Transcatheter aortic valve replacement: from previously inoperable patients to low surgical risk patient

Authors: Dzhidzalova D.Kh., Berdibekov B.Sh., Petrosian K.V.

Company: Bakoulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russian Federation

For correspondence:  Sign in or register.

Type:  Reviews


DOI: https://doi.org/10.24022/1997-3187-2021-15-4-440-455

For citation: Dzhidzalova D.Kh., Berdibekov B.Sh., Petrosian K.V. Transcatheter aortic valve replacement: from previously inoperable patients to low surgical risk patients. Creative Cardiology. 2021; 15 (4): 440–55 (in Russ.). DOI: 10.24022/1997-3187-2021-15-4-440-455

Received / Accepted:  15.11.2021 / 20.12.2021

Keywords: aortic stenosis transcatheter aortic valve replacement surgical aortic valve

Subscribe 🔒

 

Abstract

With an increase in life expectancy and an aging population, aortic stenosis is by far the most common valvular heart disease. The invention of transcatheter aortic valve replacement (TAVR) revolutionized the treatment of severe aortic stenosis. The improvement of transcatheter devices, the optimization of the procedure, and the increased experience of surgeons have increased the safety of TAVR. As a result of large randomized studies, the transcatheter procedure showed encouraging results in patients with severe aortic stenosis of different surgical risk spectrum compared with surgical aortic valve replacement, which led to an expansion of indications for TAVR. This review presents a brief history, the evolution of transcatheter bioprostheses, the formation of the procedure as an alternative to open-heart surgery, as well as the current state of TAVR.

References

  1. Nkomo V.T., Gardin J.M., Skelton T.N., Gottdiener J.S., Scott C.G., Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006; 368 (9540): 1005–11. DOI: 10.1016/S0140-6736(06)69208-8
  2. D'Arcy J.L., Coffey S., Loudon M.A., Kennedy A., Pearson-Stuttard J., Birks J. et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the Ox VALVE Population Cohort Study. Eur. Heart J. 2016; 37 (47): 3515–22. DOI: 10.1093/eurheartj/ehw229
  3. Osnabrugge R.L., Mylotte D., Head S.J., Van Mieghem N.M., Nkomo V.T. 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. DOI: 10.1016/j.jacc.2013.05.015
  4. Généreux P., Stone G.W., O'Gara P.T., MarquisGravel G., Redfors B., Giustino G. et al. Natural history, diagnostic approaches, and therapeutic strategies for patients with asymptomatic severe aortic stenosis. J. Am. Coll. Cardiol. 2016; 67 (19): 2263–88. DOI: 10.1016/j.jacc.2016.02.057
  5. Otto C.M., Prendergast B. Aortic-valve stenosis – from patients at risk to severe valve obstruction. N. Engl. J. Med. 2014; 371 (8): 744–56. DOI: 10.1056/NEJMra1313875
  6. Lindman B.R., Clavel M.A., Mathieu P., Iung B., Lancellotti P., Otto C.M. et al. Calcific aortic stenosis. Nat. Rev. Dis. Primers. 2016; 2: 16006. DOI: 10.1038/nrdp.2016.6
  7. Yutzey K.E., Demer L.L., Body S.C., Huggins G.S., Towler D.A., Giachelli C.M. et al. Calcific aortic valve disease: a consensus summary from the Alliance of Investigators on Calcific Aortic Valve Disease. Arterioscler. Thromb. Vasc. Biol. 2014; 34 (11): 2387–93. DOI: 10.1161/ATVBAHA.114.302523
  8. Turina J., Hess O., Sepulcri F., Krayenbuehl H.P. Spontaneous course of aortic valve disease. Eur. Heart J. 1987; 8 (5): 471–83. DOI: 10.1093/oxfordjournals.eurheartj.a062307
  9. Pellikka P.A., Nishimura R.A., Bailey K.R., Tajik A.J. The natural history of adults with asymptomatic, hemodynamically significant aortic stenosis. J. Am. Coll. Cardiol. 1990; 15 (5): 1012–7. DOI: 10.1016/0735-1097(90)90234-g
  10. Varadarajan P., Kapoor N., Bansal R.C., Pai R.G. Survival in elderly patients with severe aortic stenosis is dramatically improved by aortic valve replacement: Results from a cohort of 277 patients aged > or=80 years. Eur. J. Cardiothorac Surg. 2006; 30 (5): 722–7. DOI: 10.1016/j.ejcts.2006.07.028
  11. Vahanian A., Beyersdorf F., Praz F., Milojevic M., Baldus S., Bauersachs J. et al. ESC/EACTS Scientific Document Group, 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. 2021; ehab395. DOI: 10.1093/eurheartj/ehab395
  12. Chan K.L., Teo K., Dumesnil J.G., Ni A., Tam J. ASTRONOMER Investigators. Effect of lipid lowering with rosuvastatin on progression of aortic stenosis: results of the aortic stenosis progression observation: measuring effects of rosuvastatin (ASTRONOMER) trial. Circulation. 2010; 121 (2): 306–14. DOI: 10.1161/CIRCULATIONAHA.109.900027
  13. Rossebø A.B., Pedersen T.R., Boman K., Brudi P., Chambers J.B., Egstrup K. et al. SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N. Engl. J. Med. 2008; 359 (13): 1343–56. DOI: 10.1056/NEJMoa0804602
  14. Cowell S.J., Newby D.E., Prescott R.J., Bloomfield P., Reid J., Northridge D.B., Boon N.A. Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) investigators. A randomized trial of intensive lipid-lowering therapy in calcific aortic stenosis. N. Engl. J. Med. 2005; 352 (23): 2389–97. DOI: 10.1056/NEJMoa043876
  15. Petrosyan K.V., Dadabaev G.M., Titov D.A., Sorkomov M.N., Salokhiddinov M.A. et al. Successful aortic valve replacement using the valve-in-valve technique after a previous aortic valve replacement with the Arbor Trilogy sutureless two-piece biological prosthesis. Russian Journal of Endovascular Surgery. 2021; 8 (2): 215–21. DOI: 10.24183/2409-4080-2021-8-2-215-221 (in Russ.).
  16. Généreux P., Piazza N., Alu M.C., Nazif T., Hahn R.T., Pibarot P. et al. Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research. J. Am. Coll. Cardiol. 2021; 77 (21): 2717–46. DOI: 10.1016/j.jacc.2021.02.038
  17. Carroll J.D., Edwards F.H., Marinac-Dabic D., Brindis R.G., Grover F.L., Peterson E.D. et al. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies. J. Am. Coll. Cardiol. 2013; 62 (11): 1026–34. DOI: 10.1016/j.jacc.2013.03.060
  18. Bockeria L.A., Alekyan B.G., Pursanov M.G., Mironenko V.A., Boсkeria O.L., Makarenko V.N. et al. Transcatheter implantation of the aortic valve: the first experience in Russia. Thoracic and Cardiovascular Surgery. 2011; 2: 4–10 (in Russ.).
  19. Alekyan B.G., Grigoryan A.M., Staferov A.V., Staferov A.V., Karapetyan N.G. Endovascular diagnosis and treatment of heart and vascular diseases in the Russian Federation – 2020. Endovascular surgery. 2021; 8 (special edition). DOI: 10.24183/2409-4080-2021-8S-S5-S248 (in Russ.)
  20. Transcatheter Aortic Valve Implantation (TAVI) market: https://www.alliedmarketresearch.com/tavi-market (дата обращения 02.11.2021 /accessed November 02, 2021)
  21. Effler D.B., Favaloro R., Groves L.K.. Heart valve replacement. Clinical experience. Ann. Thorac. Surg. 1965; 1: 4–24. DOI: 10.1016/s0003-4975(10)66717-3
  22. Cribier A., Savin T., Saoudi N., Rocha P., Berland J., Letac B. Percutaneous transluminal valvuloplasty of acquired aortic stenosis in elderly patients: an alternative to valve replacement? Lancet. 1986; 1 (8472): 63–7. DOI: 10.1016/s0140-6736(86)90716-6
  23. Andersen H.R., Knudsen L.L., Hasenkam J.M. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur. Heart J. 1992; 13 (5): 704–8. DOI: 10.1093/oxfordjournals.eurheartj.a060238
  24. 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. DOI: 10.1161/01.cir.0000047200.36165.b8
  25. Popma J.J., Deeb G.M., Yakubov S.J., Mumtaz M., Gada H., O'Hair D. et al. Evolut low risk trial investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N. Engl. J. Med. 2019; 380 (18): 1706–15. DOI: 10.1056/NEJMoa1816885
  26. Mack M.J., Leon M.B., Thourani V.H., Makkar R., Kodali S.K., Russo M. PARTNER 3 investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N. Engl. J. Med. 2019; 380 (18): 1695–705. DOI: 10.1056/NEJMoa1814052
  27. Reardon M.J., Van Mieghem N.M., Popma J.J., Kleiman N.S., Søndergaard L., Mumtaz M. et al. SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N. Engl. J. Med. 2017; 376 (14): 1321–31. DOI: 10.1056/NEJMoa1700456
  28. Leon M.B., Smith C.R., Mack M.J., Makkar R.R., Svensson L.G., Kodali S.K. et al. PARTNER 2 investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N. Engl. J. Med. 2016; 374 (17): 1609–20. DOI: 10.1056/NEJMoa1514616
  29. Thourani V.H., Kodali S., Makkar R.R., Herrmann H.C., Williams M., Babaliaros V. et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016; 387 (10034): 2218–25. DOI: 10.1016/S0140-6736(16)30073-3
  30. Cahill T.J., Terre J.A., George I. Over 15 years: the advancement of transcatheter aortic valve replacement. Ann. Cardiothorac. Surg. 2020; 9 (6): 442–51. DOI: 10.21037/acs-2020-av-24. PMID: 33312902
  31. Rheude T., Pellegrini C., Lutz J., Alvarez-Covarrubias H.A., Lahmann A.L., Mayr N.P. et al. Transcatheter aortic valve replacement with balloon-expandable valves: comparison of SAPIEN 3 ultra versus SAPIEN 3. JACC Cardiovasc. Interv. 2020; 13 (22): 2631–8. DOI: 10.1016/j.jcin.2020.07.013
  32. Adams D.H., Popma J.J., Reardon M.J., Yakubov S.J., Coselli J.S., Deeb G.M. et al. U.S. CoreValve clinical investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N. Engl. J. Med. 2014; 370 (19): 1790–8. DOI: 10.1056/NEJMoa1400590
  33. Manoharan G., Walton A.S., Brecker S.J., Pasupati S., Blackman D.J., Qiao H. et al. Treatment of symptomatic severe aortic stenosis with a novel resheathable supra-annular self-expanding transcatheter aortic valve system. JACC Cardiovasc. Interv. 2015; 8 (10): 1359–67. DOI: 10.1016/j.jcin. 2015.05.015
  34. Salaun E., Pibarot P., Rodés-Cabau J. Transcatheter aortic valve replacement: procedure and outcomes. Cardiol. Clin. 2020; 38 (1): 115–28. DOI: 10.1016/j.ccl.2019.09.007
  35. Sorajja P., Kodali S., Reardon M.J., Szeto W.Y., Chetcuti S.J., Hermiller J., Jr. et al. Outcomes for the commercial use of self-expanding prostheses in transcatheter aortic valve replacement: a report from the STS/ACC TVT registry. JACC Cardiovasc. Interv. 2017; 10 (20): 2090–8. DOI: 10.1016/j.jcin. 2017.07.027
  36. Wyler von Ballmoos M.C., Reardon M.J., Williams M.R., Mangi A.A., Kleiman N.S., Yakubov S.J. et al. Three-year outcomes with a contemporary self-expanding transcatheter valve from the evolut PRO US clinical study. Cardiovasc. Revasc. Med. 2021; 26: 12–6. DOI: 10.1016/j.carrev.2020.11.007
  37. Bazylev V.V., Voevodin A.B., Zaharova A.S., Rosseikin E.V. Immediate clinical and hemodynamic results of transcatheter implantation of aortic valve prosthesis. Circulation Pathology and Cardiac Surgery (Patologiya Krovoobrashcheniya i Kardiokhirurgiya). 2018; 22 (3): 17–24. DOI: 10.21688- 1681-3472-2018-3-17-24 (in Russ.).
  38. Bazylev V.V., Voevodin A.B., Shalygina A.S. Medium-term results of transcatheter implantation of MedLab-CT aortic valve prosthesis. Russian Journal of Cardiology. 2019; 24 (8): 65–9 (in Russ.). DOI: 10.15829/1560-4071-2019-8-65-69
  39. Thiele H., Kurz T., Feistritzer H.J., Stachel G., Hartung P., Eitel I. et al. Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial. Eur. Heart J. 2020; 41 (20): 1890–9. DOI: 10.1093/eurheartj/ehaa036
  40. Abdel-Wahab M., Landt M, Neumann F.J., Massberg S., Frerker C., Kurz T. et al. CHOICE investigators. 5-Year outcomes after TAVR with balloon-expandable versus self-expanding valves: results from the CHOICE randomized clinical trial. JACC Cardiovasc. Interv. 2020; 13 (9): 1071–82. DOI: 10.1016/j.jcin.2019.12.026
  41. Alperi A., Faroux L., Muntané-Carol G., RodésCabau J. Meta-analysis comparing early outcomes following transcatheter aortic valve implantation with the evolut versus sapien 3 valves. Am. J. Cardiol. 2021; 139: 87–96. DOI: 10.1016/j.amjcard.2020.10.041
  42. Kappetein A.P., Head S.J., Généreux P., Piazza N., van Mieghem N.M., Blackstone E.H. et al. Valve Academic Research Consortium (VARC)-2. updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur. J. Cardiothorac Surg. 2012; 42 (5): S45–60. DOI: 10.1093/ejcts/ezs533
  43. Leon M.B., Smith C.R., Mack M., Miller D.C., Moses J.W., Svensson L.G. et al. PARTNER trial investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N. Engl. J. Med. 2010; 363 (17): 1597–607. DOI: 10.1056/NEJMoa1008232
  44. Makkar R.R., Fontana G.P., Jilaihawi H., Kapadia S., Pichard A.D., Douglas P.S. et al. PARTNER trial investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N. Engl. J. Med. 2012; 366 (18): 1696–704. DOI: 10.1056/NEJMoa1202277
  45. Smith C.R., Leon M.B., Mack M.J., Miller D.C., Moses J.W., Svensson L.G. et al. PARTNER trial investigators. Transcatheter versus surgical aorticvalve replacement in high-risk patients. N. Engl. J. Med. 2011; 364 (23): 2187–98. DOI: 10.1056/NEJMoa1103510
  46. Deeb G.M., Reardon M.J., Chetcuti S., Patel H.J., Grossman P.M., Yakubov S.J. et al. CoreValve US clinical investigators. 3-year outcomes in high-risk patients who underwent surgical or transcatheter aortic valve replacement. J. Am. Coll. Cardiol. 2016; 67 (22): 2565–74. DOI: 10.1016/j.jacc.2016.03.506
  47. Vahanian A., Alfieri O., Andreotti F., Antunes M.J., Barón-Esquivias G., Baumgartner H. et al. Guidelines on the management of valvular heart disease (version 2012). Eur. Heart J. 2012; 33 (19): 2451–96. DOI: 10.1093/eurheartj/ehs109
  48. Nishimura R.A., Otto C.M., Bonow R.O., Carabello B.A., Erwin J.P., 3rd, Guyton R.A. et al. American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 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 (22): e57–185. DOI: 10.1016/j.jacc.2014.02.536
  49. Makkar R.R., Thourani V.H., Mack M.J., Kodali S.K., Kapadia S., Webb J.G. et al. PARTNER 2 investigators. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N. Engl. J. Med. 2020; 382 (9): 799–809. DOI: 10.1056/NEJMoa1910555
  50. Nishimura R.A., Otto C.M., Bonow R.O., Carabello B.A., Erwin J.P., 3rd, Fleisher L.A. 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 (25): e1159–95. DOI: 10.1161/CIR.0000000000000503
  51. Baumgartner H., Falk V., Bax J.J., De Bonis M., Hamm C., Holm P.J. ESC scientific document group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur. Heart J. 2017; 38 (36): 2739–91. DOI: 10.1093/eurheartj/ehx391
  52. Thyregod H.G., Steinbrüchel D.A., Ihlemann N., Nissen H., Kjeldsen B.J., Petursson P. 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 (20): 2184–94. DOI: 10.1016/j.jacc.2015.03.014
  53. Thyregod H.G.H., Ihlemann N., Jørgensen T.H., Nissen H., Kjeldsen B.J., Petursson P. et al. Fiveyear clinical and echocardiographic outcomes from the Nordic Aortic Valve Intervention (NOTION) randomized clinical trial in lower surgical risk patients. Circulation. 2019; 139: 2714–23. DOI: 10.1161/CIRCULATIONAHA.118.036606
  54. Søndergaard L., Ihlemann N., Capodanno D., Jørgensen T.H., Nissen H., Kjeldsen B.J. Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J. Am. Coll. Cardiol. 2019; 73 (5): 546–53. DOI: 10.1016/j.jacc.2018.10.083
  55. Troels H.J., Thyregod G.H., Ihlemann N., Nissen H., Petursson P., Kjeldsen B. et al. Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement. Eur. Heart J. 2021; 42 (30): 2912–9. DOI: 10.1093/eurheartj/ehab375
  56. Leon M.B., Mack M.J., Hahn R.T., Thourani V.H., Makkar R., Kodali S.K. et al. PARTNER 3 investigators. Outcomes 2 years after transcatheter aortic valve replacement in patients at low surgical risk. J. Am. Coll. Cardiol. 2021; 77 (9): 1149–61. DOI: 10.1016/j.jacc.2020.12.052

About Authors

  • Diana Kh. Dzhidzalova, Postgraduate; ORCID
  • Bektur Sh. Berdibekov, Cardiologist; ORCID
  • Karen V. Petrosian, Dr. Med. Sci., Endovascular Surgeon, Head of Department; ORCID

Chief Editor

Leo A. Bockeria, MD, PhD, DSc, Professor, Academician of Russian Academy of Sciences, President of Bakoulev National Medical Research Center for Cardiovascular Surgery