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Randomized Controlled Trial
. 2026 Feb 9;27(2):247-260.
doi: 10.1093/ehjci/jeaf245.

Comparative 30-day echocardiographic outcomes of Myval vs. Sapien and Evolut THVs: insights from LANDMARK trial

Osama Soliman  1   2 , 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 , Mohamed Mouden  15 , 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 , Dolores Mesa Rubio  31   32   33 , Oskar Angerås  34   35 , Won-Keun Kim  36   37 , Jürgen Rothe  38   39 , Ivica Kristić  40 , Vicente Peral  41 , Ben J L Van den Branden  8 , Ashokkumar Thakkar  42 , Udita Chandra  42 , Dina Neiroukh  1   2 , Cagri Ayhan  1   2 , Mahmoud Y Nosir  43 , Magdi S Yacoub  1   2 , Sanaa Ali  1   2 , Mohamad Altamimi  1   2 , Hesham Elzomor  44 , Patrick W Serruys  43 , Andreas Baumbach  45   46
Affiliations
Randomized Controlled Trial

Comparative 30-day echocardiographic outcomes of Myval vs. Sapien and Evolut THVs: insights from LANDMARK trial

Osama Soliman et al. Eur Heart J Cardiovasc Imaging. .

Abstract

Aims: Several factors, including device design, annulus size, and sizing strategies, influence transcatheter heart valve (THV) haemodynamic outcomes in patients with aortic stenosis (AS). This sub-study evaluates early (30-day) echocardiographic outcomes of the Myval, Sapien, and Evolut THV series, focusing on haemodynamic performance and valve durability.

Methods and results: The LANDMARK trial is a prospective, randomised, multicentre, open-label, non-inferiority trial comparing 384 patients implanted with Myval THV series to 384 receiving Sapien and Evolut THV series. Haemodynamic assessments followed Valve Academic Research Consortium-3 recommendations. At 30-day, haemodynamic device success rates were 85.9%, 77.8, and 85.4% for Myval, Sapien, and Evolut THV series, respectively (PMyval-Sapien = 0.03 and PMyval-Evolut = 0.98). Significant improvements in peak aortic flow velocity, pressure gradients, effective orifice area (EOA), Doppler velocity index (DVI), and cardiac indices were observed across all groups, except for unchanged left ventricular ejection fraction. Moderate prosthesis-patient mismatch (PPM) was less frequent with Myval THV series(11.3%) vs. Sapien THV series(21.8%), but higher than Evolut THV series (5.3%) (PMyval-Sapien = 0.0024, PMyval-Evolut = 0.0396), while severe PPM showed no significant differences (4.2% vs. 6.3% vs. 1.8%; PMyval-Sapien = 0.394, PMyval-Evolut = 0.2438). Rates of ≥ moderate paravalvular leak (PVL) were lower in Myval (3.5%), and Sapien (1.7%) compared with Evolut THV series (8.3%) (PMyval-Sapien = 0.3769, PMyval-Evolut = 0.0336). Myval THV series required minimal oversizing compared with Evolut THV series (P < 0.0001).

Conclusion: The Myval THV series demonstrates short-term haemodynamic performance comparable to Evolut THV series and superior to Sapien THV series. Including intermediate sizes minimizes oversizing, underscoring its potential as an alternative for TAVI patients. Long-term follow-up is necessary to confirm these findings.

Clinical trial registration: ClinicalTrials.gov: NCT04275726, EudraCT number 2020-000,137-40.

Keywords: Evolut; Myval; PPM; Sapien; TAVI; THV; aortic regurgitation; aortic stenosis; aortic valve; balloon expandable BEV; echocardiography; haemodynamic; non-inferiority; randomized trial; self expandable SEV; stenosis; transcatheter heart valve.

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Conflict of interest statement

Conflict of interest: O.S. reports research grants from Biosensors, Boston Scientific, Cardiawave and Meril Life Sciences. N.v.R. 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.A.-S. reports being a proctor for Medtronic, Boston Scientific, and Meril Life Sciences. A.I. reports institutional fees from Medtronic and Abbott; consulting fees from Meril Life Sciences, Angiocare, Abbott, Philips, and Translumina. P.L. received travel support from Meril Life Sciences to attend the conference. D.U. reports payment/honoraria from Meril Life Sciences, Medtronic and Abbott; and a member of the Medtronic EMEA surgical advisory board. B.M. 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 programme, 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.H. reports speaker fees from Novartis, Edwards Life Sciences, Meril and Abbott vascular outside the submitted work. P.M. 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.D.S.A. reports lecture fees from Medtronic and Novartis; travel support from Medtronic, Terumo and Boston Scientific. A.L. 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. A.I. reports consulting fees, payment/honoraria for lectures, presentations from Meril Life Sciences, Sahajanand Medical Technologies and Cardionovum. K.T. reports proctorship with Abbott, Meril and Medtronic; consulting fee from Gore Medical; Board member Hellenic Society of Cardiology. F.B. reports consulting fees, payment/honoraria/speaker fees from Meril Life Sciences. D.M.R. reports minor lecture fees from Edwards and Abbott. O.A. reports proctorship and speaker fees from Meril Life and Abbott Medical; speaker fees from Medtronic; research grant from Abbott. W.-K.K. 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.R. 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.T., and U.C. are full employees of Meril Life Sciences. P.W.S. reports consultancy fees from SMT, Novartis, Meril Life Sciences, and Philips. A.B. 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.

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