Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Didier Tchétché
  • Francesca Ziviello
  • Chiara De Biase
  • Thomas Hovasse
  • Lionel Leroux
  • Anna Sonia Petronio
  • Christophe Saint Etienne
  • Rui Campante Teles
  • Thomas Modine
  • Arnaud Sudre
  • Emmanuel Teiger
  • Darren Mylotte
  • Geraud Souteyrand
  • Nicolo Piazza
  • Frederic Casassus
  • Marco Angelilis
  • Thiago Nolasco
  • Saiffullah Siddiqui
  • Isabella Kardys
  • Nicolas Dumonteil
  • Nicolas M. Van Mieghem
Background: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited.

Aims: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry.

Methods: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria.

Results: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm2.
OriginalsprogEngelsk
TidsskriftEuroIntervention
Vol/bind19
Udgave nummer6
Sider (fra-til)502-511
Antal sider10
ISSN1774-024X
DOI
StatusUdgivet - 2023
Eksternt udgivetJa

Bibliografisk note

Funding Information:
Medtronic provided a research grant to Clinique Pasteur to conduct the trial. The clinical research organisation was Axiodis, France.

Publisher Copyright:
© Europa Digital & Publishing 2023. All rights reserved.

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