Interventions for valvular disease and heart failure

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

EuroIntervention 2023;19:502-511. DOI: 10.4244/EIJ-D-23-00021

Didier Tchétché
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
1. Clinique Pasteur, Toulouse, France; 2. Erasmus Medical Center, Rotterdam, the Netherlands; 3. Rigshopitalet, Copenhagen, Denmark; 4. Hôpital Privé Jacques Cartier, Massy, France; 5. Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; 6. A.O.U. Pisana, Pisa, Italy; 7. Centre Hospitalier Régional Universitaire, Tours, France; 8. Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal; 9. Centre Hospitalier Universitaire de Lille, Lille, France; 10. Centre Hospitalier Universitaire Henri-Mondor, Créteil, France; 11. University Hospital Galway, Galway, Ireland; 12. CHU de Clermont-Ferrand, Clermont-Ferrand, France; 13. McGill University Health Centre, Montreal, QC, Canada; 14. Clinique Saint-Augustin, Bordeaux, France

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, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies.

Conclusions: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

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