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Multicenter Study
. 2021 May 1;97(6):E875-E886.
doi: 10.1002/ccd.29259. Epub 2020 Sep 14.

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

Hiromu Hase  1 , Nobuhiro Yoshijima  1 , Ryo Yanagisawa  1 , Makoto Tanaka  1 , Hikaru Tsuruta  1 , Hideyuki Shimizu  2 , Keiichi Fukuda  1 , Toru Naganuma  3 , Kazuki Mizutani  4 , Masahiro Yamawaki  5 , Norio Tada  6 , Futoshi Yamanaka  7 , Shinichi Shirai  8 , Minoru Tabata  9 , Hiroshi Ueno  10 , Kensuke Takagi  11 , Yusuke Watanabe  12 , Masanori Yamamoto  13   14 , Kentaro Hayashida  1 ; OCEAN-TAVI Investigators
Affiliations
Multicenter Study

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

Hiromu Hase et al. Catheter Cardiovasc Interv. .

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.

Keywords: indexed effective orifice area; prosthesis-patient mismatch; transcatheter heart valves; valve-in-valve.

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References

REFERENCES

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