Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis.
Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices.



This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices.



The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015.



Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99).



The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184).
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Sung-Han
SH
Yoon
Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
Thierry
T
Lefèvre
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea. Electronic address: drjmahn@gmail.com.
Jung-Ming
JM
Ahn
Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Gidon Y
GY
Perlman
Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Danny
D
Dvir
Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy San Raffaele Hospital, Milan, Italy.
Azeem
A
Latib
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
Marco
M
Barbanti
Department for General and Interventional Cardiology, University Heart Center, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
Florian
F
Deuschl
The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark.
Ole
O
De Backer
Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Philipp
P
Blanke
Department of Cardiovascular Surgery, Hospital Cardiologique, Lille, France.
Thomas
T
Modine
Department of Radiology, Section of Cardiovascular Radiology, University of Freiburg, Bad Krozingen, Germany.
Gregor
G
Pache
Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Franz-Josef
FJ
Neumann
Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Philipp
P
Ruile
Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
Takahide
T
Arai
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
Yohei
Y
Ohno
Heart Center Brandenburg in Bernau, Bernau, Germany.
Hidehiro
H
Kaneko
Department of Cardiology, National University Heart Centre, Singapore.
Edgar
E
Tay
Department for General and Interventional Cardiology, University Heart Center, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
Niklas
N
Schofer
University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland.
Erik W
EW
Holy
The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark.
Ngai H V
NHV
Luk
Division of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia.
Gerald
G
Yong
Division of Vascular Surgery, Changhai Hospital, Shanghai, China.
Qingsheng
Q
Lu
Department of Cardiology, National University Heart Centre, Singapore; Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
William K F
WKF
Kong
Department of Cardiology, National University Heart Centre, Singapore.
Jimmy
J
Hon
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Hsien-Li
HL
Kao
Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong.
Michael
M
Lee
Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.
Wei-Hsian
WH
Yin
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Duk-Woo
DW
Park
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Soo-Jin
SJ
Kang
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Seung-Whan
SW
Lee
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Young-Hak
YH
Kim
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Cheol Whan
CW
Lee
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Seong-Wook
SW
Park
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
Hyo-Soo
HS
Kim
Heart Center Brandenburg in Bernau, Bernau, Germany.
Christian
C
Butter
Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
Omar K
OK
Khalique
Department for General and Interventional Cardiology, University Heart Center, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
Ulrich
U
Schaefer
University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland.
Fabian
F
Nietlispach
Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
Susheel K
SK
Kodali
Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
Martin B
MB
Leon
Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Jian
J
Ye
Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
Bernard
B
Chevalier
Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Jonathon
J
Leipsic
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Victoria
V
Delgado
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Jeroen J
JJ
Bax
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
Corrado
C
Tamburino
Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy San Raffaele Hospital, Milan, Italy.
Antonio
A
Colombo
The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark.
Lars
L
Søndergaard
Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
John G
JG
Webb
Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
Seung-Jung
SJ
Park
D000368:Aged; D001021:Aortic Valve / Q000002:abnormalities* / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000209:etiology / Q000601:surgery*; D000082882:Bicuspid Aortic Valve Disease; D004867:Equipment Design; D005260:Female; D006349:Heart Valve Diseases / Q000150:complications / Q000601:surgery*; D006801:Humans; D008297:Male; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*
mortality; new device; paravalvular leak