
Objectives: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial.
Aims: Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs.
View Article and Find Full Text PDFCatheter Cardiovasc Interv
June 2022
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Background: The natural history of peridevice leak (PDL) following left atrial appendage occlusion (LAAO) is unknown. This study sought to investigate changes of PDL from 2 until 12 months after LAAO, using cardiac computed tomography (CT), and to assess the potential association between persistent PDL and clinical outcomes METHODS: Single-center observational study of Amplatzer LAAO implants between 2010 and 2017 (n = 206). Patients with 2 and 12 months cardiac CT were included in the study (n = 153).
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