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

DOI: 10.1007/s00595-014-0855-y

Cite this article as:
Sawa, Y., Takayama, M., Mitsudo, K. et al. Surg Today (2015) 45: 34. doi:10.1007/s00595-014-0855-y

Abstract

Purpose

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).

Methods

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.

Results

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.

Conclusions

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.

Keywords

Aortic valve stenosisTranscatheter aortic valve replacementAortic valve replacement

Supplementary material

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

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