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  • Title: Valve Performance Between Latest-Generation Balloon-Expandable and Self-Expandable Transcatheter Heart Valves in a Small Aortic Annulus.
    Author: Hioki H, Yamamoto M, Shirai S, Ohno Y, Yashima F, Naganuma T, Yamawaki M, Watanabe Y, Yamanaka F, Mizutani K, Ryuzaki T, Noguchi M, Izumo M, Takagi K, Asami M, Ueno H, Nishina H, Otsuka T, Suzuyama H, Yamasaki K, Nishioka K, Hachinohe D, Fuku Y, Hayashida K, OCEAN-TAVI Investigators.
    Journal: JACC Cardiovasc Interv; 2024 Nov 25; 17(22):2612-2622. PubMed ID: 39603775.
    Abstract:
    BACKGROUND: Transcatheter aortic valve replacement (TAVR) using a self-expandable valve (SEV) promotes better hemodynamics compared with a balloon-expandable valve (BEV) in a small aortic annulus (SAA). OBJECTIVES: The authors sought to compare hemodynamic properties and clinical outcomes between the latest-generation BEV and SEV after TAVR for SAA. METHODS: We retrospectively analyzed 1,227 patients undergoing TAVR for aortic stenosis with SAA, defined as an annulus area ≤430 mm2, using the BEV (SAPIEN3 Ultra RESILIA, Edwards Lifesciences) and SEV (Evolut FX, Medtronic). The impact of valve design on severe prosthesis-patient mismatch, aortic valve mean pressure gradient ≥20 mm Hg, paravalvular leakage (PVL) ≥ mild, new permanent pacemaker implantation (PMI), and modified VARC-3 device success at discharge was evaluated using logistic regression and propensity score analysis. RESULTS: Of 1,227 patients, 798 (65.0%) underwent TAVR with BEV implantation. TAVR using BEV had a relatively higher rate of severe prosthesis-patient mismatch (OR: 1.74; 95% CI: 0.54-5.62) and significantly higher incidence of mean pressure gradient ≥20 mm Hg (OR: 2.05; 95% CI: 0.91-4.62) than that using SEV. By contrast, the BEV showed significantly lower incidence of PVL ≥ mild (OR: 0.19; 95% CI: 0.14-0.26), and new PMI (OR: 0.53; 95% CI: 0.33-0.86). The rate of device success was comparable between the BEV and the SEV. These results were confirmed by propensity score analysis. CONCLUSIONS: In TAVR for SAA, SEV demonstrated better hemodynamics than the latest BEV, whereas the latest BEV had lower incidences of PVL ≥ mild and new PMI than the SEV.
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