1. Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.
- Author
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Scotti A, Sturla M, Costa G, Saia F, Pilgrim T, Abdel-Wahab M, Garot P, Gandolfo C, Branca L, Santos IA, Mylotte D, Bedogni F, De Backer O, Nombela Franco L, Webb J, Ribichini FL, Mainardi A, Andreaggi S, Mazzapicchi A, Tomii D, Laforgia P, Cannata S, Fiorina C, Fezzi S, Criscione E, Lunardi M, Poletti E, Mazzucca M, Quagliana A, Montarello N, Hennessey B, Mon-Noboa M, Akodad M, Meier D, De Marco F, Adamo M, Sgroi C, Reddavid CM, Valvo R, Strazzieri O, Motta SC, Frittitta V, Dipietro E, Comis A, Melfa C, Calì M, Sammartino S, Laterra G, Thiele H, Sondergaard L, Tamburino C, Barbanti M, and Latib A
- Subjects
- Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prosthesis Design, Treatment Outcome, Registries, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement, Stroke etiology
- Abstract
Background: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored., Objectives: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli., Methods: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes., Results: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm
2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001)., Conclusions: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection., Competing Interests: Funding Support and Author Disclosures Dr Scotti has served as a consultant for Edwards Lifesciences and NeoChord. Dr Pilgrim has received research, travel, or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; and has received speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Dr Meier has received an institutional grant from Edwards Lifesciences. Dr Barbanti is a consultant for Boston Scientifics, Edwards Lifesciences, and Medtronic. Dr Latib has served on advisory boards for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord, VDyne, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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