Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study).
Aged
Aged, 80 and over
Aortic Valve Insufficiency
/ surgery
Aortic Valve Stenosis
/ surgery
Bioprosthesis
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
Humans
Male
Product Surveillance, Postmarketing
Proportional Hazards Models
Prospective Studies
Prosthesis Design
Prosthesis Failure
Reoperation
Transcatheter Aortic Valve Replacement
/ instrumentation
Journal
The American journal of cardiology
ISSN: 1879-1913
Titre abrégé: Am J Cardiol
Pays: United States
ID NLM: 0207277
Informations de publication
Date de publication:
01 04 2021
01 04 2021
Historique:
received:
10
09
2020
revised:
10
12
2020
accepted:
15
12
2020
pubmed:
1
1
2021
medline:
7
4
2021
entrez:
31
12
2020
Statut:
ppublish
Résumé
Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate over time and therefore may necessitate a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve study, which evaluated transcatheter aortic valve implantation using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective Valve-in-Valve study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation, or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve transcatheter aortic valve implantation cases. Two-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality rate was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs 7.6%, p = 0.025). Discharge mean gradients ≥20 mm Hg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3 to 22.1]. In patients with failing surgical aortic bioprostheses, valve-in-valve treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.
Identifiants
pubmed: 33383007
pii: S0002-9149(20)31397-7
doi: 10.1016/j.amjcard.2020.12.047
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02209298']
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
118-124Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.