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 - Funding Information:
The authors thank all OCEAN‐TAVI investigators and Dr. Higashimori at Kishiwada Tokusyukai Hospital. The OCEAN‐TAVI registry is supported by Edwards Lifesciences, Medtronic, and Daiichi Sankyo Company.
Funding Information:
The OCEAN‐TAVI registry is an ongoing nonrandomized, multicenter prospective registry affiliated with 14 high‐volume centers. This registry was established to monitor and record the procedural results and postprocedural clinical outcomes of TAVR. The inclusion criteria of this registry have been reported. This trial is registered with the University Hospital Medical Information Network (UMIN000020423). The study protocol was developed in accordance with the Declaration of Helsinki and approved by the ethics review board at each treatment site. Informed consent for data collection was obtained from all patients. Between October 2013 and May 2017, a total of 2,588 patients with severe aortic stenosis undergoing TAVR with the self‐expanding THVs (CoreValve and Evolut R, Medtronic, Minneapolis, MN), or balloon‐expandable THVs (Sapien XT and Sapien 3, Edwards Lifesciences) were prospectively included in the OCEAN‐TAVI registry. Baseline clinical and functional characteristics, as well as in‐hospital and follow‐up data, were also prospectively collected. The OCEAN‐TAVI Registry received financial support and grants from Edwards Lifesciences, Medtronic, and Daiichi Sankyo, but these sponsors have nothing to do with the content of this study. 12‐14
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 -