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Cardiovascular

Cost-effectiveness analysis of transcatheter aortic valve implantation in aortic stenosis patients at low- and intermediate-surgical risk in Japan

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Pages 697-707 | Received 05 Mar 2024, Accepted 19 Apr 2024, Published online: 06 May 2024

References

  • Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005–1011. doi: 10.1016/S0140-6736(06)69208-8.
  • Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366(18):1696–1704. doi: 10.1056/NEJMoa1202277.
  • Campo J, Tsoris A, Kruse J, et al. Prognosis of severe asymptomatic aortic stenosis with and without surgery. Ann Thorac Surg. 2019;108(1):74–79. doi: 10.1016/j.athoracsur.2019.01.031.
  • Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American college of cardiology. American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143(5):e35–e71.
  • Clark MA, Arnold SV, Duhay FG, et al. Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a medicare claims analysis. Circ Cardiovasc Qual Outcomes. 2012;5(5):697–704. doi: 10.1161/CIRCOUTCOMES.112.966002.
  • Izumi C, Matsuyama R, Asaoka M, et al. Valvular heart disease in Japan: characteristics and treatment of patients in acute care hospitals in 2019. J Cardiol. 2023;82(1):29–34. doi: 10.1016/j.jjcc.2023.03.007.
  • Takeji Y, Taniguchi T, Morimoto T, et al. Transcatheter aortic valve implantation versus conservative management for severe aortic stenosis in real clinical practice. PLOS One. 2019;14(9):e0222979. doi: 10.1371/journal.pone.0222979.
  • Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187–2198. doi: 10.1056/NEJMoa1103510.
  • Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609–1620. doi: 10.1056/NEJMoa1514616.
  • Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695–1705. doi: 10.1056/NEJMoa1814052.
  • Leon MB, Mack MJ, Hahn RT, et al. Outcomes 2 years after transcatheter aortic valve replacement in patients at low surgical risk. J Am Coll Cardiol. 2021;77(9):1149–1161. doi: 10.1016/j.jacc.2020.12.052.
  • Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016;387(10034):2218–2225. doi: 10.1016/S0140-6736(16)30073-3.
  • Kaneko T, Vemulapalli S, Kohsaka S, et al. Practice patterns and outcomes of transcatheter aortic valve replacement in the United States and Japan: a report from joint data harmonization initiative of STS/ACC TVT and J‐TVT. J Am Heart Assoc. 2022;11(6):e023848. doi: 10.1161/JAHA.121.023848.
  • Notice on the calculation of the price of medical materials for specific insurance. (no. 305009) 2020. Available from: https://www.mhlw.go.jp/web/t_doc?dataId=00tc4902&dataType=1&pageNo=2.
  • Shiroiwa T, Fukuda T, Ikeda S, et al. Development of an official guideline for the economic evaluation of drugs/medical devices in Japan. Value Health. 2017;20(3):372–378. doi: 10.1016/j.jval.2016.08.726.
  • Guideline for Preparing Cost-Effectiveness Evaluation to the Central Social Insurance Medical Council Ministry of Health, Labour, and Welfare. 2022 [13 April 2023]. Available from: https://c2h.niph.go.jp/tools/guideline/guideline_en.pdf.
  • MDV database overview: MDV EBM insight. [October 24, 2023]. Available from: https://en.mdv.co.jp/ebm/about-mdv-database/mdv-database-overview/.
  • Baron SJ, Thourani VH, Kodali S, et al. Effect of SAPIEN 3 transcatheter valve implantation on health status in patients with severe aortic stenosis at intermediate surgical risk: results from the PARTNER S3i trial. JACC: cardiovascular Interventions. 2018;11(12):1188–1198.
  • Shiroiwa T, Fukuda T, Ikeda S, et al. Japanese population norms for preference-based measures: EQ-5D-3L, EQ-5D-5L, and SF-6D. Qual Life Res. 2016;25(3):707–719. doi: 10.1007/s11136-015-1108-2.
  • Baron SJ, Magnuson EA, Lu M, et al. Health status after transcatheter versus surgical aortic valve replacement in low-risk patients with aortic stenosis. J Am Coll Cardiol. 2019;74(23):2833–2842. doi: 10.1016/j.jacc.2019.09.007.
  • Shiroiwa T, Noto S, Fukuda T. Japanese population norms of EQ-5D-5L and health utilities index mark 3: disutility catalog by disease and symptom in community settings. Value Health. 2021;24(8):1193–1202. doi: 10.1016/j.jval.2021.03.010.
  • Shimizu U, Aoki H, Sakagami M, et al. Walking ability, anxiety and depression, significantly decrease EuroQol 5-Dimension 5-level scores in older hemodialysis patients in Japan. Arch Gerontol Geriatr. 2018;78:96–100. doi: 10.1016/j.archger.2018.06.006.
  • Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement in low-risk patients at five years. N Engl J Med. 2023;389(21):1949–1960. doi: 10.1056/NEJMoa2307447.
  • Arnold SV, Zhang Y, Baron SJ, et al. Impact of short-term complications on mortality and quality of life after transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2019;12(4):362–369. doi: 10.1016/j.jcin.2018.11.008.
  • Ministry of Health LaW. Handbook of health and welfare statistics. 2021. [Online]. Available from: https://www.mhlw.go.jp/english/database/db-hh/1-2.html.
  • Shiroiwa T, Murata T, Morii Y, et al. Comparison of value set based on DCE and/or TTO data: scoring for EQ-5D-5L health states in Japan. Health Qual Life Outcomes. 2016; 22(1):16–654. doi: 10.1016/j.jval.2016.03.1834.
  • Kuck KH, Leidl R, Frankenstein L, 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;40(3):1031–1046. doi: 10.1007/s12325-022-02392-y.
  • Pinar E, García de Lara J, Hurtado J, et al. Cost-effectiveness analysis of the SAPIEN 3 transcatheter aortic valve implant in patients with symptomatic severe aortic stenosis. Rev Esp Cardiol. 2022;75(4):325–333. doi: 10.1016/j.rec.2021.02.013.
  • Medical fee information provision service: transcatheter prosthesis valve set: Ministry of Health, Labour and Welfare. 2022 [21 Mar 2023]. Available from: https://shinryohoshu.mhlw.go.jp/shinryohoshu/searchMenu/doSearchInputTp.
  • Medical fee information provision service: transcatheter valve replacement: Ministry of Health, Labour and Welfare. 2022 [21 March 2023]. Available from: https://shinryohoshu.mhlw.go.jp/shinryohoshu/searchMenu/doSearchInputSp.
  • Kamae I, Hashimoto Y, Koretsune Y, et al. Cost-effectiveness analysis of apixaban against warfarin for stroke prevention in patients with nonvalvular atrial fibrillation in Japan. Clin Ther. 2015;37(12):2837–2851. doi: 10.1016/j.clinthera.2015.10.007.
  • Hattori N, Hirayama T, Katayama Y. Medical care for chronic-phase stroke in Japan. Neurol Med Chir. 2012;52(4):175–180. doi: 10.2176/nmc.52.175.
  • Cost of dialysis treatment: Cost burden when receiving dialysis. Available at. https://www.zjk.or.jp/kidney-disease/expense/dialysis/. [21 Mar 2023]. Available from: https://www.zjk.or.jp/kidney-disease/expense/dialysis/.
  • Inoue S, Nakao K, Hanyu M, et al. Cost-effectiveness of transcatheter aortic valve implantation using a balloon-expandable valve in Japan: experience from the Japanese pilot health technology assessment. Value Health Reg Issues. 2020;21:82–90. doi: 10.1016/j.vhri.2019.07.013.
  • Ministry of Health Law. Outline of the revision of medical fees of 2022. https://www.mhlw.go.jp/content/12400000/001079187.pdf. (accessed March 21, 2023).
  • Consumer Price Index/2020 Base Consumer Price Index/Annual Report: Price Statistics Office. Consumption Statistics Division, Statistical Research Department, Statistics Bureau, Japan; 2020 [30 March 2023]. Available from: https://www.e-stat.go.jp/stat-search/files?page=1&layout=datalist&toukei=00200573&tstat=000001150147&cycle=7&tclass1=000001150150&stat_infid=000032177636&tclass2val=0.
  • Hasegawa M, Komoto S, Shiroiwa T, et al. Formal implementation of cost-effectiveness evaluations in Japan: a unique health technology assessment system. Value Health. 2020;23(1):43–51. doi: 10.1016/j.jval.2019.10.005.
  • Izumi C, Eishi K, Ashihara K, et al. JCS/JSCS/JATS/JSVS 2020 guidelines on the management of valvular heart disease. Circ J. 2020;84(11):2037–2119. doi: 10.1253/circj.CJ-20-0135.
  • Madhavan MV, Kodali SK, Thourani VH, et al. Outcomes of SAPIEN 3 transcatheter aortic valve replacement compared with surgical valve replacement in intermediate-risk patients. J Am Coll Cardiol. 2023;82(2):109–123. doi: 10.1016/j.jacc.2023.04.049.
  • Kodali S, Thourani VH, White J, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J. 2016;37(28):2252–2262. doi: 10.1093/eurheartj/ehw112.
  • Kodali S. SAPIEN 3 Transcatheter Aortic Valve Replacement Compared with Surgery inIntermediate risk Patients: a Propensity Matched Analysis of 5 year Outcomes2020 Transcatheter Valve Therapies (TVT) Summit; 18-20 June 2020; Virtual 2020.
  • Makkar RR, Thourani VH, Mack MJ, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med. 2020;382(9):799–809. doi: 10.1056/NEJMoa1910555.
  • Gilard M, Eltchaninoff H, Iung B, 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; 25(4):605–613. doi: 10.1016/j.jval.2021.10.003.
  • Goodall G, Lamotte M, Ramos M, et al. Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients. J Med Econ. 2019;22(4):289–296. doi: 10.1080/13696998.2018.1559600.
  • Tarride JE, Luong T, Goodall G, et al. A Canadian cost-effectiveness analysis of SAPIEN 3 transcatheter aortic valve implantation compared with surgery, in intermediate and high-risk severe aortic stenosis patients. Clinicoecon Outcomes Res. 2019;11:477–486. doi: 10.2147/CEOR.S208107.
  • Baron SJ, Wang K, House JA, et al. Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at intermediate risk: results from the PARTNER 2 trial. Circulation. 2019;139(7):877–888. doi: 10.1161/CIRCULATIONAHA.118.035236.
  • Galper BZ, Golden J, Rhee J, et al. Implementation of a post-transcatheter valve replacement (TAVR) fast-track care protocol with a focus on next-day discharge. J Am Coll Cardiol. 2018;71(11):A1224. doi: 10.1016/S0735-1097(18)31765-0.
  • Heathcote L, Srivastava T, Sarmah A, et al. A systematic review and statistical analysis of factors influencing the cost-effectiveness of transcatheter aortic valve implantation for symptomatic severe aortic stenosis. Clinicoecon Outcomes Res. 2023;15:459–475. doi: 10.2147/CEOR.S392566.
  • Herrmann HC, Thourani VH, Kodali SK, et al. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation. 2016;134(2):130–140. doi: 10.1161/CIRCULATIONAHA.116.022797.
  • Ando T, Briasoulis A, Holmes AA, et al. Sapien 3 versus sapien XT prosthetic valves in transcatheter aortic valve implantation: a meta-analysis. Int J Cardiol. 2016;220:472–478. doi: 10.1016/j.ijcard.2016.06.159.
  • Galper BZ, Chinnakondepalli KM, Wang K, et al. Economic outcomes of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis and low surgical risk: results from the PARTNER 3 trial. Circulation. 2023;147(21):1594–1605. doi: 10.1161/CIRCULATIONAHA.122.062481.
  • Kodera S, Kiyosue A, Ando J, et al. Cost effectiveness of transcatheter aortic valve implantation in patients with aortic stenosis in Japan. J Cardiol. 2018;71(3):223–229. doi: 10.1016/j.jjcc.2017.10.008.
  • Shih YT, Liu L. Use of claims data for cost and cost-effectiveness research. Semin Radiat Oncol. 2019;29(4):348–353. doi: 10.1016/j.semradonc.2019.05.009.
  • Daniel JB, Smriti S, Philip AM, et al. Long-Term durability of transcatheter aortic valve prostheses. J Am Coll Cardiol. 2019;73(5):537–545.
  • Ando T, Kumamaru H, Kohsaka S, et al. Procedural volume and outcomes of transfemoral transcatheter aortic valve replacement: from a Japanese nationwide registry. Am J Cardiol. 2023;209:36–41. doi: 10.1016/j.amjcard.2023.09.094.
  • Eerdekens R, Kats S, Grutters JP, 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;22(1):24. doi: 10.1186/s12962-024-00531-6.
  • Baron SJ, Ryan MP, Moore KA, et al. Contemporary costs associated with transcatheter versus surgical aortic valve replacement in medicare beneficiaries. Circ Cardiovasc Interv. 2022;15(3):e011295.