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Economic implications and cost effectiveness of TAVI

Efficacy of TAVI in all-risk patients with aortic stenosis

Many studies have shown improved efficacy of transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in improving clinical symptoms and quality of life in patients across all-risk aortic stenosis.1,2,3 It is well-documented that, compared with SAVR, TAVI reduces length of stay and rehospitalisation, lowers stroke risk, and reduces all-cause mortality.1

TAVI cost-effectiveness in question

Less well-documented is the cost effectiveness of TAVI compared with SAVR. Despite the adoption of minimalist TAVI,4,5 improved technology and increased eligible patient populations, the cost effectiveness of TAVI remains a highly contentious issue.6

It is reported that there are 115,000 eligible aortic stenosis candidates for TAVI who are deemed inoperable or of high and intermediate risk across the EU; this is expected to increase to 177,000 with expansion into low-risk patients.7 Given this rapid growth in TAVI uptake, there is a great need for economic evaluation; particularly, in relation to allocation of scarce healthcare resources.7,8

This has prompted several studies to evaluate the cost effectiveness of TAVI vs SAVR, and recent analyses are consistently showing that TAVI is a cost-effective therapy.6,9-11,13-16 Minimalist TAVI is proven to have increased benefits compared with conventional TAVI and, therefore, a reduction in overall resource utilisation, which is expected to increase the cost effectiveness of TAVI compared with SAVR.12

TAVI vs SAVR in different risk populations

Low risk

The economic value of TAVI is confirmed in a study showing that cost savings are driven by lower initial procedural costs and long-term costs with SAPIEN 3 valve compared to SAVR.13 SAPIEN 3 valve also gains additional quality adjusted life years (QALY) through lower risk of mortality and better health-related quality of life.13

These results are consistent with non-European studies. In Australia, the marginally higher procedural costs of TAVI, compared to SAVR, were seen to be offset by shorter lengths of hospitalisation and lower acute complication costs.14 Over the patient lifetime, it was confirmed that balloon-expandable TAVI (BE-TAVI) is cost-effective compared to SAVR, with self-expanding TAVI (SE-TAVI) being the economically dominant option.14  A Canadian study also found incremental cost effectiveness ratios (ICERs) for BE-TAVI and SE-TAVI were $27,196/QALY and $59,641/QALY, respectively.15

The cost effectiveness of TAVI was also reflected in a US cohort who received TAVI using the

SAPIEN 3 valve.16 The PARTNER 3 economic study showed that reduced hospital length of stay was the main factor in offsetting procedural costs and, at a 2-year follow-up, TAVI costs were substantially lower than for SAVR.16 The highest saving was for patients with moderate to severe symptoms, for whom the 2-year cost savings were >$6000/patient.16 In this way, TAVI was confirmed to be the economically dominant strategy with 95% probability of being cost-effective compared to SAVR.16

High and intermediate risk

In high- and intermediate-risk patients with aortic stenosis, TAVI generated higher procedural costs compared with SAVR, which were attributed to the higher valve acquisition costs; however, transfemoral TAVI resulted in greater reductions in length of stay compared with SAVR, which is believed to offset the higher procedural costs, and thus results in a better ICER.8

It has been purported that SAPIEN 3 valve facilitates the efficient management of severe aortic stenosis in high- and intermediate-risk patients, resulting in the cost effectiveness of TAVI.9 Pinar et al. reported cost-effectiveness of TAVI using a SAPIEN 3 valve in high- and intermediate-risk patients in a Spanish economic model, reporting a 75% predictability of cost effectiveness (Table 1).9 Lorenzoni et al. reported cost effectiveness in an Italian economic model for high and intermediate risk (Table 1).10 In both models, it is assumed that TAVI would be cost effective at frequently cited willingness-to-pay thresholds.9,10

Furthermore, Goodall et al. reported the cost effectiveness of TAVI in a French economic model in intermediate-risk patients with the SAPIEN 3 valve (Table 1).11 Reported life expectancy and QALYs (0.42 years and 0.41 QALYs, respectively) demonstrated clear clinical benefits. Lifetime cost savings of €439 with TAVI were reported compared with SAVR, with 100% likelihood of cost effectiveness at a €15,000 willingness-to-pay threshold.11

Author Year Country Surgical risk ICER WTP threshold Probability of cost-effectiveness
Pinar9 2021 Spain High €5329/LYG   75% Cost-effective
    Intermediate €7910/LYG      
Lorenzoni10 2021 Italy High €11,209/QALY €25,000 90-100% Cost-effective
    intermediate €8338/QALY      
Goodall11 2018 France Intermediate risk   €15000 100 Dominant
Markov model over a 15-year time horizon. ICER, incremental cost-effectiveness ratio; LYG, life year gained; QALY, quality-adjusted life year; WTP, willingness-to-pay.

The economic point of view: is TAVI good value for money compared with other therapeutic options?

Therapy costs associated with TAVI include the device, procedural costs, initial and repeat hospitalisations, drugs used, perioperative and long-term complications, and physicians’ fees.8 Higher acquisition costs for TAVI compared with SAVR are partially offset in all-risk groups because of its effectiveness and safety profile;10 predominantly, this includes lower procedural costs, shorter length of stay in hospital, and a reduced need for cardiac rehabilitation.11 Therefore, the cost of therapy for aortic stenosis in all-risk surgical populations is not simply a cost comparison of implantable devices, as this ignores multiple factors such as lifetime costs, clinical benefits, impact on hospital resources, capacities and patient preference. 6,8,11 Furthermore, TAVI must result in both improved quality of life and gains in life expectancy in order to be considered cost effective.8

TAVI may become the reference treatment for selected patients with severe AS.13

  • Patients want lower risk of complications, reduced hospital readmissions, and improved recovery rate and quality of life.13
  • For healthcare providers, TAVI with SAPIEN 3 valve offers a reduced organisational and resource impact (i.e., lower general anaesthesia), with shorter hospital stays and lower risk of complications (including infections).13
  • When assessing the healthcare budget impact of TAVI versus SAVR, policy makers are encouraged to take a broad, systematic view.13

A comprehensive understanding of the clinical and economic implications of TAVI is necessary to enable appropriate policy and funding decisions; it is expected that further breakthroughs in TAVI technology will heighten its performance to equal or exceed that of SAVR.6,11 As the technique improves, learning curves, economies of scale, and technological innovations may have profound effects on the results.8,17 It is expected that TAVI might be more cost effective when new-generation devices are used and if profound clinical experience is guaranteed.17

References

  1. Mack MJ, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695–705.
  2. Smith CR, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–98.
  3. Thourani VH et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016;387(10034):2218-25.
  4. Barbanti M, et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. Euro Intervention 2019;15:147–54.
  5. Wood DA, et al. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home of Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centres. JACC Cardiovasc Interv 2019;12:459–69.
  6. Piperata A, et al. TAVR, SAVR and MI-AVR. Good things come to those who wait. J. Clin. Med. 2020;9:3392
  7. Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Eur Heart J 2018;0:1–8.
  8. Gialama F, et al. Systematic Review of the Cost-effectiveness of Transcatheter Interventions for Valvular Heart Disease. Eur Heart J Qual Care Clin Outcomes 2018;4:81-90.
  9. Pinar E, et al. Cost-effectiveness analysis of the SAPIEN 3 transcatheter aortic valve implant in patients with symptomatic severe aortic stenosis. Rev Esp Cardiol (Engl Ed) 2021;S1885-5857(21)00130-4.
  10. Lorenzoni V, et al. The cost-effectiveness of transcatheter aortic valve implantation: exploring the Italian National Health System perspective and different patient risk groups. European Journal of Health Economics. 2021;22(9):1349-1363.
  11. Goodall G, et al. Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients. Journal of Medical Economics 2019;4:289-296
  12. Windecker S. PCR statement on TAVI signals “paradigm shift” in treatment of severe symptomatic AS. Available from: https://cardiovascularnews.com/pcr-statement-on-tavi-signals-paradigm-shift-in-treatment-of-severe-symptomatic-as/
  13. Gilard M, et al. cost-Effectiveness Analysis of SAPIEN 3 Transcatheter Aortic Valve Implantation Procedure Compared With Surgery in Patients With Severe Aortic Stenosis at Low Risk of Surgical Mortality in France. Value in Health. 2021.
  14. Zhou JY, et al. Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis. Heart, Lung and Circulation. 2021;30:547-554.
  15. Tam DY, et al. The cost-effectiveness of transcatheter aortic valve replacement in low surgical risk patients with severe aortic stenosis. 2021;7:556-563.
  16. Cohen DJ, et al. Economic Outcomes of TAVR vs. SAVR for Low-Risk Patients: Results from the PARTNER 3 Trial. 2021.
  17. Edlinger C, et al. Economic assessment of traditional surgical valve replacement versus use of transfemoral intervention in degenerative aortic stenosis. Minerva Medica. 2021;112(3):372-383

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