Journal article
Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis.
- Yoon SH Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- Lefèvre T Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
- Ahn JM Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea. Electronic address: drjmahn@gmail.com.
- Perlman GY Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
- Dvir D Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
- Latib A Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy San Raffaele Hospital, Milan, Italy.
- Barbanti M Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
- Deuschl F Department for General and Interventional Cardiology, University Heart Center, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
- De Backer O The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark.
- Blanke P Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
- Modine T Department of Cardiovascular Surgery, Hospital Cardiologique, Lille, France.
- Pache G Department of Radiology, Section of Cardiovascular Radiology, University of Freiburg, Bad Krozingen, Germany.
- Neumann FJ Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
- Ruile P Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
- Arai T Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
- Ohno Y Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
- Kaneko H Heart Center Brandenburg in Bernau, Bernau, Germany.
- Tay E Department of Cardiology, National University Heart Centre, Singapore.
- Schofer N Department for General and Interventional Cardiology, University Heart Center, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
- Holy EW University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland.
- Luk NHV The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark.
- Yong G Division of Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia.
- Lu Q Division of Vascular Surgery, Changhai Hospital, Shanghai, China.
- Kong WKF Department of Cardiology, National University Heart Centre, Singapore; Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
- Hon J Department of Cardiology, National University Heart Centre, Singapore.
- Kao HL Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
- Lee M Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong.
- Yin WH Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.
- Park DW Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- Kang SJ Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- Lee SW Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- Kim YH Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- Lee CW Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- Park SW Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- Kim HS Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
- Butter C Heart Center Brandenburg in Bernau, Bernau, Germany.
- Khalique OK Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
- Schaefer U Department for General and Interventional Cardiology, University Heart Center, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
- Nietlispach F University Heart Center, Cardiology and Cardiovascular Surgery, University Hospital Zürich, Zurich, Switzerland.
- Kodali SK Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
- Leon MB Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
- Ye J Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
- Chevalier B Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
- Leipsic J Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
- Delgado V Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
- Bax JJ Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
- Tamburino C Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
- Colombo A Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy San Raffaele Hospital, Milan, Italy.
- Søndergaard L The Heart Centre, Rigshospitalet University Hospital, Copenhagen, Denmark.
- Webb JG Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
- Park SJ Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
- 2016-09-10
Published in:
- Journal of the American College of Cardiology. - 2016
mortality
new device
paravalvular leak
Aged
Aortic Valve
Aortic Valve Stenosis
Equipment Design
Female
Heart Valve Diseases
Humans
Male
Transcatheter Aortic Valve Replacement
English
BACKGROUND
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.
OBJECTIVES
This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices.
METHODS
The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015.
RESULTS
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).
CONCLUSIONS
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).
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.
OBJECTIVES
This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices.
METHODS
The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015.
RESULTS
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).
CONCLUSIONS
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).
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jacc.2016.06.041
- PMID 27609682
- Persistent URL
- https://sonar.ch/global/documents/298509
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