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

Abstract

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] cm 2 /m 2 , 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.