• Matthew R Reynolds, Yang Lei, Kaijun Wang, Khaja Chinnakondepalli, Katherine A Vilain, Elizabeth A Magnuson, Benjamin Z Galper, Christopher U Meduri, Suzanne V Arnold, Suzanne J Baron, Michael J Reardon, David H Adams, Jeffrey J Popma, David J Cohen, and CoreValve US High Risk Pivotal Trial Investigators.
• Harvard Clinical Research Institute, Boston, Massachusetts; Department of Cardiology, Lahey Hospital and Medical Center, Burlington, Massachusetts. Electronic address: matthew.reynolds@hcri.harvard.edu.
• J. Am. Coll. Cardiol. 2016 Jan 5; 67 (1): 29-38.

BackgroundPrevious studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.ObjectivesThe 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.MethodsWe 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.ResultsRelative 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.ConclusionsIn 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.StandardsWith 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).Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

23 keywords...

hide…