Prospective Validation of Intra- and Interobserver Reproducibility of a New Point Shear Wave Elastographic Technique for Assessing Liver Stiffness in Patients with Chronic Liver Disease.

Abstract

ObjectiveTo assess intra- and inter-observer reproducibility of a new point shear wave elastography technique (pSWE, S-Shearwave, Samsung Medison) and compare its accuracy in assessing liver stiffness (LS) with an established pSWE technique (Virtual Touch Quantification, VTQ).Materials and MethodsThirty-three patients were enrolled in this Institutional Review Board-approved prospective study. LS values were measured by VTQ on an Acuson S2000 system (Siemens Healthineer) and S-Shearwave on an RS-80A (Samsung Medison) in the same session, followed by two further S-Shearwave sessions for inter- and intra-observer variation at 8-hour intervals. The technical success rate (SR) and reliability of the measurements of both pSWE techniques were compared. The intra- and inter-observer reproducibility of S-Shearwave was determined by intraclass correlation coefficients (ICCs). LS values were measured by both methods of pSWE. The diagnostic performance in severe fibrosis (F ≥ 3) and cirrhosis (F = 4) was evaluated using the receiver operating characteristics curve analysis and the Obuchowski measure with the LS values of transient elastography as the referenced standard.ResultsThe VTQ (100%, 33/33) and S-Shearwave (96.9%, 32/33) techniques did not display a significant difference in technical SR (p = 0.63) or reliability of LS measurements (96.9%, 32/33; 93.9%, 30/32, respectively, p = 0.61). The inter- and intra-observer agreement for LS measurements using the S-Shearwave technique was excellent (ICC = 0.98 and 0.99, respectively). The mean LS values of both pSWE techniques were not significantly different and exhibited a good correlation (r = 0.78). To detect F ≥ 3 and F = 4, VTQ and S-Shearwave showed comparable diagnostic accuracy as indicated by the following outcomes: areas under receiver operating characteristics curve (AUROC) = 0.87 (95% confidence intervals [CI] 0.70–0.96), 0.89 for VTQ (95% CI 0.74–0.97), respectively; and AUROC = 0.84 (95% CI 0.67–0.94), 0.94 (95% CI 0.80–0.99) for S-Shearwave (p > 0.48), respectively. The Obuchowski measures were similarly high for S-Shearwave and VTQ (0.94 vs. 0.95).ConclusionS-Shearwave shows excellent inter- and intra-observer agreement and diagnostic effectiveness comparable to VTQ in detecting LS.