OBJECTIVES: To develop a core cost-effectiveness model for the assessment of sutureless aortic valve (SuAV) in comparison to conventional vale replacement (cAVR), and transcatheter aortic valve implantation (TAVI) applying it in the Brazilian setting.

METHODS: The model simultaneously analyzes short-term (30 days perioperative) and long-term outcomes (overall, hospitalization-free days and on-dialysis survival). All patients enter the model during the perioperative state which uses discrete simulation modelling techniques (10,000 simulations) and survivors continue to the lifetime Markov part of the model to track long-term outcomes. Overall survival (OS) can be estimated directly from long-term follow up OS studies (base case utilizing data from Muneretto et al 2015), or indirectly through an intervention impact on paravalvular leakage (proxy of OS). Analysis was conducted from healthcare payer perspective, and direct costs estimates sourced from clinical practice in Brazil. Utilities have been estimated according to the different quality of life estimates for different heart failure NYHA classes, as heart failure is a direct consequence of ineffective AVR intervention. Both, costs and utilities were annually discounted at rate of 3%.

RESULTS: Based on local Brazilian costing data, SuAV replacement results in cost savings ($-8,047) followed by incremental effectiveness (1.001QALY) compared to TAVI, and should be regarded as a pharmacoeconomically dominant intervention. In comparison with cAVR, the SuAV remains more costly, however results in additional health gains. Respectively for these comparisons, the incremental cost-effectiveness ratio of the SuAV is $8,225/QALY, and $13,079/QALY, which is lower than the informal cost-effectiveness threshold for Brazil ($26,762/QALY).

CONCLUSIONS: A novel modelling approach was used to estimate the cost-effectiveness associated with the SuAV. Direct OS estimation sourced from long-term clinical studies was applied through common parametric distributions fits. Base case cost-effectiveness results Brazilian healthcare setting indicate pharmacoeconomic dominance of the SuAV in comparison to TAVI, and acceptable cost-effectiveness versus cAVR.