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Canadian Journal of Cardiology

Real-World Health-Economic Considerations Around Aortic-Valve Replacement in a Publicly Funded Health System

  • Derrick Y. Tam
    Affiliations
    Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author
  • Rafael Neves Miranda
    Affiliations
    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada

    Division of Cardiology, Department of Medicine, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    ICES, Toronto, Ontario, Canada
    Search for articles by this author
  • Malak Elbatarny
    Affiliations
    Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
    Search for articles by this author
  • Harindra C. Wijeysundera
    Correspondence
    Corresponding author: Dr Harindra Wijeysundera, Schulich Heart Centre, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Room A202, Toronto, Ontario M4N 3M5, Canada. Tel.: +1-416-480-4527.
    Affiliations
    Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada

    Division of Cardiology, Department of Medicine, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    ICES, Toronto, Ontario, Canada
    Search for articles by this author
Published:April 30, 2021DOI:https://doi.org/10.1016/j.cjca.2020.11.015

      Abstract

      Herein, we describe the unique interplay among biomedical ethics, principles of distributive justice, and economic theory to highlight the role of health technology assessments to compare therapeutic options for aortic valve replacement. From the perspective of the Canadian health care system, transcatheter aortic-valve implantation is associated with higher costs but also higher incremental health benefits compared with surgical aortic-valve replacement. At current willingness to pay thresholds, transcatheter aortic-valve replacement is likely cost effective across the spectrum of risk, from inoperable patients to those at low surgical risk. However, we highlight the nuances within each subgroup of surgical risk that merit careful consideration by the heart team. Moreover, incorporation of patients and their preferences in decision-making is key. In particular, in young, low-risk patients, there remains uncertainty regarding the optimal treatment, with unique concerns around valve durability, selection of valve prosthesis, and consideration for special procedures such as the Ross procedure. Nonetheless, current research suggests that, universally, patients prefer a less invasive approach compared with a more invasive approach. Finally, we highlight that there remain critical issues around timeliness of access to care and unacceptable geographic inequities across Canada. Further research into alternative funding mechanisms and integrated cross-sector care pathways is necessary to address these issues.

      Résumé

      Nous décrirons ci-après l'interaction unique entre l'éthique biomédicale, les principes de justice distributive et la théorie économique afin de souligner le rôle des évaluations des technologies de la santé dans la comparaison des options thérapeutiques pour le remplacement valvulaire aortique. Du point de vue du système de soins de santé canadien, l'implantation valvulaire aortique par cathéter est associée à des coûts plus élevés, mais aussi à des bienfaits différentiels accrus en matière de santé, comparativement à la chirurgie de remplacement valvulaire aortique. Selon les seuils de disposition à payer actuels, l'implantation valvulaire aortique par cathéter est est probablement une approche rentable pour les patients à divers stades du spectre de risque, en allant des patients inopérables à ceux chez qui le risque chirurgical est faible. Toutefois, nous soulignons les nuances au sein de chacun des sous-groupes de risque chirurgical qui méritent d'être soigneusement prises en considération par l'équipe de cardiologie. De plus, il est essentiel de tenir compte des patients et de leurs préférences dans le processus décisionnel. Chez les patients jeunes à faible risque, particulièrement, le traitement optimal demeure incertain, et certaines préoccupations concernant la durabilité de la valve, le choix de la prothèse valvulaire et la possibilité de recourir à une intervention spéciale, comme la procédure de Ross, sont propres à ce sous-groupe. La recherche actuelle suggère néanmoins que de façon universelle, les patients préfèrent une approche moins invasive à une approche plus invasive. Finalement, nous rappellerons qu'il subsiste encore des enjeux importants concernant les temps d'attente pour l'accès aux soins et des inégalités géographiques inacceptables au sein du Canada. De plus amples recherches sont requises pour trouver d’autres mécanismes de financement et des approches transversales de soins intégrés afin de remédier à ces enjeux.
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      References

        • Leon M.B.
        • Smith C.R.
        • Mack M.
        • et al.
        Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.
        N Engl J Med. 2010; 363: 1597-1607
        • Leon M.B.
        • Smith C.R.
        • Mack M.J.
        • et al.
        Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.
        N Engl J Med. 2016; 374: 1609-1620
        • 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
        • Nishimura R.A.
        • Otto C.M.
        • Bonow R.O.
        • et al.
        2017 AHA/ACC focused update of the 2014 aha/acc guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
        Circulation. 2017; 135: e1159-e1195
        • Asgar A.W.
        • Ouzounian M.
        • Adams C.
        • et al.
        2019 Canadian Cardiovascular Society Position statement for transcatheter aortic valve implantation.
        Can J Cardiol. 2019; 35: 1437-1448
        • Sud M.
        • Tam D.Y.
        • Wijeysundera H.C.
        The economics of transcatheter valve interventions.
        Can J Cardiol. 2017; 33: 1091-1098
        • Beauchamp T.L.
        • Childress J.F.
        Principles of Biomedical Ethics.
        7 ed. Oxford University Press, Oxford, United Kingdom2013: 250-301
        • Gibson J.L.
        • Martin D.K.
        • Singer P.A.
        Evidence, economics and ethics: resource allocation in health services organizations.
        Healthc Q. 2005; 8: 50-59
        • Goodman C.
        HTA and innovation of value: getting to know you.
        Int J Technol Assess Health Care. 2013; 29: 351-352
        • Detsky A.S.
        • Naglie G.
        • Krahn M.D.
        • Naimark D.
        • Redelmeier D.A.
        Primer on medical decision analysis: Part 1–Getting started.
        Med Decis Making. 1997; 17: 123-125
        • Mandelblatt J.S.
        • Ramsey S.D.
        • Lieu T.A.
        • Phelps C.E.
        Evaluating frameworks that provide value measures for health care interventions.
        Value Health. 2017; 20: 185-192
      1. Paulden M. McCabe C. Theoretical Models of the Cost-Effectiveness Threshold, Value Assessment, and Health Care System Sustainability. University of Alberta, Edmonton, Alberta, Canada2018
        • Laupacis A.
        • Feeny D.
        • Detsky A.S.
        • Tugwell P.X.
        How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations.
        CMAJ. 1992; 146: 473-481
        • Anderson J.L.
        • Heidenreich P.A.
        • Barnett P.G.
        • et al.
        ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines.
        Circulation. 2014; 129: 2329-2345
        • Marshall D.A.
        • Douglas P.R.
        • Drummond M.F.
        • et al.
        Guidelines for conducting pharmaceutical budget impact analyses for submission to public drug plans in Canada.
        Pharmacoeconomics. 2008; 26: 477-495
        • Smith C.R.
        • Leon M.B.
        • Mack M.J.
        • et al.
        Transcatheter versus surgical aortic-valve replacement in high-risk patients.
        N Engl J Med. 2011; 364: 2187-2198
        • Adams D.H.
        • Popma J.J.
        • Reardon M.J.
        • et al.
        Transcatheter aortic-valve replacement with a self-expanding prosthesis.
        N Engl J Med. 2014; 370: 1790-1798
        • Neyt M.
        • Van Brabandt H.
        • Devriese S.
        • Van De Sande S.
        A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population.
        BMJ Open. 2012; 2e001032
        • Simons C.T.
        • Cipriano L.E.
        • Shah R.U.
        • Garber A.M.
        • Owens D.K.
        • Hlatky M.A.
        Transcatheter aortic valve replacement in nonsurgical candidates with severe, symptomatic aortic stenosis: a cost-effectiveness analysis.
        Circ Cardiovasc Qual Outcomes. 2013; 6: 419-428
        • Reynolds M.R.
        • Magnuson E.A.
        • Wang K.
        • et al.
        Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).
        Circulation. 2012; 125: 1102-1109
        • Reynolds M.R.
        • Magnuson E.A.
        • Lei Y.
        • et al.
        Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A).
        J Am Coll Cardiol. 2012; 60: 2683-2692
        • Fried L.P.
        • Tangen C.M.
        • Walston J.
        • et al.
        Frailty in older adults: evidence for a phenotype.
        J Gerontol A Biol Sci Med Sci. 2001; 56: M146-M156
        • Tam D.Y.
        • Qiu F.
        • Elbaz-Greener G.
        • et al.
        Predictors of cumulative health care costs associated with transcatheter aortic valve replacement in severe aortic stenosis.
        Can J Cardiol. 2020; 36: 1244-1251
        • Okoh A.K.
        • Haik N.
        • Haik B.
        • et al.
        Periprocedural complications after transcatheter aortic valve replacement and their impact on resource utilization.
        Cardiovasc Revasc Med. 2020; 21: 1086-1090
        • Patel J.N.
        • Ahmad M.
        • Kim M.
        • et al.
        Relation of frailty to cost for patients undergoing transcatheter aortic valve implantation.
        Am J Cardiol. 2020; 125: 469-474
        • Osnabrugge R.L.J.
        • Mylotte D.
        • Head S.J.
        • et al.
        Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study.
        J Am Coll Cardiol. 2013; 62: 1002-1012
        • Iung B.
        • Cachier A.
        • Baron G.
        • et al.
        Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery?.
        Eur Heart J. 2005; 26: 2714-2720
        • Durko A.P.
        • Osnabrugge R.L.
        • Van Mieghem N.M.
        • et al.
        Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections.
        Eur Heart J. 2018; 39: 2635-2642
        • Health Quality Ontario
        Transcatheter aortic valve implantation for treatment of aortic valve stenosis: a health technology assessment.
        Ont Health Technol Assess Ser. 2016; 16: 1-94
        • Asgar A.
        • Lauck S.
        • Lambert L.
        • et al.
        Canadian Cardiovascular Society National Quality Report: Transcatheter aortic valve implantation.
        (Available at:) (Accessed September 14, 2020)
        • Hancock-Howard R.L.
        • Feindel C.M.
        • Rodés-Cabau J.
        • et al.
        Cost effectiveness of transcatheter aortic valve replacement compared to medical management in inoperable patients with severe aortic stenosis: Canadian analysis based on the PARTNER Trial Cohort B findings.
        J Med Econ. 2013; 16: 541-566
        • Sehatzadeh S.
        • Doble B.
        • Xie F.
        • et al.
        Transcatheter aortic valve implantation (TAVI) for treatment of aortic valve stenosis: An evidence update.
        Ont Health Technol Assess Ser. 2013; 13: 1-40
        • Doble B.
        • Blackhouse G.
        • Goeree R.
        • Xie F.
        Cost-effectiveness of the Edwards SAPIEN transcatheter heart valve compared with standard management and surgical aortic valve replacement in patients with severe symptomatic aortic stenosis: a Canadian perspective.
        Thorac Cardiovasc Surg. 2013; 146: 52-60
        • Tam D.Y.
        • Hughes A.
        • Fremes S.E.
        • et al.
        A cost-utility analysis of transcatheter versus surgical aortic valve replacement for the treatment of aortic stenosis in the population with intermediate surgical risk.
        J Thorac Cardiovasc Surg. 2018; 155: 1978-19788.e1
        • 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
        • Tam D.Y.
        • Azizi P.M.
        • Fremes S.E.
        • Chikwe J.
        • Gaudino M.
        • Wijeysundera H.C.
        The cost-effectiveness of transcatheter aortic valve replacement in low surgical risk patients with severe aortic stenosis.
        Eur Heart J Qual Care Clin Outcomes. 2020; ([Epub ahead of print])https://doi.org/10.1093/ehjqcco/qcaa058
        • Ontario Health (Quality)
        Transcatheter aortic valve implantation in patients with severe, symptomatic aortic valve stenosis at intermediate surgical risk: a health technology assessment.
        Ont Health Technol Assess Ser. 2020; 20: 1-121
        • Reardon M.J.
        • Van Mieghem N.M.
        • Popma J.J.
        • et al.
        Surgical or transcatheter aortic-valve replacement in intermediate-risk patients.
        N Engl J Med. 2017; 376: 1321-1331
        • Tam D.Y.
        • Vo T.X.
        • Wijeysundera H.C.
        • et al.
        Transcatheter vs surgical aortic valve replacement for aortic stenosis in low-intermediate risk patients: a meta-analysis.
        Can J Cardiol. 2017; 33: 1171-1179
        • Baron S.J.
        • Wang K.
        • House J.A.
        • et al.
        Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at intermediate risk.
        Circulation. 2019; 139: 877-888
        • Barili F.
        • Freemantle N.
        • Parolari A.
        Five-year outcomes with transcatheter aortic-valve replacement.
        N Engl J Med. 2020; 383: 594-596
        • Makkar R.R.
        • Thourani V.H.
        • Mack M.J.
        • et al.
        Five-year outcomes of transcatheter or surgical aortic-valve replacement.
        N Engl J Med. 2020; 382: 799-809
        • Tam D.Y.
        • Chu M.W.
        Paravalvular leak after transcatheter aortic valve implantation: trading one disease for another?.
        Exp Rev Cardiovasc Ther. 2014; 12: 407-411
        • 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
        • 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
        • Thyregod H.G.H.
        • Steinbrüchel D.A.
        • Ihlemann N.
        • et al.
        Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial.
        J Am Coll Cardiol. 2015; 65: 2184-2194
        • 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; 374: 1609
        • Mazine A.
        • El-Hamamsy I.
        • Verma S.
        • et al.
        Ross procedure in adults for cardiologists and cardiac surgeons: JACC State-of-the-Art Review.
        J Am Coll Cardiol. 2018; 72: 2761-2777
        • Mylotte D.
        • Osnabrugge R.L.J.
        • Windecker S.
        • et al.
        Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization.
        J Am Coll Cardiol. 2013; 62: 210-219
        • Wijeysundera H.C.
        • Henning K.A.
        • Qiu F.
        • et al.
        Inequity in access to transcatheter aortic valve replacement: a pan-canadian evaluation of wait-times.
        Can J Cardiol. 2020; 36: 844-851
        • Wijeysundera H.C.
        • Wong W.W.L.
        • Bennell M.C.
        • et al.
        Impact of wait times on the effectiveness of transcatheter aortic valve replacement in severe aortic valve disease: a discrete event simulation model.
        Can J Cardiol. 2014; 30: 1162-1169
        • Elbaz-Greener G.
        • Masih S.
        • Fang J.
        • et al.
        Temporal trends and clinical consequences of wait-times for trans-catheter aortic valve replacement: a population-based study.
        Circulation. 2018; 138: 483-493
        • Dewey T.M.
        • Herbert M.A.
        • Ryan W.H.
        • et al.
        Influence of surgeon volume on outcomes with aortic valve replacement.
        Ann Thorac Surg. 2012; 93 (discussion 1112-3): 1107-1112
        • Vemulapalli S.
        • Carroll J.D.
        • Mack M.J.
        • et al.
        Procedural volume and outcomes for transcatheter aortic-valve replacement.
        N Engl J Med. 2019; 380: 2541-2550
        • Salemi A.
        • Sedrakyan A.
        • Mao J.
        • et al.
        Individual operator experience and outcomes in transcatheter aortic valve replacement.
        JACC Cardiovasc Interv. 2019; 12: 90-97
        • Green C.P.
        • Porter C.B.
        • Bresnahan D.R.
        • Spertus J.A.
        Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure.
        J Am Coll Cardiol. 2000; 35: 1245-1255
        • Arnold S.V.
        • Reynolds M.R.
        • Wang K.
        • et al.
        Health status after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis at increased surgical risk: results from the CoreValve US pivotal trial.
        JACC Cardiovasc Interv. 2015; 8: 1207-1217
        • Baron S.J.
        • Arnold S.V.
        • Wang K.
        • et al.
        Health status benefits of transcatheter vs surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk: results from the PARTNER 2 randomized clinical trial.
        JAMA Cardiol. 2017; 2: 837-845
        • Lytvyn L.
        • Guyatt G.H.
        • Manja V.
        • et al.
        Patient values and preferences on transcatheter or surgical aortic valve replacement therapy for aortic stenosis: a systematic review.
        BMJ Open. 2016; 6e014327
        • Marsh K.
        • Hawken N.
        • Brookes E.
        • Kuehn C.
        • Liden B.
        Patient-centered benefit-risk analysis of transcatheter aortic valve replacement.
        F1000Res. 2019; 8: 394
        • Korteland N.M.
        • Ahmed Y.
        • Koolbergen D.R.
        • et al.
        Does the use of a decision aid improve decision making in prosthetic heart valve selection? A multicenter randomized trial.
        Circ Cardiovasc Qual Outcomes. 2017; 10e003178
        • Coylewright M.
        • O'Neill E.
        • Sherman A.
        • et al.
        The learning curve for shared decision-making in symptomatic aortic stenosis.
        JAMA Cardiol. 2020; 5: 442-448
        • Ontario Health (Quality)
        Transcatheter aortic valve implantation in patients with severe aortic valve stenosis at low surgical risk: a health technology assessment.
        Ont Health Technol Assess Ser. 2020; 20: 1-148