Early TAVI Estimated to Save Costs and Improve Outcomes in Saudi Arabia

A new economic evaluation estimates that offering transcatheter aortic valve implantation (TAVI) to people in Saudi Arabia with asymptomatic severe aortic stenosis would save the health system money while improving quality and length of life, compared with the traditional strategy of clinical surveillance until symptoms appear. The analysis, published in Frontiers in Cardiovascular Medicine, is the first to assess this question from the perspective of the Saudi healthcare system, and it found that early TAVI using the SAPIEN 3 or SAPIEN 3 Ultra valve was the dominant strategy in nearly every scenario tested. Because the findings come from a mathematical model rather than a head-to-head study conducted in Saudi Arabia, they represent projections of what early intervention could achieve, not measured outcomes from local patients.

Aortic stenosis is the narrowing of the aortic valve, a prevalent valvular heart disease estimated to affect around 5% of people over 65 years worldwide. Once severe aortic stenosis becomes symptomatic and is left untreated, mortality rises sharply, with reported increases of 60% to 90% over five years. The asymptomatic form of severe disease carries its own burden: an estimated 44% increased risk of mortality over four years. Historically, roughly one-third of people with aortic stenosis are diagnosed while still asymptomatic, and this group has generally been kept under clinical surveillance, with aortic valve replacement delayed until symptoms develop or systolic function declines. A longer time to intervention has been associated with progressively increasing healthcare costs in symptomatic populations.

The clinical rationale for intervening earlier rests largely on randomised trial evidence. The EARLY TAVR trial (NCT03042104) recruited 901 individuals with asymptomatic severe aortic stenosis to receive either clinical surveillance or early TAVI with balloon-expandable SAPIEN 3 or SAPIEN 3 Ultra valves. Over a median follow-up of 3.8 years, early TAVI was associated with a 0.8% reduction in death, a 2.5% reduction in stroke, and a 20.8% reduction in unplanned cardiovascular hospitalisations compared with surveillance. A recent meta-analysis of four randomised controlled trials involving 1,427 patients likewise observed significant reductions in heart failure-related hospitalisation (hazard ratio 0.31) and cardiovascular mortality (hazard ratio 0.56). This evidence contributed to the 2025 European guidelines, which endorse early aortic valve replacement for asymptomatic severe aortic stenosis when procedural risk is low, with a Class 2a, Level A recommendation.

Saudi Arabia has dedicated guidelines for the clinical management of aortic stenosis, but they do not yet endorse TAVI for the asymptomatic population, because they were published before the EARLY TAVR trial concluded. Saudi clinicians often follow the European guidelines, which are internationally recognised and incorporate more recent evidence. At the same time, recent national policy has called for a strategic initiative to raise awareness, enhance timely diagnosis, and improve the management of valvular heart disease. The research team, led by Hussain Abdulrahman Al-Omar of King Saud University together with colleagues at the York Health Economics Consortium, King Saud Medical City, Edwards Lifesciences and the Saudi Ministry of Health, aimed to determine whether early TAVI would represent good value for money in the Saudi setting.

The analysis was a cost-utility analysis built on a Markov model with three health states: alive and well, stroke, and death. The model ran over a lifetime horizon with 30-day cycles and included a tunnel state capturing heart failure-related hospitalisations, which patients could enter repeatedly. Clinical inputs came primarily from the EARLY TAVR trial, with the modelled cohort reflecting a starting age of 75.8 years and 69.1% male participants. In the surveillance arm, valve replacement was delayed until symptom progression, with the timing extrapolated from trial data using an exponential distribution; 1.8% of surveillance patients received surgical rather than transcatheter replacement. Costs were drawn from Saudi sources, including Ministry of Health costing directories and published Saudi cost literature, with a non-disabling stroke cost adjusted from a United Kingdom benchmark using a purchasing power parity factor. Because no Saudi health technology assessment guidelines existed, the analysts adopted the 3.5% annual discount rate used by NICE and set the willingness-to-pay threshold at SAR 131,706, derived from gross domestic product per capita for the 2024 cost year.

The base case results indicated that, over a lifetime, early TAVI would cost less and deliver more than surveillance. Per person, the model estimated a cost saving of SAR 33,414 (about $8,910), a quality-adjusted life year gain of 0.17, and a life-year gain of 0.12. In probabilistic sensitivity analysis based on 1,000 iterations, TAVI had a 97.3% probability of being cost-effective at the chosen threshold. The model projected that, compared with surveillance, early TAVI would be accompanied by nine fewer strokes per 100 people over a lifetime, twelve fewer heart failure-related hospitalisations per 100 people, and three fewer permanent pacemaker implantations per 100 people. Median survival was projected at 10.25 years with TAVI versus 10.08 years with surveillance. One counterbalancing outcome was a projected increase of four reinterventions per 100 people in the TAVI arm, which the authors anticipated because TAVI patients receive their valve earlier and therefore have longer exposure to potential valve deterioration.

The single most influential driver of the results was the weighting of disabling stroke in the surveillance arm, followed by the discounting of costs and the weighting of disabling stroke in the TAVI arm. Disabling strokes carry high ongoing costs in the model, estimated at SAR 207,452 per year, along with substantially reduced quality of life and elevated mortality risk. Because the surveillance strategy delays valve replacement, patients spend longer exposed to elevated stroke and hospitalisation risks, which accumulates cost and lost quality-adjusted survival. Deterministic sensitivity analysis, varying all parameters by plus or minus 20%, and threshold analyses on reintervention rates, stroke costs and pacemaker costs all left TAVI cost-effective with positive net monetary benefit.

Scenario analyses reinforced the base case. When stroke and hospitalisation rates beyond five years were set equal across the two arms, when pacemaker implantation proportions were equalised, when alternative reintervention data sources were used, when mortality inputs were changed, and when the time horizon was shortened to five years, TAVI remained dominant in every scenario. The five-year horizon still produced a small life-year gain of 0.003 and cost savings, because fewer strokes and hospitalisations occurred even in the short term. A scenario delaying valve replacement in the surveillance arm by six months reduced the net monetary benefit relative to the base case. The trial-based mortality scenario produced the largest differences, increasing the estimated quality-adjusted life year gain to 0.57 and the life-year gain to 0.64, reflecting the fact that the EARLY TAVR trial reported higher survival in this population than general population life tables predict.

The authors acknowledge several limitations. The Markov model is memoryless, meaning it cannot track time since the index valve procedure, so the reintervention probability in the surveillance arm had to be assumed constant at 0.13% per cycle rather than increasing over time as seen in practice, which may misestimate downstream reintervention timing and costs. Lifetime projections require extrapolation beyond the trial’s median 3.8-year follow-up, and the long-term durability of TAVI valves beyond ten years remains uncertain. The analysis also assumed that EARLY TAVR outcomes generalise to the Saudi population, yet the trial enrolled participants aged 65 or older who were eligible for transfemoral TAVI at low surgical risk. Saudi Arabia’s population is ageing rapidly, projected to increase by 43% by 2050, with substantial multimorbidity including a diabetes prevalence of 23.1%, and high rates of diabetes and autonomic neuropathy can influence symptom presentation and disease progression. These dynamics were not explicitly parameterised in the model. Real-world wait times for valve replacement are often longer than the trial’s median 32 days from decision to treatment, and low utilisation of aortic valve replacement in Saudi Arabia, along with a lack of designated valve clinics particularly in peripheral hospitals, may reduce the effectiveness of clinical surveillance and could actually increase TAVI’s relative benefit.

Another constraint is the paucity of Saudi-specific data on health-related quality of life. Although EQ-5D-5L value sets exist for Saudi Arabia, age-adjusted Saudi population norms have not been derived, so the model applied health-state utility adjustments to United Kingdom general population norms, an assumption that may not hold. Discount rates and the willingness-to-pay threshold were likewise approximated from other sources. The authors note that because TAVI emerged as a dominant intervention, the choice of threshold does not affect the study’s conclusion. Within those caveats, the model estimates that implementing early TAVI for asymptomatic severe aortic stenosis at low procedural risk could reduce costs on the Saudi health budget while improving quality-adjusted survival, supporting policies that promote early detection of aortic stenosis and timely intervention before symptoms develop. The authors add that establishing the precise optimal timing for intervention remains an important area for future research, and that future real-world registry studies in Saudi Arabia will be valuable to evaluate whether local patient complexity modifies the projected comparative cost-effectiveness.

Subject of Research: Cost-effectiveness modelling of early TAVI versus clinical surveillance for asymptomatic severe aortic stenosis in Saudi Arabia

Article Title: Cost-effectiveness of transcatheter aortic valve implantation for asymptomatic severe aortic stenosis in the Kingdom of Saudi Arabia

Article References: Al-Omar, H. A., Montgomery, M., Davies, H., Greaves, E., Davis, R., Hillcoat, L., Rahbi, H. J., Salem, A., Candolfi, P., & Rabiah, A. A. (2026). Cost-effectiveness of transcatheter aortic valve implantation for asymptomatic severe aortic stenosis in the Kingdom of Saudi Arabia. Frontiers in Cardiovascular Medicine, 13, 1937664. https://doi.org/10.3389/fcvm.2026.1937664

Image Credits: AI Generated

DOI: 10.3389/fcvm.2026.1937664

Keywords: aortic stenosis, TAVI, cost-effectiveness, Saudi Arabia, EARLY TAVR trial, clinical surveillance, Markov model, health economics, valvular heart disease, quality-adjusted life years, SAPIEN 3, health technology assessment