TY - JOUR
T1 - Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis
T2 - the international, multicentre, prospective BIVOLUTX registry
AU - Tchetche, Didier
AU - Ziviello, Francesca
AU - De Biase, Chiara
AU - de Backer, Ole
AU - Hovasse, Thomas
AU - Leroux, Lionel
AU - Petronio, Anna-Sonia
AU - Saint-Etienne, Christophe
AU - Teles, Rui Campante
AU - Modine, Thomas
AU - Sudre, Arnaud
AU - Teiger, Emmanuel
AU - Mylotte, Darren
AU - Souteyrand, Geraud
AU - Piazza, Nicolo
AU - Casassus, Frederic
AU - Sondergaard, Lars
AU - Angelillis, Marco
AU - Nolasco, Tiago
AU - Siddiqui, Saiffullah
AU - Kardys, Isabella
AU - Dumonteil, Nicolas
AU - Van Mieghem, Nicolas M
PY - 2023/8/21
Y1 - 2023/8/21
N2 - 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.
AB - 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.
KW - Aortic Valve Stenosis
KW - Aortic Valve/diagnostic imaging
KW - Bicuspid Aortic Valve Disease/etiology
KW - Constriction, Pathologic
KW - Death
KW - Heart Valve Diseases/surgery
KW - Heart Valve Prosthesis
KW - Humans
KW - Mitral Valve Stenosis/surgery
KW - Prospective Studies
KW - Prosthesis Design
KW - Registries
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85168427714&partnerID=8YFLogxK
M3 - Journal article
C2 - 37203860
SN - 1774-024X
VL - 19
SP - 502
EP - 511
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 6
ER -