Recommendation for NHSScotland

TAVI is non-inferior to surgical aortic valve replacement (SAVR) for primary outcomes of all cause and cardiac mortality or disabling stroke up to two years. TAVI may be considered as an alternative to SAVR, providing similar symptom and quality of life improvements in patients with severe symptomatic aortic stenosis (AS) who are considered operable but at intermediate surgical risk.

The choice of procedure should be guided by detailed individualised assessment of risk factors including age, anatomical feasibility, frailty, previous cardiac surgery and life expectancy. Shared decision-making with patients around choice of procedure for severe AS should also take into account that, compared with SAVR, the long-term durability of TAVI has not been established.

Based on commonly accepted UK cost-effectiveness thresholds, TAVI at list prices is unlikely to be cost-effective in this patient group. Cost-effectiveness is primarily driven by the valve cost. In trials, relative clinical outcomes tended to be more favourable via the transfemoral (TF) access route and, as such, TF TAVI – combined with a reduction in the device cost – increases the likelihood of TAVI being cost effective compared with SAVR.

NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.

What were we asked to look at?

We were asked to provide advice on the clinical and cost effectiveness of TAVI for the treatment of patients with severe symptomatic aortic stenosis who are at intermediate surgical risk, compared with SAVR.

Why is this important?

For patients with severe symptomatic aortic stenosis, surgical aortic valve replacement (SAVR) is the reference treatment where surgical risk is low. For those assessed by a heart team as being at increased surgical risk transcatheter aortic valve implantation (TAVI) is an alternative and less invasive procedure.

Referred by

National Planning Team of the NHSScotland National Planning Board.