First results from the ACURATE Prime XL human feasibility study.
Aortic stenosis
Paravalvular leak
Transcatheter aortic valve replacement
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
received:
15
05
2023
revised:
16
06
2023
accepted:
27
06
2023
pubmed:
11
7
2023
medline:
11
7
2023
entrez:
10
7
2023
Statut:
ppublish
Résumé
This prospective, open-label, single-arm study evaluated transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis with ACURATE Prime XL, an iteration of the ACURATE neo2 device designed with improved radial force and adaptations for compatibility with a larger annulus diameter (≥ 26.5 mm and ≤ 29 mm based on pre-procedure diagnostic imaging). The composite primary device success endpoint was based on Valve Academic Research Consortium (VARC)-2 criteria. The primary safety endpoint was a composite of all-cause mortality and all stroke at 30 days. Aortic valve (AV) performance, including mean AV gradient, AV area, and grade of paravalvular leak (PVL), was assessed by an independent core laboratory. 13 male patients were enrolled at 3 Australian centers (mean age: 83.1 years; 10 of 13 were considered high/extreme operative risk). 61.5 % of patients met the primary device success endpoint. At 30 days, no patients experienced death or stroke; one patient received a permanent pacemaker. Mean AV gradient improved from baseline (42.7 ± 11.0 mmHg) to discharge (7.7 ± 2.5 mmHg) and through 30 days (7.2 ± 2.3 mmHg). Mean AV area was 0.8 ± 0.1 cm In this first-in-human feasibility study of the ACURATE Prime XL valve, there were no safety concerns, and no deaths or strokes within 30 days. Valve hemodynamics were favorable, and no patient had >mild PVL.
Sections du résumé
BACKGROUND/PURPOSE
OBJECTIVE
This prospective, open-label, single-arm study evaluated transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis with ACURATE Prime XL, an iteration of the ACURATE neo2 device designed with improved radial force and adaptations for compatibility with a larger annulus diameter (≥ 26.5 mm and ≤ 29 mm based on pre-procedure diagnostic imaging).
METHODS
METHODS
The composite primary device success endpoint was based on Valve Academic Research Consortium (VARC)-2 criteria. The primary safety endpoint was a composite of all-cause mortality and all stroke at 30 days. Aortic valve (AV) performance, including mean AV gradient, AV area, and grade of paravalvular leak (PVL), was assessed by an independent core laboratory.
RESULTS
RESULTS
13 male patients were enrolled at 3 Australian centers (mean age: 83.1 years; 10 of 13 were considered high/extreme operative risk). 61.5 % of patients met the primary device success endpoint. At 30 days, no patients experienced death or stroke; one patient received a permanent pacemaker. Mean AV gradient improved from baseline (42.7 ± 11.0 mmHg) to discharge (7.7 ± 2.5 mmHg) and through 30 days (7.2 ± 2.3 mmHg). Mean AV area was 0.8 ± 0.1 cm
CONCLUSIONS AND RELEVANCE
CONCLUSIONS
In this first-in-human feasibility study of the ACURATE Prime XL valve, there were no safety concerns, and no deaths or strokes within 30 days. Valve hemodynamics were favorable, and no patient had >mild PVL.
Identifiants
pubmed: 37429793
pii: S1553-8389(23)00673-5
doi: 10.1016/j.carrev.2023.06.028
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-5Informations de copyright
Copyright © 2023. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: