Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.

Details

Serval ID
serval:BIB_E13E7EAD3A04
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli: The OPERA-TAVI Registry.
Journal
JACC. Cardiovascular interventions
Author(s)
Scotti A., Sturla M., Costa G., Saia F., Pilgrim T., Abdel-Wahab M., Garot P., Gandolfo C., Branca L., Santos I.A., Mylotte D., Bedogni F., De Backer O., Nombela Franco L., Webb J., Ribichini F.L., 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 C.M., Valvo R., Strazzieri O., Motta S.C., Frittitta V., Dipietro E., Comis A., Melfa C., Calì M., Sammartino S., Laterra G., Thiele H., Sondergaard L., Tamburino C., Barbanti M., Latib A.
ISSN
1876-7605 (Electronic)
ISSN-L
1936-8798
Publication state
Published
Issued date
11/03/2024
Peer-reviewed
Oui
Volume
17
Number
5
Pages
681-692
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored.
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.
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.
Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm <sup>2</sup> 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).
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.
Keywords
Humans, Aortic Valve/diagnostic imaging, Aortic Valve/surgery, Aortic Valve Stenosis/diagnostic imaging, Aortic Valve Stenosis/surgery, Prosthesis Design, Heart Valve Prosthesis, Treatment Outcome, Transcatheter Aortic Valve Replacement, Registries, Stroke/etiology, aortic stenosis, balloon expandable, self-expanding, small annuli, transcatheter aortic valve replacement
Pubmed
Web of science
Create date
14/03/2024 18:15
Last modification date
25/05/2024 7:12
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