Author + information
- Received November 20, 2015
- Revision received January 4, 2016
- Accepted January 4, 2016
- Published online April 25, 2016.
- Gidon Y. Perlman, MDa,
- Philipp Blanke, MDa,
- Danny Dvir, MDa,
- Gregor Pache, MDb,
- Thomas Modine, MDc,
- Marco Barbanti, MDd,
- Erik W. Holy, MDe,
- Hendrik Treede, MDf,
- Philipp Ruile, MDb,
- Franz-Josef Neumann, MDb,
- Caterina Gandolfo, MDg,
- Francesco Saia, MDh,
- Corrado Tamburino, MDd,
- George Mak, MDa,
- Christopher Thompson, MDa,
- David Wood, MDa,
- Jonathon Leipsic, MDa and
- John G. Webb, MDa,∗ ()
- aDepartment of Cardiology, St. Paul’s Hospital, Vancouver, British Columbia, Canada
- bDepartments of Radiology and Cardiology, University Heart Center Freiburg-Bad Krozingen, Germany
- cDepartment of Cardiovascular Surgery, Hôpital Cardiologique, Lille, France
- dDepartment of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy
- eCardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland
- fDepartment of Cardiovascular Surgery, University Heart Center, Hamburg, Germany
- gOspedale Civico, Palermo, Italy
- hCardiovascular Department, Institute of Cardiology, University of Bologna, Policlinico St. Orsola-Malpighi, Bologna, Italy
- ↵∗Reprint requests and correspondence:
Dr. John Webb, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
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.
Drs. Blanke, Dvir, Pache, Barbanti, and Webb are consultants for Edwards Lifesciences. Dr. Neumann's institution has received research grants, speaker honoraria, and travel support from Edwards Lifesciences. Dr. Gandolfo is a proctor for Edwards Lifesciences. Dr. Saia has received consulting fees from Abbott Vascular, Eli Lilly and Company, AstraZeneca, The Medicines Company, St. Jude Medical, and Medtronic; and speaker’s fees from Abbott Vascular, Eli Lilly and Company, AstraZeneca, St. Jude Medical, Terumo, Biosensors, Edwards Lifesciences, Sorin, and Boston Scientific. Dr. Tamburino has received honoraria from Abbott, Medtronic, and St. Jude Medical. Dr. Thompson has received travel support from Edwards Lifesciences. Dr. Wood is a consultant for Edwards Lifesciences; and has received clinical trials/grant support from Edwards Lifesciences. Dr. Leipsic is a consultant and provides the core laboratory for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 20, 2015.
- Revision received January 4, 2016.
- Accepted January 4, 2016.
- 2016 American College of Cardiology Foundation