Transcatheter Aortic Valve Replacement in the USA

  • Jose F. Condado
  • Hanna Jensen
  • Vinod H. ThouraniEmail author


Transcatheter aortic valve replacement (TAVR) is the preferred treatment for severe aortic stenosis (AS) in patients considered to be extreme-risk surgical risk and is an alternative to surgical aortic valve replacement (SAVR) in high-risk patients. Currently, the balloon-expandable SAPIEN valve and the self-expanding CoreValve are approved for TAVR in the USA. An additional four TAVR valves (Lotus, Portico, Direct Flow, and JenaValve) are in clinical trials in the USA.

TAVR outcomes have improved over the past decade due to improvements in patient selection, operative techniques, and prevention of common complications. First, improvement of patient selection is possible with a comprehensive evaluation by a heart team using a multi-imaging strategy. Second, improvement of operative techniques is a consequence of increase operator experience and broadening of percutaneous access options. While transfemoral TAVR is the procedure of choice, transapical, transaortic, transcarotid, subclavian, and transcaval alternative access routes are also being performed. Third, improving the prevention of common complications, such as neurologic events, vascular injury, conduction abnormalities, paravalvular leaks, and acute kidney injury, is now possible with an improvement in devices and a more clear understanding of specific preoperative risk factors.

Finally, TAVR is continuously evolving in the USA. In selected patients, minimalist transfemoral TAVR is feasible to avoid general anesthesia leading to a decrease in resource utilization and cost of the procedure. The potential treatment of a failing surgically implanted aortic bioprosthesis (valve-in-valve) with TAVR is also emerging as a treatment alternative in high-risk patients. Within the last year, clinical trials which evaluated the expanding role of TAVR in intermediate-risk patients have shown superiority with the transfemoral access compared to surgery in mortality. Newer randomized trials to expand the indications of TAVR to lower-risk patients are ongoing in the USA.


Transcatheter aortic valve replacement Balloon aortic valvuloplasty Paravalvular regurgitation Valve-in-valve 


  1. 1.
    Go AS, et al. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014;129:28–292.CrossRefGoogle Scholar
  2. 2.
    Nkomo VT, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005–11.CrossRefGoogle Scholar
  3. 3.
    Ross J, Braunwald E. Aortic stenosis. Circulation. 1968;38:S61–7.CrossRefGoogle Scholar
  4. 4.
    Nishimura RA, et al. 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 Practice Guidelines. J Am Coll Cardiol. 2014;63:57–185.CrossRefGoogle Scholar
  5. 5.
    Holmes DR, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59:1200–54.CrossRefGoogle Scholar
  6. 6.
    Thourani VH, 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.CrossRefGoogle Scholar
  7. 7.
    Bach DS. Prevalence and characteristics of unoperated patients with severe aortic stenosis. J Heart Valve Dis. 2011;20:284–91.PubMedGoogle Scholar
  8. 8.
    Cribier A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006–8.CrossRefGoogle Scholar
  9. 9.
    Abdel-Wahab M, et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA. 2014;311:1503–14.CrossRefGoogle Scholar
  10. 10.
    Smith CR, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98.CrossRefGoogle Scholar
  11. 11.
    Kodali SK, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686–95.CrossRefGoogle Scholar
  12. 12.
    Mack MJ, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385:2477–84.CrossRefGoogle Scholar
  13. 13.
    Leon MB, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.CrossRefGoogle Scholar
  14. 14.
    Kapadia SR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385:2485–91.CrossRefGoogle Scholar
  15. 15.
    Makkar RR, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696–704.CrossRefGoogle Scholar
  16. 16.
    Leon MB, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;375:700–1.PubMedGoogle Scholar
  17. 17.
    Kodali S, 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;37:2252–62.CrossRefGoogle Scholar
  18. 18.
    Thourani VH, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016;387:2218–25.CrossRefGoogle Scholar
  19. 19.
    Popma JJ, 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;63:1972–81.CrossRefGoogle Scholar
  20. 20.
    Adams DH, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790–8.CrossRefGoogle Scholar
  21. 21.
    Holmes DR, et al. Annual outcomes with transcatheter valve therapy. Ann Thorac Surg. 2016;101:789–800.CrossRefGoogle Scholar
  22. 22.
    Meredith Am IT, et al. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014;64:1339–48.CrossRefGoogle Scholar
  23. 23.
    Meredith IT, et al. Transfemoral aortic valve replacement with the repositionable lotus valve system in high surgical risk patients: the REPRISE I study. EuroIntervention. 2014;9:1264–70.CrossRefGoogle Scholar
  24. 24.
    Thourani VH, et al. Use of transaortic, transapical, and transcarotid transcatheter aortic valve replacement in inoperable patients. Ann Thorac Surg. 2013;96:1349–57.CrossRefGoogle Scholar
  25. 25.
    Blumenstein J, et al. First-in-man evaluation of the transapical APICA ASC access and closure device: the initial 10 patients. Eur J Cardiothorac Surg. 2013;44:1057–62.CrossRefGoogle Scholar
  26. 26.
    Lardizabal JA, et al. The transaortic approach for transcatheter aortic valve replacement: initial clinical experience in the United States. J Am Coll Cardiol. 2013;61:2341–5.CrossRefGoogle Scholar
  27. 27.
    Guyton RA, et al. Carotid artery access for transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2013;82:583–6.Google Scholar
  28. 28.
    Fraccaro C, et al. Expanding the eligibility for transcatheter aortic valve implantation the trans-subclavian retrograde approach using: the III generation CoreValve revalving system. JACC Cardiovasc Interv. 2009;2:828–33.CrossRefGoogle Scholar
  29. 29.
    Petronio AS, et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circ Cardiovasc Interv. 2010;3:359–66.CrossRefGoogle Scholar
  30. 30.
    Greenbaum AB, et al. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014;63:2795–804.CrossRefGoogle Scholar
  31. 31.
    Miller DC, et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012;143:832–43.CrossRefGoogle Scholar
  32. 32.
    Kappetein AP, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document. Eur Heart J. 2012;33:2403–18.CrossRefGoogle Scholar
  33. 33.
    Alli O, et al. TCT-747 transcatheter aortic valve replacement: assessment of the learning curve based on the PARTNER trial. J Am Coll Cardiol. 2013;62:227–8.CrossRefGoogle Scholar
  34. 34.
    Aguirre J, et al. Transcatheter aortic valve replacement: experience with the transapical approach, alternate access sites, and concomitant cardiac repairs. J Thorac Cardiovasc Surg. 2014;148:1417–22.CrossRefGoogle Scholar
  35. 35.
    Athappan G, et al. Influence of transcatheter aortic valve replacement strategy and valve design on stroke after transcatheter aortic valve replacement: a meta-analysis and systematic review of literature. J Am Coll Cardiol. 2014;63:2101–10.CrossRefGoogle Scholar
  36. 36.
    Fairbairn TA, et al. Diffusion-weighted MRI determined cerebral embolic infarction following transcatheter aortic valve implantation: assessment of predictive risk factors and the relationship to subsequent health status. Heart. 2012;98:18–23.CrossRefGoogle Scholar
  37. 37.
    Nombela-Franco L, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012;126:3041–53.CrossRefGoogle Scholar
  38. 38.
    Nietlispach F, et al. An embolic deflection device for aortic valve interventions. JACC Cardiovasc Interv. 2010;3:1133–8.CrossRefGoogle Scholar
  39. 39.
    Naber CK, et al. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroInterven. 2012;8:43–50.CrossRefGoogle Scholar
  40. 40.
    Genereux P, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012;60:1043–52.CrossRefGoogle Scholar
  41. 41.
    Genereux P, et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol. 2012;59:2317–26.CrossRefGoogle Scholar
  42. 42.
    Siontis GC, et al. Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol. 2014;64:129–40.CrossRefGoogle Scholar
  43. 43.
    Tamburino C, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299–308.CrossRefGoogle Scholar
  44. 44.
    Koos R, et al. Evaluation of aortic root for definition of prosthesis size by magnetic resonance imaging and cardiac computed tomography: implications for transcatheter aortic valve implantation. Int J Cardiol. 2012;158:353–8.CrossRefGoogle Scholar
  45. 45.
    Detaint D, et al. Determinants of significant paravalvular regurgitation after transcatheter aortic valve: implantation impact of device and annulus discongruence. JACC Cardiovasc Interv. 2009;2:821–7.CrossRefGoogle Scholar
  46. 46.
    Schultz CJ, et al. Correlates on MSCT of paravalvular aortic regurgitation after transcatheter aortic valve implantation using the Medtronic CoreValve prosthesis. Catheter Cardiovasc Interv. 2011;78:446–55.CrossRefGoogle Scholar
  47. 47.
    Buzzatti N, et al. Computed tomography-based evaluation of aortic annulus, prosthesis size and impact on early residual aortic regurgitation after transcatheter aortic valve implantation. Eur J Cardiothorac Surg. 2013;43:43–50.CrossRefGoogle Scholar
  48. 48.
    Gurvitch R, et al. Aortic annulus diameter determination by multidetector computed tomography: reproducibility, applicability, and implications for transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2011;4:1235–45.CrossRefGoogle Scholar
  49. 49.
    Jabbour A, et al. Multimodality imaging in transcatheter aortic valve implantation and post-procedural aortic regurgitation: comparison among cardiovascular magnetic resonance, cardiac computed tomography, and echocardiography. J Am Coll Cardiol. 2011;58:2165–73.CrossRefGoogle Scholar
  50. 50.
    Jilaihawi H, et al. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol. 2012;59:1275–86.CrossRefGoogle Scholar
  51. 51.
    Genereux P, et al. Incidence and effect of acute kidney injury after transcatheter aortic valve replacement using the new valve academic research consortium criteria. Am J Cardiol. 2013;111:100–5.CrossRefGoogle Scholar
  52. 52.
    Barbash IM, et al. Incidence and predictors of acute kidney injury after transcatheter aortic valve replacement. Am Heart J. 2012;163:1031–6.CrossRefGoogle Scholar
  53. 53.
    Babaliaros V, et al. Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv. 2014;7:898–904.CrossRefGoogle Scholar
  54. 54.
    Motloch LJ, et al. Local versus general anesthesia for transfemoral aortic valve implantation. Clin Res Cardiol. 2012;101:45–53.CrossRefGoogle Scholar
  55. 55.
    Pendyala LK, et al. Commercial versus PARTNER study experience with the transfemoral Edwards SAPIEN valve for inoperable patients with severe aortic stenosis. Am J Cardiol. 2014;113:342–7.CrossRefGoogle Scholar
  56. 56.
    Jensen HA, et al. Minimalist transcatheter aortic valve replacement: the new standard for surgeons and cardiologists using transfemoral access? J Thorac Cardiovasc Surg. 2015;150:833–9.CrossRefGoogle Scholar
  57. 57.
    Leontyev S, et al. Redo aortic valve surgery: early and late outcomes. Ann Thorac Surg. 2011;91:1120–6.CrossRefGoogle Scholar
  58. 58.
    Maganti M, et al. Redo valvular surgery in elderly patients. Ann Thorac Surg. 2009;87:521–5.CrossRefGoogle Scholar
  59. 59.
    Balsam LB, et al. Reoperative valve surgery in the elderly: predictors of risk and long-term survival. Ann Thorac Surg. 2010;90:1195–200.CrossRefGoogle Scholar
  60. 60.
    Dvir D, et al. Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry. Circulation. 2012;126:2335–44.CrossRefGoogle Scholar
  61. 61.
    Dvir D, et al. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. 2014;312:162–70.CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Austria, part of Springer Nature 2019

Authors and Affiliations

  • Jose F. Condado
    • 1
  • Hanna Jensen
    • 1
  • Vinod H. Thourani
    • 2
    Email author
  1. 1.Structural Heart and Valve Center, Emory University School of MedicineAtlantaUSA
  2. 2.Department of Cardiac Surgery, MedStar Heart and Vascular InstituteGeorgetown University School of MedicineWashington, DCUSA

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