Advertisement

Implementation Issues for Transcatheter Aortic Valve Implantation: Access, Value, Affordability, and Wait Times

  • Harindra C. WijeysunderaEmail author
  • Gabby Elbaz-Greener
  • Derrick Y. Tam
  • Stephen E. Fremes
Chapter

Abstract

Transcatheter aortic valve replacement (TAVR) has rapidly transitioned from an innovative procedure intended for compassionate use to the standard of care for elderly patients with severe aortic stenosis. With the growth in the indications for TAVR, demand for this procedure has grown exponentially. This growth has put pressure on funding and infrastructure. In this chapter, we examine these implementation issues through an examination of disparities in access to TAVR, reimbursement concerns related to TAVR value and affordability, the impact of the imbalance between demand and supply in terms of wait times, the consequences of prolonged wait times, and finally the complexities associated with addressing infrastructure limitations.

Keywords

Implementation TAVR Wait times Affordability Cost drivers Mortality Hospitalization Volume-outcome 

References

  1. 1.
    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;106(24):3006–8.PubMedCrossRefGoogle Scholar
  2. 2.
    Cribier A. Development of transcatheter aortic valve implantation (TAVI): a 20-year odyssey. Arch Cardiovasc Dis. 2012;105(3):146–52.PubMedCrossRefGoogle Scholar
  3. 3.
    Cribier A. The development of transcatheter aortic valve replacement (TAVR). Glob Cardiol Sci Pract. 2016;2016(4):e201632.PubMedPubMedCentralGoogle Scholar
  4. 4.
    Lawrie GM. Role of transcatheter aortic valve implantation (TAVI) versus conventional aortic valve replacement in the treatment of aortic valve disease. Methodist Debakey Cardiovasc J. 2012;8(2):4–8.PubMedPubMedCentralCrossRefGoogle Scholar
  5. 5.
    Dvir D, Barbash IM, Ben-Dor I, Okubagzi P, Satler LF, Waksman R, et al. The development of transcatheter aortic valve replacement in the USA. Arch Cardiovasc Dis. 2012;105(3):160–4.PubMedCrossRefGoogle Scholar
  6. 6.
    Barbanti M, Webb JG, Gilard M, Capodanno D, Tamburino C. Transcatheter aortic valve implantation in 2017: state of the art. EuroIntervention. 2017;13(AA):AA11–21.PubMedPubMedCentralCrossRefGoogle Scholar
  7. 7.
    Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, 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(11):1002–12.PubMedCrossRefGoogle Scholar
  8. 8.
    Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597–607.PubMedCrossRefGoogle Scholar
  9. 9.
    Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187–98.PubMedPubMedCentralCrossRefGoogle Scholar
  10. 10.
    Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609–20.CrossRefPubMedGoogle Scholar
  11. 11.
    Jones DA, Tchetche D, Forrest J, Hellig F, Lansky A, Moat N. The SURTAVI study: TAVI for patients with intermediate risk. EuroIntervention. 2017;13(5):e617–e20.PubMedCrossRefGoogle Scholar
  12. 12.
    Hamm CW, Arsalan M, Mack MJ. The future of transcatheter aortic valve implantation. Eur Heart J. 2016;37(10):803–10.PubMedCrossRefGoogle Scholar
  13. 13.
    Vahl TP, Kodali SK, Leon MB. Transcatheter aortic valve replacement 2016: a modern-day “through the looking-glass” adventure. J Am Coll Cardiol. 2016;67(12):1472–87.PubMedCrossRefGoogle Scholar
  14. 14.
    Brian D, Smith RT, Vella V. The role of product life cycle in medical technology innovation. J Med Market. 2013;13(1):37–43.CrossRefGoogle Scholar
  15. 15.
    Mylotte D, Osnabrugge RLJ, Windecker S, Lefevre T, de Jaegere P, Jeger R, et al. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;62(3):210–9.PubMedCrossRefGoogle Scholar
  16. 16.
    Parma R, Dabrowski M, Ochala A, Witkowski A, Dudek D, Siudak Z, et al. The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland. Postepy Kardiol Interwencyjnej. 2017;13(1):10–7.PubMedPubMedCentralGoogle Scholar
  17. 17.
    Asgar AW, Lauck S, Ko D, Lambert LJ, Kass M, Adams C, et al. The transcatheter aortic valve implantation (TAVI) quality report: a call to arms for improving quality in Canada. Can J Cardiol. 2018;34(3):330–2.PubMedCrossRefGoogle Scholar
  18. 18.
    Kearney P, Stokoe G, Breithardt G, Longson C, Marco J, Morgan J, et al. Improving patient access to novel medical technologies in Europe. Eur Heart J. 2006;27(7):882–5.PubMedCrossRefGoogle Scholar
  19. 19.
    Ryden L, Stokoe G, Breithardt G, Lindemans F, Potgieter A. Task Force 2 of the Cardiovascular Round Table of the European Society of C. Patient access to medical technology across Europe. Eur Heart J. 2004;25(7):611–6.PubMedCrossRefGoogle Scholar
  20. 20.
    Cerfolio RJ. What is value health care and who is the judge? Eur J Cardiothorac Surg. 2017;52(6):1015–7.PubMedCrossRefGoogle Scholar
  21. 21.
    Porter ME. What is value in health care? N Engl J Med. 2010;363(26):2477–81.PubMedCrossRefGoogle Scholar
  22. 22.
    Sud M, Tam DY, Wijeysundera HC. The economics of transcatheter valve interventions. Can J Cardiol. 2017;33(9):1091–8.PubMedCrossRefGoogle Scholar
  23. 23.
    Anderson JL, Heidenreich PA, Barnett PG, Creager MA, Fonarow GC, Gibbons RJ, 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(22):2329–45.PubMedCrossRefGoogle Scholar
  24. 24.
    Reynolds MR, Magnuson EA, Wang K, Lei Y, Vilain K, Walczak J, 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(9):1102–9.PubMedPubMedCentralCrossRefGoogle Scholar
  25. 25.
    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;2(3):e001032.PubMedPubMedCentralCrossRefGoogle Scholar
  26. 26.
    Reynolds MR, Magnuson EA, Lei Y, Wang K, Vilain K, Li H, 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(25):2683–92.PubMedPubMedCentralCrossRefGoogle Scholar
  27. 27.
    Tam DY, Hughes A, Fremes SE, Youn S, Hancock-Howard RL, Coyte PC, 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;155:1978–1988.e1.PubMedCrossRefGoogle Scholar
  28. 28.
    Cohen D. Surgical aortic valve replacement in intermediate risk patients results from the PARTNER 2A and Sapien 3 Intermediate Risk Trials. https://www.acc.org/~/media/Clinical/PDF-Files/Approved-PDFs/2017/10/24/TCT17_Presentation_Slides/Tue_Oct31/PARTNER-2A-SAPIEN-3-Cost-Effectiveness-TCT-2017.pdf. TCT; October 31, 2017.
  29. 29.
    CADTH. Guidelines for the economic evaluation of health technologies. 4th ed. https://www.cadth.ca. Ottawa: Canadian Agency for Drugs and Technologies; 2017.Google Scholar
  30. 30.
    Grover FL, Vemulapalli S, Carroll JD, Edwards FH, Mack MJ, Thourani VH, et al. 2016 annual report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol. 2017;69(10):1215–30.PubMedPubMedCentralCrossRefGoogle Scholar
  31. 31.
    Gaede L, Kim WK, Blumenstein J, Liebetrau C, Dorr O, Nef H, et al. Temporal trends in transcatheter and surgical aortic valve replacement: an analysis of aortic valve replacements in Germany during 2012–2014. Herz. 2017;42(3):316–24.PubMedCrossRefGoogle Scholar
  32. 32.
    Health Quality Ontario. Transcatheter aortic valve implantation for treatment of aortic stenosis: a health technology assessment. 2016;16:1–94.Google Scholar
  33. 33.
    Wijeysundera HC, Li L, Braga V, Pazhaniappan N, Pardhan AM, Lian D, et al. Drivers of healthcare costs associated with the episode of care for surgical aortic valve replacement versus transcatheter aortic valve implantation. Open Heart. 2016;3(2):e000468.PubMedPubMedCentralCrossRefGoogle Scholar
  34. 34.
    McCarthy FH, Savino DC, Brown CR, Bavaria JE, Kini V, Spragan DD, et al. Cost and contribution margin of transcatheter versus surgical aortic valve replacement. J Thorac Cardiovasc Surg. 2017;154(6):1872–80.e1.PubMedPubMedCentralGoogle Scholar
  35. 35.
    Ribera A, Slof J, Andrea R, Falces C, Gutierrez E, Del Valle-Fernandez R, et al. Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: cost-utility and its determinants. Int J Cardiol. 2015;182:321–8.PubMedCrossRefGoogle Scholar
  36. 36.
    Robinson JC, Pozen A, Tseng S, Bozic KJ. Variability in costs associated with total hip and knee replacement implants. J Bone Joint Surg Am. 2012;94(18):1693–8.PubMedCrossRefGoogle Scholar
  37. 37.
  38. 38.
    Siciliani L, Borowitz M, Moran V. Waiting time policies in the health sector: what works? OECD health policy studies. Paris: OECD Publishing; 2013.Google Scholar
  39. 39.
    Ansell D, Crispo JAG, Simard B, Bjerre LM. Interventions to reduce wait times for primary care appointments: a systematic review. BMC Health Serv Res. 2017;17(1):295.PubMedPubMedCentralCrossRefGoogle Scholar
  40. 40.
    Viberg N, Forsberg BC, Borowitz M, Molin R. International comparisons of waiting times in health care—limitations and prospects. Health Policy. 2013;112(1–2):53–61.PubMedCrossRefGoogle Scholar
  41. 41.
  42. 42.
    Legare JF, Li D, Buth KJ. How established wait time benchmarks significantly underestimate total wait times for cardiac surgery. Can J Cardiol. 2010;26(1):e17–21.PubMedPubMedCentralCrossRefGoogle Scholar
  43. 43.
    Kent H. Waiting-list web site “inaccurate” and “misleading,” BC doctors complain. CMAJ. 1999;161(2):181–2.PubMedPubMedCentralGoogle Scholar
  44. 44.
    Lund O, Nielsen TT, Emmertsen K, Flo C, Rasmussen B, Jensen FT, et al. Mortality and worsening of prognostic profile during waiting time for valve replacement in aortic stenosis. Thorac Cardiovasc Surg. 1996;44(6):289–95.PubMedCrossRefGoogle Scholar
  45. 45.
    Munt BI, Humphries KH, Gao M, Moss RR, Thompson CR. True versus reported waiting times for valvular aortic stenosis surgery. Can J Cardiol. 2006;22(6):497–502.PubMedPubMedCentralCrossRefGoogle Scholar
  46. 46.
    Lauck S, Stub D, Webb J. Monitoring wait times for transcatheter aortic valve implantation: a need for national benchmarks. Can J Cardiol. 2014;30(10):1150–2.PubMedCrossRefGoogle Scholar
  47. 47.
    Nuis RJ, Dager AE, van der Boon RM, Jaimes MC, Caicedo B, Fonseca J, et al. Patients with aortic stenosis referred for TAVI: treatment decision, in-hospital outcome and determinants of survival. Neth Heart J. 2012;20(1):16–23.PubMedCrossRefGoogle Scholar
  48. 48.
    Elbaz-Greener G, Masih S, Fang J, Ko DT, Lauck SB, Webb JG, et al. Temporal trends and clinical consequences of wait-times for trans-catheter aortic valve replacement: a population based study. Circulation. 2018;138:483–93.PubMedCrossRefGoogle Scholar
  49. 49.
    Wijeysundera HC, Wong WW, Bennell MC, Fremes SE, Radhakrishnan S, Peterson M, 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(10):1162–9.PubMedCrossRefGoogle Scholar
  50. 50.
    Bainey KR, Natarajan MK, Mercuri M, Lai T, Teoh K, Chu V, et al. Treatment assignment of high-risk symptomatic severe aortic stenosis patients referred for transcatheter AorticValve implantation. Am J Cardiol. 2013;112(1):100–3.PubMedCrossRefGoogle Scholar
  51. 51.
    Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376(14):1321–31.CrossRefPubMedGoogle Scholar
  52. 52.
    Arbel Y, Zivkovic N, Mehta D, Radhakrishnan S, Fremes SE, Rezaei E, et al. Factors associated with length of stay following trans-catheter aortic valve replacement—a multicenter study. BMC Cardiovasc Disord. 2017;17(1):137.PubMedPubMedCentralCrossRefGoogle Scholar
  53. 53.
    Sud M, Qui F, Austin PC, Ko DT, Wood D, Czarnecki A, et al. Short length of stay after elective transfemoral transcatheter aortic valve replacement is not associated with increased early or late readmission risk. J Am Heart Assoc. 2017;6(4):e005460.PubMedPubMedCentralCrossRefGoogle Scholar
  54. 54.
    Arnold SV, Reynolds MR, Lei Y, Magnuson EA, Kirtane AJ, Kodali SK, et al. Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial. Circulation. 2014;129(25):2682–90.PubMedPubMedCentralCrossRefGoogle Scholar
  55. 55.
    Arnold SV, Spertus JA, Lei Y, Green P, Kirtane AJ, Kapadia S, et al. How to define a poor outcome after transcatheter aortic valve replacement: conceptual framework and empirical observations from the placement of aortic transcatheter valve (PARTNER) trial. Circ Cardiovasc Qual Outcomes. 2013;6(5):591–7.PubMedPubMedCentralCrossRefGoogle Scholar
  56. 56.
    Olsson K, Naslund U, Nilsson J, Hornsten A. Experiences of and coping with severe aortic stenosis among patients waiting for transcatheter aortic valve implantation. J Cardiovasc Nurs. 2016;31(3):255–61.PubMedCrossRefGoogle Scholar
  57. 57.
    Forman JM, Currie LM, Lauck SB, Baumbusch J. Exploring changes in functional status while waiting for transcatheter aortic valve implantation. Eur J Cardiovasc Nurs. 2015;14(6):560–9.PubMedCrossRefGoogle Scholar
  58. 58.
    Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011;58(24):e44–122.PubMedCrossRefGoogle Scholar
  59. 59.
    Bridgewater B, Hooper T, Munsch C, Hunter S, von Oppell U, Livesey S, et al. Mitral repair best practice: proposed standards. Heart. 2006;92(7):939–44.PubMedCrossRefGoogle Scholar
  60. 60.
    Holmes DR Jr, Mack MJ. Transcatheter valve therapy a professional society overview from the american college of cardiology foundation and the society of thoracic surgeons. J Am Coll Cardiol. 2011;58(4):445–55.PubMedCrossRefGoogle Scholar
  61. 61.
    Tommaso CL, Bolman RM 3rd, Feldman T, Bavaria J, Acker MA, Aldea G, et al. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, part 1: transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59(22):2028–42.PubMedCrossRefGoogle Scholar
  62. 62.
    Vahanian A, Alfieri O, Al-Attar N, Antunes M, Bax J, Cormier B, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2008;29(11):1463–70.PubMedCrossRefGoogle Scholar
  63. 63.
    Kim LK, Minutello RM, Feldman DN, Swaminathan RV, Bergman G, Singh H, et al. Association between transcatheter aortic valve implantation volume and outcomes in the United States. Am J Cardiol. 2015;116(12):1910–5.PubMedCrossRefGoogle Scholar
  64. 64.
    de Biasi AR, Paul S, Nasar A, Girardi LN, Salemi A. National analysis of short-term outcomes and volume-outcome relationships for transcatheter aortic valve replacement in the era of commercialization. Cardiology. 2016;133(1):58–68.PubMedCrossRefGoogle Scholar
  65. 65.
    Badheka AO, Patel NJ, Panaich SS, Patel SV, Jhamnani S, Singh V, et al. Effect of hospital volume on outcomes of transcatheter aortic valve implantation. Am J Cardiol. 2015;116(4):587–94.PubMedCrossRefGoogle Scholar
  66. 66.
    Patel HJ, Herbert MA, Drake DH, Hanson EC, Theurer PF, Bell GF, et al. Aortic valve replacement: using a statewide cardiac surgical database identifies a procedural volume hinge point. Ann Thorac Surg. 2013;96(5):1560–5; discussion 5–6PubMedCrossRefGoogle Scholar
  67. 67.
    Gonzalez AA, Dimick JB, Birkmeyer JD, Ghaferi AA. Understanding the volume-outcome effect in cardiovascular surgery: the role of failure to rescue. JAMA Surg. 2014;149(2):119–23.PubMedPubMedCentralCrossRefGoogle Scholar
  68. 68.
    Carroll JD, Vemulapalli S, Dai D, Matsouaka R, Blackstone E, Edwards F, et al. Procedural experience for transcatheter aortic valve replacement and relation to outcomes: the STS/ACC TVT registry. J Am Coll Cardiol. 2017;70(1):29–41.PubMedCrossRefGoogle Scholar
  69. 69.
    Bestehorn K, Eggebrecht H, Fleck E, Bestehorn M, Mehta RH, Kuck KH. Volume-outcome relationship with transfemoral transcatheter aortic valve implantation (TAVI): insights from the compulsory German Quality Assurance Registry on Aortic Valve Replacement (AQUA). EuroIntervention. 2017;13(8):914–20.PubMedCrossRefGoogle Scholar
  70. 70.
    Krasopoulos G, Falconieri F, Benedetto U, Newton J, Sayeed R, Kharbanda R, et al. European real world trans-catheter aortic valve implantation: systematic review and meta-analysis of European national registries. J Cardiothorac Surg. 2016;11(1):159.PubMedPubMedCentralCrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Harindra C. Wijeysundera
    • 1
    • 2
    • 3
    Email author
  • Gabby Elbaz-Greener
    • 1
  • Derrick Y. Tam
    • 2
    • 4
  • Stephen E. Fremes
    • 2
    • 4
  1. 1.Division of Cardiology, Department of Medicine, Schulich Heart Centre, Sunnybrook Health Sciences CentreUniversity of TorontoTorontoCanada
  2. 2.Institute of Health Policy, Management and EvaluationUniversity of TorontoTorontoCanada
  3. 3.Institute for Clinical Evaluative Sciences (ICES)TorontoCanada
  4. 4.Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences CentreUniversity of TorontoTorontoCanada

Personalised recommendations