1. Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study.
- Author
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Perlman GY, Blanke P, Dvir D, Pache G, Modine T, Barbanti M, Holy EW, Treede H, Ruile P, Neumann FJ, Gandolfo C, Saia F, Tamburino C, Mak G, Thompson C, Wood D, Leipsic J, and Webb JG
- Subjects
- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis etiology, Aortic Valve Stenosis mortality, Bicuspid Aortic Valve Disease, Canada, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization mortality, Europe, Female, Heart Valve Diseases diagnostic imaging, Heart Valve Diseases mortality, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Humans, Male, Prosthesis Design, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Aortic Valve abnormalities, Aortic Valve Stenosis therapy, Cardiac Catheterization methods, Heart Valve Diseases complications, Heart Valve Prosthesis Implantation methods
- Abstract
Objectives: This study evaluated the results of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis (AS) using a new-generation TAVR device., Background: A bicuspid AS is often considered a relative contraindication to TAVR. Although initial reports have demonstrated feasibility using early-generation devices, outcomes have not matched those seen with tricuspid AS. Paravalvular aortic regurgitation (AR) has been particularly problematic., Methods: We collected baseline characteristics, procedural data, and 30-day clinical follow-up findings from 8 centers in Europe and Canada that had performed TAVR in bicuspid AS using the SAPIEN 3 valve., Results: 51 patients underwent TAVR using the SAPIEN 3 valve. Patient mean age was 76.2 ± 9.3 years and the Society of Thoracic Surgeons predicted risk of mortality scores were 5.2 ± 3.7%. Bicuspid valve types were: type 0, 11.8%; type 1, 82.3%; and type 2, 1.9%. There were no cases of valve embolization or need for a second valve. Post-dilation was performed in 7.8%. The mean aortic gradient decreased from 49.4 ± 16.0 mm Hg to 11.2 ± 4.7 mm Hg. Post-implantation AR was none/trivial in 63% and mild in 37%. There were no cases of moderate or severe AR. At 30-day follow-up, there were 2 deaths (3.9%), 2 major vascular complications, and 12 patients (23.5%) required pacemaker implantation., Conclusions: TAVR in bicuspid AS using a new-generation device was feasible and effective with favorable valve performance and no cases of moderate or severe AR., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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