TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study.
Aged
Aged, 80 and over
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Bioprosthesis
Europe
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
/ adverse effects
Hemodynamics
Humans
Israel
Male
Postoperative Complications
/ etiology
Product Surveillance, Postmarketing
Prosthesis Design
Prosthesis Failure
Recovery of Function
Risk Assessment
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement
/ adverse effects
Trauma Severity Indices
Treatment Outcome
TAVR
aortic stenosis
self-expanding
valve-in-valve
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
27 05 2019
27 05 2019
Historique:
received:
06
11
2018
revised:
15
02
2019
accepted:
19
02
2019
entrez:
25
5
2019
pubmed:
28
5
2019
medline:
14
7
2020
Statut:
ppublish
Résumé
The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation. Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery. VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve. Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later. Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298).
Sections du résumé
OBJECTIVES
The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation.
BACKGROUND
Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery.
METHODS
VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve.
RESULTS
Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later.
CONCLUSIONS
Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298).
Identifiants
pubmed: 31122349
pii: S1936-8798(19)30567-9
doi: 10.1016/j.jcin.2019.02.029
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02209298']
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
923-932Investigateurs
Martine Gilard
(M)
Thomas Modine
(T)
Jean Philippe Verhoye
(JP)
Lionel Leroux
(L)
Frédéric Casassus
(F)
Geraud Souteyrand
(G)
Thibaut Manigold
(T)
Emmanuel Teiger
(E)
Didier Champagnac
(D)
Didier Tchétché
(D)
Dominique Grisoli
(D)
Bernard Chevalier
(B)
Gregoire Dambrin
(G)
Bertrand Marcheix
(B)
Werner Scholtz
(W)
David Holzhey
(D)
Won-Keun Kim
(WK)
Axel Harnath
(A)
Ulrich Schäfer
(U)
Ran Kornowski
(R)
Victor Guetta
(V)
Federica Ettori
(F)
Anna Sonia Petronio
(AS)
Francesco Bedogni
(F)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.