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Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN-TAVI registry.

  • Hase, Hiromu1
  • Yoshijima, Nobuhiro1
  • Yanagisawa, Ryo1
  • Tanaka, Makoto1
  • Tsuruta, Hikaru1
  • Shimizu, Hideyuki2
  • Fukuda, Keiichi1
  • Naganuma, Toru3
  • Mizutani, Kazuki4
  • Yamawaki, Masahiro5
  • Tada, Norio6
  • Yamanaka, Futoshi7
  • Shirai, Shinichi8
  • Tabata, Minoru9
  • Ueno, Hiroshi10
  • Takagi, Kensuke11
  • Watanabe, Yusuke12
  • Yamamoto, Masanori13, 14
  • Hayashida, Kentaro1
  • 1 Department of Cardiology, Keio University School of Medicine, Tokyo, Japan. , (Japan)
  • 2 Department of Cardiovascular Surgery, Keio University School of Medicine, Tokyo, Japan. , (Japan)
  • 3 New Tokyo Hospital, Matsudo, Japan. , (Japan)
  • 4 Department of Cardiology, Osaka City General Hospital, Osaka, Japan. , (Japan)
  • 5 Saiseikai Yokohama-City Eastern Hospital, Tsurumi, Japan. , (Japan)
  • 6 Sendai Kousei Hospital, Sendai, Japan. , (Japan)
  • 7 Shonan Kamakura General Hospital, Kamakura, Japan. , (Japan)
  • 8 Kokura Memorial Hospital, Kokura, Japan. , (Japan)
  • 9 Department of Cardiovascular Surgery, Tokyo Bay Urayasu-Ichikawa Medical Center, Chiba, Japan. , (Japan)
  • 10 Toyama University Hospital, Toyama, Japan. , (Japan)
  • 11 Ogaki Municipal Hospital, Gifu, Japan. , (Japan)
  • 12 Teikyo University School of Medicine, Tokyo, Japan. , (Japan)
  • 13 Toyohashi Heart Center, Toyohashi, Japan. , (Japan)
  • 14 Nagoya Heart Center, Nagoya, Japan. , (Japan)
Published Article
Catheterization and Cardiovascular Interventions
Wiley (John Wiley & Sons)
Publication Date
Sep 14, 2020
DOI: 10.1002/ccd.29259
PMID: 32926552


To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli. In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm2 /m2 , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p = .81). TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups. © 2020 Wiley Periodicals LLC.

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