Background: Type 2 diabetes mellitus (T2DM), obesity, hyperlipidemia, and hypertension are considered risk factors for developing non-alcoholic fatty liver disease (NAFLD). This study aims to assess steatosis and fibrosis severity in a cohort of T2DM patients, using vibration controlled transient elastography (VCTE) and controlled attenuation parameter (CAP). Material and method: We performed a prospective study in which, in each patient, we aimed for 10 valid CAP and liver stiffness measurements (LSM). To discriminate between fibrosis stages, we used the following VCTE cut-offs: F ≥ 2–8.2 kPa, F ≥ 3–9.7 kPa, and F4 - 13.6 kPa. To discriminate between steatosis stages, we used the following CAP cut-offs: S1 (mild) – 274 dB/m, S2 (moderate) – 290dB/m, S3 (severe) – 302dB/m. Results: During the study period, we screened 776 patients; 60.3% had severe steatosis, while 19.4% had advanced fibrosis. Female gender, BMI, waist circumference, elevated levels of AST, total cholesterol, triglycerides, blood glucose, and high LSM were associated with severe steatosis (all p-value < 0.05). BMI, waist circumference, elevated levels of AST, HbA1c, and CAP were associated with advanced fibrosis (all p-values < 0.05). Conclusion: Higher BMI (obesity) comprises a higher risk of developing severe steatosis and fibrosis. Individualized screening strategies should be established for NAFLD according to different BMI.

Aim: To evaluate the performance of 2D shear-wave elastography from General Electric (2D-SWE.GE) for the noninvasiveassessment of liver fibrosis and to identify liver stiffness (LS) cut-off values for predicting different stages of fibrosisusing Transient Elastography (TE) as the reference method. Material and method: We included 331 consecutive subjectswith or without chronic hepatopathies in whom LS was evaluated in the same session by means of 2 elastographic techniques:TE and 2D-SWE.GE. Reliable LS measurements were defined for TE as the median value of 10 measurements with a successrate of ≥60% and an interquartile range (IQR)<30% and for 2D-SWE.GE as the median value of 10 measurements acquiredin a homogenous area and an IQR<30%. To discriminate between TE fibrosis stages we used the following cut-offs: F2- 7;F3- 9.5 and F4- 12kPa. Results: Reliable LS measurements were obtained in 95.8% subjects by 2D-SWE.GE, and 94.2%by TE (p=0.44). Based on TE cut-off values we divided our cohort into four groups: F<2: 30.1%; F=2: 10.2%; F=3: 12.2%;F=4: 47.5%. A strong correlation was found between the LS values obtained by the 2 methods: r=0.83, p<0.0001.LS valuesobtained by 2D-SWE.GE were significantly lower than those obtained by TE: 10.14±4.24 kPa vs. 16.72±13.4 kPa (p<0.0001).The best cut-off value for F≥2, F≥3 and for F=4 were 6.7, 8.2 and 9.3 kPa. Conclusions: The best 2D-SWE.GE cut-off valuesfor predicting F≥2, F≥3 and F=4 were 6.7, 8.2 and 9.3kPa.

Assessment of liver stiffness provides important diagnostic and prognostic information in patients with chronic liver disease. To investigate whether the use of quality criteria (i) improves the concordance between transient elastography (TE) and a novel point shear wave elastography technique (ElastPQ®) and (ii) impacts on the performance of ElastPQ® for liver fibrosis staging using TE as the reference standard. In this multicenter retrospective study, data of patients undergoing liver stiffness measurements (LSM) in five European centers were collected. TE was performed with FibroScan® (Echosens, France) and ElastPQ® with EPIQ® or Affiniti® systems (Philips, The Netherlands). The agreement between TE and ElastPQ® LSMs was assessed with Lin's concordance correlation coefficient (CCC). Diagnostic performance of ElastPQ® was assessed by the area under receiver operating characteristic (AUROC) curves. Overall, 664 patients were included: mean age: 54.8(13.5) years, main etiologies: viral hepatitis (83.1%) and NAFLD (7.5%). CCC increased significantly when LSMs with ElastPQ® were obtained with IQR/M ≤ 30% (p < 0.001). The diagnostic performance of ElastPQ® for fibrosis staging also increased if LSM values were obtained with IQR/M ≤ 30%. Quality criteria should be followed when using ElastPQ® for LSM, since the concordance with TE fibrosis staging was better at an ElastPQ® IQR/M ≤ 30.

Background & Aims: Liver stiffness (LS) measurement by Transient Elastography (TE) has been widely accepted as a tool for fibrosis assessment. The aim of this study was to assess LS dynamics in a group of patients with HCV liver cirrhosis after interferon free treatment (IFT).Methods: This two-center clinical trial included 225 patients with compensated HCV cirrhosis (all genotype 1b), who received IFT for 12 weeks. All patients were evaluated by means of TE at the beginning and at the end of treatment (EOT), and a subgroup (170 patients) also 12 weeks after EOT; all of them had sustained viral response (SVR). Reliable LS measurements (LSM) were defined as a median value of 10 valid LSM, with IQR <30% and SR ≥60%. Both M and XL probes were used. For diagnosing cirrhosis we used a cut-off value of 12kPa as proposed by the Tsochatzis meta-analysis. We considered a decrease or increase of more than 10% in LSM as being significant.Results: Out of 225 subjects, reliable measurements were obtained in 93.7%, so that the final analysis included 211 patients. The mean LS values decreased significantly after IFT: 26.4±11.7 vs. 23.5±13.3 kPa (p=0.01). Most patients, 59.2% (125/211) presented more than 10% decrease in LS values, 24.1% (51/211) had stable LS values, while in 16.4% (35/211) cases, the LS values increased. In the subgroup of 170 patients with LSM also performed 12 weeks after EOT (SVR), the mean LS values were significantly lower as compared to baseline: 21.3±11 kPa vs. 27.4±11.9 kPa (p<0.0001) and also as compared to EOT: 21.3±11 kPa vs. 23.7±13.3 kPa (p<0.0001).Conclusion: In our patients with HCV liver cirrhosis, the mean LS values evaluated by TE significantly decreased after antiviral treatment at EOT and also 12 weeks after EOT as compared to baseline. Overall, about 60% of patients had LS values at EOT lower than at baseline, while 12 weeks after EOT about 75% of patients had LS values lower than at baseline. –.Abbreviations: APRI: aspartate aminotransferase platelet ratio index; BMI: body mass index; DAA: direct acting agents; EOT: end of treatment; FIB-4: fibrosis 4; HBV: hepatitis B virus; HCV: hepatitis C virus; IFT: interferon free treatment; IQR: interquartile range; LS: liver stiffness; LSM: liver stiffness measurements; SR: success rate; SVR: sustained viral response; TE: Transient Elastography.

Background & Aims: Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. The aim of our study was to evaluate a population of diabetic patients regarding the severity of liver steatosis and liver fibrosis. Methods: The study included 392 type 2 diabetic patients prospectively randomized, evaluated in the same session by transabdominal ultrasound to assess steatosis and by liver elastography to assess fibrosis (Transient Elastography – TE, FibroScan, EchoSens). Steatosis severity was graded using a semi-quantitative scale (S0-no steatosis; S1-mild steatosis; S2-moderate steatosis; S3-severe steatosis). For differentiation between stages of liver fibrosis, the following cut-off values were used (Wong et al., 2010): F2-F3: 7-10.2kPa, F4≥10.3 kPa. Results: Reliable elastographic measurements were obtained in 76% (298/392) patients. By using the proposed cut-off values, significant fibrosis (F2-F3) was found in 18.8% (56) patients with steatosis, while 13.8% (41) had cirrhosis (F4). Significant fibrosis (F2-F3) was found in 20.4% (20/98) of the patients with S1, in 18.6% (22/118) of those with S2 and in 31.8% (14/44) of those with S3, while cirrhosis (F4) was diagnosed in 7.1% (7/98) patients with S1, in 20.3% (24/118) of those with S2 and in 22.7% (10/44) of those with S3. Conclusions: Liver steatosis diagnosed by ultrasound is very frequently found in type 2 diabetes mellitus patients, more than half of them having moderate/severe steatosis. A significant liver stiffness increase was found in more than 30% of these patients. Liver stiffness assessment in type 2 diabetic patients should be performed systematically to identify those with significant liver fibrosis. . Abbreviations: 2D-SWE: Two Dimensional Shear Waves Elastography; ALT: alanine aminotransferase; AP: alkaline phosphatase; ARFI: Acoustic Radiation Force Impulse; AST: aspartate aminotransferase; AUROC: area under the receiver operating characteristic; BMI: body mass index; DM: diabetes mellitus; GGT: gammaglutamyl transpeptidase; HbA1c: glycated hemoglobin; HBsAg: hepatitis B virus surface antigen; HBV: hepatitis B virus; HCV: hepatitis C virus; LC: liver cirrhosis; LS: liver stiffness; NAFLD: nonalcoholic fatty liver disease; NASH: nonalcoholic steatohepatitis; TE: transient elastography; US: ultrasound.