One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

Details

Serval ID
serval:BIB_12D425EBA8CE
Type
Article: article from journal or magazin.
Collection
Publications
Title
One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.
Journal
EuroIntervention
Author(s)
Costa G., Saia F., Pilgrim T., Abdel-Wahab M., Garot P., Sammartino S., Gandolfo C., Branca L., Latib A., Amat-Santos I., Mylotte D., De Marco F., De Backer O., Nombela Franco L., Akodad M., Ribichini F.L., Bedogni F., Mazzapicchi A., Tomii D., Laforgia P., Cannata S., Fiorina C., Scotti A., Fezzi S., Criscione E., Poletti E., Mazzucca M., Lunardi M., Mainardi A., Andreaggi S., Quagliana A., Montarello N.J., Hennessey B., Mon-Noboa M., Meier D., Adamo M., Sgroi C., Reddavid C.M., Strazzieri O., Crescenzia Motta S., Frittitta V., Dipietro E., Comis A., Melfa C., Calì M., Laterra G., Thiele H., Webb J.G., Sondergaard L., Tamburino C., Barbanti M.
ISSN
1969-6213 (Electronic)
ISSN-L
1774-024X
Publication state
Published
Issued date
01/01/2024
Peer-reviewed
Oui
Volume
20
Number
1
Pages
95-103
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking.
We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice.
Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology.
Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all p <sub>interaction</sub> >0.10).
One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.
Keywords
Humans, Transcatheter Aortic Valve Replacement/adverse effects, Aortic Valve/diagnostic imaging, Aortic Valve/surgery, Aortic Valve Stenosis/surgery, Heart Valve Prosthesis/adverse effects, Treatment Outcome, Registries, Stroke/etiology, Prosthesis Design
Pubmed
Web of science
Create date
17/01/2025 5:31
Last modification date
24/02/2025 11:34
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