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

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 Angelilis; Thiago 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 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 Angelilis, Thiago Nolasco, Saiffullah SiddiquiIsabella Kardys, Nicolas Dumonteil, Nicolas M. Van Mieghem

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › peer review

15 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	EuroIntervention
Vol/bind	19
Udgave nummer	6
Sider (fra-til)	502-511
Antal sider	10
ISSN	1774-024X
DOI	https://doi.org/10.4244/EIJ-D-23-00021
Status	Udgivet - 2023
Udgivet eksternt	Ja

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.

Adgang til dokumentet

10.4244/EIJ-D-23-00021

Citationsformater

Tchétché, D., Ziviello, F., De Biase, C., De Backer, O., Hovasse, T., Leroux, L., Petronio, A. S., Etienne, C. S., Teles, R. C., Modine, T., Sudre, A., Teiger, E., Mylotte, D., Souteyrand, G., Piazza, N., Casassus, F., Sondergaard, L., Angelilis, M., Nolasco, T., ... Van Mieghem, N. M. (2023). Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry. EuroIntervention, 19(6), 502-511. https://doi.org/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. / 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 › peer review

Tchétché, D, Ziviello, F, De Biase, C, De Backer, O, Hovasse, T, Leroux, L, Petronio, AS, Etienne, CS, Teles, RC, Modine, T, Sudre, A, Teiger, E, Mylotte, D, Souteyrand, G, Piazza, N, Casassus, F, Sondergaard, L, Angelilis, M, Nolasco, T, Siddiqui, S, Kardys, I, Dumonteil, N & Van Mieghem, NM 2023, 'Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry', EuroIntervention, bind 19, nr. 6, s. 502-511. https://doi.org/10.4244/EIJ-D-23-00021

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. / Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis : the international, multicentre, prospective BIVOLUTX registry. I: EuroIntervention. 2023 ; Bind 19, Nr. 6. s. 502-511.

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

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, 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.",

keywords = "aortic stenosis, degenerative valve, MSCT, TAVI",

author = "Didier Tch{\'e}tch{\'e} and Francesca Ziviello and {De Biase}, Chiara and {De Backer}, Ole and Thomas Hovasse and Lionel Leroux and Petronio, {Anna Sonia} and Etienne, {Christophe Saint} and Teles, {Rui Campante} and Thomas Modine and Arnaud Sudre and Emmanuel Teiger and Darren Mylotte and Geraud Souteyrand and Nicolo Piazza and Frederic Casassus and Lars Sondergaard and Marco Angelilis and Thiago Nolasco and Saiffullah Siddiqui and Isabella Kardys and Nicolas Dumonteil and {Van Mieghem}, {Nicolas M.}",

year = "2023",

doi = "10.4244/EIJ-D-23-00021",

language = "English",

volume = "19",

pages = "502--511",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "Europa Digital & Publishing",

number = "6",

}

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.

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 -