Original Research

DOI: 10.4244/EIJ-D-24-00966

Intra- versus supra-annular self-expanding transcatheter heart valves in small aortic annuli

Masanori Yamamoto1,2,3, MD; Toshinobu Ryuzaki4, MD; Hirofumi Hioki5, MD; Ai Kagase3, MD; Shinichi Shirai6, MD; Yohei Ohno7, MD; Fumiaki Yashima8, MD; Toru Naganuma9, MD; Masahiro Yamawaki10, MD; Yusuke Watanabe11, MD; Futoshi Yamanaka12, MD; Kazuki Mizutani13, MD; Masahiko Noguchi14, MD; Masaki Izumo15, MD; Kensuke Takagi16, MD; Masahiko Asami17, MD; Hiroshi Ueno18, MD; Hidetaka Nishina19, MD; Hiroto Suzuyama20, MD; Kazumasa Yamasaki21, MD; Kenji Nishioka22, MD; Daisuke Hachinohe23, MD; Yasushi Fuku24, MD; Toshiaki Otsuka25, MD; Kentaro Hayashida4, MD; on behalf of the OCEAN-TAVI investigators

Abstract

Background: Clinical data are scarce comparing supra-annular self-expanding valves (SA-SEVs) and intra-annular (IA)-SEVs after transcatheter aortic valve implantation (TAVI), particularly in patients with a small aortic annulus (SAA).

Aims: We aimed to compare early clinical outcomes, including echocardiographic parameters, between the latest generation of IA-SEV and SA-SEV after TAVI in patients with SAA.

Methods: Focused on patients with SAA, defined as an annulus area ≤430 mm2, the data of 919 patients who underwent TAVI with an IA-SEV (n=518, Navitor) or an SA-SEV (n=401, Evolut FX) were retrospectively extracted. Differences in valve design on postprocedural results were investigated between the two groups and in the propensity score-matched (PSM) cohort.

Results: The postprocedural effective orifice area (EOA), indexed EOA, and mean pressure gradient (mPG) were similar in the overall cohort between the two groups (allp>0.05), whereas the mPG was higher with IA-SEVs than with SA-SEVs (8.74±5.01 mmHg vs 7.84±4.43 mmHg; p=0.049) after PSM (n=219 patients/group). There were no significant differences in the incidence of severe prosthesis-patient mismatch (1.9% vs 0.9%; p=0.405) or paravalvular leakage ≥mild (34.1% vs 42.2%; p=0.084) between the 2 groups in the PSM cohort. The rates of technical success (95.9% vs 95.8%), device success at discharge (91.3% vs 87.8%), and in-hospital death (1.4% vs 0.5%) were comparable in the overall cohort (allp>0.05). These results were not changed in the PSM cohort (allp>0.05).

Conclusions: The latest-generation IA-SEV and SA-SEV demonstrated similar clinical results except for a few echocardiographic findings after TAVI in patients with SAA.

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Volume 21 Number 13
Jul 7, 2025
Volume 21 Number 13
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