Validation of a New Point Shear-Wave Elastography Method for Noninvasive Assessment of Liver Fibrosis: A Prospective Multicenter Study

Abstract

Objective: To validate the diagnostic value of a new point shear-wave elastography method, S-shearwave elastography (S-SWE; Samsung Medison Co., Ltd.), in noninvasive assessment of liver fibrosis. Materials and Methods: In this prospective multicenter study, liver stiffness (LS) measurements for 600 participants were obtained with both S-SWE and transient elastography (TE). The rates of unsuccessful LS measurements in S-SWE and TE were compared, and correlations between S-SWE and TE measurements were assessed. In 107 patients with histologic reference data, the optimal LS cut-off values for predicting severe fibrosis and cirrhosis on S-SWE were determined using receiver operating characteristic (ROC) curve analysis. The LS cut-off values in S-SWE were then validated in 463 patients without histologic reference data by using TE values as the reference standard, and the sensitivity and specificity of the cut-off values for predicting severe fibrosis and cirrhosis were calculated. Results: The frequency of unsuccessful LS measurements on TE (4.5%, 27/600) was significantly higher than that (0.7%, 4/600) on S-SWE (p < 0.001). LS measurements on S-SWE showed a significant correlation with TE values (r = 0.880, p < 0.001). In 107 patients with histological reference data, the areas under the ROC curves on S-SWE were 0.845 and 0.850, with optimal cut-offs of 7.0 kilopascals (kPa) and 9.7 kPa, for the diagnosis of severe fibrosis and cirrhosis, respectively. Using these cut-off values, S-SWE showed sensitivities of 92.9% and 97.4% and specificities of 89.5% and 83.1% in TE-based evaluations of severe fibrosis and cirrhosis, respectively. Conclusion: LS measurements on S-SWE were well correlated with those on TE. In addition, S-SWE provided good diagnostic performance for staging of hepatic fibrosis, with a lower rate of unsuccessful LS measurements compared with TE.