Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study.
OBJECTIVE
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.
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
Gidon Y
GY
Perlman
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
Philipp
P
Blanke
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
Danny
D
Dvir
Departments of Radiology and Cardiology, University Heart Center Freiburg-Bad Krozingen, Germany.
Gregor
G
Pache
Department of Cardiovascular Surgery, Hôpital Cardiologique, Lille, France.
Thomas
T
Modine
Department of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
Marco
M
Barbanti
Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.
Erik W
EW
Holy
Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
Hendrik
H
Treede
Departments of Radiology and Cardiology, University Heart Center Freiburg-Bad Krozingen, Germany.
Philipp
P
Ruile
Departments of Radiology and Cardiology, University Heart Center Freiburg-Bad Krozingen, Germany.
Franz-Josef
FJ
Neumann
Ospedale Civico, Palermo, Italy.
Caterina
C
Gandolfo
Cardiovascular Department, Institute of Cardiology, University of Bologna, Policlinico St. Orsola-Malpighi, Bologna, Italy.
Francesco
F
Saia
Department of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
Corrado
C
Tamburino
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
George
G
Mak
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
Christopher
C
Thompson
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
David
D
Wood
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
Jonathon
J
Leipsic
Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada. Electronic address: John.webb@vch.ca.
John G
JG
Webb
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000002:abnormalities* / Q000000981:diagnostic imaging; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D000082882:Bicuspid Aortic Valve Disease; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D005060:Europe; D005260:Female; D006349:Heart Valve Diseases / Q000150:complications* / Q000000981:diagnostic imaging / Q000401:mortality; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
aortic stenosis; bicuspid; transcatheter aortic valve replacement