OBJECTIVES: A growing evidence base supports the clinical and economic benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in inoperable, high, or intermediate surgical risk patients with severe symptomatic aortic stenosis (sSAS). This study aims to assess the cost-effectiveness of TAVI over SAVR in low surgical risk (LR) sSAS patients using clinical outcomes data from a recent pivotal trial in conjunction with German direct healthcare costs and patient outcomes data.

METHODS: A previously published two-stage cost-utility model was adapted to the German context to assess changes in costs and HRQOL following a TAVI and a SAVR intervention from the German Statutory Health Insurance perspective. An initial decision tree structure captured short-term outcomes including adverse events, extracted from the trial for both the TAVI and the SAVR arms. This was followed by a Markov model with four health states, capturing disease progression and longer-term patient outcomes. Costs were measured in 2021 Euros and benefits in QALYs gained. The simulated time horizon was lifetime, and accrued costs and benefits were discounted at 3% annually. The effect of uncertainty in model assumptions and parameters were explored through multiple sensitivity and scenario analyses.

RESULTS: In comparison to SAVR, TAVI resulted in improved outcomes and slightly higher costs over a lifetime horizon. The base case results demonstrated improved QALYs (+0.72) and slightly increased costs (€ 8664) per patient for TAVI compared with SAVR, yielding an incremental cost effectiveness ratio of € 12037/QALY per patient. These results were robust across multiple sensitivity analyses.

CONCLUSIONS: In this study, TAVI improves outcomes in LR sSAS patients and slightly increases costs. These results from the first ever cost-effectiveness study of TAVI in Germany are informative for policy makers as treatment with TAVI as compared to SAVR in LR sSAS patients yields an attractive cost per QALY ratio.