Cost-effectiveness analysis of transcatheter aortic valve implantation for asymptomatic severe aortic stenosis across nine European countries
Key result
Early TAVI is cost-saving and improves QALYs over surveillance in asymptomatic severe aortic stenosis.
- Dominant strategy (cost-effectiveness probabilities 97.3% to 99.9%)
- n=901
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Why the study?
Early aortic valve replacement provides demonstrated benefits over clinical surveillance for asymptomatic severe aortic stenosis, but the economic impact of TAVI in this population required estimation.
Does early TAVI improve cost-effectiveness and clinical outcomes compared to clinical surveillance in patients with asymptomatic severe aortic stenosis?
Key Points
- To estimate the economic impact and cost-effectiveness of transcatheter aortic valve implantation compared with clinical surveillance in patients with asymptomatic severe aortic stenosis across nine European countries.
- A lifetime Markov model with three health states (alive and well, stroke, and death) was developed using clinical inputs from the EARLY TAVR trial (NCT03042104) and literature sources.
- Cost-utility analysis compared TAVI (SAPIEN 3/SAPIEN 3 Ultra valve) against clinical surveillance with delayed aortic valve replacement upon symptom onset.
- Clinical event rates were estimated using parametric survival analysis, alongside deterministic, probabilistic, and scenario sensitivity analyses across nine European healthcare systems.
- Early TAVI was the economically dominant strategy across all nine countries, with cost-effectiveness probabilities ranging from 97.3% (UK) to 99.9% (Belgium).
- Per-person incremental cost savings ranged from -£1788 (UK) to -CHF15 802 (Switzerland), with quality-adjusted life year (QALY) gains between 0.18 (Germany, UK) and 0.23 (Switzerland).
- Deterministic modelling estimated an increase in median survival of 0.16–0.25 years, alongside per-person decreases in strokes (0.03–0.05), heart failure hospitalizations (0.12–0.14), and permanent pacemaker implantations (0.03).
Structured PICO
Does early TAVI improve cost-effectiveness and clinical outcomes compared to clinical surveillance in patients with asymptomatic severe aortic stenosis?
P
Population
A cost-effectiveness Markov model based on 901 patients with asymptomatic severe aortic stenosis, mean age 75.8 years, evaluating early TAVI versus clinical surveillance across nine European countries.
I
Intervention
Early transcatheter aortic valve implantation (TAVI) using SAPIEN 3/SAPIEN 3 Ultra valve
C
Comparator
Clinical surveillance (CS) with delayed aortic valve replacement upon symptom onset
O
Outcome
Cost-effectiveness (incremental costs and quality-adjusted life years) over a lifetime horizon
Main Result
Effect estimate: Dominant strategy (cost-effectiveness probabilities 97.3% to 99.9%)
Early TAVI is a cost-saving and health-improving strategy compared to clinical surveillance for asymptomatic severe aortic stenosis, supporting recent guideline recommendations for early intervention.
Limitations
- EARLY TAVR trial participants were predominantly white, eligible for transfemoral TAVI, at low surgical risk, and received a balloon-expandable valve
- Outcomes from US and Canada assumed generalizable to Europe
- Time to AVR in clinical surveillance arm informed by trial (median 32 days) which may be longer in real-world practice
- Memoryless nature of Markov models and assumption of maximum one stroke per lifetime
- Long-term durability of bioprosthesis based on intermediate and high-surgical risk populations
- Trial participants predominantly white, low surgical risk, transfemoral approach
- Assumed US/Canada trial outcomes generalizable to Europe
- Trial CS arm time to AVR (32 days) may be shorter than real-world
- Memoryless nature of Markov models
- Long-term valve durability based on higher-risk populations
Ask about this paper
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“These new data reinforce the need to move away from a 'wait-and-see' approach for patients with asymptomatic severe AS. In Europe, approximately 100,000 patients suffer from asymptomatic severe AS every year. Treating patients earlier – before symptoms develop – not only improves clinical outcomes but also optimises healthcare costs and resource utilisation.”
DPDr. Patrizio Lancellotti
“The study by Généreux et al. addresses this gap in a timely and comprehensive manner. Building on the clinical foundation provided by the EARLY TAVR trial, the authors extended the analysis to a lifetime perspective, modelling the cost-effectiveness of early TAVI across nine European countries.”
DMDr. Magnus BäckProfessor of Cardiology
“Interpretation of these findings must also consider the characteristics of the population studied. The EARLY TAVR trial predominantly enrolled patients with progressive valve disease and relatively low surgical risk, representing a selected subset of the broader asymptomatic severe AS population. Whether these findings generalize across the full clinical spectrum remains uncertain.”
Implication
Supports modeled cost savings with early TAVI in asymptomatic severe AS; leaves open prospective economic confirmation beyond simulation.
Abstract
Aims: Asymptomatic severe aortic stenosis (aSAS) is associated with morbidity, with mortality increasing once symptoms develop. Benefits of early aortic valve replacement (AVR) over clinical surveillance (CS) with delayed AVR upon symptom onset have been demonstrated, and it is now recommended from the latest European Guidelines if procedural risk is low (Class IIa, Level A). The aim of this study is to estimate the economic impact of transcatheter aortic valve implantation (TAVI) for the treatment of aSAS. Methods and results: A cost-utility analysis compared TAVI using the SAPIEN 3/SAPIEN 3 Ultra valve vs. CS in patients with aSAS across nine European countries. A lifetime Markov model captured peri-procedural and long-term outcomes across three health states: alive and well, stroke, and death. Inputs were derived from the EARLY TAVR trial (NCT03042104) and literature sources. Clinical event rates were estimated via parametric survival analysis. Transcatheter aortic valve implantation treatment for patients with aSAS was modelled to be the economically dominant strategy for treating aSAS across all nine European healthcare systems, with cost-effectiveness probabilities ranging from 97.3% (UK) to 99.9% (Belgium). Incremental results per person included cost savings from -£1788 (UK) to -CHF15 802 (Switzerland), quality-adjusted life years gains of 0.18 (Germany, UK) to 0.23 (Switzerland), and life-year gains of 0.12 (UK) to 0.17 (Belgium). Annual discounting of upfront TAVI costs vs. delayed AVR costs drove results. Conclusion: For patients with aSAS, early intervention with TAVI is estimated to deliver greater health benefits and reduce costs compared with CS. These findings support policies promoting early detection and timely intervention before symptom onset.
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
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Cite This Study
Généreux et al. (2026) studied Asymptomatic severe aortic stenosis (aSAS) (n=901). Early transcatheter aortic valve implantation (TAVI) vs. Clinical surveillance with delayed AVR upon symptom onset was evaluated on Cost-effectiveness (incremental cost-effectiveness ratio, QALYs, and costs) (Dominant strategy (cost-effectiveness probabilities 97.3% to 99.9%)). Early TAVI was modeled to be the economically dominant strategy for treating asymptomatic severe aortic stenosis across nine European countries, yielding cost savings and QALY gains compared to clinical surveillance.