Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

Ignacio J. Amat-Santos; Mario García-Gómez; Federico de Marco; Kim Won-Keun; Joao Brito; Jonathan Halim; John Jose; Gunasekaran Sengotuvelu; Ashok Seth; Christian Terkelsen; Marcin Protasiewicz; Nelson Bonilla; Bruno García; Juan Pablo Sánchez-Luna; Sara Blasco-Turrión; José Carlos González; Esther González-Bartol; Alexander J.J. Ijsselmuiden; Itziar Gómez-Salvador; Manuel Carrasco Moraleja; Alberto San Román

doi:10.1016/j.recesp.2023.02.007

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

Ignacio J. Amat-Santos^*, Mario García-Gómez, Federico de Marco, Kim Won-Keun, Joao Brito, Jonathan Halim, John Jose, Gunasekaran Sengotuvelu, Ashok Seth, Christian Terkelsen, Marcin Protasiewicz, Nelson Bonilla, Bruno García, Juan Pablo Sánchez-Luna, Sara Blasco-Turrión, José Carlos González, Esther González-Bartol, Alexander J.J. Ijsselmuiden, Itziar Gómez-Salvador, Manuel Carrasco MoralejaAlberto San Román

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin - Hjertesygdomme

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Abstract

Introduction and objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+ (EP + ). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. Results: A total of 360 patients (age 76.6 ± 7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP + (30.3%). The mean STS score was 3.6 ± 1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP + : 81.3%), mainly due to higher residual aortic gradients with S3U and greater ≥ moderate aortic regurgitation (AR) with EP +. No significant differences were found in the unadjusted rate of pacemaker implantation. Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP + showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP +, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes. Full English text available from:www.revespcardiol.org/en

Originalsprog	Engelsk
Tidsskrift	Revista Espanola de Cardiologia
Vol/bind	76
Nummer	11
Sider (fra-til)	872-880
Antal sider	9
ISSN	0300-8932
DOI	https://doi.org/10.1016/j.recesp.2023.02.007
Status	Udgivet - nov. 2023

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10.1016/j.recesp.2023.02.007

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Amat-Santos, I. J., García-Gómez, M., de Marco, F., Won-Keun, K., Brito, J., Halim, J., Jose, J., Sengotuvelu, G., Seth, A., Terkelsen, C., Protasiewicz, M., Bonilla, N., García, B., Sánchez-Luna, J. P., Blasco-Turrión, S., González, J. C., González-Bartol, E., Ijsselmuiden, A. J. J., Gómez-Salvador, I., ... San Román, A. (2023). Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study. Revista Espanola de Cardiologia, 76(11), 872-880. https://doi.org/10.1016/j.recesp.2023.02.007

@article{244715d1fc054e9097c9ef461e9a667a,

title = "Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study",

abstract = "Introduction and objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+ (EP + ). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. Results: A total of 360 patients (age 76.6 ± 7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP + (30.3%). The mean STS score was 3.6 ± 1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP + : 81.3%), mainly due to higher residual aortic gradients with S3U and greater ≥ moderate aortic regurgitation (AR) with EP +. No significant differences were found in the unadjusted rate of pacemaker implantation. Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP + showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP +, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes. Full English text available from:www.revespcardiol.org/en",

keywords = "Aortic stenosis, Balloon-expandable prosthesis, Transcatheter aortic valve replacement, Transcatheter heart valve, VARC-3 consensus",

author = "Amat-Santos, {Ignacio J.} and Mario Garc{\'i}a-G{\'o}mez and {de Marco}, Federico and Kim Won-Keun and Joao Brito and Jonathan Halim and John Jose and Gunasekaran Sengotuvelu and Ashok Seth and Christian Terkelsen and Marcin Protasiewicz and Nelson Bonilla and Bruno Garc{\'i}a and S{\'a}nchez-Luna, {Juan Pablo} and Sara Blasco-Turri{\'o}n and Gonz{\'a}lez, {Jos{\'e} Carlos} and Esther Gonz{\'a}lez-Bartol and Ijsselmuiden, {Alexander J.J.} and Itziar G{\'o}mez-Salvador and {Carrasco Moraleja}, Manuel and {San Rom{\'a}n}, Alberto",

year = "2023",

month = nov,

doi = "10.1016/j.recesp.2023.02.007",

language = "English",

volume = "76",

pages = "872--880",

journal = "Revista Espanola de Cardiologia",

issn = "0300-8932",

publisher = "Elsevier Espana",

number = "11",

}

Amat-Santos, IJ, García-Gómez, M, de Marco, F, Won-Keun, K, Brito, J, Halim, J, Jose, J, Sengotuvelu, G, Seth, A, Terkelsen, C, Protasiewicz, M, Bonilla, N, García, B, Sánchez-Luna, JP, Blasco-Turrión, S, González, JC, González-Bartol, E, Ijsselmuiden, AJJ, Gómez-Salvador, I, Carrasco Moraleja, M & San Román, A 2023, 'Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study', Revista Espanola de Cardiologia, bind 76, nr. 11, s. 872-880. https://doi.org/10.1016/j.recesp.2023.02.007

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study. / Amat-Santos, Ignacio J.; García-Gómez, Mario; de Marco, Federico et al.
I: Revista Espanola de Cardiologia, Bind 76, Nr. 11, 11.2023, s. 872-880.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis

T2 - the TRITON study

AU - Amat-Santos, Ignacio J.

AU - García-Gómez, Mario

AU - de Marco, Federico

AU - Won-Keun, Kim

AU - Brito, Joao

AU - Halim, Jonathan

AU - Jose, John

AU - Sengotuvelu, Gunasekaran

AU - Seth, Ashok

AU - Terkelsen, Christian

AU - Protasiewicz, Marcin

AU - Bonilla, Nelson

AU - García, Bruno

AU - Sánchez-Luna, Juan Pablo

AU - Blasco-Turrión, Sara

AU - González, José Carlos

AU - González-Bartol, Esther

AU - Ijsselmuiden, Alexander J.J.

AU - Gómez-Salvador, Itziar

AU - Carrasco Moraleja, Manuel

AU - San Román, Alberto

PY - 2023/11

Y1 - 2023/11

N2 - Introduction and objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+ (EP + ). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. Results: A total of 360 patients (age 76.6 ± 7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP + (30.3%). The mean STS score was 3.6 ± 1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP + : 81.3%), mainly due to higher residual aortic gradients with S3U and greater ≥ moderate aortic regurgitation (AR) with EP +. No significant differences were found in the unadjusted rate of pacemaker implantation. Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP + showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP +, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes. Full English text available from:www.revespcardiol.org/en

AB - Introduction and objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+ (EP + ). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. Results: A total of 360 patients (age 76.6 ± 7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP + (30.3%). The mean STS score was 3.6 ± 1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP + : 81.3%), mainly due to higher residual aortic gradients with S3U and greater ≥ moderate aortic regurgitation (AR) with EP +. No significant differences were found in the unadjusted rate of pacemaker implantation. Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP + showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP +, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes. Full English text available from:www.revespcardiol.org/en

KW - Aortic stenosis

KW - Balloon-expandable prosthesis

KW - Transcatheter aortic valve replacement

KW - Transcatheter heart valve

KW - VARC-3 consensus

UR - http://www.scopus.com/inward/record.url?scp=85160340478&partnerID=8YFLogxK

U2 - 10.1016/j.recesp.2023.02.007

DO - 10.1016/j.recesp.2023.02.007

M3 - Journal article

C2 - 36898524

AN - SCOPUS:85160340478

SN - 0300-8932

VL - 76

SP - 872

EP - 880

JO - Revista Espanola de Cardiologia

JF - Revista Espanola de Cardiologia

IS - 11

ER -

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

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