Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation.


Journal

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
ISSN: 1969-6213
Titre abrégé: EuroIntervention
Pays: France
ID NLM: 101251040

Informations de publication

Date de publication:
18 Sep 2023
Historique:
pmc-release: 18 09 2024
medline: 19 9 2023
pubmed: 11 8 2023
entrez: 11 8 2023
Statut: ppublish

Résumé

Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting. We aimed to evaluate the safety and feasibility of Myval in NCAR. This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed. A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

Sections du résumé

BACKGROUND BACKGROUND
Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting.
AIMS OBJECTIVE
We aimed to evaluate the safety and feasibility of Myval in NCAR.
METHODS METHODS
This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed.
RESULTS RESULTS
A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm
CONCLUSIONS CONCLUSIONS
Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

Identifiants

pubmed: 37565470
pii: EIJ-D-23-00344
doi: 10.4244/EIJ-D-23-00344
pmc: PMC10500190
pii:
doi:

Types de publication

Observational Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

580-588

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Auteurs

Juan Pablo Sanchez-Luna (JP)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Pedro Martín (P)

Cardiology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, Spain.

Antonio E Dager (AE)

Cardiology Department, Angiografía de Occidente Hospital, Cali, Colombia.

Pablo D Charry (PD)

Cardiology Department, Clínica Medilaser, Neiva, Colombia.

Javier R Beltrán (JR)

Cardiology Department, Los Comuneros Hospital Universitario de Bucaramanga, Bucaramanga, Colombia.

Ángel Sánchez-Recalde (Á)

Cardiology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.

Francesco Giannini (F)

Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.

Antonio Gómez-Menchero (A)

Cardiology Department, Hospital Juan Ramón Jimenez, Huelva, Spain.

Manuel Pan (M)

Cardiology Department, Hospital Reina Sofía, Cordoba, Spain and University of Cordoba (IMIBIC), Cordoba, Spain.

Alfonso Ielasi (A)

Cardiology Department, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.

Andrea Monastyrski (A)

Cardiology Department, Hospital Universitario Val d'Hebron, Barcelona, Spain.

Marco Barbanti (M)

Cardiology Department, Policlinico-Vittorio Emanuele Hospital, Catania, Italy.

Francisco Fernandez-Avilés (F)

Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.

Marco Bruno Ancona (MB)

Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.

Abdurashid Mussayev (A)

Cardiology Department, National Research Cardiac Surgery Center, Astana, Kazakhstan.

Juan Pablo De Brahi (JP)

Cardiology Department, Sanatorio de La Trinidad Mitre, Buenos Aires, Argentina.

Pablo Lamelas (P)

Cardiology Department, Instituto Cardiovascular, Buenos Aires, Argentina.

Andrés Sánchez-Pérez (A)

Cardiology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, Spain.

Melissa García Puerta (M)

Cardiology Department, Angiografía de Occidente Hospital, Cali, Colombia.

Miguel Ortiz (M)

Cardiology Department, Angiografía de Occidente Hospital, Cali, Colombia.

Jose Carlos Gonzalez-Gutiérrez (JC)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Giorgio Marengo (G)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Javier Gómez (J)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Esther Gonzalez-Bartol (E)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Alexander Stepanenko (A)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Itziar Gomez-Salvador (I)

Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Madrid, Spain.

J Alberto San Román (JA)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Madrid, Spain.

Ignacio J Amat-Santos (IJ)

Cardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Madrid, Spain.

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