Journal Article

Initial Findings Concerning the Latest Self-Expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data

Yamamoto, Masanori, Tada, Norio, Noguchi, Masahiko, Suzuyama, Hiroto, Watanabe, Yusuke, Hayashida, Kentaro, Fuku, Yasushi, Takagi, Kensuke, Yamawaki, Masahiro, Nishina, Hidetaka, Shirai, Shinichi, Otsuka, Toshiaki, Asami, Masahiko, Ohno, Yohei, Izumo, Masaki, Yamasaki, Kazumasa, Ueno, Hiroshi, Naganuma, Toru, Hachinohe, Daisuke, Yashima, Fumiaki, Yamanaka, Futoshi, Nishioka, Kenji, Mizutani, Kazuki

2025

Overview

Data concerning the clinical effect of the latest-generation self-expandable transcatheter heart valve (Evolut FX) remain limited. We aimed to assess the in-hospital outcomes of 3 bioprosthetic valves (Evolut EPO, PRO+, and FX). We analyzed data from a Japanese multicenter registry involving 634 consecutive patients who underwent transcatheter aortic valve replacement with Evolut FX up until October 2023. Patients who underwent transcatheter aortic valve replacement with Evolut EPO between 2018 and 2020 (n = 1,128), and those with Evolut EPO+ between 2020 and 2023 (n = 1,696) served as the control groups. The exclusion criteria comprised patients on dialysis with a history of infective endocarditis or with insufficient data. Unmatched comparisons among the 3 valves were conducted, followed by a propensity score–matched comparison between Evolut EPO+ and FX. In the unmatched cohort, among the Evolut EPO, PRO+, and FX groups, all vascular complications (7.8% vs 5.2% vs 4.5%, respectively, p <0.01) and new pacemaker implantation rates (11.2% vs 6.1% vs 7.7%, respectively, p <0.01) differed significantly. In the propensity score–matched analysis, the rate of all bleeding events was significantly higher in the Evolut EPO+ group (11.0%) than in the FX group (7.0%) (p = 0.02), whereas all vascular complications (4.6% vs 4.6%, respectively, p = 1.00) and new pacemaker implantation (5.9% vs 7.6%, respectively, p = 0.28) rates were comparable. The incidence of stroke in the FX group was approximately half that of the EP+ group (3.7% vs 1.9%, p = 0.095), without statistical significance. In conclusion, compared with the Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce the incidence of in-hospital stroke.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Aged / Aged, 80 and over / Aorta / Aortic valve / Aortic Valve Stenosis - surgery / Bioprosthesis / Bleeding / Calcification / Cardiovascular disease / Clinical outcomes / Dialysis / Endocarditis / Evolut FX / Female / Heart Valve Prosthesis / Heart valves / Hemodialysis / Hemodynamics / Hospitals / Humans / Implantation / Japan - epidemiology / Male / Medical equipment / Mortality / pacemaker implantation / Pacemakers / Patient safety / Patients / Postoperative Complications - epidemiology / Propensity Score / Prosthesis Design / Registries / self-expandable transcatheter heart valve / stroke / Transcatheter Aortic Valve Replacement / Variables / Vein & artery diseases