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

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.

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).

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.

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