Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial

Elfatih A. Hasabo; Niels van Royen; Ignacio J. Amat-Santos; Martin Hudec; Matjaz Bunc; Alexander IJsselmuiden; Peep Laanmets; Daniel Unic; Bela Merkely; Renicus S. Hermanides; Vlasis Ninios; Marcin Protasiewicz; Benno J. W M Rensing; Pedro L. Martin; Fausto Feres; Manuel De Sousa Almeida; Eric van Belle; Axel Linke; Alfonso Ielasi; Matteo Montorfano; Mark Webster; Konstantinos Toutouzas; Emmanuel Teiger; Francesco Bedogni; Michiel Voskuil; Manuel Pan; Oskar Angerås; Won Keun Kim; Jürgen Rothe; Ivica Kristić; Vicente Peral; Ben J.L. Van den Branden; Ashokkumar Thakkar; Udita Chandra; Cagri Ayhan; Dina Neiroukh; Mahmoud Y. Nosir; Magdi S. Yacoub; Sanaa Ali; Mohamad Altamimi; Hesham Elzomor; Patrick W. Serruys; Andreas Baumbach; Osama Soliman

doi:10.1016/j.ijcha.2025.101804

Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial

Elfatih A. Hasabo
, Niels van Royen
, Ignacio J. Amat-Santos
, Martin Hudec
, Matjaz Bunc
, Alexander IJsselmuiden
, Peep Laanmets
, Daniel Unic
, Bela Merkely
, Renicus S. Hermanides
, Vlasis Ninios
, Marcin Protasiewicz
, Benno J. W M Rensing
, Pedro L. Martin
, Fausto Feres
, Manuel De Sousa Almeida
, Eric van Belle
, Axel Linke
, Alfonso Ielasi
, Matteo Montorfano

Mark Webster, Konstantinos Toutouzas, Emmanuel Teiger, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angerås, Won Keun Kim, Jürgen Rothe, Ivica Kristić, Vicente Peral, Ben J.L. Van den Branden, Ashokkumar Thakkar, Udita Chandra, Cagri Ayhan, Dina Neiroukh, Mahmoud Y. Nosir, Magdi S. Yacoub, Sanaa Ali, Mohamad Altamimi, Hesham Elzomor, Patrick W. Serruys, Andreas Baumbach, Osama Soliman^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Background: The quantitative videodensitometric aortography (QVDA) has reliably quantified post-TAVI aortic regurgitation (AR). However, this method has not yet been evaluated in randomized trials comparing various transcatheter heart valve (THV) systems. Here, we investigated the QVDA of AR following TAVI for severe aortic stenosis among Myval, Sapien, and Evolut THV series as part of the LANDMARK trial. Methods: The final aortograms, either without or after balloon post-dilatation (BPD) were analyzed using the advanced CAAS-A-Valve 2.1.2 software. The regurgitant fraction (RF) was computed and categorized into none/trace AR (RF < 86 %), mild AR (6 % ≤ 8RF ≤ 817 %), and moderate/severe AR (RF > 17 %). Results: Five hundred ninety-six final analyzable aortograms and 97 aortograms following BPD were included in the analysis. The BPD resulted in a significant reduction of RF in the Myval [12.0(6.0–18.5) vs 2.0(1.0, 5.5);p = 0.0002], Sapien[18.0(1.0–19.0) vs. 2.0(1.0–3.0); p = 0.04206] and Evolut [10.5 (6.0–15.0) vs 5.0 (1.0–8.0); p = 0.0009]. The rate of final RF > 17 % was lower in the Myval(2.0 %) compared to Evolut(8.00 %), but similar to the Sapien series (4.0 %)(P_Myval-Sapien = 0.2333, P_Myval-Evolut = 0.0057). In the as-treated population, the Myval series demonstrated a comparable RF to the Sapien series, but a significantly lower RF compared to the Evolut [Myval: 3.0 %(1.0–7.0), Sapien:3.0 %(1.0–7.0), Evolut:5.0 %(1.0–10.0)], P_Myval-Sapien = 0.8997,P_Myval-Evolut = 0.0010]. Conclusion: The QVDA highlights the superior performance of the Myval THV series compared to the Evolut THV series, with the lowest rate of moderate/severe RF among the three THV series, and could be used with echocardiography to help in detecting cases with none/trace AR.

Original language	English
Article number	101804
Journal	IJC Heart and Vasculature
Volume	61
DOIs	https://doi.org/10.1016/j.ijcha.2025.101804
Publication status	Published - Dec 2025

Keywords

Aortic regurgitation
Balloon post-dilatation
Regurgitant fraction
Transcatheter aortic valve implantation
Videodensitometry

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Hasabo, E. A., van Royen, N., Amat-Santos, I. J., Hudec, M., Bunc, M., IJsselmuiden, A., Laanmets, P., Unic, D., Merkely, B., Hermanides, R. S., Ninios, V., Protasiewicz, M., W M Rensing, B. J., Martin, P. L., Feres, F., Sousa Almeida, M. D., van Belle, E., Linke, A., Ielasi, A., ... Soliman, O. (2025). Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial. IJC Heart and Vasculature, 61, Article 101804. https://doi.org/10.1016/j.ijcha.2025.101804

@article{75d0212f512442519956e4de690240aa,

title = "Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial",

abstract = "Background: The quantitative videodensitometric aortography (QVDA) has reliably quantified post-TAVI aortic regurgitation (AR). However, this method has not yet been evaluated in randomized trials comparing various transcatheter heart valve (THV) systems. Here, we investigated the QVDA of AR following TAVI for severe aortic stenosis among Myval, Sapien, and Evolut THV series as part of the LANDMARK trial. Methods: The final aortograms, either without or after balloon post-dilatation (BPD) were analyzed using the advanced CAAS-A-Valve 2.1.2 software. The regurgitant fraction (RF) was computed and categorized into none/trace AR (RF < 86 \%), mild AR (6 \% ≤ 8RF ≤ 817 \%), and moderate/severe AR (RF > 17 \%). Results: Five hundred ninety-six final analyzable aortograms and 97 aortograms following BPD were included in the analysis. The BPD resulted in a significant reduction of RF in the Myval [12.0(6.0–18.5) vs 2.0(1.0, 5.5);p = 0.0002], Sapien[18.0(1.0–19.0) vs. 2.0(1.0–3.0); p = 0.04206] and Evolut [10.5 (6.0–15.0) vs 5.0 (1.0–8.0); p = 0.0009]. The rate of final RF > 17 \% was lower in the Myval(2.0 \%) compared to Evolut(8.00 \%), but similar to the Sapien series (4.0 \%)(PMyval-Sapien = 0.2333, PMyval-Evolut = 0.0057). In the as-treated population, the Myval series demonstrated a comparable RF to the Sapien series, but a significantly lower RF compared to the Evolut [Myval: 3.0 \%(1.0–7.0), Sapien:3.0 \%(1.0–7.0), Evolut:5.0 \%(1.0–10.0)], PMyval-Sapien = 0.8997,PMyval-Evolut = 0.0010]. Conclusion: The QVDA highlights the superior performance of the Myval THV series compared to the Evolut THV series, with the lowest rate of moderate/severe RF among the three THV series, and could be used with echocardiography to help in detecting cases with none/trace AR.",

keywords = "Aortic regurgitation, Balloon post-dilatation, Regurgitant fraction, Transcatheter aortic valve implantation, Videodensitometry",

author = "Hasabo, \{Elfatih A.\} and \{van Royen\}, Niels and Amat-Santos, \{Ignacio J.\} and Martin Hudec and Matjaz Bunc and Alexander IJsselmuiden and Peep Laanmets and Daniel Unic and Bela Merkely and Hermanides, \{Renicus S.\} and Vlasis Ninios and Marcin Protasiewicz and \{W M Rensing\}, \{Benno J.\} and Martin, \{Pedro L.\} and Fausto Feres and \{Sousa Almeida\}, \{Manuel De\} and \{van Belle\}, Eric and Axel Linke and Alfonso Ielasi and Matteo Montorfano and Mark Webster and Konstantinos Toutouzas and Emmanuel Teiger and Francesco Bedogni and Michiel Voskuil and Manuel Pan and Oskar Anger{\aa}s and Kim, \{Won Keun\} and J{\"u}rgen Rothe and Ivica Kristi{\'c} and Vicente Peral and \{Van den Branden\}, \{Ben J.L.\} and Ashokkumar Thakkar and Udita Chandra and Cagri Ayhan and Dina Neiroukh and Nosir, \{Mahmoud Y.\} and Yacoub, \{Magdi S.\} and Sanaa Ali and Mohamad Altamimi and Hesham Elzomor and Serruys, \{Patrick W.\} and Andreas Baumbach and Osama Soliman",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s)",

year = "2025",

month = dec,

doi = "10.1016/j.ijcha.2025.101804",

language = "English",

volume = "61",

journal = "IJC Heart and Vasculature",

issn = "2352-9067",

publisher = "Elsevier",

}

Hasabo, EA, van Royen, N, Amat-Santos, IJ, Hudec, M, Bunc, M, IJsselmuiden, A, Laanmets, P, Unic, D, Merkely, B, Hermanides, RS, Ninios, V, Protasiewicz, M, W M Rensing, BJ, Martin, PL, Feres, F, Sousa Almeida, MD, van Belle, E, Linke, A, Ielasi, A, Montorfano, M, Webster, M, Toutouzas, K, Teiger, E, Bedogni, F, Voskuil, M, Pan, M, Angerås, O, Kim, WK, Rothe, J, Kristić, I, Peral, V, Van den Branden, BJL, Thakkar, A, Chandra, U, Ayhan, C, Neiroukh, D, Nosir, MY, Yacoub, MS, Ali, S, Altamimi, M, Elzomor, H, Serruys, PW, Baumbach, A & Soliman, O 2025, 'Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial', IJC Heart and Vasculature, vol. 61, 101804. https://doi.org/10.1016/j.ijcha.2025.101804

TY - JOUR

T1 - Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series

T2 - Results from the LANDMARK trial

AU - Hasabo, Elfatih A.

AU - van Royen, Niels

AU - Amat-Santos, Ignacio J.

AU - Hudec, Martin

AU - Bunc, Matjaz

AU - IJsselmuiden, Alexander

AU - Laanmets, Peep

AU - Unic, Daniel

AU - Merkely, Bela

AU - Hermanides, Renicus S.

AU - Ninios, Vlasis

AU - Protasiewicz, Marcin

AU - W M Rensing, Benno J.

AU - Martin, Pedro L.

AU - Feres, Fausto

AU - Sousa Almeida, Manuel De

AU - van Belle, Eric

AU - Linke, Axel

AU - Ielasi, Alfonso

AU - Montorfano, Matteo

AU - Webster, Mark

AU - Toutouzas, Konstantinos

AU - Teiger, Emmanuel

AU - Bedogni, Francesco

AU - Voskuil, Michiel

AU - Pan, Manuel

AU - Angerås, Oskar

AU - Kim, Won Keun

AU - Rothe, Jürgen

AU - Kristić, Ivica

AU - Peral, Vicente

AU - Van den Branden, Ben J.L.

AU - Thakkar, Ashokkumar

AU - Chandra, Udita

AU - Ayhan, Cagri

AU - Neiroukh, Dina

AU - Nosir, Mahmoud Y.

AU - Yacoub, Magdi S.

AU - Ali, Sanaa

AU - Altamimi, Mohamad

AU - Elzomor, Hesham

AU - Serruys, Patrick W.

AU - Baumbach, Andreas

AU - Soliman, Osama

PY - 2025/12

Y1 - 2025/12

N2 - Background: The quantitative videodensitometric aortography (QVDA) has reliably quantified post-TAVI aortic regurgitation (AR). However, this method has not yet been evaluated in randomized trials comparing various transcatheter heart valve (THV) systems. Here, we investigated the QVDA of AR following TAVI for severe aortic stenosis among Myval, Sapien, and Evolut THV series as part of the LANDMARK trial. Methods: The final aortograms, either without or after balloon post-dilatation (BPD) were analyzed using the advanced CAAS-A-Valve 2.1.2 software. The regurgitant fraction (RF) was computed and categorized into none/trace AR (RF < 86 %), mild AR (6 % ≤ 8RF ≤ 817 %), and moderate/severe AR (RF > 17 %). Results: Five hundred ninety-six final analyzable aortograms and 97 aortograms following BPD were included in the analysis. The BPD resulted in a significant reduction of RF in the Myval [12.0(6.0–18.5) vs 2.0(1.0, 5.5);p = 0.0002], Sapien[18.0(1.0–19.0) vs. 2.0(1.0–3.0); p = 0.04206] and Evolut [10.5 (6.0–15.0) vs 5.0 (1.0–8.0); p = 0.0009]. The rate of final RF > 17 % was lower in the Myval(2.0 %) compared to Evolut(8.00 %), but similar to the Sapien series (4.0 %)(PMyval-Sapien = 0.2333, PMyval-Evolut = 0.0057). In the as-treated population, the Myval series demonstrated a comparable RF to the Sapien series, but a significantly lower RF compared to the Evolut [Myval: 3.0 %(1.0–7.0), Sapien:3.0 %(1.0–7.0), Evolut:5.0 %(1.0–10.0)], PMyval-Sapien = 0.8997,PMyval-Evolut = 0.0010]. Conclusion: The QVDA highlights the superior performance of the Myval THV series compared to the Evolut THV series, with the lowest rate of moderate/severe RF among the three THV series, and could be used with echocardiography to help in detecting cases with none/trace AR.

AB - Background: The quantitative videodensitometric aortography (QVDA) has reliably quantified post-TAVI aortic regurgitation (AR). However, this method has not yet been evaluated in randomized trials comparing various transcatheter heart valve (THV) systems. Here, we investigated the QVDA of AR following TAVI for severe aortic stenosis among Myval, Sapien, and Evolut THV series as part of the LANDMARK trial. Methods: The final aortograms, either without or after balloon post-dilatation (BPD) were analyzed using the advanced CAAS-A-Valve 2.1.2 software. The regurgitant fraction (RF) was computed and categorized into none/trace AR (RF < 86 %), mild AR (6 % ≤ 8RF ≤ 817 %), and moderate/severe AR (RF > 17 %). Results: Five hundred ninety-six final analyzable aortograms and 97 aortograms following BPD were included in the analysis. The BPD resulted in a significant reduction of RF in the Myval [12.0(6.0–18.5) vs 2.0(1.0, 5.5);p = 0.0002], Sapien[18.0(1.0–19.0) vs. 2.0(1.0–3.0); p = 0.04206] and Evolut [10.5 (6.0–15.0) vs 5.0 (1.0–8.0); p = 0.0009]. The rate of final RF > 17 % was lower in the Myval(2.0 %) compared to Evolut(8.00 %), but similar to the Sapien series (4.0 %)(PMyval-Sapien = 0.2333, PMyval-Evolut = 0.0057). In the as-treated population, the Myval series demonstrated a comparable RF to the Sapien series, but a significantly lower RF compared to the Evolut [Myval: 3.0 %(1.0–7.0), Sapien:3.0 %(1.0–7.0), Evolut:5.0 %(1.0–10.0)], PMyval-Sapien = 0.8997,PMyval-Evolut = 0.0010]. Conclusion: The QVDA highlights the superior performance of the Myval THV series compared to the Evolut THV series, with the lowest rate of moderate/severe RF among the three THV series, and could be used with echocardiography to help in detecting cases with none/trace AR.

KW - Aortic regurgitation

KW - Balloon post-dilatation

KW - Regurgitant fraction

KW - Transcatheter aortic valve implantation

KW - Videodensitometry

UR - https://www.scopus.com/pages/publications/105017159241

U2 - 10.1016/j.ijcha.2025.101804

DO - 10.1016/j.ijcha.2025.101804

M3 - Article

AN - SCOPUS:105017159241

SN - 2352-9067

VL - 61

JO - IJC Heart and Vasculature

JF - IJC Heart and Vasculature

M1 - 101804

ER -

Quantitative videodensitometric assessment of aortic regurgitation in Myval, Sapien, and Evolut THV series: Results from the LANDMARK trial

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