title: First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial.
abstract: BACKGROUND
  The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI.
  
  
  RESULTS
  Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4±6.6 years vs. 84.5±6.1 years, p=0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2±11.7% vs. 15.6±8.0%, p<0.01). Body surface area was smaller in the PREVAIL JAPAN cohort (1.41±0.14m(2) vs. 1.72±0.18m(2); p<0.01) as was the annulus diameter (20.4±1.46mm vs. 22.0±1.84mm, p<0.01). The transfemoral approach was used in 57.8% in the Japanese cohort vs. 51.5% in the Massy cohort. Device success was similar (89.1% vs. 94.1%, p=0.21, respectively), as well as 30-day and 6-month survival rates (92.2% vs. 90.7% and 89.1% vs. 83.1%, p=0.71 and p=0.25, respectively). The incidence of major vascular complications was not significantly different between the two groups (9.4% vs. 5.9%, p=0.23, respectively). A higher post-procedural mean pressure gradient was observed in the PREVAIL JAPAN cohort (12.7±11.4mmHg vs. 10.1±3.6mmHg, p=0.01), but satisfactory improvement in 6-month functional status was obtained in both cohorts (76.5% vs. 77.2%, p=0.91).
  
  
  CONCLUSIONS
  Clinical outcomes after TAVI in the patients included in the PREVAIL JAPAN trial were acceptable and as safe as that of a single-center European cohort.
authors.affiliation: Institut Cardiovasculaire Paris Sud, Massy, France. Electronic address: yusuke0831@gmail.com.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Watanabe
authors.affiliation: Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Hayashida
authors.affiliation: Sakakibara Heart Institute, Tokyo, Japan.
authors.forename: Morimasa
authors.initials: M
authors.lastname: Takayama
authors.affiliation: Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Mitsudo
authors.affiliation: Osaka University, Osaka, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
authors.affiliation: Sakakibara Heart Institute, Tokyo, Japan.
authors.forename: Shuichiro
authors.initials: S
authors.lastname: Takanashi
authors.affiliation: Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Tatsuhiko
authors.initials: T
authors.lastname: Komiya
authors.affiliation: Osaka University, Osaka, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Kuratani
authors.affiliation: Sakakibara Heart Institute, Tokyo, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Tobaru
authors.affiliation: Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Goto
authors.affiliation: Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: Osaka University, Osaka, Japan.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Sawa
authors.affiliation: Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D001024:Aortic Valve Stenosis / Q000601:surgery; D044466:Asian People / Q000706:statistics & numerical data; D001830:Body Surface Area; D002986:Clinical Trials as Topic; D007564:Japan; D010297:Paris; D011446:Prospective Studies; D015996:Survival Rate; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods / Q000401:mortality; D016896:Treatment Outcome; D044465:White People / Q000706:statistics & numerical data
keywords: Aortic stenosis; Clinical outcome; Transcatheter aortic valve implantation