Validation of Velacur Liver Stiffness and Attenuation in Patients With Metabolic Dysfunction-Associated Steatotic...

As clinicians prepare to screen and manage the influx of patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), new systems to help with patient assessment and management need to undergo rigorous evaluation and validation. This study is a validation of liver stiffness and ultrasound attenuation as measured by Velacur against magnetic resonance elastography (MRE) and magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Patients with a history of MASLD or MASH were enrolled prospectively at 2 sites. Patients received MRE, MRI-PDFF, and Velacur scans within 28 days. The magnetic resonance (MR) results were used as the reference, and MR-based cutoffs were used to define disease status. For each MR cutoff, the area under the receiver operator characteristic (AUROC) is calculated for Velacur shear wave absolute vibro-elastography (S-WAVE; elasticity) and attenuation coefficient estimate (ACE; attenuation). These results are compared to previously published results using 2 one-sided t-tests.

A total of 106 patients were enrolled. Of those, 87 patients had valid Velacur, MRE, and MRI-PDFF scans. Mean age and body mass index were 58.9 years and 32.3 kg/m², and 50% of patients had diabetes. For each MRE cutoff, the resulting S-WAVE AUROC was >0.9, with the AUROC for advanced fibrosis being 0.95 (0.88, 0.98). For MRI-PDFF cutoffs, the ACE AUROC for >11%, or moderate steatosis, was 0.89 (0.80, 0.94). Velacur demonstrated excellent discriminatory ability for liver stiffness when compared to MRE, with AUROCs ranging from 0.91 to 0.96. When compared to MRI-PDFF, Velacur demonstrated AUROCs from 0.84 to 0.89. These results align with previous results, in which AUROCs ranged from 0.83 to 0.97 for S-WAVE and 0.91 to 0.94 for ACE.

In this validation study, Velacur has shown a repeatable performance with excellent AUROCs, using MR-based measures as the reference. This shows Velacur is a useful tool for clinicians to assess patients with MASLD and MASH at point-of-care.