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. 2025 Sep 29:61:101804.
doi: 10.1016/j.ijcha.2025.101804. eCollection 2025 Dec.

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

Elfatih A Hasabo  1   2 , Niels van Royen  3 , Ignacio J Amat-Santos  4   5 , Martin Hudec  6 , Matjaz Bunc  7 , Alexander IJsselmuiden  8   9   10 , Peep Laanmets  11 , Daniel Unic  12 , Bela Merkely  13 , Renicus S Hermanides  14 , Vlasis Ninios  15 , Marcin Protasiewicz  16 , Benno J W M Rensing  17 , Pedro L Martin  18 , Fausto Feres  19 , Manuel De Sousa Almeida  20 , Eric van Belle  21 , Axel Linke  22 , Alfonso Ielasi  23 , Matteo Montorfano  24   25 , Mark Webster  26 , Konstantinos Toutouzas  27 , Emmanuel Teiger  28 , Francesco Bedogni  29 , Michiel Voskuil  30 , Manuel Pan  31 , Oskar Angerås  32   33 , Won-Keun Kim  34   35 , Jürgen Rothe  36   37 , Ivica Kristić  38 , Vicente Peral  39 , Ben J L Van den Branden  8 , Ashokkumar Thakkar  40 , Udita Chandra  40 , Cagri Ayhan  1   2 , Dina Neiroukh  1   2 , Mahmoud Y Nosir  1   2 , Magdi S Yacoub  1   2 , Sanaa Ali  1   2 , Mohamad Altamimi  1   2 , Hesham Elzomor  41 , Patrick W Serruys  42 , Andreas Baumbach  43   44 , Osama Soliman  1   2
Affiliations

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

Elfatih A Hasabo et al. Int J Cardiol Heart Vasc. .

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.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Osama Soliman reports research grants from Biosensors, Boston Scientific, Cardiawave and Meril Life Sciences. P.W. Serruys reports consultancy fees from SMT, Novartis, Meril Life Sciences, and Philips. N. van Royen reports grant funding and personal fees from Abbott; grants from Philips, Biotronik, and Medtronic; and speaker fees from MicroPort, Bayer, and RainMed Medical outside the submitted work. I.J. Amat-Santos reports being a proctor for Medtronic, Boston Scientific, and Meril Life Sciences. A. Ijsselmuiden reports institutional fees from Medtronic and Abbott; consulting fees from Meril Life Sciences, Angiocare, Abbott, Philips, and Translumina. P. Laanmets received travel support from Meril Life Sciences to attend the conference. D. Unic reports payment/honoraria from Meril Life Sciences, Medtronic and abbott; and a member of the Medtronic EMEA surgical advisory board. B. Merkely reports institutional grants and speaker fees from Boehringer Ingelheim, DUKE Clinical Institute, and Novartis; institutional fees from Biotronik and Eli Lilly; direct personal payment from Daiichi Sankyo; national leader for Librexia program, New Amsterdam trial, DAPA ACT HF-TIMI 68 trial, FINEARTS-HF trial, REALIZE-K trial, SOS-AMI trial, DELIVER trial, GARDEN-TIMI 74 trial, ENDEAVOR trial, EMPACT-MI trial, CARDINAL-HF trial; rector of Semmelweis University, Director and chair of the Heart and Vascular Center of Semmelweis University. R.S. Hermanides reports speaker fees from Novartis, Edwards Life Sciences, Meril and Abbott vascular outside the submitted work. P. Martin reports proctorship grant from Meril Life Sciences; payment or honoraria for lectures, presentations from Meril Life Sciences, Boston Scientific Iberica, Abbott; Advisory board member for Medtronic Spain. M. De Sousa Almeida reports lecture fees from Medtronic and Novartis; travel support from Medtronic, Terumo and Boston Scientific. A. Linke received grants from Edward Lifesciences and Novartis; speaker honoraria from Edward Lifesciences, Boston Scientific, AbioMed, Pfizer, Astra Zeneca, Boehringer, Abbott, MSD, Corvia, Daiichi, and Meril; travel support from Meril, AbioMed and abbott; Stock option holder with Picardia, Transverse Medical and Filterlex. Alfonso Ielasi reports consulting fees, payment/honoraria for lectures, presentations from Meril Life Sciences, Sahajanand Medical Technologies and Cardionovum. K. Toutouzas reports proctorship with Abbott, Meril and Medtronic; consulting fee from Gore Medical; Board member Hellenic Society of Cardiology. F. Bedogni reports proctorship and consulting fees from Meril Life Sciences and Medtronic. Dolores Mesa Rubio reports minor lecture fees from Edwards and Abbott. O. Angerås reports proctorship and speaker fees from Meril Life and Abbott Medical; speaker fees from Medtronic; research grant from Abbott. W.-K. Kim reports honoraria or consultancy fees from Edwards Lifesciences, Boston Scientific, Meril Life Sciences, JenaValve, Abbott and P&F; advisory board member for P&F. J. Rothe reports personal fees for consulting/proctoring from Meril Life Sciences, Medtronic, Abbott and Qatna; and travel support for attending meetings from Meril Life Sciences, Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. A Thakkar, and U Chandra are full employees of Meril Life Sciences. P.W. Serruys reports consultancy fees from SMT, Novartis, Meril Life Sciences, and Philips. A. Baumbach reports consultation fees from Meril Life Sciences, Biotronik and Jenavalve; Lecture fees or honoraria from Biotronik; participation in DSMB for Pi Cardia and Faraday. The other authors have no conflicts of interest to declare.].

Figures

None
Graphical abstract
Fig. 1
Fig. 1
Representation of the quantitative videodensitometric calculation of regurgitant fraction with videodensitometry.
Fig. 2
Fig. 2
Flow chart diagram of aortogram analysis.
Fig. 3
Fig. 3
Line chart showing non-analysabilty over time.
Fig. 4
Fig. 4
RF before and after BPD in (A) overall participants, (B) Myval, Sapien and Evolut THVs series.
Fig. 5
Fig. 5
RF of final aortogram in Myval, Sapien and Evolut THVs series.
Fig. 6
Fig. 6
Cumulative incidence of RF in (A) overall, (B) Myval, Sapien and Evolut THV series.
Fig. 6
Fig. 6
Cumulative incidence of RF in (A) overall, (B) Myval, Sapien and Evolut THV series.
Fig. 7
Fig. 7
Correlation of Echocardiography at discharge point with videodensitometry.
See this image and copyright information in PMC

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