TY - JOUR
T1 - Comparative 30-day Echocardiographic Outcomes of Myval versus Sapien and Evolut THVs
T2 - Insights from LANDMARK Trial
AU - Soliman, Osama
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 - Mouden, Mohamed
AU - Ninios, Vlasis
AU - Protasiewicz, Marcin
AU - Rensing, Benno J W M
AU - Martin, Pedro L
AU - Feres, Fausto
AU - Almeida, Manuel De Sousa
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 - Rubio, Dolores Mesa
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 - Neiroukh, Dina
AU - Ayhan, Cagri
AU - Nosir, Mahmoud Y
AU - Yacoub, Magdi S
AU - Ali, Sanaa
AU - Altamimi, Mohamad
AU - Elzomor, Hesham
AU - Serruys, Patrick W
AU - Baumbach, Andreas
N1 - Publisher Copyright:
© 2025 The Author(s).
PY - 2026/2/9
Y1 - 2026/2/9
N2 - 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.
AB - 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.
U2 - 10.1093/ehjci/jeaf245
DO - 10.1093/ehjci/jeaf245
M3 - Article
C2 - 40875489
SN - 2047-2404
VL - 27
SP - 247
EP - 260
JO - European heart journal. Cardiovascular Imaging
JF - European heart journal. Cardiovascular Imaging
IS - 2
ER -