Risk stratification of MASLD-related advanced fibrosis using a novel point-of-care device: the Hepatoscope.

AIM: Patients with type 2 diabetes (T2D) and obesity are at increased risk of metabolic dysfunction-associated steatotic liver disease (MASLD) with advanced fibrosis (AF), requiring systematic non-invasive assessment using liver stiffness measurement (LSM) or the ELF test. However, access to these biomarkers remains limited in diabetology. We therefore evaluated the diagnostic performance of a new point-of-care ultrasound device, Hepatoscope, for the risk stratification of AF.

METHODS

Participants with T2D and/or obesity and MASLD age 40-80 years, BMI <40 kg/m2 prospectively included in a multi-centre study (NCT04435054) underwent LSM using vibration controlled transient elastography (LSM-VCTE, FibroScan) and 2D-transient elastography (LSM-2DTE) using Hepatoscope version 1 and ELF. Post-acquisition reprocessing of the LSM-2DTE data using the CE approved version 2 (LSM-2DTE-2) was performed in a subgroup of n = 120 participants. The area under the ROC curve (AUROC) and 95% confidence interval (CI) were assessed for the detection of intermediate to high-risk of AF, defined by LSM-VCTE ≥ 8 kPa.

RESULTS

Among 294 participants (83.3% T2D, 42.5% female, 71.4% obesity), 24.8% had LSM-VCTE ≥ 8 kPa. Significant correlation was observed between LSM-VCTE and LSM-2DTE-1 r: 0.37 [0.26-0.47], P < 0.001 and was higher between LSM-VCTE and LSM-2DTE-2: r: 0.61 [0.47-0.71], P < 0.001. In the subgroup of 120 participants, the AUROC (95%CI) of LSM-2DTE-2 for the detection of LSM-VCTE ≥ 8 kPa was 0.81 (0.72-0.89) compared to 0.64 (0.52-0.75) for ELF.

CONCLUSION

This proof-of-concept study provides evidence supporting the role of LSM-2DTE using the Hepatoscope in the risk stratification of AF in diabetology settings. Larger studies are needed to validate its performance.