Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement

Abstract

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.

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).

Keywords: aortic stenosis; cost-benefit analysis; heart valve prosthesis; quality-adjusted life-years; transcatheter valve therapy.

Figure 1. Sensitivity Analysis on Total Costs for Index TAVR Admissions

The impact of reduced index TAVR admission costs on the ICER for TAVR versus SAVR, shown as $/QALY gained (red line) or $/LY gained (blue line). Reductions of ~$1,650 per admission would result in the ICERs falling below the threshold of $50,000 per QALY gained, considered to represent high economic value. ICER = incremental cost-effectiveness ratio; LY = life-year; QALY = quality-adjusted life-year; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

Central Illustration. TAVR with a Self-Expanding Prosthesis Versus SAVR: Cost-Effectiveness Results

Mean incremental 12-month costs and benefits (TAVR – SAVR) are plotted on the cost-effectiveness plane with benefits expressed as QALYs (top panel) or LYs (bottom panel). Dark circles represent base case estimates, the surrounding white circles represent individual results for 1,000 replications of the study using bootstrap resampling, and the dashed lines represent a willingness to pay threshold of $50,000 per QALY/LY gained (in green) or $150,000 per QALY/LY gained (in purple). For both effectiveness outcomes, the point estimates are near $50,000 per QALY/LY gained and ~90% of replicates are below $150,000 per QALY/LY gained. See text and Table 3 for additional details. LY = life-year; QALY = quality-adjusted life-year; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.