Surgery Today

, Volume 45, Issue 1, pp 34–43

Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial

  • Yoshiki Sawa
  • Morimasa Takayama
  • Kazuaki Mitsudo
  • Shinsuke Nanto
  • Shuichiro Takanashi
  • Tatsuhiko Komiya
  • Toru Kuratani
  • Tetsuya Tobaru
  • Tsuyoshi Goto
Original Article



Transcatheter aortic valve replacement (TAVR) is suggested to be less invasive and/or equally effective in comparison to conventional aortic valve replacement for high-risk symptomatic aortic stenosis patients. We herein report the initial results of a pivotal clinical trial of TAVR in Japan (the PREVAIL JAPAN).


Sixty-four aortic stenosis patients (mean age 84.3 ± 6.1 years) not suitable for surgery were enrolled at three centers in Japan, with a primary composite endpoint of the 6-month post-procedure improvements in the aortic valve area and New York Heart Association (NYHA) functional classification.


A transfemoral approach was used in 37 patients and a transapical approach was used in 27. The device success rate was 91.9 %. After 30 days and 6 months, the rates of mortality from any cause were 8.1 and 11.3 %, respectively. At 6 months, symptomatic stroke was found in 3.1 % of the patients, and silent infarction in 7.8 %. The aortic valve area and mean pressure gradient were significantly improved over time with both approaches (p < 0.001). At 6 months, the NYHA functional classification based on a conventional physician’s assessment was improved in 87.9 % of the patients.


We found results that were equivalent to those in other major TAVR trials, such as an acceptable 30-day survival (91.9 %), suggesting that balloon-expandable TAVR is effective for small Japanese AS patients classified as high-risk or inoperable.


Aortic valve stenosis Transcatheter aortic valve replacement Aortic valve replacement 

Supplementary material

595_2014_855_MOESM1_ESM.pdf (113 kb)
Supplementary material 1 (PDF 92 kb)


  1. 1.
    Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. 1998;113:1109–14.PubMedCrossRefGoogle Scholar
  2. 2.
    C. M. Otto, Valve disease: timing of aortic valve surgery, Heart 200 Chart. In: Ross J Jr, Braunwald E (eds.) Aortic Stenosis. Circulation. 1968;38 (Suppl 1):61–67.Google Scholar
  3. 3.
    Schwarz F, Baumann P, Manthey J, Hoffmann M, Schuler G, Mehmel HC, et al. The effect of aortic valve replacement on survival. Circulation. 1982;66:1105–10.PubMedCrossRefGoogle Scholar
  4. 4.
    Murphy ES, Lawson RM, Starr A, Rahimtoola SH. Severe aortic stenosis in patients 60 years of age or elder: left ventricular function and 10-year survival after valve replacement. Circulation. 1981;64(II):184–8.Google Scholar
  5. 5.
    Lund O. Preoperative risk evaluation and stratification of long-term survival after valve replacement for aortic stenosis: reasons for earlier operative intervention. Circulation. 1990;82:124–39.PubMedCrossRefGoogle Scholar
  6. 6.
    Bouma BJ, van Den Brink RB, van Der Meulen JH, Verheul HA, Cheriex EC, Hamer HP, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart. 1999;82:143–8.PubMedCentralPubMedCrossRefGoogle Scholar
  7. 7.
    Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005;26:2714–20.PubMedCrossRefGoogle Scholar
  8. 8.
    Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006;82:2111–5.PubMedCrossRefGoogle Scholar
  9. 9.
    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;106:3006–8.PubMedCrossRefGoogle Scholar
  10. 10.
    Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, et al. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004;43:698–703.PubMedCrossRefGoogle Scholar
  11. 11.
    Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, 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;47:1214–23.PubMedCrossRefGoogle Scholar
  12. 12.
    Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344–51.PubMedCrossRefGoogle Scholar
  13. 13.
    Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008;135:732–8.PubMedCrossRefGoogle Scholar
  14. 14.
    Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.PubMedCrossRefGoogle Scholar
  15. 15.
    Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366:1696–704.PubMedCrossRefGoogle Scholar
  16. 16.
    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;364:2187–98.PubMedCrossRefGoogle Scholar
  17. 17.
    Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686–95.PubMedCrossRefGoogle Scholar
  18. 18.
    Maeda K, Kuratani T, Mizote I, Shimamura K, Takeda Y, Torikai K, et al. Early Experience of transcatheter aortic valve replacement in Japan. Circ J. 2013;77:359–62.PubMedCrossRefGoogle Scholar
  19. 19.
    Kodali SK, O’Neill WW, Moses JW, Williams M, Smith CR, Tuzcu M, et al. Early and late (1-year) outcomes following transcatheter aortic valve implantation in patients with severe aortic stenosis (from the United States REVIVAL Trial). Am J Cardiol. 2011;107:1058–64.PubMedCrossRefGoogle Scholar
  20. 20.
    Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document. J Thorac Cardiovasc Surg. 2012;145:6–23.PubMedCrossRefGoogle Scholar
  21. 21.
    Shroyer ALW, Plomondon ME, Grover FI, Edwards FH, The Society of Thoracic Surgeons’ National Database Committee. The 1996 coronary artery bypass risk model: the Society of Thoracic Surgeons Adult Cardiac National Database. Ann Thorac Surg. 1999;67:1205–8.PubMedCrossRefGoogle Scholar
  22. 22.
    Nashef SAM, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R, et al. European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg. 1999;16:9–13.PubMedCrossRefGoogle Scholar
  23. 23.
    Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, et al. Thirty-day results of the SAPIEN aortic bioprosthesis European outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010;122:62–9.PubMedCrossRefGoogle Scholar
  24. 24.
    Sasayama S, Izumi T, Matsuzaki M, Matsumori A, Asanoi H, Momomura S, et al. Improvement of quality of life with nocturnal oxygen therapy in heart failure patients with central sleep apnea. Circ J. 2009;73:1255–62.PubMedCrossRefGoogle Scholar
  25. 25.
    Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN aortic bioprosthesis European outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011;124:425–33.PubMedCrossRefGoogle Scholar
  26. 26.
    Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010;121:870–8.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Japan 2014

Authors and Affiliations

  • Yoshiki Sawa
    • 1
  • Morimasa Takayama
    • 2
  • Kazuaki Mitsudo
    • 3
  • Shinsuke Nanto
    • 1
  • Shuichiro Takanashi
    • 2
  • Tatsuhiko Komiya
    • 3
  • Toru Kuratani
    • 1
  • Tetsuya Tobaru
    • 2
  • Tsuyoshi Goto
    • 3
  1. 1.Department of Cardiovascular SurgeryOsaka University Graduate School of MedicineSuitaJapan
  2. 2.Sakakibara Heart InstituteFuchuJapan
  3. 3.Kurashiki Central HospitalKurashikiJapan

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