Skip to main navigation menu Skip to main content Skip to site footer

Original article

Vol. 154 No. 10 (2024)

Transcatheter aortic valve implantation with SAPIEN 3 versus surgical aortic valve replacement in patients with symptomatic severe aortic stenosis at low risk of surgical mortality: a cost-utility analysis for Switzerland

DOI
https://doi.org/10.57187/s.3558
Cite this as:
Swiss Med Wkly. 2024;154:3558
Published
24.10.2024

Summary

AIMS OF THE STUDY: The 2021 European Society of Cardiology Guidelines on valvular heart disease recommend transcatheter aortic valve implantation (TAVI) for patients with symptomatic severe aortic stenosis at low surgical risk and age ≥75 years who are suitable for a transfemoral approach (recommendation class IA) based on two large randomised controlled trials (PARTNER 3 and Evolut Low Risk) comparing transcatheter aortic valve implantation with surgical aortic valve replacement (SAVR). Whether such an approach is cost-effective in Switzerland remains unclear. The aim of this cost-utility analysis was to compare transcatheter aortic valve implantation with SAPIEN 3 versus surgical aortic valve replacement in symptomatic severe aortic stenosis patients at low risk of surgical mortality from the perspective of Swiss compulsory health insurance using data from the PARTNER 3 trial (reflecting specifically the safety and efficacy of the SAPIEN 3 TAVI device).

METHODS: A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted from the perspective of the Swiss compulsory health insurance system, using local or geographically close general population mortality and utility data, unit costs and medical resource use from publicly available sources and based on expert opinion. The model had a lifetime horizon with a 3% yearly discounting factor. The cost–utility analysis estimated changes in both direct healthcare costs and health-related quality-adjusted life years for transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with symptomatic severe aortic stenosis at low risk of surgical mortality.

RESULTS: Overall, transcatheter aortic valve implantation with SAPIEN 3 resulted in lifetime costs per patient of CHF 79,534 and quality-adjusted life years per patient of 9.64, compared with surgical aortic valve replacement lifetime costs and quality-adjusted life years per patient of CHF 76,891 and 8.96, respectively. Compared with surgical aortic valve replacement, transcatheter aortic valve implantation was estimated to offer an incremental improvement of +0.68 quality-adjusted life years per patient at an increased cost of +CHF 2643 per patient over a lifetime horizon. The incremental cost-effectiveness ratio was CHF 3866 per quality-adjusted life year gained and remained below CHF 50,000 per quality-adjusted life year gained across several sensitivity analyses.

CONCLUSIONS: This analysis suggests that transcatheter aortic valve implantation using the SAPIEN 3 device is likely to be a highly cost-effective alternative for symptomatic severe aortic stenosis patients at a low risk of surgical mortality, treated in the contemporary Swiss setting. These findings may help to inform a holistic approach when making policy decisions for the management of this patient group.

References

  1. Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Bärwolf C, Levang OW, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231–43. doi: https://doi.org/10.1016/S0195-668X(03)00201-X DOI: https://doi.org/10.1016/S0195-668X(03)00201-X
  2. Otto CM. Timing of aortic valve surgery. Heart. 2000 Aug;84(2):211–8. doi: https://doi.org/10.1136/heart.84.2.211 DOI: https://doi.org/10.1136/heart.84.2.211
  3. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec;106(24):3006–8. doi: https://doi.org/10.1161/01.CIR.0000047200.36165.B8 DOI: https://doi.org/10.1161/01.CIR.0000047200.36165.B8
  4. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al.; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct;363(17):1597–607. doi: https://doi.org/10.1056/NEJMoa1008232 DOI: https://doi.org/10.1056/NEJMoa1008232
  5. Beyersdorf F, Vahanian A, Milojevic M, Praz F, Baldus S, Bauersachs J, et al.; ESC/EACTS Scientific Document Group. Erratum to: 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur J Cardiothorac Surg. 2022 Mar;61(4):964. doi: https://doi.org/10.1093/ejcts/ezab557 DOI: https://doi.org/10.1093/ejcts/ezab557
  6. Falk V, Baumgartner H, Bax JJ, De Bonis M, Hamm C, Holm PJ, et al.; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur J Cardiothorac Surg. 2017 Oct;52(4):616–64. doi: https://doi.org/10.1093/ejcts/ezx324 DOI: https://doi.org/10.1093/ejcts/ezx324
  7. Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, et al.; PARTNER 2 Investigators. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2020 Jan;382(9):799–809. doi: https://doi.org/10.1056/NEJMoa1910555 DOI: https://doi.org/10.1056/NEJMoa1910555
  8. Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Søndergaard L, Mumtaz M, et al.; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr;376(14):1321–31. doi: https://doi.org/10.1056/NEJMoa1700456 DOI: https://doi.org/10.1056/NEJMoa1700456
  9. Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, et al.; PARTNER 3 Investigators. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021 Mar;77(9):1149–61. doi: https://doi.org/10.1016/j.jacc.2020.12.052 DOI: https://doi.org/10.1016/j.jacc.2020.12.052
  10. Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al.; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May;380(18):1695–705. doi: https://doi.org/10.1056/NEJMoa1814052 DOI: https://doi.org/10.1056/NEJMoa1814052
  11. Mack MJ, Leon MB, Thourani VH, Pibarot P, Hahn RT, Genereux P, et al.; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023 Nov;389(21):1949–60. doi: https://doi.org/10.1056/NEJMoa2307447 DOI: https://doi.org/10.1056/NEJMoa2307447
  12. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al.; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb;43(7):561–632. doi: https://doi.org/10.1093/eurheartj/ehab395 DOI: https://doi.org/10.1093/ejcts/ezac209
  13. 832.112.31. KS. Anhang 1 der Krankenpflege-Leistungsverordnung (KLV). Vergütungspflicht der obligatorischen Krankenpflegeversicherung für bestimmte ärztliche Leistungen 2023. Available from: https://www.bag.admin.ch/dam/bag/de/dokumente/kuv-leistungen/leistungen-und-tarife/aerztliche-leistungen/Anhang1-KLV/aenderungen_klv_anh1_010723.pdf.download.pdf/aenderungen_klv_anh1_010723.pdf
  14. Gilard M, Eltchaninoff H, Iung B, Lefèvre T, Spaulding C, Dumonteil N, 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 Health. 2022 Apr;25(4):605–13. doi: https://doi.org/10.1016/j.jval.2021.10.003 DOI: https://doi.org/10.1016/j.jval.2021.10.003
  15. Mennini FS, Meucci F, Pesarini G, Vandoni P, Lettino M, Sarmah A, et al. Cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in low surgical risk aortic stenosis patients. Int J Cardiol. 2022 Jun;357:26–32. doi: https://doi.org/10.1016/j.ijcard.2022.03.034 DOI: https://doi.org/10.1016/j.ijcard.2022.03.034
  16. Vázquez Rodríguez J, Pinar Bermúdez E, Zamorano Gómez J, Burgos J, Diaz-Fernandez J, Garcia del Blanco B, et al. Cost-effectiveness of SAPIEN 3 transcatheter aortic valve implantation in low surgical mortality risk patients in Spain. REC Interv Cardiol. 2023;5:38–45. doi: https://doi.org/10.24875/RECICE.M22000340 DOI: https://doi.org/10.24875/RECICE.M22000340
  17. Kuck KH, Leidl R, Frankenstein L, Wahlers T, Sarmah A, Candolfi P, et al. Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk. Adv Ther. 2023 Mar;40(3):1031–46. doi: https://doi.org/10.1007/s12325-022-02392-y DOI: https://doi.org/10.1007/s12325-022-02392-y
  18. Dubois C, Adriaenssens T, Annemans L, Bosmans J, Callebaut B, Candolfi P, et al. Transcatheter aortic valve implantation versus surgical aortic valve replacement in severe aortic stenosis patients at low surgical mortality risk: a cost-effectiveness analysis in Belgium. Acta Cardiol. 2024 Feb;79(1):46–57. doi: https://doi.org/10.1080/00015385.2023.2282283 DOI: https://doi.org/10.1080/00015385.2023.2282283
  19. Eerdekens R, Kats S, Grutters JP, Green M, Shore J, Candolfi P, et al. Cost-utility analysis of TAVI compared with surgery in patients with severe aortic stenosis at low risk of surgical mortality in the Netherlands. Cost Eff Resour Alloc. 2024 Mar;22(1):24. doi: https://doi.org/10.1186/s12962-024-00531-6 DOI: https://doi.org/10.1186/s12962-024-00531-6
  20. FOPH. Federal Office of Public Health. Health technology assessment (HTA). Available from: https://www.bag.admin.ch/bag/en/home/versicherungen/krankenversicherung/krankenversicherung-leistungen-tarife/hta.html
  21. Abbott JH, Wilson R, Pryymachenko Y, Sharma S, Pathak A, Chua JY. Economic evaluation: a reader’s guide to studies of cost-effectiveness. Arch Physiother. 2022 Dec;12(1):28. doi: https://doi.org/10.1186/s40945-022-00154-1 DOI: https://doi.org/10.1186/s40945-022-00154-1
  22. Szende A, Janssen B, Cabases J. Self-Reported Population Health: An International Perspective based on EQ-5D. Dordrecht (NL): Springer open. Copyright 2014. DOI: https://doi.org/10.1007/978-94-007-7596-1
  23. SGK. Swiss TAVI Registry. Data provided by SGK 2021 2021. Available from: https://www.swisstavi.ch/
  24. Bourguignon T, El Khoury R, Candolfi P, Loardi C, Mirza A, Boulanger-Lothion J, et al. Very Long-Term Outcomes of the Carpentier-Edwards Perimount Aortic Valve in Patients Aged 60 or Younger. Ann Thorac Surg. 2015 Sep;100(3):853–9. doi: https://doi.org/10.1016/j.athoracsur.2015.03.105 DOI: https://doi.org/10.1016/j.athoracsur.2015.03.105
  25. Swiss DR. Datenspiegel SwissDRG 13.0 2024. Available from: https://www.swissdrg.org/de/akutsomatik/swissdrg-system-1302024/fallpauschalenkatalog
  26. Swiss DR. RCG Katalog ST Reha 1.0 / 2022 2022. Available from: https://www.swissdrg.org/application/files/4216/1598/6342/ST_Reha_1.0_RCG_Katalog.pdf
  27. Swiss Medical Association. Ambulante Tarife Tarmed. Version 01.09.00_BR_KVG. Available from: https://browser.tartools.ch/de/tarmed_kvg
  28. FOPH. Federal Office of Public Health. Spezialitätenliste (SL). Available from: https://www.spezialitätenliste.ch/Default.aspx
  29. Pletscher M, Plessow R, Eichler K, Wieser S. Cost-effectiveness of dabigatran for stroke prevention in atrial fibrillation in Switzerland. Swiss Med Wkly. 2013 Jan;143:w13732. doi: https://doi.org/10.4414/smw.2013.13732 DOI: https://doi.org/10.4414/smw.2013.13732
  30. Statbureau. Germany Inflation Calculators 2020. Available from: https://www.statbureau.org/en/germany/inflation-calculators?dateBack=2005-1-1&dateTo=2020-12-1&amount=7266.42
  31. Ludwig S, Theis C, Wolff C, Nicolle E, Witthohn A, Götte A. Complications and associated healthcare costs of transvenous cardiac pacemakers in Germany. J Comp Eff Res. 2019 Jun;8(8):589–97. doi: https://doi.org/10.2217/cer-2018-0114 DOI: https://doi.org/10.2217/cer-2018-0114
  32. OECD. OECD Data. Purchasing power parities (PPP) 2021. Available from: https://data.oecd.org/conversion/purchasing-power-parities-ppp.htm
  33. Baron SJ, Wang K, House JA, Magnuson EA, Reynolds MR, Makkar R, et al. Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk. Circulation. 2019 Feb;139(7):877–88. doi: https://doi.org/10.1161/CIRCULATIONAHA.118.035236 DOI: https://doi.org/10.1161/CIRCULATIONAHA.118.035236
  34. HAS-Sante. SAPIEN 3 treatment of severe symptomatic aortic stenosis in low-risk surgical patients in France 2021. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2021-04/sapien3_9022021_avis_economique_vf2.pdf
  35. HIQA (Health Information and Quality Authority). Health Technology Assessment of transcatheter aortic valve implantation (TAVI) in patients with severe symptomatic aortic stenosis at low and intermediate risk of surgical complications 2019. Available from: https://www.hiqa.ie/sites/default/files/2019-12/TAVI_HTA.pdf
  36. NIPH (Norwegian Institute of Public Health). Transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and low surgical risk and across surgical risk groups: a health technology assessment 2021. Available from: https://www.fhi.no/en/publ/2021/TAVI-vs-SAVR-for-patients-with-severe-aortic-stenosis-and-low-surgical-risk-and-across-surgical-risk-groups/
  37. Tam DY, Azizi PM, Fremes SE, Chikwe J, Gaudino M, Wijeysundera HC. The cost-effectiveness of transcatheter aortic valve replacement in low surgical risk patients with severe aortic stenosis. Eur Heart J Qual Care Clin Outcomes. 2021 Oct;7(6):556–63. doi: https://doi.org/10.1093/ehjqcco/qcaa058 DOI: https://doi.org/10.1093/ehjqcco/qcaa058
  38. Zhou JY, Liew D, Duffy SJ, Walton A, Htun N, Stub D. Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis. Heart Lung Circ. 2021 Apr;30(4):547–54. doi: https://doi.org/10.1016/j.hlc.2020.09.934 DOI: https://doi.org/10.1016/j.hlc.2020.09.934
  39. Huygens SA, van der Kley F, Bekkers JA, Bogers AJ, Takkenberg JJ, Rutten-van Mölken MP. Beyond the clinical impact of aortic and pulmonary valve implantation: health-related quality of life, informal care and productivity. Eur J Cardiothorac Surg. 2019 Apr;55(4):751–9. doi: https://doi.org/10.1093/ejcts/ezy382 DOI: https://doi.org/10.1093/ejcts/ezy382
  40. SAFE (Stroke Alliance For Europe). The burden of stroke in Germany 2017. Available from: https://www.safestroke.eu/wp-content/uploads/2017/12/SAFE_STROKE_GERMANY.pdf
  41. Blum S, Aeschbacher S, Coslovsky M, Meyre PB, Reddiess P, Ammann P, et al.; BEAT-AF and Swiss-AF investigators. Long-term risk of adverse outcomes according to atrial fibrillation type. Sci Rep. 2022 Feb;12(1):2208. doi: https://doi.org/10.1038/s41598-022-05688-9 DOI: https://doi.org/10.1038/s41598-022-05688-9
  42. FSO. Federal Statistical Office. Kohortensterbetafeln für die Schweiz (1876-2030) nach Geburtsjahrgang, Geschlecht und Alter 2019. Available from: https://www.pxweb.bfs.admin.ch/pxweb/de/px-x-0102020300_101/px-x-0102020300_101/px-x-0102020300_101.px/
  43. Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ. 2016 Sep;354:i4482. doi: https://doi.org/10.1136/bmj.i4482 DOI: https://doi.org/10.1136/bmj.i4482
  44. Gandjour A, Stock S. A national hypertension treatment program in Germany and its estimated impact on costs, life expectancy, and cost-effectiveness. Health Policy. 2007 Oct;83(2-3):257–67. doi: https://doi.org/10.1016/j.healthpol.2007.01.003 DOI: https://doi.org/10.1016/j.healthpol.2007.01.003
  45. Ali M, MacIsaac R, Quinn TJ, Bath PM, Veenstra DL, Xu Y, et al. Dependency and health utilities in stroke: data to inform cost-effectiveness analyses. Eur Stroke J. 2017 Mar;2(1):70–6. doi: https://doi.org/10.1177/2396987316683780 DOI: https://doi.org/10.1177/2396987316683780
  46. Walter E, Voit M, Eichhober G. Cost-effectiveness analysis of apixaban compared to other direct oral anticoagulants for prevention of stroke in Austrian atrial fibrillation patients. Expert Rev Pharmacoecon Outcomes Res. 2021 Apr;21(2):265–75. doi: https://doi.org/10.1080/14737167.2020.1798233 DOI: https://doi.org/10.1080/14737167.2020.1798233

Most read articles by the same author(s)

1 2 > >>