Author + information
- Received July 21, 2014
- Revision received September 10, 2014
- Accepted October 8, 2014
- Published online March 1, 2015.
- Tae-Hyun Yang, MD∗,†,
- John G. Webb, MD∗,
- Philipp Blanke, MD∗,
- Danny Dvir, MD∗,
- Nicolaj C. Hansson, MD‡,
- Bjarne L. Nørgaard, MD‡,
- Christopher R. Thompson, MD∗,
- Martyn Thomas, MD§,
- Olaf Wendler, MD‖,
- Alec Vahanian, MD¶,
- Dominique Himbert, MD¶,
- Susheel K. Kodali, MD#,
- Rebecca T. Hahn, MD#,
- Vinod H. Thourani, MD∗∗,
- Gerhard Schymik, MD††,
- Bruce Precious, MD∗,
- Adam Berger, MD∗,
- David A. Wood, MD∗,
- Philippe Pibarot, MD‡‡,
- Josep Rodés-Cabau, MD‡‡,
- Wael A. Jaber, MD§§,
- Martin B. Leon, MD#,
- Thomas Walther, MD‖‖ and
- Jonathon Leipsic, MD∗∗ ()
- ∗Department of Medical Imaging and Division of Cardiology, St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- †Inje University Busan Paik Hospital, Busan, South Korea
- ‡Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark
- §Department of Cardiology, St. Thomas's Hospital, London, United Kingdom
- ‖Department of Surgery, King's College Hospital/King's Health Partners, London, United Kingdom
- ¶Department of Cardiology, Bichat Hospital, Paris, France
- #Department of Cardiology, Columbia University Medical Center/New York Presbyterian Hospital, New York, New York
- ∗∗Department of Surgery, Emory University School of Medicine, Atlanta, Georgia
- ††Department of Cardiology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany
- ‡‡Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
- §§Cleveland Clinic, Cleveland, Ohio
- ‖‖Department of Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany
- ↵∗Reprint requests and correspondence:
Dr. Jonathon Leipsic, St. Paul’s Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Objectives This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform.
Background The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known.
Methods Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography.
Results Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR.
Conclusions Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.
- annulus area
- multidetector computed tomography
- paravalvular aortic regurgitation
- transcatheter aortic valve replacement
Dr. Yang received unrestricted research grants from the Inje Research and Scholarship Foundation in 2013. Dr. Webb is a consultant to Edwards Lifesciences. Dr. Hansson has received grant support from Edwards Lifesciences. Dr. Nørgaard has received unrestricted research grants from Siemens and Edwards Lifesciences; and is a consultant to Edwards Lifesciences. Dr. Thompson has received minor honoraria from Edwards Lifesciences. Dr. Thomas is a consultant to Edwards Lifesciences. Dr. Wendler is a proctor for the Edwards Lifesciences Transcatheter Heart Valve program; and in the local principal investigator for the SAPIEN 3 trial. Dr. Vahanian serves on the advisory board of Medtronic; and has received speaking fees from Edwards Lifesciences. Dr. Himbert is a consultant and proctor for Edwards Lifesciences. Dr. Kodali is a consultant to Edwards Lifesciences and Meril; serves on the scientific advisory boards of Thubrikar Aortic Valve, Inc., and Meril; is a principal investigator for Claret Medical; has received research and grant support from Edwards Lifesciences and Claret Medical; and has equity in Thubrikar Aortic Valve Inc. Dr. Hahn is a speaker for and consultant to TC3. Dr. Thourani is a consultant to Edwards Lifesciences. Dr. Schymik is a proctor for Edwards Lifesciences. Dr. Wood is a consultant to Edwards Lifesciences. Dr. Pibarot has received a research grant from Edwards Lifesciences. Dr. Rodés-Cabau is a consultant to and has received a research grant from Edwards Lifesciences. Dr. Leon is a consultant to Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 21, 2014.
- Revision received September 10, 2014.
- Accepted October 8, 2014.
- 2015 American College of Cardiology Foundation