Ruling-in and Ruling-out Significant Fibrosis and Cirrhosis in Patients with Chronic Hepatitis C Using a Shear Wave Measurement Method
Giovanna Ferraioli1, Laura Maiocchi1, Raffaella Lissandrin1, Carmine Tinelli2, Annalisa De Silvestri2, and Carlo Filice1 on behalf of the Liver Fibrosis Study Group*
1) Infectious Diseases Department, Fondazione IRCCS Policlinico S. Matteo, Medical School University of Pavia;
2) Clinical Epidemiology and Biometric Unit, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
Aims: To prospectively assess the cutoff values of a point shear wave measurement (SWM) method for ruling-in and ruling-out significant fibrosis and cirrhosis using transient elastography (TE) as the reference standard.
Method: Consecutive patients with chronic hepatitis C were enrolled. Liver stiffness was assessed with the SWM method implemented on the HI VISION Ascendus ultrasound system (Hitachi Ltd, Japan) and with the TE method of the FibroScan® device (Echosens, France). For staging significant fibrosis (F≥2) and cirrhosis (F=4) we used the TE cutoffs of 7.0 and 12.0 kiloPascal (kPa), respectively. The diagnostic performance of SWM was assessed by calculating the area under the receiver operating characteristic (AUROC) curve. Cutoffs with specificity or sensitivity > 90% were chosen to rule-in or rule-out F≥2 and F=4.
Results: 445 individuals [235 males, 210 females; mean age, 61.1 (13.3) years] were studied: 190 (42.7%) individuals had F0-F1 fibrosis stage, 82 (18.4%) F2, 46 (10.3%) F3, and 127 (28.6%) F4 fibrosis stage. For ruling-in F≥2 the SWM cutoff was 6.78 kPa [sensitivity, 76.9%(70.6-82.4); specificity, 90.3% (85.0-94.3)] and for ruling-out it was 5.55 kPa [sensitivity, 90.6% (85.8-94.1); specificity, 72.2% (64.9-78.6)]. For ruling-in F=4 the SWM cutoff was 9.15 kPa [sensitivity, 83.3% (74.4-90.2); specificity, 90.1% (86.0-93.2)] and for ruling-out it was 8.41 kPa [sensitivity, 90.6% (82.9-95.6); specificity, 82.2% (77.3-86.4)]. AUROCs were 0.92 (0.89-0.94) for F≥2 and 0.94 (0.91-0.96) for F=4.
Conclusions. In clinical practice, the use of a dual cutoff of SWM may increase the confidence in staging liver fibrosis with a non-invasive shear wave elastography technique.
Key words: transient elastography – shear wave elastography – liver cirrhosis – chronic hepatitis C – liver stiffness.
Abbreviations: ARFI: acoustic radiation force impulse; AUROC: area under the ROC curve; CCC: concordance correlation coefficient; IQR/M: interquartile range/median; LSM: liver stiffness measurement; ROC: receiver operating characteristic; pSWE: point shear wave elastography; SWM: shear wave measurement; TE: transient elastography; US: ultrasound.