A balloon-expandable transcatheter valve with intermediate sizing reduced prosthesis-patient mismatch by nearly half in small annuli while matching contemporary devices in overall clinical outcomes at one year, according to investigators. Published online Monday in the Journal of the American College of Cardiology, the analysis of data from the LANDMARK trial reported no significant difference in the composite of death, stroke or valve-related hospitalization between the Myval series (Meril Life) and established SAPIEN (Edwards Lifesciences) and Evolut (Medtronic) valves. Indeed, the study showed that intermediate sizes (21.5mm, 24.5mm, and 27.5mm) allowed more precise annular matching than standard 2mm or 3mm increments, said the authors, led by Patrick W. Serruys, MD, PhD, from the University of Galway, Ireland. "The lack of difference in the three robust 1-year endpoints demonstrates that Myval compares favorably in safety and efficacy with two contemporary gold standard THVs," the team wrote. Study details The LANDMARK investigators randomized 768 patients with symptomatic severe aortic stenosis across 31 hospitals in Europe, Brazil and New Zealand. Patients received either Myval (n=384) or contemporary valves (n=384), with the latter group split equally between SAPIEN and Evolut. Mean age was 80 years, 48% were female and median Society of Thoracic Surgeons (STS) risk score was 2.6%. At one year, freedom from all-cause mortality, stroke or procedure- or valve-related hospitalization was 87.0% with Myval versus 86.9% with contemporary valves (risk difference: -0.1%; 95% confidence interval [CI]: -4.9 to 4.7; p = 1.00). The exploratory non-inferiority analysis confirmed Myval was non-inferior (one-sided 95% CI: 3.9%; p < 0.0001), researchers reported. All-cause mortality occurred in 7.2% versus 7.1% (p = 1.00). Stroke rates were 5.7% with Myval and 3.4% with contemporary valves (difference: 2.3%; 95% CI: -0.6 to 5.2; p = 0.22). Hospitalizations for valve-related causes occurred in 4.3% versus 5.4% (p = 0.61), according to the analysis. Serruys and colleagues noted that hemodynamic outcomes varied by device type, investigators found, adding that compared to SAPIEN, Myval had lower mean gradients (9.51 versus 10.54 mmHg; p = 0.047) and larger effective orifice areas (2.11 versus 1.95 cm²; p = 0.006). But Evolut outperformed Myval with lower gradients (6.53 versus 9.51 mmHg; p < 0.0001) and larger areas (2.25 versus 2.11 cm²; p = 0.008). Sizing advantage In patients with annular areas ≤430 mm², moderate or severe prosthesis-patient mismatch occurred in 17.3% of Myval recipients versus 33.9% of SAPIEN recipients (P = 0.029), the authors reported. No significant difference emerged between Myval and Evolut (17.3% versus 8.3%; P = 0.22). New permanent pacemaker rates were similar: 17.6% for Myval, 19.2% for SAPIEN and 18.9% for Evolut, despite deeper implantation depths than typically reported, researchers noted. Five patients required valve reintervention, all in the contemporary group. The extended composite endpoint incorporating quality-of-life deterioration showed no difference between groups (80.5% versus 77.3% event-free; P = 0.33), investigators stated. Echocardiographic follow-up was achieved in 94% of survivors. The trial will continue follow-up to 10 years. Source: Serruys PW, Tobe A, van Royen N, et al. One-year outcomes of novel balloon-expandable versus contemporary transcatheter heart valves in severe aortic stenosis: the LANDMARK trial. J Am Coll Cardiol. 2025 November 26 (Article in Press) doi: 10.1016/j.jacc.2025.10.076. Image Credit: Image Supply Co – stock.adobe.com