1,388
Views
1
CrossRef citations to date
0
Altmetric
Cardiovascular

Budget impact analysis of a bioprosthetic valve with a novel tissue versus mechanical aortic valve replacement in patients older than 65 years with aortic stenosis in Saudi Arabia

ORCID Icon, ORCID Icon, , ORCID Icon, , & show all
Pages 1149-1157 | Received 20 Sep 2022, Accepted 04 Oct 2022, Published online: 20 Oct 2022

References

  • Iung B, Vahanian A. Epidemiology of valvular heart disease in the adult. Nat Rev Cardiol. 2011;8(3):162–172.
  • Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. The Lancet. 2006;368(9540):1005–1011.
  • De Sciscio P, Brubert J, De Sciscio M, et al. Quantifying the shift toward transcatheter aortic valve replacement in low-risk patients: a meta-analysis. Circ Cardiovasc Qual Outcomes. 2017;10:e003287.
  • Iung B, Baron G, Butchart EG, 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;24(13):1231–1243.
  • Khraif RM, Salam AA, Elsegaey I, et al. Changing age structures and ageing scenario of the arab world. Soc Indic Res. 2015;121(3):763–785.
  • Karlin NJ, Weil J, Felmban W. Aging in Saudi Arabia. Gerontol Geriatr Med. 2016;2:2333721415623911.
  • Gire J. Cultural variations in perceptions of aging. In: Cross-cultural psychology, contemporary themes and perspectives. Chichester (UK): Wiley-Blackwell; 2011. p. 110–130.
  • United Nations Department of Economic and Social Affairs. Population by broad age groups [Internet]. World Population Prospects 2022 - Population Division. 2022. [cited 2022 Jul 12]. Available from: https://population.un.org/wpp/Graphs/DemographicProfiles/Line/682.
  • Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics–2013 update: a report from the American Heart Association. Circulation. 2013;127(1):e6–e245.
  • Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart disease and stroke statistics - 2010 update: a report from the American heart association. Circulation. 2010;121(7):948–954.
  • Varadarajan P, Kapoor N, Bansal RC, et al. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006;82(6):2111–2115.
  • Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(23):2440–2492.
  • Coylewright M, Palmer R, O'Neill ES, et al. Patient-defined goals for the treatment of severe aortic stenosis: a qualitative analysis. Health Expect. 2016;19(5):1036–1043.
  • Alatawi FO, Abuelatta RA, AlAhmedi AB, et al. Clinical outcomes with transcatheter aortic valve implantation at a single cardiac center in Saudi Arabia. Ann Saudi Med. 2018;38(3):167–173.
  • Glaser N, Jackson V, Holzmann MJ, et al. Aortic valve replacement with mechanical vs. biological prostheses in patients aged 50–69 years. Eur Heart J. 2016;37(34):2658–2667.
  • Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation. 2021;143(5):e72–e227.
  • Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J. 2022;43(7):561–632.
  • Puskas JD, Bavaria JE, Svensson LG, et al. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017;52(3):432–439.
  • Flameng W, Hermans H, Verbeken E, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149(1):340–345.
  • De La Fuente AB, Wright GA, Olin JM, et al. Advanced integrity preservation technology reduces bioprosthesis calcification while preserving performance and safety. J Heart Valve Dis. 2015;24:101–109.
  • Bartus K, Litwinowicz R, Bilewska A, et al. Final 5-year outcomes following aortic valve replacement with a RESILIATM tissue bioprosthesis. Eur J Cardiothorac Surg. 2021;59(2):434–441.
  • Brennan JM, Edwards FH, Zhao Y, et al. Long-term safety and effectiveness of mechanical versus biologic aortic valve prostheses in older patients: results from the Society of Thoracic Surgeons Adult Cardiac Surgery National Database. Circulation. 2013;127(16):1647–1655.
  • Lopez-Marco A, Grant SW, Mohamed S, et al. Impact of Mechanical Aortic Prostheses in hospital stay and anticoagulation related complications. J Surg Res. 2021;04(02):187–196.
  • Syenza Data on File. Aortic valve market research and price comparisons. Syenza; 2022.
  • Al-Omar HA, Aljuffali IA, Solà-Morales O. Value drivers for pharmaceutical products in health technology assessment (HTA) in Saudi Arabia: results from a capacity building, Multi-Stakeholder workshop. Saudi Pharm J. 2021;29(9):946–954.
  • Al-Omar HA, Attuwaijri AA, Aljuffali IA. Pharmaceutical companies’ views on a health technology assessment (HTA) entity in Saudi Arabia. Saudi Pharm J. 2020;28(6):662–668.
  • Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices–budget impact analysis. Value Health. 2007;10(5):336–347.
  • Microsoft Corporation. Microsoft Excel, Version 2208 [Internet]. 2022. Available from: https://office.microsoft.com/excel.
  • General Authority for Statistics. Population estimates in the midyear of 2021 [Internet]. General Authority for Statistics; 2021. Available from: https://www.stats.gov.sa/en/43.
  • Baghai M, Wendler O, Grant SW, et al. Aortic valve surgery in the UK, trends in activity and outcomes from a 15-year complete national series. Eur J Cardiothorac Surg. 2021;60(6):1353–1357.
  • Andell P, Li X, Martinsson A, et al. Epidemiology of valvular heart disease in a Swedish nationwide hospital-based register study. Heart. 2017;103(21):1696–1703.
  • Bourguignon T, Bouquiaux-Stablo A-L, Candolfi P, et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015;99(3):831–837.
  • Bavaria JE, Griffith B, Heimansohn DA, et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with RESILIA tissue. Ann Thorac Surg. 2022. DOI:10.1016/j.athoracsur.2021.12.058
  • Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC guidelines for the management of infective endocarditis: the task force for the management of infective endocarditis of the european society of cardiology (ESC). endorsed by: European association for Cardio-Thoracic surgery (EACTS), the european association of nuclear medicine (EANM). Eur Heart J. 2015;36(44):3075–3128.
  • Attia T, Yang Y, Svensson LG, et al. Similar long-term survival after isolated bioprosthetic versus mechanical aortic valve replacement: a propensity-matched analysis. J Thor Cardiovasc Surg. 2021. Available from: https://www.jtcvs.org/article/S0022-5223(21)00059-3/fulltext.
  • World Health Organization. Global health observatory, life tables [Internet]. WHO. World Health Organization; [cited 2021 Sep 21]. Available from: https://apps.who.int/gho/data/view.main.61440?lang=en
  • Zhao DF, Seco M, Wu JJ, et al. Mechanical versus bioprosthetic aortic valve replacement in middle-aged adults: a systematic review and meta-analysis. Ann Thorac Surg. 2016;102(1):315–327.
  • Bourguignon T, Lhommet P, El Khoury R, et al. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50–65 years. Eur J Cardiothorac Surg. 2016;49(5):1462–1468.
  • Kytö V, Ahtela E, Sipilä J, et al. Mechanical versus biological valve prosthesis for surgical aortic valve replacement in patients with infective endocarditis. Interact Cardiovasc Thorac Surg. 2019;29(3):386–392.
  • Etnel JRG, Huygens SA, Grashuis P, et al. Bioprosthetic aortic valve replacement in nonelderly adults: a systematic review, meta-analysis, microsimulation. Circ Cardiovasc Qual Outcomes. 2019;12:e005481.
  • Tackling G, Lala V. Endocarditis antibiotic regimens. Treasure Island (FL): StatPearls Publishing; 2022. [cited 2022 Jun 24]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK542162/.
  • Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: Diagnosis, antimicrobial therapy, and management of complications. Circulation. 2015;132(15):1435–1486.
  • Tukey JW. Exploratory data analysis. Reading (MA): Addison-Wesley Pub. Co.; 1977. [cited 2022 Sep 12]. Available from: http://archive.org/details/exploratorydataa00tuke_0.
  • InterQuartile Range (IQR) [Internet]. [cited 2022 Sep 12]. Available from: https://sphweb.bumc.bu.edu/otlt/MPH-Modules/BS/BS704_SummarizingData/BS704_SummarizingData7.html.
  • Wilbring M, Tugtekin S-M, Alexiou K, et al. Transapical transcatheter aortic valve implantation vs conventional aortic valve replacement in high-risk patients with previous cardiac surgery: a propensity-score analysis. Eur J Cardiothorac Surg. 2013;44(1):42–47.
  • Carapinha JL, Al-Omar HA, Alqoofi F, et al. Budget impact analysis of transcatheter aortic valve replacement in low, intermediate, and high-risk patients with severe aortic stenosis in Saudi Arabia. J Med Econ. 2022;25(1):77–86.
  • International Comparison Program (ICP) [Internet]. World Bank. [cited 2022 Jul 14]. Available from: https://www.worldbank.org/en/programs/icp.
  • Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease: Developed by the task force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2022;43(7):561–632.
  • Keeling D, Baglin T, Tait C, et al. Guidelines on oral anticoagulation with warfarin – fourth edition. Br J Haematol. 2011;154(3):311–324.
  • Saudi Food and Drug Authority. Drugs List [Internet]. Saudi Food and Drug Authority; 2022. Available from: https://sfda.gov.sa/en/drugs-list.
  • Hersi AS, Osenenko KM, Kherraf SA, et al. Cost-effectiveness of apixaban for stroke prevention in non-valvular atrial fibrillation in Saudi Arabia. Ann Saudi Med. 2019;39(4):265–278.
  • Al-Senani F, Al-Johani M, Salawati M, et al. A national economic and clinical model for ischemic stroke care development in Saudi Arabia: a call for change. Int J Stroke. 2019;14(8):835–842.
  • Alharthy A, Karakitsos D. King Saud Medical City Intensive Care Unit: a critical and cost-focused appraisal. Saudi Crit Care J. 2019;3(1):19–23.
  • Altowaijri A, Alshehri N, Balkhi B, et al. PCV50 economic burden of major cardiovascular diseases and ischemic stroke in Saudi Arabia: a cost of illness study. Value Health. 2020;23:S495–S496.
  • Johnston KM, Osenenko KM, Qatami L, et al. Health care resource utilization and costs in individuals with atrial fibrillation in United Arab Emirates and Kingdom of Saudi Arabia: a retrospective cohort study. Int J Int Med. 2015;4:17–25.
  • 1 USD to SAR - US Dollars to Saudi Arabian Riyals Exchange Rate [Internet]. [cited 2022 Sep 12]. Available from: https://www.xe.com/currencyconverter/convert/?Amount=1&From=USD&To=SAR.
  • Nguyen TC, Walker T, Gunnarsson C, et al. Long-term healthcare expenditures over time for tissue and mechanical aortic valve replacement. Ann Thorac Surg. 2021;112(2):526–531.
  • Potter S, Davies C, Davies G, et al. The use of micro-costing in economic analyses of surgical interventions: a systematic review. Health Econ Rev. 2020;10(1):3.
  • Bobade RA, Helmers RA, Jaeger TM, et al. Time-driven activity-based cost analysis for outpatient anticoagulation therapy: direct costs in a primary care setting with optimal performance. J Med Econ. 2019;22(5):471–477.
  • Pibarot P, Borger MA, Clavel M-A, et al. Study design of the prospective non-randomized single-arm multicenter evaluation of the durability of aortic bioprosthetic valves with RESILIA tissue in subjects under 65 years old (RESILIENCE trial)*. Struct Heart. 2020;4(1):46–52.