Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry
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Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis : the international, multicentre, prospective BIVOLUTX registry. / Tchétché, Didier; Ziviello, Francesca; De Biase, Chiara; De Backer, Ole; Hovasse, Thomas; Leroux, Lionel; Petronio, Anna Sonia; Etienne, Christophe Saint; Teles, Rui Campante; Modine, Thomas; Sudre, Arnaud; Teiger, Emmanuel; Mylotte, Darren; Souteyrand, Geraud; Piazza, Nicolo; Casassus, Frederic; Sondergaard, Lars; Angelilis, Marco; Nolasco, Thiago; Siddiqui, Saiffullah; Kardys, Isabella; Dumonteil, Nicolas; Van Mieghem, Nicolas M.
I: EuroIntervention, Bind 19, Nr. 6, 2023, s. 502-511.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis
T2 - the international, multicentre, prospective BIVOLUTX registry
AU - Tchétché, Didier
AU - Ziviello, Francesca
AU - De Biase, Chiara
AU - De Backer, Ole
AU - Hovasse, Thomas
AU - Leroux, Lionel
AU - Petronio, Anna Sonia
AU - Etienne, Christophe Saint
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 - Angelilis, Marco
AU - Nolasco, Thiago
AU - Siddiqui, Saiffullah
AU - Kardys, Isabella
AU - Dumonteil, Nicolas
AU - Van Mieghem, Nicolas M.
N1 - Publisher Copyright: © Europa Digital & Publishing 2023. All rights reserved.
PY - 2023
Y1 - 2023
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 stenosis
KW - degenerative valve
KW - MSCT
KW - TAVI
U2 - 10.4244/EIJ-D-23-00021
DO - 10.4244/EIJ-D-23-00021
M3 - Journal article
C2 - 37203860
AN - SCOPUS:85168427714
VL - 19
SP - 502
EP - 511
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 6
ER -
ID: 396931474