OBJECTIVES: A growing evidence base supports the clinical and economic benefits of TAVI over surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic stenosis (sSAS) who are inoperable or at high- or intermediate-risk of surgical mortality. This study aims to assess the cost-effectiveness of TAVI over SAVR in sSAS patients at low risk of surgical mortality using clinical outcomes from a recent pivotal trial in conjunction with Spanish direct healthcare costs and health-related quality of life data.

METHODS: A two-stage cost-utility model was developed to assess the changes in costs and health-related quality of life following a TAVI and a SAVR intervention from the Spanish NHS perspective. An initial decision tree structure captured short-term outcomes including adverse events, which were extracted from the trial for both the TAVI and the SAVR arms. This was followed by a Markov model with four health states (alive and well, atrial fibrillation, disabling stroke, dead) capturing disease progression and longer-term outcomes for patients. The simulated time horizon was lifetime and accrued costs and benefits were discounted at 3% annually. The effect of uncertainty in model parameters and robustness of the results were explored though deterministic and probabilistic sensitivity analysis as well as multiple scenario analyses.

RESULTS: In comparison to SAVR, TAVI resulted in improved outcomes and slightly higher costs. The base case results demonstrated increases of 0.95 QALYs with lifetime costs of € 3522 per patient for TAVI compared with SAVR. PSA results showed 99.9% likelihood of cost-effectiveness at € 30000 willingness-to-pay threshold. These results are robust with TAVI remaining cost-effective across multiple scenario analyses.

CONCLUSIONS: In this analysis, TAVI improves clinical outcomes and slightly increases costs. These initial results are promising and suggests that TAVI is a cost-effective therapy for low risk sSAS patients in Spain.