Author + information
- Received October 26, 2018
- Revision received January 11, 2019
- Accepted February 5, 2019
- Published online June 3, 2019.
- Adel Aminian, MDa,∗ (, )
- Boris Schmidt, MDb,
- Patrizio Mazzone, MDc,
- Sergio Berti, MDd,
- Sven Fischer, MDe,
- Matteo Montorfano, MDf,
- Simon Cheung Chi Lam, MDg,
- Juha Lund, MDh,
- Federico M. Asch, MDi,
- Ryan Gage, MSj,
- Ignacio Cruz-Gonzalez, MDk,
- Heyder Omran, MDl,
- Giuseppe Tarantini, MDm and
- Jens Erik Nielsen-Kudsk, MD, DMScn
- aDepartment of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium
- bCardioangiologisches Centrum Bethanien, Agaplesion Markus Krankenhaus, Medizinische Klinik 3 – Kardiologie, Frankfurt, Germany
- cArrhythmology and Cardiac Pacing Unit, Ospedale San Raffaele, Milan, Italy
- dDepartment of Interventional and Diagnostic Cardiology, Fondazione Toscana Gabriele Monasterio, Pisa, Italy
- eDepartment of Cardiology, Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, Germany
- fInterventional Cardiology Unit, Ospedale San Raffaele, Milan, Italy
- gDepartment of Medicine, Queen Mary Hospital, Hong Kong
- hHeart Center, Turku University Hospital, Turku, Finland
- iCardiovascular Core Laboratories, MedStar Health Research Institute, Washington Hospital Center, Washington, DC
- jStructural Heart Clinical Affairs, Abbott, St. Paul, Minnesota
- kDepartment of Medicine, Universitario de Salamanca, Salamanca, Spain
- lDepartment of Medicine – Cardiology, St. Marien Hospital, Bonn, Germany
- mDepartment of Interventional Cardiology, University of Padua, Padua, Italy
- nDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- ↵∗Address for correspondence:
Dr. Adel Aminian, Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Chaussée de Bruxelles 140, 6042 Charleroi, Belgium.
Objectives This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).
Background DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.
Methods A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.
Results Device implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).
Conclusions Following LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.
Abbott funded the prospective global Amulet Observational Study. No funding was provided for this analysis. Dr. Aminian has served as a proctor and consultant for Abbott and Boston Scientific. Dr. Schmidt has served as a consultant for Boston Scientific and Medtronic. Dr. Mazone has served as a consultant for Abbott, Boston Scientific, and Medtronic. Dr. Fischer has served as a proctor for Biotronik and Boston Scientific; and is a consultant for Abbott. Dr. Montorfano has served as a proctor for Abbott, Boston Scientific, and Edwards Lifesciences. Dr. Lam has served as a proctor for Abbott, while not receiving consulting fees. Dr. Asch has served as the director of an academic core laboratory with institutional contracts with Abbott and Boston Scientific. Mr. Gage is an employee of Abbott. Dr. Cruz-Gonzalez has served as a proctor for Abbott, Boston Scientific, and Lifetech; and is a consultant for Boston Scientific. Dr. Omran has served as a proctor and consultant for Abbott. Dr. Tarantini has served as a consultant for AstraZeneca, The Medicines Company, Edwards Lifesciences, and Daiichi Sankyo/Eli Lilly and Co. Dr. Nielsen-Kudsk has served as a proctor for Abbott; and is a consultant for Abbott and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 26, 2018.
- Revision received January 11, 2019.
- Accepted February 5, 2019.
- 2019 American College of Cardiology Foundation
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