TY - JOUR
T1 - Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus
T2 - The OCEAN-TAVI registry
AU - OCEAN-TAVI investigators
AU - Hase, Hiromu
AU - Yoshijima, Nobuhiro
AU - Yanagisawa, Ryo
AU - Tanaka, Makoto
AU - Tsuruta, Hikaru
AU - Shimizu, Hideyuki
AU - Fukuda, Keiichi
AU - Naganuma, Toru
AU - Mizutani, Kazuki
AU - Yamawaki, Masahiro
AU - Tada, Norio
AU - Yamanaka, Futoshi
AU - Shirai, Shinichi
AU - Tabata, Minoru
AU - Ueno, Hiroshi
AU - Takagi, Kensuke
AU - Watanabe, Yusuke
AU - Yamamoto, Masanori
AU - Hayashida, Kentaro
N1 - Publisher Copyright:
© 2020 Wiley Periodicals LLC.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - 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.
AB - 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.
KW - indexed effective orifice area
KW - prosthesis-patient mismatch
KW - transcatheter heart valves
KW - valve-in-valve
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U2 - 10.1002/ccd.29259
DO - 10.1002/ccd.29259
M3 - Article
C2 - 32926552
AN - SCOPUS:85090956978
SN - 1522-1946
VL - 97
SP - E875-E886
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 6
ER -