The Korean journal of internal medicine

  • 제33권3호
  • /
  • Pages.474-482
  • /
  • 2018
  • /
  • 1226-3303(pISSN)
  • /
  • 2005-6648(eISSN)
대한내과학회 (The Korean Association of Internal Medicine)
권호 표지
DOI QR코드

DOI QR Code

Expanding transcatheter aortic valve replacement into uncharted indications

  • Kang, Guson (Division of Cardiovascular Medicine, Department of Medicine and Cardiovascular Institute, Stanford University) ;
  • Kim, Juyong Brian (Division of Cardiovascular Medicine, Department of Medicine and Cardiovascular Institute, Stanford University)
  • 투고 : 2018.01.09
  • 심사 : 2018.01.31
  • 발행 : 2018.05.01
⟨ 이전 논문 다음 논문 ⟩

초록

Since the first-in-man transcatheter delivery of an aortic valve prosthesis in 2002, the landscape of aortic stenosis therapeutics has shifted dramatically. While initially restricted to non-surgical cases, progressive advances in transcatheter aortic valve replacement and our understanding of its safety and efficacy have expanded its use in intermediate and possibly low surgical risk patients. In this review, we explore the past, present, and future of transcatheter aortic valve replacement.

키워드

참고문헌

  1. Ross J Jr, Braunwald E. Aortic stenosis. Circulation 1968;38(1 Suppl):61-67.
  2. Bonow RO, Greenland P. Population-wide trends in aortic stenosis incidence and outcomes. Circulation 2015;131:969-971. https://doi.org/10.1161/CIRCULATIONAHA.115.014846
  3. Eveborn GW, Schirmer H, Heggelund G, Lunde P, Rasmussen K. The evolving epidemiology of valvular aortic stenosis. The Tromso study. Heart 2013;99:396-400. https://doi.org/10.1136/heartjnl-2012-302265
  4. Leon MB, Smith CR, Mack M, et al. Transcatheter aorticvalve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-1607. https://doi.org/10.1056/NEJMoa1008232
  5. Harken DE, Taylor WJ, Lefemine AA, et al. Aortic valve replacement with a caged ball valve. Am J Cardiol 1962;9:292-299. https://doi.org/10.1016/0002-9149(62)90047-4
  6. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-3008. https://doi.org/10.1161/01.CIR.0000047200.36165.B8
  7. Leon MB. Global TAVR market poised to exceed DES market by 2025 [Internet]. TCTMD, 2015 [cited 2018 Feb 7]. Available from: https://www.tctmd.com/news/global-tavrmarket-poised-exceed-des-market-2025.
  8. Tastet L, Simard L, Clavel MA. Severe and asymptomatic aortic stenosis management challenge: knowing that we do not really know. Curr Treat Options Cardiovasc Med 2017;19:33. https://doi.org/10.1007/s11936-017-0533-7
  9. Iung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: the Euro Heart Survey on Valvular Heart Disease. Eur Heart J 2003;24:1231-1243. https://doi.org/10.1016/S0195-668X(03)00201-X
  10. 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;1:63-67.
  11. Cribier A, Eltchaninoff H, Tron C, et al. Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol 2006;47:1214-1223. https://doi.org/10.1016/j.jacc.2006.01.049
  12. Grube E, Laborde JC, Gerckens U, et al. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation 2006;114:1616-1624. https://doi.org/10.1161/CIRCULATIONAHA.106.639450
  13. Barbash IM, Waksman R. Overview of the 2011 Food and Drug Administration Circulatory System devices panel of the Medical Devices Advisory Committee meeting on the Edwards $SAPIEN^{TM}$ transcatheter heart valve. Circulation 2012;125:550-555. https://doi.org/10.1161/CIRCULATIONAHA.111.059873
  14. Food and Drug Administration. Corevalve Extreme Risk approval letter [Internet]. Silver Spring (MD): FDA, 2014 [cited 2018 Feb 7]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130021a.pdf.
  15. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187-2198. https://doi.org/10.1056/NEJMoa1103510
  16. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686-1695. https://doi.org/10.1056/NEJMoa1200384
  17. Mack MJ, Leon MB, Smith CR, 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;385:2477-2484. https://doi.org/10.1016/S0140-6736(15)60308-7
  18. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790-1798. https://doi.org/10.1056/NEJMoa1400590
  19. Lange R, Schreiber C, Gotz W, et al. First successful transapical aortic valve implantation with the Corevalve revalving system: a case report. Heart Surg Forum 2007;10:E478-E479. https://doi.org/10.1532/HSF98.20071140
  20. Medtronic. CoreValve important safety information [Internet]. Luxembourg City (LU): Medtronic CV Luxembourg S.a.r.l., c2015 [cited 2018 Feb 7]. Available from: http://www.corevalve.com/us/safety-information/index.htm.
  21. Wood S. FDA expands Sapien TAVI indication to highrisk surgical patients [Internet]. New York (NY): Medscape Medical News, c1994 [cited 2018 Feb 7]. Available from: https://www.medscape.com/viewarticle/772966.
  22. Medtronic. Medtronic CoreValve$^{(R)}$ system receives FDA approval for patients at high risk for surgery [Internet]. Minneapolis (MN): Medtronic, c2015 [cited 2018 Feb 7]. Available from: http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1939539.
  23. Nielsen HH, Klaaborg KE, Nissen H, et al. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. EuroIntervention 2012;8:383-389. https://doi.org/10.4244/EIJV8I3A58
  24. Thyregod HG, Steinbruchel DA, 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. https://doi.org/10.1016/j.jacc.2015.03.014
  25. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609-1620. https://doi.org/10.1056/NEJMoa1514616
  26. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediaterisk patients. N Engl J Med 2017;376:1321-1331. https://doi.org/10.1056/NEJMoa1700456
  27. Food and Drug Administration. Edwards SAPIEN XT high risk approval letter [Internet]. Silver Spring (MD): FDA, 2015 [cited 2018 Feb 7]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S034a.pdf.
  28. Edwards Lifesciences. Edwards SAPIEN XT valve receives FDA approval for pulmonic procedures [Internet]. Irvine (CA): Edwards Lifesciences Corporation, c2018 [cited 2018 Feb 7]. Available from: http://www.edwards.com/ns20160302.
  29. Food and Drug Administration. FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery [Internet]. Silver Spring (MD): FDA, 2016 [cited 2018 Feb 7]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517281.htm.
  30. Food and Drug Administration. Edwards SAPIEN 3 high risk approval letter [Internet]. Silver Spring (MD): FDA, 2015 [cited 2018 Feb 7]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031a.pdf.
  31. Medtronic. Medtronic expands TAVR access to more patients with symptomatic, severe aortic stenosis upon intermediate risk FDA approval [Internet]. Minneapolis (MN): Medtronic, c2015 [cited 2018 Feb 7]. Available from: http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2285395.
  32. Kang DH, Park SJ, Rim JH, et al. Early surgery versus conventional treatment in asymptomatic very severe aortic stenosis. Circulation 2010;121:1502-1509. https://doi.org/10.1161/CIRCULATIONAHA.109.909903
  33. Connolly HM, Oh JK, Orszulak TA, et al. Aortic valve replacement for aortic stenosis with severe left ventricular dysfunction. Prognostic indicators. Circulation 1997;95:2395-2400. https://doi.org/10.1161/01.CIR.95.10.2395
  34. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438-2488. https://doi.org/10.1016/j.jacc.2014.02.537
  35. Taniguchi T, Morimoto T, Shiomi H, et al. Initial surgical versus conservative strategies in patients with asymptomatic severe aortic stenosis. J Am Coll Cardiol 2015;66:2827-2838. https://doi.org/10.1016/j.jacc.2015.10.001
  36. Shively BK. Evolving concepts about aortic stenosis. Cardiol Rev 1998;6:325-333.
  37. Edwards FH, Cohen DJ, O'Brien SM, et al. Development and validation of a risk prediction model for in-hospital mortality after transcatheter aortic valve replacement. JAMA Cardiol 2016;1:46-52. https://doi.org/10.1001/jamacardio.2015.0326
  38. American College of Cardiology; The Society of Thoracic Surgeons. TAVR in-hospital mortality risk calculator [Internet]. American College of Cardiology; The Society of Thoracic Surgeons, 2016 [cited 2018 Feb 7]. Available from: http://tools.acc.org/tavrrisk/#!/content/evaluate/.
  39. Popma JJ, Adams DH, Reardon MJ, 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. https://doi.org/10.1016/j.jacc.2014.02.556
  40. Kim JB, Kobayashi Y, Moneghetti KJ, et al. GDF-15 (growth differentiation factor 15) is associated with lack of ventricular recovery and mortality after transcatheter aortic valve replacement. Circ Cardiovasc Interv 2017;10:e005594. https://doi.org/10.1161/CIRCINTERVENTIONS.117.005594
  41. Lindman BR, Breyley JG, Schilling JD, et al. Prognostic utility of novel biomarkers of cardiovascular stress in patients with aortic stenosis undergoing valve replacement. Heart 2015;101:1382-1388. https://doi.org/10.1136/heartjnl-2015-307742
  42. Kobayashi Y, Kim JB, Moneghetti KJ, et al. Dynamic changes in aortic impedance after transcatheter aortic valve replacement and its impact on exploratory outcome. Int J Cardiovasc Imaging 2017;33:1693-1701. https://doi.org/10.1007/s10554-017-1155-6
  43. Ito A, Iwata S, Mizutani K, et al. Echocardiographic parameters predicting acute hemodynamically significant mitral regurgitation during transfemoral transcatheter aortic valve replacement. Echocardiography 2018;35:353-360. https://doi.org/10.1111/echo.13792
  44. Roule V, Placente A, Sabatier R, et al. Angles between the aortic root and the left ventricle assessed by MDCT are associated with the risk of aortic regurgitation after transcatheter aortic valve replacement. Heart Vessels 2018;33:58-65. https://doi.org/10.1007/s00380-017-1032-1