The diagnostic value of S-Shearwave Imaging™

for non-invasive assessment of liver fibrosis

in patients with chronic liver disease

RS85

Sang Gyune Kim1

Jae Young Jang2

1
Digestive Disease Center and Research Institute, Department of Internal Medicine,
Soonchunhyang University School of Medicine, Bucheon, Korea.
2
Department of Internal Medicine, Soonchunhyang University School of Medicine, Seoul, Korea.
Introduction

Background

Chronic liver diseases (CLD) are important health issues worldwide [1]. The Most common
cause of chronic liver diseases include chronic hepatitis B virus (HBV) and hepatitis C
virus (HCV) infection, alcoholic and non-alcoholic fatty liver disease, and autoimmune
hepatitis [2].

Chronic liver injury cause liver fibrosis, which induces liver anatomical change and an
increase of liver stiffness [2, 3]. Liver fibrosis progresses and eventually leads to cirrhosis,
portal hypertension, hepatic insufficiency, and hepatocellular carcinoma (HCC) [3].

With the rising prevalence of chronic liver disease, interest is increasing in the
development of noninvasive methods of estimation of liver fibrosis. The diagnosis and
staging of hepatic fibrosis has become important in clinical decision making [4].

Purpose

The purpose of this study to assess the diagnostic performance of S-Shearwave Imaging™
for the prediction of liver fibrosis staging in patients with chronic liver disease, as compared
with liver biopsy result classified by METAVIR scoring system.
Methods

The study was performed under ethics approval from Institutional clinical research ethics
committee. Written informed consent was obtained from all participants.

Between May and December 2018, a total of 116 patients with chronic liver disease were
prospectively enrolled in two tertiary care hospitals. A total of 115 patients with chronic liver
disease who met eligibility criteria were included. One patient who had unreliable measurement
was excluded.

All patients underwent 2D-Shearwave elastography (2D-SWE) examination, liver biopsy and
laboratory test. Liver biopsy was used as a reference method for assessing liver fibrosis.
2D-SWE examination for liver stiffness measurement was performed using S-Shearwave
Imaging™ application on RS85 Ultrasound system equipped with a convex array CA1-7A
transducer (Samsung Medison Co., Ltd.).

S-Shearwave Imaging™ provides an image containing both a stiffness map and a RMI map.
A stiffness map shows a pattern of stiff (red color) and soft (blue color). And a reliable
measurement index (RMI) map indicates the relative reliable elasticity value as white to
yellow and less reliable value as red to black.

A Reliable 2D-SWE measurement was considered as (1) when homogenous color pattern in
a ROI, (2) RMI is above 0.3, (3) IQR (reflecting the variability of measurements) less than 30%
of the median liver stiffness measurements value from 10 measurements in each patients
(IQR/Median liver stiffness measurements <30%) [5]. Ten consecutive mean 2D-SWE
measurements could obtain in different 2D-SWE image frames. A quantitative elasticity
value is expressed in both Young’s modulus (kPa) and shearwave speed (m/sec).

The diagnostic performance of S-Shearwave Imaging™ was investigated in the different stage of
liver fibrosis and evaluated with areas under the receiver operating characteristics curves (AUROC),
sensitivity, specificity, positive predictive value and negative predictive value. Finally, we summarized
optimal liver stiffness cutoff values of 2D-SWE for predicting different liver fibrosis stage.
Result

The characteristics of participants

Sixty three (55%) patients were male. Most common etiology of chronic liver disease was
non-alcoholic fatty liver disease (31%) followed by Chronic hepatitis B (22%). Liver fibrosis
stage consisted of F0 (18%), F1 (19%), F2 (24%), F3 (22%) and F4 (17%) (Table 1).

Table 1. Patients’ characteristics (n=115)

Parameters No. of patients (%)

Mean Age (years) 49.4 ± 12.9
Gender
└ Male 63 (55%)
└ Female 52 (45%)
Etiology
└ HBV (hepatitis B virus) 25 (22%)
└ NAFLD (nonalcoholic fatty liver disease) 35(31%)
└ ALD (alcoholic liver disease) 22 (19%)
└ HCV (hepatitis C virus) 5 (4%)
└ Others 28 (24%)
Fibrosis Stage†
└ F0 21 (18%)
└ F1 22 (19%)
└ F2 28 (24%)
└ F3 25 (22%)
└ F4 19 (17%)

† Histopathological results for liver fibrosis stage were evaluated according to the METAVIR scoring system [6].

Liver fibrosis assessed by METAVIR scoring system: no fibrosis (F0), any fibrosis (≥F1), significant fibrosis (≥F2),
severe fibrosis (≥F3) and cirrhosis (F4) [7].
 Diagnostic performances for liver fibrosis stage

Overall, 2D-SWE was well correlated with histologic fibrosis stage (r=0.601, p<0.001).

The cutoff value of 2D-SWE for distinguishing significant fibrosis was 5.9kPa. And the
cutoff value of 2D-SWE for diagnosis of liver cirrhosis was 9.6kPa (Table 2).

Table 2. Diagnostic accuracy and optimal cutoff values of 2D-SWE for the diagnosis of liver fibrosis (n=115)

Fibrosis Stage ≥F2 (95% CI) ≥F3 (95% CI) F4 (95% CI)
Cutoff, kPa 5.9 7.6 9.6
AUROC 0.851 (0.773-0.911) 0.917 (0.868-0.967) 0.889 (0.882-0.956)
Sensitivity, % 88.9 (64/72) 95.5 (42/44) 95.0 (19/20)
Specificity, % 74.4 (32/43) 81.7 (58/71) 82.1 (78/95)
PPV, % 85.3 (64/75) 76.4 (42/55) 52.8 (19/36)
NPV, % 80.0 (32/40) 96.7 (58/60) 98.7 (78/79)

Abbreviation: AUROC: Area under ROC curve analysis, CI: Confidence Interval, PPV: Positive predictive
value, NPV: Negative predictive value

(A) F0-F1 versus F2-F4 (≥F2) (B) F0-F2 versus F3-F4 (≥F3) (C) F0-F3 versus F4
Cutoff value=5.9 kPa Cutoff value=7.6 kPa Cutoff value=9.6 kPa

Fig. 1. ROC curves for 2D-SWE for difference fibrosis stage

 The AUROC was 0.851 for significant fibrosis (≥F 2), 0.917 for severe fibrosis (≥F 3), and
0.889 for cirrhosis (F4) (Table 2 and Fig. 1.). And Box plots of 2D-SWE for each fibrosis stage
are shown in Fig. 2.
40.00

30.00
2D-SWE (kPa)

20.00

10.00

.00

0 1 2 3 4
Liver Fibrosis (METAVIR Stage)

F0 F1 F2 F3 F4
N 21 22 28 25 19
Mean 5.33 6.86 7.25 11.71 14.70
SD 0.93 3.03 2.84 6.32 5.70

Fig. 2. Box plots of 2D-SWE for each Liver fibrosis METAVIR Stage.

Table 3. Inter-observer agreement for 2D-SWE measurements

Inter-observer agreement (ICC) 0.997 (p<0.001)

To evaluate the Inter-observer reproducibility of 2D-SWE using RS85 S-Shearwave

Imaging™, the mean values from each participant were compared between operator 1 and
operator 2, and assessed by Intraclass Correlation Coefficient (ICC). The inter-observer
agreement was considered to be excellent with an ICC of 0.997 (p<0.001) (Table 3.)

10 measurements of liver stiffness using S-Shearwave Imaging™ were obtained in ROI.

2D-SWE images with different liver fibrosis stage are shown in Fig. 3. These cases were diagnosed
as F1, F2 and F4 according to the METAVIR classification of liver biopsy results.
 (F1) A patient with NAFLD
Mean: 5.35 kPa (1.3 m/s)

(F2) A patient with NAFLD

Mean: 6.50 kPa (1.5 m/s)

(F4) A patient with chronic HBV infection and cirrhosis.

Mean: 19.75 kPa (2.6 m/s)

Fig. 3. 2D-SWE image and median stiffness value using RS85 S-Shearwave Imaging™
Conclusion

Liver stiffness (LS) measurement using S-Shearwave Imaging™ developed by Samsung

Medison was well correlated with severity of liver fibrosis in patients with chronic liver
diseases. In addition, inter-observer reproducibility of S-Shearwave Imaging™ was excellent.
In conclusion, S-Shearwave Imaging™ can be a useful and reliable method for noninvasive and
quantitative assessment of liver fibrosis.
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