Valvular & structural heart disease

Comparative 30-day echocardiographic outcomes of Myval vs. Sapien and Evolut transcatheter heart valve (THVs): insights from LANDMARK trial

Eur Heart J Cardiovasc ImagingPublished prospective, randomised, multicentre, open-label, non-inferiority trial

Authors' 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.

Study context

Population
Patients with aortic stenosis (AS) undergoing transcatheter heart valve (THV) implantation384 Myval THV series vs 384 Sapien and Evolut THV series
Comparison
Myval THV series vs Sapien and Evolut THV series
  • Myval THV seriesn = 384
Methodological detailssub-study
  • Sub-study

Primary result

As reported in the abstract

Haemodynamic device success · 30-day

Myval THV series

85.9%

Sapien THV series

77.8

Evolut THV series

85.4%

Myval THV series vs Sapien THV series: PMyval-Sapien = 0.03 · Myval THV series vs Evolut THV series: PMyval-Evolut = 0.98

Further findings

Moderate prosthesis-patient mismatch (PPM) · 30-day — Myval THV series vs Sapien THV series · less frequent with Myval

PMyval-Sapien = 0.0024

Severe PPM · 30-day — Myval THV series vs Sapien THV series · no significant differences

PMyval-Sapien = 0.394

≥ moderate paravalvular leak (PVL) · 30-day — Myval THV series vs Sapien THV series

PMyval-Sapien = 0.3769

OutcomeP value
Moderate prosthesis-patient mismatch (PPM) · 30-dayMyval THV series vs Evolut THV series · higher with MyvalPMyval-Evolut = 0.0396
Severe PPM · 30-dayMyval THV series vs Evolut THV series · no significant differencesPMyval-Evolut = 0.2438
≥ moderate paravalvular leak (PVL) · 30-dayMyval THV series vs Evolut THV series · lower with MyvalPMyval-Evolut = 0.0336
Oversizing · Myval THV series vs Evolut THV series · minimal oversizing with Myval
P < 0.0001

Peak aortic flow velocity, pressure gradients, effective orifice area (EOA), Doppler velocity index (DVI), cardiac indices, left ventricular ejection fraction · 30-day

Significant improvements across all groups, except for unchanged left ventricular ejection fraction

Original publication

Comparative 30-day echocardiographic outcomes of Myval vs. Sapien and Evolut THVs: insights from LANDMARK trial. Eur Heart J Cardiovasc Imaging. Published 28 August 2025. doi:10.1093/ehjci/jeaf245

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