Initial Findings Concerning the Latest Self-Expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data - 17/12/24
, Masanori Yamamoto, MD, PhD b, c, d, Shinichi Shirai, MD, PhD e, Norio Tada, MD, PhD f, Toru Naganuma, MD, PhD g, Masahiro Yamawaki, MD, PhD h, Futoshi Yamanaka, MD, PhD i, Kazuki Mizutani, MD, PhD j, Masahiko Noguchi, MD, PhD k, Hiroshi Ueno, MD, PhD l, Kensuke Takagi, MD, PhD m, Yohei Ohno, MD, PhD n, Masaki Izumo, MD, PhD o, Hidetaka Nishina, MD, PhD p, Hiroto Suzuyama, MD, PhD q, Kazumasa Yamasaki, MD, PhD r, Kenji Nishioka, MD, PhD s, Daisuke Hachinohe, MD, PhD t, Yasushi Fuku, MD, PhD u, Toshiaki Otsuka, MD, PhD v, w, Masahiko Asami, MD, PhD x, Yusuke Watanabe, MD, PhD y, Kentaro Hayashida, MD, PhD zon behalf of the
OCEAN-TAVI investigators
Résumé |
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.
Le texte complet de cet article est disponible en PDF.Keywords : bleeding, Evolut FX, pacemaker implantation, self-expandable transcatheter heart valve, stroke, transcatheter aortic valve replacement
Plan
| Funding: The OCEAN-TAVI registry was supported by Edwards Life Sciences (Irvine, California), Medtronic (Dublin, Ireland), Boston Scientific (Marlborough, Massachussets), Abbott Medical (Abbott Park, Illinois), and Daiichi-Sankyo (Tokyo, Japna). |
Vol 235
P. 59-66 - janvier 2025 Retour au numéro
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