Cohen DJ, Ryschon AM, Garner AM, Yeh RW, Reardon MR, Pietzsch, JB Cost-Effectiveness of TAVR for Low-Risk Patients: Updated Results from the Evolut Low Risk Trial Cardiovascular Research Technologies 2024, 2024 March 11

Purpose
The cost-effectiveness of transcatheter aortic valve replacement (TAVR) vs. surgical aortic valve replacement (SAVR) across the spectrum of surgical mortality risk has been reported previously. Earlier analyses relied on 1–2-year trial data, leading to uncertainty about lifetime survival projections. Recently, 4-year follow-up data from the Evolut Low Risk Trial have been presented, showing a durable numerical survival benefit with TAVR. We used these data to update previous cost-effectiveness results from the US healthcare system perspective.

Methods
A previously published decision-analytic model was used to estimate strategy-specific outcomes and costs over a patient’s lifetime. Mortality, stroke, and other adverse event (AE) data were based on 4-year follow-up from the Evolut LR trial, which randomized 1414 patients to TAVR using the Evolut platform (N=730) or to surgery using any commercially available bioprosthesis (N=684). Beyond 4-years, the observed in-trial mortality benefit was assumed to diminish over the ensuing year, after which we assumed no further difference in survival between TAVR and SAVR, with annual mortality modeled according to age- and gender-specific lifetable data for the US. Costs were based on Medicare claims data, a sample of trial-collected billing data, and published fee schedules. EQ-5D utilities were sourced from the trial. Per current US guidelines, costs and effects were discounted at 3% per annum.The primary analysis outcome was the incremental cost-effectiveness ratio (ICER) for TAVR vs. SAVR, reported as cost per quality-adjusted life year (QALY) gained and evaluated against established cost-effectiveness thresholds of $50,000 per QALY gain (high value) and $150,000 per QALY gained (intermediate value). Additionally, survival benefit, measured in life years (LY) gained, was calculated. Results were determined using the 4-year data and also based on the original 1-year follow-up data, for comparison.

Results
As previously described, the Evolut LR trial randomized 1414 patients to TAVR using the Evolut platform (N=730) vs. SAVR using any commercially available bioprosthesis (N=684).  Baseline characteristics were well balanced between TAVR and SAVR including mean age (74.1 vs. 73.7 years) and mean Society of Thoracic Surgeons Predicted Risk of Mortality (2.0% vs. 1.9%). The estimated cost at 30 days (including index procedure, hospitalization, and rehabilitation) was $5,189 lower with TAVR compared with SAVR ($45,887 vs. $51,075). When the 4-year data were projected over a lifetime horizon, lifetime costs were projected to be slightly higher with TAVR (mean difference $559) while life expectancy and quality-adjusted life expectancy were projected to increase by 0.36 LYs, and 0.26 QALYs, respectively.  The resulting lifetime ICER was $2,119 per QALY gained, consistent with high economic value.By comparison, a similar analysis based on 1-year follow-up data resulted in substantially smaller gains in both life-expectancy and quality-adjusted life expectancy (0.14 LYs and 0.13 QALYs), demonstrating the importance of longer-term survival in determining both the benefit of TAVR compared with SAVR and in increasing confidence in the lifetime projections. 

Conclusions
Based on recently presented 4-year data from the Evolut Low Risk Trial, TAVR using the Evolut valve is projected to provide high economic value compared with SAVR for low-risk patients.  These findings are driven largely by the observed survival benefit of TAVR over SAVR at 4 years and demonstrate the importance of long-term follow-up for defining the economic value of TAVR for this population.