Controlled Attenuation Parameter Cutoff Value Research Articles

Reproducibility and accuracy of a pocket-size ultrasound device in assessing liver steatosis

BackgroundThis diagnostic prospective study compared the feasibility and diagnostic accuracy of Pocket-size Ultrasound Devices (PUDs) against standard ultrasound (US) in detecting liver steatosis using the controlled attenuation parameter (CAP) and liver biopsy as reference standards. Materials and MethodsConsecutive patients with chronic liver diseases were assessed for the presence of steatosis using PUD and US. A CAP cut-off value >275 dB/m was applied to establish ≥S1. A 26-patient subgroup underwent liver biopsy. PUD reproducibility was evaluated using Cohen's k statistic. Diagnostic accuracy of PUD and US was given as Sensibility (Sn), Specificity (Sp), Positive and Negative Predictive Values (PPV, NPV), positive and negative Likelihood Ratio (LR+, LR-). Results81 consecutive patients (69% males) with multiple etiologies were enroled. PUD inter-observer agreement was good (k 0.77, 95%CI 0.62–0.93). PUD and US identified ≥S1 according to CAP values respectively with Sn 0.87, Sp 0.61, PPV 0.49, NPV 0.91, LR+ 2.04, LR- 0.07, AUROC 0.74 and Sn 0.96, Sp 0.54, PPV 0.47, NPV 0.97, LR+ 2.10, LR- 0.07, AUROC 0.75. ConclusionsPUD shows good reproducibility and diagnostic accuracy in ruling liver steatosis out, representing a useful point-of-care tool to avail of hepatologists interested in excluding NAFLD, but with basic US skills.

Prevalence and predictors of metabolic-associated fatty liver disease in liver transplant recipients: A cross-sectional prospective study.

Metabolic-associated fatty liver disease (MAFLD) has emerged as a significant global health concern. However, the prevalence and predictors of MAFLD in post-liver transplantation (LT) patients remain uncertain. This study aimed to determine the prevalence and predictors of MAFLD in LT recipients and to assess the effectiveness of controlled attenuation parameter (CAP) values in diagnosing post-transplant MAFLD. A cross-sectional prospective study was conducted involving 128 adult patients who had undergone LT, and had received liver imaging, and vibration-controlled transient elastography (VCTE). MAFLD was diagnosed on the basis of the presence of liver steatosis detected through imaging and specific metabolic risk abnormalities. The prevalence of MAFLD after LT was 34.4%, with 22.1% categorized as de novo MAFLD, and 12.3% as recurrent MAFLD. Posttransplant diabetes (OR: 4.88; 95% CI 1.30-18.34; p=0.019) and higher CAP values (OR: 1.04; 95% CI 1.02-1.06; p=0000) were identified as independent predictors of post-LT MAFLD. A CAP cutoff value of 270 dB/m exhibited an area under the receiver operating curve of 0.84 in detecting MAFLD. These findings underscore the notable prevalence of MAFLD in liver transplant recipients and suggest the potential utility of VCTE as a non-invasive tool for its detection.

The relationship between metabolic dysfunction-associated fatty liver disease and low muscle mass in an asymptomatic Korean population.

Metabolic (dysfunction)-associated fatty liver disease (MAFLD) emphasizes the metabolic dysfunction in nonalcoholic fatty liver disease (NAFLD). Although the relationship between low muscle mass and NAFLD has been suggested, the effect of MAFLD on low muscle mass is yet to be investigated. In this study, we examined the relationship between MAFLD and low muscle mass in an asymptomatic Korean population. Examinees who underwent FibroScan® and bioelectrical impedance analyses on the same day during the period of June 2017 to December 2019 were included. Hepatic steatosis was diagnosed using controlled attenuation parameter (CAP) with two cut-off values of 248 and 294dB/m. Low muscle mass was defined based on appendicular skeletal muscle mass/body weight (wt) or body mass index (BMI) ratios of two standard deviations below the sex-specific mean for healthy young adults. Subjects were divided into four subgroups: diabetic MAFLD (presence of diabetes mellitus [DM]), metabolic dysfunction (MD) MAFLD (≥2 metabolic abnormalities without DM), overweight MAFLD (overweight/obese without DM and <2 metabolic abnormalities) and no MAFLD. Among all of the 6414 subjects (mean 53.9years of age; 85.4% male), the prevalence of MAFLD was 49.9% and 22.7% for CAP cut-off values of 248 and 294dB/m, respectively. In the multivariate analysis, MAFLD was associated with an increased risk of both low muscle mass_wt (odds ratio [OR] 1.80, 95% confidence interval [CI] 1.38-2.35, P<0.001) and low muscle mass_BMI (OR 1.31, 95% CI 1.01-1.70, P=0.042). The risk of low muscle mass_wt and low muscle mass_BMI increased the most in the diabetic MAFLD subgroup compared with the no-MAFLD group (OR 2.11, 95% CI 1.51-2.96, P<0.001 and OR 1.51, 95% CI 1.08-2.13, P=0.017). There was an increased risk of low muscle mass_wt in the MD MAFLD subgroup (OR 1.73, 95% CI 1.31-2.28, P<0.001). Comparable results were observed when the CAP cut-off value of 294dB/m was applied. The presence of MAFLD is significantly associated with increased risk of low muscle mass with varying risks according to the MAFLD subgroups. Clinicians should be aware of the differentiated risk of low muscle mass across the subgroups of MAFLD.

Accuracy of steatosis and fibrosis NAFLD scores in relation to vibration controlled transient elastography: An NHANES analysis

BackgroundNon-alcoholic fatty liver disease (NAFLD) is highly prevalent and increasing in the United States. Based on patient characteristics and biochemical profiles, predictive indices have been formulated to evaluate the presence and severity of NAFLD. This study evaluates the accuracy of these indices versus vibration-controlled transient elastography (VCTE™) to screen at-risk populations for NAFLD. MethodsSubjects from the NHANES datasets (2017-2018) without other liver diseases with completed VCTE™ data were studied (n = 5062). Hepatic steatosis and fibrosis scores were calculated and compared with controlled attenuation parameter (CAP) and elastography measurements of VCTE™, respectively. ResultsThe prevalence of NAFLD was 58.5%. Against a CAP cut-off value of ≥238 dB/m for diagnosing fatty liver, the US fatty liver index [US-FLI] had the highest positive predictive value (90%) and specificity (63.7%). The coefficient of correlation against CAP was strong for fatty liver index [FLI] (r = 0.645) and US-FLI (r = 0.608). The hepatic steatosis index [HSI] had the highest negative predictive value (82.1%) and sensitivity (75%) for ruling out steatosis. HSI and FLI, which use commonly obtained clinical parameters, had a high diagnostic odds ratios (21.2 and 18.6, respectively) compared to US-FLI (4.97), which requires insulin levels in the calculation. These findings were similar across all ethnicities studied. ConclusionUS-FLI is a reliable scoring system to diagnose patients with fatty liver. HSI and FLI are more easily calculated and can be used in clinical practices to diagnose NAFLD in at-risk populations.

Accuracy of controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) for assessing steatosis and fibrosis in non-alcoholic fatty liver disease: A systematic review and meta-analysis.

SummaryBackgroundNon-alcoholic fatty liver disease (NAFLD) is a common chronic liver disease, and among the non-invasive tests, controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) have shown better diagnostic performance in NAFLD. This meta-analysis aimed to evaluate the performance of CAP and LSM for assessing steatosis and fibrosis in NAFLD.MethodsWe searched the PubMed, Web of Science, Cochrane Library, and Embase databases for relevant articles published up to February 13th, 2022, and selected studies that met the inclusion and exclusion criteria, and evaluated the quality of evidence. Then we pooled sensitivity (SE), specificity (SP), and area under receiver operating characteristic (AUROC) curves. A random effect model was applied regardless of heterogeneity. Meta-regression analysis and subgroup analysis were performed to explore heterogeneity, and Fagan plot analysis was used to evaluate clinical utility. This meta-analysis was completed in Nanjing, Jiangsu and registered on PROSPERO (CRD42022309965).FindingsA total of 10537 patients from 61 studies were included in our meta-analysis. The AUROC of CAP were 0·924, 0·794 and 0·778 for steatosis grades ≥ S1, ≥ S2 and = S3, respectively, and the AUROC of LSM for detecting fibrosis stages ≥ F1, ≥ F2, ≥ F3, and = F4 were 0·851, 0·830, 0·897 and 0·925, respectively. Subgroup analysis revealed that BMI ≥ 30 kg/m² had lower accuracy for diagnosing S ≥ S1, ≥ S2 than BMI<30 kg/m². For the mean cut-off values, significant differences were found in CAP values among different body mass index (BMI) populations and LSM values among different regions. For diagnosing S ≥ S1, ≥ S2 and = S3, the mean CAP cut-off values for BMI ≥ 30 kg/m² were 30·7, 28·2, and 27·9 dB/m higher than for BMI < 30 kg/m² (P = 0·001, 0·001 and 0·018, respectively). For diagnosing F ≥ F2 and = F4, the mean cut-off values of Europe and America were 0·96 and 2·03 kPa higher than Asia (P = 0·027, P = 0·034), respectively. In addition, the results did not change significantly after sensitivity analysis and the trim and fill method to correct for publication bias, proving that the conclusions are robust.InterpretationThe good performance of CAP and LSM for the diagnosis of mild steatosis (S ≥ S1), advanced liver fibrosis (F ≥ F3), and cirrhosis (F = F4) can be used to screen for NAFLD in high-risk populations. Of note, the accuracy of CAP for the detection of steatosis in patients with obesity is reduced and requires specific diagnostic values. For LSM, the same diagnostic values can be used when the appropriate probes are selected based on BMI and the automated probe selection tool. The performance of CAP and LSM in assessing steatosis in patients with obesity, moderate to severe steatosis, and low-grade fibrosis should be further validated and improved in the future.FundingThe study was funded by the Priority Academic Program Development of Jiangsu Higher Education Institutions (PAPD).

MO481: Novel Predictors of CKD in Metabolic Fatty Liver Disease Patients: Steatosis Vs Fibrosis. A Prospective Study Using Transient Elastography With Controlled Attenuation Parameter

Abstract BACKGROUND AND AIMS Recent data have proven that NAFLD (nonalcoholic fatty liver disease) and NASH (nonalcoholic steatohepatitis) increase the risk of CKD. Changing the concept of NAFLD to MAFLD (metabolic dysfunction associated fatty liver disease) changes the data of inclusion of patients in the new category and also the relationship with CKD. Our study aimed to explore this relation using liver steatosis and liver fibrosis assessments by transient elastography (TE) with controlled attenuation parameter (CAP). METHOD We prospectively evaluated 402 diabetic patients with MAFLD and high CKD risk using TE with CAP (FibroScan®). CKD was defined according to Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines. Inclusion criteria: patients &amp;gt;18 years old and the presence of MALFD. Exclusion criteria: pregnancy, ascites, outliers, known chronic liver disease, decompensated liver disease, cardiac pacemaker, end-stage renal disease, heart failure, unreliable or invalid TE and CAP measurements, AST and ALT levels &amp;gt;5 times the upper limit of normal. Transient elastography was performed with the FibroScan® device. To discriminate between fibrosis and steatosis stages, we used the TE and CAP cut-off values from a published multicentric trial compared with biopsy. Logistic regression and stepwise multiple logistic regression were used to evaluate the factors associated with CKD. In addition, ROC analysis was used to assess the performance of CAP and TE in predicting CKD. The study was conducted &amp;gt;1 year period. RESULTS The prevalence of CKD in our group was 60.8%. Patients with CKD had higher mean LSM and CAP values than those without CKD (LSM 8.64 ± 4.30 versus 8.03 ± 6.57; P = .04 and CAP 320.09 ± 57.12 versus 306.29 ± 61.21; P = .04). We found that hepatic steatosis was a better predictor of CKD than fibrosis. Univariate regression showed that CAP values &amp;gt; 353 dB/m were predictive of CKD, and multivariate regression analysis (after adjustment according to sex, BMI, LDLc, HDLc and fasting glucose) showed that CAP values &amp;gt;353 dB/m were more strongly associated with the presence of CKD compared with LSM (fibrosis) values. CONCLUSION In patients with MAFLD, CAP-assessed steatosis appears to be a better predictor of CKD compared with LSM-assessed hepatic fibrosis.

The Prevalence and Determinants of Hepatic Steatosis Assessed by Controlled Attenuation Parameter in Thai Chronic Hepatitis C Patients.

Aims To describe the prevalence of hepatic steatosis using a controlled attenuation parameter (CAP) and to identify the determinants associated with steatosis in Thai chronic hepatitis C patients. Patients and Methods. An observational study was conducted among consecutive chronic hepatitis C patients who underwent vibration-controlled transient elastography (VCTE, FibroScan®) with CAP and followed up at Rajavithi Hospital, Bangkok, Thailand, between June 2018 and May 2019. Hepatic steatosis (i.e., steatosis grades S1-3) was defined by the CAP cutoff value of ≥248 (dB/m). VCTE with CAP assessments and medical records were retrospectively reviewed, and the prevalence and determinants of hepatic steatosis were analyzed. Results A total of 197 eligible patients, of whom 127 (64.5%) were male, were included. The mean age was 54.52 years (SD 9.49 years), and 41.1% of subjects had a body mass index ≥ 25. The prevalence of hepatic steatosis was 26.9%. The mean liver stiffness measurement (LSM) was 21.50 kPa (SD 15.58 kPa), and 61.9% of the study population had cirrhosis, which was defined as LSM ≥ 12.5 kPa. Genotype (GT) 3 was predominant at 40.1%, followed by GT1 at 38.1% and GT6 at 21.8%. The median serum hepatitis C virus viral load was 1,100,000 IU/mL (range 5,824-20,436,840). The significant determinants of hepatic steatosis were obesity (aOR 8.58 (95% CI: 3.41-21.54)) and diabetes mellitus (aOR 3.30 (95% CI: 1.24-8.78)). Conclusion A large proportion of these Thai chronic hepatitis C patients (26.9%) had hepatic steatosis, which was strongly associated with host metabolic factors, e.g., obesity (BMI ≥ 25) and diabetes mellitus. These cofactors contributed to the progression of liver disease to cirrhosis and required concurrent management with antiviral therapy.

Bariatric Surgery in Nonalcoholic Fatty Liver Disease (NAFLD): Impact Assessment Using Paired Liver Biopsy and Fibroscan.

Bariatric surgery is associated with a positive impact on the degree of hepatic steatosis and inflammation in nonalcoholic associated fatty liver disease (NAFLD), although its effect on fibrosis is contentious. The role of Fibroscan in the post-bariatric assessment of hepatic steatosis and fibrosis is unclear. This work aims to study the impact of bariatric surgery on the course of NAFLD using both invasive (liver biopsy) and non-invasive tests (biochemical parameters and Fibroscan). In this prospective study, the impact of bariatric surgery on the course of NAFLD was assessed using paired liver biopsy (intra-operative and post-bariatric surgery 1-year follow-up). The liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) cutoffs for the assessment of hepatic fibrosis and steatosis, respectively, were calculated in both pre- and post-bariatric settings. Fifty-eight patients (70.7% females, mean age 39.2years) underwent paired liver biopsy. Post-bariatric surgery 1-year liver biopsy showed significant improvement in all the histopathological parameters of NAFLD. The mean NAFLD Activity Score declined from 2.81 (± 1.08) to 1.31 (± 1.39) post-bariatric surgery. Thirty (51.7%) patients showed improvement in fibrosis, eighteen (31%) no change, and ten (17.2%) had worsening. Worsening of fibrosis was associated with a higher median age of 44.5 versus 38years (p value = 0.033). The CAP cutoff values for the various stages of hepatic steatosis were higher pre-operatively as compared with those obtained post-bariatric surgery. Bariatric surgery is associated with significant improvement in histopathological parameters of NAFLD. Fibroscan shows good diagnostic accuracy in detecting advanced stage and grade of NAFLD.

How Good Are Controlled Attenuation Parameter Scores from Fibroscan to Assess Steatosis, NASH, and Fibrosis?

The objective of our study was to determine the concordance rates of steatosis staging by controlled attenuation parameter (CAP) scores from transient elastography (TE) in comparison with liver histology in patients with chronic liver disease and to determine the optimal CAP cutoffs to predict the severity of steatosis and identify those with nonalcoholic steatohepatitis (NASH). Patients (n = 217) who had both CAP scores and liver biopsy within a period of 90days were retrospectively studied. Histology was graded in a blinded fashion by a single pathologist; steatosis was graded on a scale from 0 to 3. Nonalcoholic fatty liver disease activity scores (NAS) scores were calculated for all patients. Optimal CAP cut-points were selected by maximum Youden's index. Area under receiver operating characteristic curve (AUROC) for CAP (using cutoff value ≥ 278dB/m) in differentiating steatosis 1-3 from 0 was 0.82 (95% CI 0.75-0.89), and 0.79 (95% CI 0.70-0.88) in differentiating steatosis 0-1 from 2 to 3 using CAP cutoff value ≥ 301dB/m. With CAP cutoff value ≥ 301dB/m, CAP identified NAS 3 or above with AUROC of 0.82 (95% CI 0.74-0.89). The AUROC for TE in differentiating fibrosis (cutoff 11.9kPa) 3-4 from 0 to 2 was 0.85 (95% CI 0.77-0.92), and 0.84 (95% CI 0.74-0.93) in differentiating (cutoff 14.4kPa) 4 from 0 to 3. Transient elastography is a good modality to accurately diagnose steatosis and NASH and can also differentiate advanced liver fibrosis from early stages.

Diagnostic Performance of Vibration-Controlled Transient Elastography in Liver Transplant Recipients

Vibration-controlled transient elastography (VCTE) is a non-invasive tool for detecting hepatic steatosis and fibrosis in patients who have not received liver transplants. We aimed to evaluate the diagnostic performance of VCTE in detection of hepatic steatosis and fibrosis in patients who have undergone liver transplantation. We performed a prospective study of 99 liver transplant recipients assessed by VCTE using a standard protocol. Controlled attenuation parameter cutoff values for pairwise steatosis grade and liver stiffness measurements (LSM) and cutoff values for pairwise fibrosis stage were determined using cross-validated area under the receiver operating characteristics (AUROC) curve analyses. We calculated sensitivity (fixed at 90%) and specificity (fixed at 90%) values. A controlled attenuation parameter cutoff value of 270 dB/m detected any hepatic steatosis with an AUROC of 0.88 (95% CI, 0.78-0.93). VCTE detected steatosis grades 2-3 vs 0-1 with an AUROC of 0.94 (95% CI, 0.89-0.99) and steatosis grade 3 vs 0-2 was similar and AUROC of 0.89 (95% CI, 0.83-0.96). When we used an LSM cutoff value of 10.5 kPa, VCTE identified patients with advanced fibrosis (fibrosis stages≥3) with an AUROC of 0.94 (95% CI, 0.88-0.99). At fixed sensitivity, the cutoff LSM value of 10.5k Pa excluded advanced fibrosis with a negative predictive value of 0.99. At fixed specificity, the cutoff LSM value of 16.9 kPa detected advanced fibrosis with a sensitivity of 0.86, a positive predictive value (PPV) of 0.40, and a negative predictive value of 0.99. VCTE accurately detects hepatic steatosis and fibrosis in recipients of liver transplants. This non-invasive method might be used to identify patients in need of confirmatory liver biopsy analysis.

Body mass index-based controlled attenuation parameter cut-offs for assessment of hepatic steatosis in non-alcoholic fatty liver disease.

In patients with liver disease, etiology and body mass index (BMI) affects controlled attenuation parameter (CAP) assessment using FibroScan. We aimed to assess the performance characteristics of CAP for hepatic steatosis in patients with non-alcoholic fatty liver disease (NAFLD) stratified into obese (BMI ≥ 30kg/m2) and non-obese (BMI < 30kg/m2) subgroups. In this prospective study, 219 consecutive adult NAFLD patients, with an available FibroScan value (liver stiffness measurement-[LSM] and CAP) and liver biopsy, were included. Receiver operating characteristic curves were used for assessment of the CAP cut-off values predicting different stages of hepatic steatosis. The mean ± standard deviation age of patients was 39.7 ± 10.5years, 116 (53%) were males, and median (interquartile range) BMI was 31.8 (25.7-43.8) kg/m2. One hundred (45.7%) and 119 (54.3%) patients were non-obese and obese, respectively. The median values of CAP and LSM were significantly higher among obese patients as compared with the non-obese ones: 333 (304-368) vs. 320 (296-345) dB/m, p = 0.002 and 8.3 (6.1-11.4) vs. 6.6 (5.7-10.3) kPa, p = 0.012, respectively. Among non-obese NAFLD, optimal CAP cut-off values for steatosis (S) ≥ S1, ≥ S2, and ≥ S3 were 275dB/m, 319dB/m, and 337dB/m, respectively. The corresponding CAP values among obese patients were higher as 285dB/m, 340dB/m, and 355dB/m, respectively. BMI independently predicted CAP on multivariate analysis. The discordance of 2-grades between CAP and biopsy measured steatosis was seen in 13% in non-obese and 19.3% in obese NAFLD. CAP overestimated steatosis more often than underestimating it, with a higher proportion in obese NAFLD. In patients with NAFLD, interpretation of CAP requires consideration of BMI.

Noninvasive and Convenient Screening of Metabolic Syndrome Using the Controlled Attenuation Parameter Technology: An Evaluation Based on Self-Paid Health Examination Participants.

Background: There is a medical need for an easy, fast, and non-invasive method for metabolic syndrome (MetS) screening. This study aimed to assess the ability of FibroScan to detect MetS, in participants who underwent a self-paid health examination. Methods: A retrospective cohort study was conducted on all adults who underwent a self-paid health examination comprising of an abdominal transient elastography inspection using FibroScan 502 Touch from March 2015 to February 2019. FibroScan can assess the level of liver fibrosis by using a liver stiffness score, and the level of liver steatosis by using the controlled attenuation parameter (CAP) score. The logistic regression analysis and receiver operating characteristic curve were applied to select significant predictors and assess their predictability. A final model that included all significant predictors that are found by univariate analysis, and a convenient model that excluded all invasive parameters were created. Results: Of 1983 participants, 13.6% had a physical status that fulfilled MetS criteria. The results showed that the CAP score solely could achieve an area under the curve (AUC) of 0.79 (0.76–0.82) in predicting MetS, and the AUC can be improved to 0.88 (0.85–0.90) in the final model. An AUC of 0.85 (0.83–0.88) in predicting MetS was obtained in the convenient model, which includes only 4 parameters (CAP score, gender, age, and BMI). A panel of predictability indices (the ranges of sensitivity, specificity, positive and negative likelihood ratio: 0.78–0.89, 0.66–0.82, 2.64–4.47, and 0.17–0.26) concerning gender- and BMI-specific CAP cut-off values (range: 191.65–564.95) were presented for practical reference. Conclusions: Two prediction systems were proposed for identifying individuals with a physical status that fulfilled the MetS criteria, and a panel of predictability indices was presented for practical reference. Both systems had moderate predictive performance. The findings suggested that FibroScan evaluation is appropriate as a first-line MetS screening; however, the variation in prediction performance of such systems among groups with varying metabolic derangements warrants further studies in the future.

Assessing the risk of hepatocellular carcinoma by combining liver stiffness and the controlled attenuation parameter

Ultrasound technology can now be used for liver stiffness measurement (LSM) and for evaluating the amount of hepatic fat quantitatively known as the controlled attenuation parameter (CAP). This study aimed to determine the applicable cut-off values of LSM and the CAP for primary hepatocellular carcinoma (HCC), and to investigate their clinical usefulness for assessing HCC risk in patients with chronic liver disease. A total of 1054 patients (88 with primary HCC and 966 without HCC) whose LSM and the CAP were measured by transient elastography with clinically evident hepatitisC virus (419 patients), hepatitisB virus (377 patients), and non-alcoholic fatty liver disease (258 patients) were enrolled in this study. Subsequently, a total of 966 patients who did not have HCC initially were followed, and the usefulness of the cut-off values of LSM and CAP for HCC development were evaluated. In hepatitisC virus patients, the incidence of HCC development was significantly higher among those with a combination of LSM ≥8.0kPa and CAP ≤221dB/m than among those with other values (log-rank test 0.0239, hazard ratio 2.66, 95%CI 1.07-6.47, P= 0.0362). In non-alcoholic fatty liver disease patients, the incidence of HCC development was significantly higher among those with a combination of LSM ≥5.4kPa and CAP ≤265dB/m than among others (log-rank test 0.0040, hazard ratio 8.91, 95% CI 1.47-67.97, P= 0.0192). In the hepatitisC virus and non-alcoholic fatty liver disease groups, a combination of LSM and the CAP cut-off values would be useful for screening to identify the high-risk group for primary HCC development.

The Hepatic Steatosis Index Is Not Accurate in Predicting the Presence of Fatty Liver Disease in Patients With Hepatitis C Who Achieve Sustained Virologic Response

Introduction: The treatment for chronic hepatitis C virus (HCV) infection has been revolutionized by direct acting antivirals with sustained virologic response (SVR) rates of 95% or higher. However, recent data suggest that nonalcoholic fatty liver disease (NAFLD) may affect up to 50% of patients who achieve SVR based on the presence of steatosis that was determined by controlled attenuation parameter (CAP). Unfortunately, CAP technology is not available for the majority of community providers that treat HCV due to cost. The aim of this study was to assess the utility of the readily available hepatic steatosis index (HSI) in predicting post-SVR NAFLD. Methods: All adult patients treated in our clinic for HCV with SVR and had CAP performed with laboratory/clinical data to calculate HSI were included in this study. Patients with significant alcohol intake and those with HCV genotype 3 infection were excluded. CAP was measured using FibroScanTM by an experienced operator and a cutoff of 248 dB/m was used. Patients fasted for 4 hours prior to CAP measurements. CAP was considered the gold standard to determine post-SVR NAFLD. HSI was calculated using the following variables (ALT, AST, BMI, diabetes and gender) with a cutoff of 36 or higher to predict steatosis. C statistics were performed to assess the accuracy of HSI. Results: A total of 96 patients achieved SVR and had both CAP and HSI done. The mean age was 59 ±11 years, 49% were male and 86% had genotype 1 HCV infection. Based on CAP cutoff value of 248 dB/m, 48/96 (50%) of patients had post-SVR NAFLD. Using HSI cutoff ≥36 for post-SVR NAFLD and in comparison to CAP, HSI had sensitivity of 50%, NPV of 58.6%, specificity of 70.83%, and PPV of 63.1%. Fourteen patients with no evidence of NAFLD on CAP would have been classified incorrectly as having NAFLD based on HSI and 24 patients with NAFLD based on CAP would have been missed by using HSI. Overall, the area under the ROC curve for HSI was poor at 0.604 (95% CI, 0.507-0.700). Conclusion: Post-SVR NAFLD is common in patients who are cured from HCV. HSI had poor performance in this setting, therefore; other readily available noninvasive score that can be used by clinicians are urgently needed to determine the presence of post-SVR NAFLD.

Vibration-Controlled Transient Elastography to Assess Fibrosis and Steatosis in Patients With Nonalcoholic Fatty Liver Disease

Vibration-controlled transient elastography (VCTE), which measures liver stiffness, has become an important tool for evaluating patients with nonalcoholic fatty liver disease (NAFLD). We aimed to determine the diagnostic accuracy of VCTE in detection of NAFLD in a multicenter cohort of patients. We performed a prospective study of 393 adults with NAFLD who underwent VCTE within 1 year of liver histology analysis (median time, 49 d; interquartile range, 25-78 d), from July 1, 2014, through July 31, 2017. Liver stiffness measurement (LSM) cut-off values for pairwise fibrosis stage and controlled attenuation parameter cut-off values for pairwise steatosis grade were determined using cross-validated area under the receiver operating characteristics curve (AUROC) analyses. Diagnostic statistics were computed at a sensitivity fixed at 90% and a specificity fixed at 90%. LSM identified patients with advanced fibrosis with an AUROC of 0.83 (95% CI, 0.79- 0.87) and patients with cirrhosis with an AUROC of 0.93 (95% CI, 0.90-0.97). At a fixed sensitivity, a cut-off LSM of 6.5 kPa excluded advanced fibrosis with a negative predictive value of 0.91, and a cut-off LSM of 12.1 kPa excluded cirrhosis with a negative predictive value of 0.99. At a fixed specificity, LSM identified patients with advanced fibrosis with a positive predictive value of 0.71 and patients with cirrhosis with a positive predictive value of 0.41. Controlled attenuation parameter analysis detected steatosis with an AUROC of 0.76 (95% CI, 0.64-0.87). In contrast, the VCTE was less accurate in distinguishing lower fibrosis stages, higher steatosis grades, or the presence of NASH. In a prospective study of adults with NAFLD, we found VCTE to accurately distinguish advanced vs earlier stages of fibrosis, using liver histology as the reference standard.

A prospective comparative assessment of the accuracy of the FibroScan in evaluating liver steatosis.

Background/aimsRecent studies have demonstrated the utility of the FibroScan® device in diagnosing liver steatosis, but its usefulness has not been thoroughly appraised. We investigated the usefulness of the controlled attenuation parameter (CAP) in detecting and quantifying liver steatosis.MethodsA prospective analysis was applied to 79 chronic liver disease patients who underwent a liver biopsy, a FibroScan investigation, ultrasonography, and hepatic steatosis index (HSI). The presence and degree of steatosis as measured by the FibroScan device, ultrasonography and HSI were compared with the results for the liver biopsy tissue.ResultsThere was substantial concordance between the liver biopsy results and the CAP as evaluated by the kappa (κ) index test for detecting liver steatosis (κCAP = 0.77, P<0.001; κultrasonography = 0.60, P<0.001; κHSI = 0.47, P<0.001). The areas under the receiver operating characteristic curve (AUROCs) of the CAP, ultrasonography, and HSI were 0.899 [95% confidence interval (CI) = 0.826–0.972)], 0.859 (95% CI = 0.779–0.939), and 0.766 (95% CI = 0.655–0.877), respectively. The optimal CAP cutoff value for differentiating between normal and hepatic steatosis was 247 dB/m, which produced sensitivity and specificity values of 91.9% and 85.7%, respectively, as well as a positive predictive value of 85.0% and a negative predictive value of 92.3%.ConclusionThe CAP produces results that are highly concordant with those of a liver biopsy in detecting steatosis. Therefore, the CAP is a noninvasive and reliable tool for evaluating liver steatosis, even in the early stages.

Diagnostic Accuracy of Controlled Attenuation Parameter for Detecting Hepatic Steatosis in Patients with Chronic Liver Disease

Introduction: Controlled attenuation parameter (CAP), measured by transient elastography, has been suggested as a noninvasive method for the detection and quantification of steatosis. We aimed to assess the accuracy of CAP to detect steatosis in patients with chronic liver disease (CLD) compared with liver histology and to evaluate factors that correlate with the CAP value. Methods: Patients with CLD who underwent liver biopsy and simultaneous CAP determination were consecutively enrolled. CAP was measured using the M probe of FibroScan® (Echosens, Paris, France). Histologically, steatosis was categorized as absent (S0: <5%), mild (S1: 5-33%), moderate (S2: 34-66%) and severe (S3: >66% of all hepatocytes). Results: We analyzed 159 patients with CLD (61% men, mean age 47.9 ± 12.9 years). We found a positive correlation between CAP and steatosis in histology (r_s = 0.869, p < 0.001), arterial hypertension (r_s = 0.222, p = 0.005), type 2 diabetes mellitus (r_s = 0.279, p < 0.001), body mass index (BMI; r_s = 0.533, p < 0.001), total cholesterol (r_s = 0.442, p < 0.001), triglycerides (r_s = 0.272, p = 0.001), and non-alcoholic fatty liver disease (NAFLD; r_s = 0.588, p < 0.001). In the multivariate analysis, BMI >25 (odds ratio [OR] 48.4, 95% confidence interval [CI] 23.78-72.95, p < 0.001), serum total cholesterol (OR 3.803, 95% CI 2.203-13.889, p = 0.008), and NAFLD etiology (OR 40.8, 95% CI 15.01-66.66, p = 0.002) were independently associated with higher CAP values. We did not find any significant correlation between CAP and the grade of necroinflammatory activity (r_s = 0.063, p = 0.808) or fibrosis (r_s = 0.071, p = 0.713) in histology and with alanine aminotransferase (r_s = 0.190, p = 0.356) or aspartate aminotransferase (r_s = 0.117, p = 0.142). Optimal CAP cutoff values for detecting steatosis ≥S1, ≥S2, and ≥S3 were 206.5, 232.5, and 282.5 dB/m, respectively. CAP performance was 0.822, 0.956, and 0.976 for diagnosing steatosis ≥S1, ≥S2, and ≥S3, respectively. Conclusions: CAP had an excellent diagnostic accuracy for the detection of steatosis in diverse CLD patients. A CAP value cutoff of <282.5 dB/m excludes severe steatosis ≥S3 with an accuracy of 98%.

A multi-center clinical study of a novel controlled attenuation parameter for assessment of fatty liver

To evaluate the controlled attenuation parameter (CAP) assessment of fatty liver and choose a cut-off value of hepatic steatosis more than 5%. Consecutive patients, 18 years or older, who had undergone percutaneous liver biopsy and CAP measurement were recruited from five liver healthcare centers in China. All enrollees were categorized as hepatic steatosis grade S0 (<5%) or S1 (5%). An M-probe equipped FibroScan 502 was used to capture CAP values. Receiver operating characteristic (ROC) curves were plotted, and the areas under (AU) the curves were calculated to determine the diagnostic efficacy. The CAP cut-off values at the optimal thresholds were defined by maximum Youden indices; sensitivity and specificity were also calculated. A total of 332 patients were enrolled in the study, including 67 patients with non-alcoholic fatty liver disease (NAFLD) and 265 with chronic hepatitis B (CHB) viru: infection. The median age (inter quartile range, IQR) of the study cohort was 39.0 (32.0-50.5) years-old. There were 46 males (68.7%) in the NAFLD group, with a median age of 37.0 (28.0-45.0) years-old, and 182 males (68.7%) in the CHB group; the differences between the two groups in median age and male: female ratio did not reach statistical significance. Multivariate linear regression analysis identified steatosis grade and body mass index (BMI) as independently associated with CAP. The median (IQR) CAP values among patients with S0 and S1 grade steatosis were 215.0 (190.0-241.0) dB/m and 294.0 (255.0-325.5) dB/m (P<0.001), respectively. For all patients, when BMI was <25 kg/m2, the ability of the AUROC of the CAP to discriminate hepatic steatosis more than or equal to 5% was 0.853, and the optimal cut-off value was 244.5 dB/m; however, when BMI≥25 kg/m2, the AUROC was 0.835 and the optimal cut-off value 269.5 dB/m. CAP can identify hepatic steatosis more than or equal to 5% and is applicable for the diagnosis of fatty liver if it is adjusted for BMI.

Utility of controlled attenuation parameter measurement for assessing liver steatosis in Japanese patients with chronic liver diseases

Steatosis is a common histological feature of chronic liver disease, especially alcoholic and non-alcoholic fatty liver disease, as well as chronic hepatitis C. A recent study showed that evaluating the controlled attenuation parameter (CAP) with transient elastography was an efficient way of non-invasively determining the severity of hepatic steatosis. The objective of this study was to prospectively evaluate the utility of CAP for diagnosing steatosis in patients with chronic liver disease. One hundred and fifty-five consecutive patients with suspected chronic liver disease underwent steatosis diagnosis using CAP, blood sample analyses, computed tomography for assessing the liver/spleen ratio and liver biopsy. Steatosis was graded according to the percentage of fat-containing hepatocytes: S0, less than 5%; S1, 5-33%; S2, 34-66%; and S3: more than 66%. The CAP was significantly correlated with steatosis grade, and there were significant differences between the CAP value of the S0 patients and those of the patients with other grades of steatosis. S0 and S1-3 hepatic steatosis were considered to represent mild and significant steatosis, respectively. The CAP values of the patients with mild and significant steatosis were significantly different (P < 0.0001). The area under the receiver-operator curve (AUROC) value of the CAP for diagnosing significant steatosis was 0.878 (95% confidence interval, 0.818-0.939), and the optimal CAP cut-off value for detecting significant steatosis was 232.5 db/m. In multivariate analysis, the CAP (P = 0.0002) and the liver to spleen ratio (P = 0.004) were found to be significantly associated with significant steatosis. The CAP is a promising tool for rapidly and non-invasively diagnosing steatosis.