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Canadian Journal of Cardiology

Annual Budget Impact Analysis Comparing Self-Expanding Transcatheter and Surgical Aortic Valve Replacement in Low-Risk Aortic Stenosis Patients

Published:September 11, 2022DOI:https://doi.org/10.1016/j.cjca.2022.06.005

      Abstract

      Background

      Transcatheter aortic valve replacement (TAVR) is approved for use across the entire spectrum of risk, including low-surgical-risk patients for severe aortic stenosis (AS). TAVR has been shown to be cost-effective compared with surgical aortic valve replacement (SAVR) in Canada. However, the affordability of implementing TAVR for low-risk AS patients from the hospital’s payers’ perspective is unknown.

      Methods

      A budget impact analysis was conducted using a 1-year time horizon to quantify the total cost of health care resource utilisation to initially treat low-risk AS patients and manage subsequent adverse events. Differences in cost between TAVR and SAVR were calculated for 100 patients for various scenarios of TAVR uptake (10% to 70%) in low-risk AS patients. Event rates and associated costs were obtained from published literature and provincial datasets. Costs were reported in 2021 Canadian dollars. One-way sensitivity analysis on key TAVR input parameters was conducted.

      Results

      Mean index hospitalisation costs of SAVR and TAVR per patient were $41,956 and $37,669, respectively. The average total costs of managing a low-risk AS patient in 1 year for TAVR and SAVR were $45,897 and $42,659, respectively. The incremental budget impacts of increasing TAVR uptake from 10% to 50% and 70% were 3% and 4.5%, respectively. One-way sensitivity analysis on key variables showed that the main contributors to the cost difference were the intensive care unit stay, permanent pacemaker rate, and hospital length of stay.

      Conclusions

      The incremental annual cost of implementing TAVR in low-risk AS patients was small, making TAVR likely an affordable strategy.

      Résumé

      Contexte

      Le remplacement valvulaire aortique par cathéter (RVAC) est une stratégie thérapeutique approuvée, quel que soit le niveau de risque des patients, y compris chez ceux présentant une sténose aortique (SA) grave et un faible risque opératoire. Au Canada, le RVAC présente un rapport coût-efficacité avantageux par rapport à celui de la chirurgie de remplacement valvulaire aortique (CRVA). Néanmoins, on ne sait pas si le recours au RVAC chez les patients présentant une SA et un faible risque opératoire est économiquement viable pour les payeurs du secteur hospitalier.

      Méthodologie

      Une analyse de l’incidence budgétaire a été effectuée pour évaluer le coût annuel total lié aux ressources de santé utilisées dans le traitement initial des patients présentant une SA et un faible risque opératoire, ainsi que pour la prise en charge des manifestations indésirables ultérieures. Les différences de coûts entre le RVAC et la CRVA ont été calculées pour 100 patients selon diverses proportions de RVAC (de 10 % à 70 %) chez les patients présentant une SA et un faible risque opératoire. Les taux d’incidence des manifestations indésirables et les coûts associés ont été tirés de la littérature scientifique et des bases de données provinciales. Les coûts ont été exprimés en dollars canadiens selon le cours de 2021. Une analyse de sensibilité unidirectionnelle a été effectuée pour les principaux paramètres d’entrée du RVAC.

      Résultats

      Les coûts d’hospitalisation moyens pour la CRVA et le RVAC étaient de 41 956 et de 37 669 dollars, respectivement. Les coûts annuels moyens pour la prise en charge d’un patient présentant une SA et un faible risque opératoire étaient de 45 897 dollars pour le RVAC et de 42 659 dollars pour la CRVA. Les valeurs d’incidence budgétaire différentielle d’une augmentation de la proportion de RVAC de 10 % à 50 % ou à 70 % étaient de 3 % et de 4,5 %, respectivement. Une analyse de sensibilité unidirectionnelle des facteurs principaux a révélé que les variables contribuant le plus à la différence de coût étaient les séjours en soins intensifs, le taux d’implantation d’un stimulateur cardiaque permanent et la durée d’hospitalisation.

      Conclusions

      Compte tenu des faibles coûts annuels supplémentaires associés à l’instauration du RVAC chez les patients présentant une SA et un faible risque opératoire, le RVAC est, selon toute vraisemblance, une stratégie que l’on peut qualifier d’abordable.
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      References

        • Joseph J.
        • Naqvi S.Y.
        • Giri J.
        • Goldberg S.
        Aortic stenosis: pathophysiology, diagnosis, and therapy.
        Am J Med. 2017; 130: 253-263
        • Stewart B.F.
        • Siscovick D.
        • Lind B.K.
        • et al.
        Clinical factors associated with calcific aortic valve disease.
        J Am Coll Cardiol. 1997; 29: 630-634
        • Osnabrugge R.L.J.
        • Mylotte D.
        • Head S.J.
        • et al.
        Aortic stenosis in the elderly.
        J Am Coll Cardiol. 2013; 62: 1002-1012
        • Rajamannan N.M.
        • Bonow R.O.
        • Rahimtoola S.H.
        Calcific aortic stenosis: an update.
        Nat Rev Cardiol. 2007; 4: 254-262
        • Walther T.
        • Blumenstein J.
        • van Linden A.
        • Kempfert J.
        Contemporary management of aortic stenosis: surgical aortic valve replacement remains the gold standard.
        Heart. 2012; 98: iv23-iv29
        • Stortecky S.
        • Buellesfeld L.
        • Wenaweser P.
        • Windecker S.
        Transcatheter aortic valve implantation: the procedure.
        Heart. 2012; 98: iv44-iv51
        • Popma J.J.
        • Adams D.H.
        • Reardon M.J.
        • et al.
        Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.
        J Am Coll Cardiol. 2014; 63: 1972-1981
        • Popma J.J.
        • Deeb G.M.
        • Yakubov S.J.
        • et al.
        Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.
        N Engl J Med. 2019; 380: 1706-1715
        • Mack M.J.
        • Leon M.B.
        • Thourani V.H.
        • et al.
        Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.
        N Engl J Med. 2019; 380: 1695-1705
        • Onorati F.
        • Quintana E.
        • El-Dean Z.
        • et al.
        Aortic valve replacement for aortic stenosis in low-, intermediate-, and high-risk patients: preliminary results from a prospective multicentre registry.
        J Cardiothorac Vasc Anesth. 2020; 34: 2091-2099
        • Vahanian A.
        • Beyersdorf F.
        • Praz F.
        • et al.
        2021 ESC/EACTS guidelines for the management of valvular heart disease.
        Eur Heart J. 2022; 43: 561-632
        • Sundt T.M.
        • Jneid H.
        Guideline update on indications for transcatheter aortic valve implantation based on the 2020 American College of Cardiology/American Heart Association guidelines for management of valvular heart disease.
        JAMA Cardiol. 2021; 6: 1088-1089
        • Tam D.Y.
        • Azizi P.M.
        • Fremes S.E.
        • et al.
        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; 7: 556-563
        • Thourani V.H.
        • Suri R.M.
        • Gunter R.L.
        • et al.
        Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients.
        Ann Thorac Surg. 2015; 99: 55-61
        • Ministry of Health and Long Term Care
        Health Data Branch Web Portal.
        (Available at:)
        • Canadian Institute for Health Information
        Patient Cost Estimator.
        (Published online 2020. Available at:)
        • Elbatarny M.
        • Tam D.Y.
        • Fremes S.E.
        Commentary: nuisance or nemesis? Postoperative atrial fibrillation increases long-term mortality regardless of sex.
        J Thorac Cardovasc Surg. 2020; 159: 1426-1427
        • Mehaffey J.H.
        • Hawkins R.B.
        • Byler M.
        • et al.
        Cost of individual complications following coronary artery bypass grafting.
        J Thorac Cardovasc Surg. 2018; 155: 875-882.e1
        • Shahim B.
        • Malaisrie S.C.
        • George I.
        • et al.
        Postoperative atrial fibrillation or flutter following transcatheter or surgical aortic valve replacement.
        JACC Cardovasc Interv. 2021; 14: 1565-1574
        • Arnold S.V.
        • Cohen D.J.
        • Dai D.
        • et al.
        Predicting quality of life at 1 year after transcatheter aortic valve replacement in a real-world population.
        Circ Cardovasc Qual Outcomes. 2018; 11e004693
        • Carroll J.D.
        • Mack M.J.
        • Vemulapalli S.
        • et al.
        STS-ACC TVT registry of transcatheter aortic valve replacement.
        Ann Thorac Surg. 2021; 111: 701-722
        • Tam D.Y.
        • Hughes A.
        • Wijeysundera H.C.
        • Fremes S.E.
        Cost-effectiveness of self-expandable transcatheter aortic valves in intermediate-risk patients.
        Ann Thorac Surg. 2018; 106: 676-683
        • Tarride J.E.
        • Luong T.
        • Goodall G.
        • Burke N.
        • Blackhouse G.
        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
        • Tam D.Y.
        • Miranda R.N.
        • Elbatarny M.
        • Wijeysundera H.C.
        Real-world health-economic considerations around aortic-valve replacement in a publicly funded health system.
        Can J Cardiol. 2021; 37: 992-1003
        • Sud M.
        • Tam D.Y.
        • Wijeysundera H.C.
        The economics of transcatheter valve interventions.
        Can J Cardiol. 2017; 33: 1091-1098
        • Sadri H.
        Breaking down the silos: transcatheter aortic valve implant vs open heart surgery.
        Healthc Manage Forum. 2020; 33: 277-281
        • Canadian Cardiovascular Society
        National quality report: transcatheter aortic valve implantation.
        October 2019 (October 2019. Available at:) (Accessed January 17, 2022)
        • Wood D.A.
        • Lauck S.B.
        • Cairns J.A.
        • et al.
        The Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers.
        JACC Cardovasc Interv. 2019; 12: 459-469
        • Porter M.E.
        • Teisberg E.O.
        Redefining Health Care: Creating Value-Based Competition on Results.
        Harvard Business School Press, 2006
        • Christensen C.M.
        • Grossman J.H.
        • Hwang J.
        The Innovator’s Prescription a Disruptive Solution for Health Care.
        McGraw-Hill Education, 2017
        • Sikka R.
        • Morath J.M.
        • Leape L.
        The Quadruple Aim: care, health, cost and meaning in work.
        BMJ Qual Saf. 2015; 24: 608-610
        • Bodenheimer T.
        • Sinsky C.
        From Triple to Quadruple Aim: care of the patient requires care of the provider.
        Ann Fam Med. 2014; 12: 573-576
        • Sadri H.
        • Sinigallia S.
        • Shah M.
        • Vanderheyden J.
        • Souche B.
        Time-driven activity-based costing for cataract surgery in Canada: the case of the Kensington Eye Institute.
        Healthc Policy. 2021; 16: 97-108
        • Tam D.Y.
        • Wijeysundera H.C.
        • Naimark D.
        • et al.
        Impact of transcatheter aortic valve durability on life expectancy in low-risk patients with severe aortic stenosis.
        Circulation. 2020; 142: 354-364
        • Tran D.T.
        • Ohinmaa A.
        • Thanh N.X.
        • et al.
        The current and future financial burden of hospital admissions for heart failure in Canada: a cost analysis.
        CMAJ Open. 2016; 4: E365-E370
        • Lau D.
        • Sandhu R.
        • Andrade J.
        • et al.
        Cost-utility of catheter ablation for atrial fibrillation in patients with heart failure: an economic evaluation.
        J Am Heart Assoc. 2021; 10: e019599
        • Lau D.
        • Pannu N.
        • James M.T.
        • et al.
        Costs and consequences of acute kidney injury after cardiac surgery: A cohort study.
        J Thorac Cardovasc Surg. 2021; 162: 880-887
        • Ontario Ministry of Health
        Schedule of benefits: physician services under the Health Insurance Act. January 24, 2022 (effective November 1, 2021).
        (Available at:)
        • Reardon M.J.
        Evolut surgical replacement and transcatheter aortic valve implantation in low risk patients—Evolut Low Risk. Paper presented at: American College of Cardiology Annual Scientific Session (ACC 2019). March 17, 2019; New Orleans, LA.
        (Available at:) (Accessed September 10, 2021)

      Linked Article

      • Open Access Budget Impact Assessment Tools: A Welcome Step in Supporting Evidence-Informed Policy Decisions
        Canadian Journal of CardiologyVol. 38Issue 10
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          Over the past several decades, transcatheter aortic valve replacement (TAVR) has emerged as a disruptive technology that transformed the management of patients with severe aortic stenosis. Initially offered to mostly older patients with aortic stenosis who were not surgical candidates because of excessive operative risk, TAVR has become an acceptable therapeutic option for operative candidates who are at high or moderate surgical risk.1,2 More recent randomized studies, such as the landmark Placement of Aortic Transcatheter Valves (PARTNER 3)3 and Evolut Low Risk4 trials, have further shifted the paradigm by demonstrating noninferiority of TAVR to surgical aortic valve replacement (SAVR) in low-risk surgical patients.
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