Valve Performance Between Latest-Generation Balloon-Expandable and Self-Expandable Transcatheter Heart Valves in a Small Aortic Annulus
- PMID: 39603775
- DOI: 10.1016/j.jcin.2024.08.049
Valve Performance Between Latest-Generation Balloon-Expandable and Self-Expandable Transcatheter Heart Valves in a Small Aortic Annulus
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.
Keywords: balloon-expandable valve; self-expandable valve; small aortic annulus; transcatheter aortic valve replacement; valve performance.
Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures The OCEAN-TAVI registry is supported by Edwards-Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and Daiichi-Sankyo. Drs Yamamoto, Shirai, Watanabe, Yamasaki, Hachinohe, and Hayashida served as clinical proctors for Edwards Lifesciences, Abbott Medical, and Medtronic. Drs Ohno, Yashima, Asami, and Nishina are clinical proctors for Medtronic. Drs Naganuma, Mizutani, Takagi, Ueno, and Fuku are clinical proctors for Edwards Lifesciences and Medtronic. Dr Izumo is a screening proctor for Edwards Lifesciences. Dr Nishioka is a clinical proctor for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The data that support the findings of this study are available on request from the corresponding author Dr Masanori Yamamoto.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
