Accès ouvert déclaré 2026 article

Comparative 30-day Echocardiographic Outcomes of Myval versus Sapien and Evolut THVs: Insights from LANDMARK Trial

Osama Soliman, Elfatih A. Hasabo, Niels van Royen, Ignacio J Amat-Santos, Martin Hudec, Matjaz Bunc, Alexander IJsselmuiden, Peep Laanmets, Daniel Unić, Bela Merkely, Renicus S Hermanides, Mohamed Mouden, 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 Teíger, Francesco Bedogni, Michiel Voskuil, Dolores Mesa Rubio, Oskar Angerås, Won-Keun Kim, Jürgen Rothe, Ivica Kristić, Vicente Peral, Ben J. L. Van den Branden, Ashokkumar Thakkar, Udita Chandra, Dina Neiroukh, Cagri Ayhan, Mahmoud Y Nosir, Magdi S Yacoub, Sanaa Ali, Mohamad Jamal Altamimi, Hesham Elzomor, Patrick W Serruys, Andreas Baumbach, Team Medisch, Child Health, Circulatory Health

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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.

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Les sujets associés

Cardiac Valve Diseases and TreatmentsCardiovascular Function and Risk FactorsCongenital Heart Disease Studies

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