Didier Tchétché; Francesca Ziviello; Chiara De Biase; Ole De Backer; 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; Lars Sondergaard; Marco Angelillis; Tiago Nolasco; Saiffullah Siddiqui; Isabella Kardys; Nicolas Dumonteil; Nicolas  M. Van Mieghem

doi:10.4244/EIJ-D-23-00021

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

Didier Tchétché¹, MD; Francesca Ziviello², MD; Chiara De Biase¹, MD, PhD; Ole De Backer³, MD, PhD; Thomas Hovasse⁴, MD; Lionel Leroux⁵, MD; Anna-Sonia Petronio⁶, MD; Christophe Saint-Etienne⁷, MD; Rui Campante Teles⁸, MD; Thomas Modine⁵, MD; Arnaud Sudre⁹, MD; Emmanuel Teiger¹⁰, MD, PhD; Darren Mylotte¹¹, MD; Geraud Souteyrand¹², MD; Nicolo Piazza¹³, MD; Frederic Casassus¹⁴, MD; Lars Sondergaard³, MD, PhD; Marco Angelillis⁶, MD; Tiago Nolasco⁸, MD; Saiffullah Siddiqui¹, MD; Isabella Kardys², MD, PhD; Nicolas Dumonteil¹, MD; Nicolas M. Van Mieghem², MD, PhD

Abstract

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,...

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