Author + information
- Received June 12, 2015
- Revision received September 23, 2015
- Accepted October 12, 2015
- Published online January 5, 2016.
- Matthew R. Reynolds, MD, MSc∗,†∗ (, )
- Yang Lei, MSc‡,§,
- Kaijun Wang, PhD‡,
- Khaja Chinnakondepalli, MS‡,
- Katherine A. Vilain, MPH‡,
- Elizabeth A. Magnuson, ScD‡,‖,
- Benjamin Z. Galper, MD, MPH¶,
- Christopher U. Meduri, MD, MPH#,
- Suzanne V. Arnold, MD, MHA‡,‖,
- Suzanne J. Baron, MD, MSc‡,‖,
- Michael J. Reardon, MD∗∗,
- David H. Adams, MD††,
- Jeffrey J. Popma, MD‡‡,
- David J. Cohen, MD, MSc‡,‖,
- CoreValve U.S. High Risk Pivotal Trial Investigators
- ∗Harvard Clinical Research Institute, Boston, Massachusetts
- †Department of Cardiology, Lahey Hospital and Medical Center, Burlington, Massachusetts
- ‡Saint Luke’s Mid America Heart Institute, Kansas City, Kansas
- §University of Kansas School of Medicine, Kansas City, Kansas
- ‖University of Missouri-Kansas City, Kansas City, Missouri
- ¶Brigham and Women’s Hospital, Boston, Massachusetts
- #Piedmont Heart Institute, Atlanta, Georgia
- ∗∗Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas
- ††The Icahn School of Medicine at Mount Sinai, New York, New York
- ‡‡Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Matthew R. Reynolds, Harvard Clinical Research Institute, 930 Commonwealth Avenue, Boston, Massachusetts 02215.
Background Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.
Objectives The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk.
Methods We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. perspective.
Results Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained.
Conclusions In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. standards. With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902)
- aortic stenosis
- cost-benefit analysis
- heart valve prosthesis
- quality-adjusted life-years
- transcatheter valve therapy
This study was supported by Medtronic, Inc. Dr. Reynolds has received research support from Medtronic; and consulting fees from Medtronic and Edwards Lifesciences. Dr. Magnuson has received grant support from Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi-Sankyo, Edwards Lifesciences, Eli Lilly, and Medtronic. Dr. Meduri has received grants for educational programs from Medtronic and Edwards Lifesciences. Dr. Baron has received speaking honoraria from Edwards Lifesciences. Dr. Reardon has received honoraria from Medtronic for participation on a surgical advisory board. Dr. Adams has received royalties through his institution from Medtronic for a patent related to a triscupid-valve annuloplasty ring and from Edwards Lifesciences for a patent related to degenerative valvular disease–specific annuloplasty rings; and is the national co–principal investigator of the CoreValve U.S. High Risk pivotal trial. Dr. Popma has received honoraria from Boston Scientific, Abbott Vascular, and St. Jude Medical for participation on medical advisory boards; institutional grants from Medtronic, Direct Flow Medical, and Cook; consulting fees from Direct Flow Medical; and he has equity in Direct Flow Medical. Dr. Cohen has received grant support from Abbott Vascular, AstraZeneca, Biomet, Boston Scientific, Edwards Lifesciences, Eli Lilly, Jannsen Pharmaceuticals, and Medtronic; and consulting fees from Abbott Vascular, AstraZeneca, Eli Lilly, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Neil Moat, MBBS, served as Guest Editor for this paper.
- Received June 12, 2015.
- Revision received September 23, 2015.
- Accepted October 12, 2015.
- American College of Cardiology Foundation