Comparative 30-day echocardiographic outcomes of Myval vs. Sapien and Evolut THVs: insights from LANDMARK trial.
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Soliman Osama, Hasabo Elfatih A, van Royen Niels, Amat-Santos Ignacio J, Hudec Martin, Bunc Matjaz, IJsselmuiden Alexander, Laanmets Peep, Unic Daniel, Merkely Bela, Hermanides Renicus S, Mouden Mohamed, Ninios Vlasis, Protasiewicz Marcin, Rensing Benno J W M, Martin Pedro L, Feres Fausto, Almeida Manuel De Sousa, van Belle Eric, Linke Axel, Ielasi Alfonso, Montorfano Matteo, Webster Mark, Toutouzas Konstantinos, Teiger Emmanuel, Bedogni Francesco, Voskuil Michiel, Rubio Dolores Mesa, Angerås Oskar, Kim Won-Keun, Rothe Jürgen, Kristić Ivica, Peral Vicente, Van den Branden Ben J L, Thakkar Ashokkumar, Chandra Udita, Neiroukh Dina, Ayhan Cagri, Nosir Mahmoud Y, Yacoub Magdi S, Ali Sanaa, Altamimi Mohamad, Elzomor Hesham, Serruys Patrick W, Baumbach Andreas
Аннотация
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.