Cost-effectiveness of transcatheter aortic valve replacement in patients with severe aortic stenosis and low surgical risk: perspective of a middle-income country's public health system.

BACKGROUND: Randomized controlled trials comparing transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and low surgical risk have demonstrated noninferiority of TAVR regarding all-cause mortality and stroke outcomes in 5- and 10-year follow-up. Nevertheless, TAVR remains a costly intervention, and its widescale adoption may affect healthcare expenditure in low- and middle-income countries. This study aimed to conduct a cost-utility analysis comparing TAVR and SAVR in patients with severe aortic stenosis at low surgical risk, from the perspective of the Brazilian Unified Health System (Sistema Único de Saúde - SUS).

METHODS: A Markov model was developed to simulate a hypothetical cohort of patients with severe aortic stenosis over a lifetime horizon. A systematic review was performed to inform efficacy and effectiveness inputs. Cost data were derived from Brazilian patient cohorts who underwent TAVR or SAVR and were expressed in international dollars (Int$). Incremental cost-effectiveness ratios (ICERs) were calculated and sensitivity analyses were performed.

RESULTS: The estimated lifetime cost was Int$ 32,341 for TAVR and Int$ 19,778 for SAVR. Lifetime quality-adjusted life-years (QALYs) were 9.90 and 9.71, respectively. The ICER for TAVR was Int$ 64,617 per QALY gained, exceeding the Brazilian willingness-to-pay threshold of Int$ 47,619 per QALY. In probabilistic sensitivity analysis, TAVR was cost-effective in 32.8% of simulations.

CONCLUSION: In patients with severe aortic stenosis at low surgical risk, TAVR was unlikely to be cost-effective compared with SAVR from the perspective of the Brazilian Unified Health System, primarily driven by cost differences between strategies.