PMID- 24595532
OWN - NLM
STAT- MEDLINE
DCOM- 20150817
LR  - 20211021
IS  - 1436-2813 (Electronic)
IS  - 0941-1291 (Linking)
VI  - 45
IP  - 1
DP  - 2015 Jan
TI  - Clinical efficacy of transcatheter aortic valve replacement for severe aortic 
      stenosis in high-risk patients: the PREVAIL JAPAN trial.
PG  - 34-43
LID - 10.1007/s00595-014-0855-y [doi]
AB  - 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.
FAU - Sawa, Yoshiki
AU  - Sawa Y
AD  - Department of Cardiovascular Surgery, Osaka University Graduate School of 
      Medicine, 2-2 Yamada-Oka, Suita, Osaka, 565-0871, Japan, 
      sawa@surg1.med.osaka-u.ac.jp.
FAU - Takayama, Morimasa
AU  - Takayama M
FAU - Mitsudo, Kazuaki
AU  - Mitsudo K
FAU - Nanto, Shinsuke
AU  - Nanto S
FAU - Takanashi, Shuichiro
AU  - Takanashi S
FAU - Komiya, Tatsuhiko
AU  - Komiya T
FAU - Kuratani, Toru
AU  - Kuratani T
FAU - Tobaru, Tetsuya
AU  - Tobaru T
FAU - Goto, Tsuyoshi
AU  - Goto T
LA  - eng
SI  - ClinicalTrials.gov/NCT01113983
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140305
PL  - Japan
TA  - Surg Today
JT  - Surgery today
JID - 9204360
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve/*surgery
MH  - Aortic Valve Stenosis/*surgery
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Risk
MH  - Severity of Illness Index
MH  - Survival Rate
MH  - Transcatheter Aortic Valve Replacement/*methods/mortality
MH  - Treatment Outcome
EDAT- 2014/03/07 06:00
MHDA- 2015/08/19 06:00
CRDT- 2014/03/06 06:00
PHST- 2013/12/19 00:00 [received]
PHST- 2014/01/08 00:00 [accepted]
PHST- 2014/03/06 06:00 [entrez]
PHST- 2014/03/07 06:00 [pubmed]
PHST- 2015/08/19 06:00 [medline]
AID - 10.1007/s00595-014-0855-y [doi]
PST - ppublish
SO  - Surg Today. 2015 Jan;45(1):34-43. doi: 10.1007/s00595-014-0855-y. Epub 2014 Mar 
      5.