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

Hiromu Hase, Nobuhiro Yoshijima, Ryo Yanagisawa, Makoto Tanaka, Hikaru Tsuruta, Hideyuki Shimizu, Keiichi Fukuda, Toru Naganuma, Kazuki Mizutani, Masahiro Yamawaki, Norio Tada, Futoshi Yamanaka, Shinichi Shirai, Minoru Tabata, Hiroshi Ueno, Kensuke Takagi, Yusuke Watanabe, Masanori Yamamoto, Kentaro Hayashida

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: 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. Background: Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli. Methods: 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. Results: 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). Conclusions: 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.

Original languageEnglish
JournalCatheterization and Cardiovascular Interventions
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • indexed effective orifice area
  • prosthesis-patient mismatch
  • transcatheter heart valves
  • valve-in-valve

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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