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Objectives: Identification of patients with nonalcoholic fatty liver disease (NAFLD) who have advanced fibrosis is crucial. Vibration controlled transient elastography (VCTE) is an alternative to biopsy, although published experience with VCTE in a US population is limited., Methods: We performed a prospective cohort of 164 biopsy-proven NAFLD patients evaluated with VCTE using an M probe and the NAFLD fibrosis score (NFS) at baseline and a repeat VCTE at 6 months. Reliable liver stiffness measurements (LSMs) were defined as 10 valid measurements and interquartile range ≤30% of the median., Results: A total of 120 (73.2%) patients had reliable LSM. The median LSMs for patients with and without F3-F4 (advanced) fibrosis were 6.6 kPA (5.3-8.9) and 14.4 kPA (12.1-24.3), respectively. The optimal LSM cutoff for advanced fibrosis was 9.9 kPA (sensitivity 95% and specificity 77%). In addition, 100% of patients with LSM<7.9 kPA did not have advanced fibrosis. A risk stratification strategy based on VCTE avoids the need for biopsy in at least the 74 (45.1%) patients correctly classified as low risk for advanced fibrosis. For the detection of F3-F4 fibrosis in patients with reliable VCTE, the area under the receiver operating curve (AUROC) is 0.93 (95% CI: 0.86-0.96). This is superior to the AUROC for the NFS (0.77), P=0.01. Patients who achieved a ≥5% weight loss at 6-month follow-up experienced improved LSM (P=0.009), independent of the changes in aminotransferase levels., Conclusions: Reliable VCTE results can rule out advanced fibrosis and avoid the need for biopsy in at least 45% of US patients with NAFLD. However, 1 in 4 patients have uninterpretable studies using the M probe.

Objectives: The risk of advanced fibrosis in nonalcoholic fatty liver disease (NAFLD) is traditionally assessed with a liver biopsy, which is both costly and associated with adverse events., Methods: We sought to compare the cost-effectiveness of four different strategies to assess fibrosis risk in patients with NAFLD: vibration controlled transient elastography (VCTE), the NAFLD fibrosis score (NFS), combination testing with NFS and VCTE, and liver biopsy (usual care). We developed a probabilistic decision analytical microsimulation state-transition model wherein we simulated a cohort of 10,000 50-year-old Americans with NAFLD undergoing evaluation by a gastroenterologist. VCTE performance was obtained from a prospective cohort of 144 patients with NAFLD., Results: Both the NFS alone and the NFS/VCTE strategies were cost effective at $5,795 and $5,768 per quality-adjusted life years (QALY), respectively. In the microsimulation, the NFS alone and NFS/VCTE strategies were the most cost-effective (dominant) in 66.8 and 33.2% of samples given a willingness-to-pay threshold of $100,000 per QALY. In a sensitivity analysis, the minimum cost per liver biopsy at which the NFS is cost saving is $339 and the maximum cost per VCTE exam at which the NFS/VCTE strategy remains cost saving is $1,593. The expected value of further research on this topic is $526 million., Conclusions: Non-invasive risk stratification with both the NFS alone and the NFS/VCTE are cost-effective strategies for the evaluation and management of patients with NAFLD presenting to a gastroenterologist. Further research is needed to better define the natural history of NAFLD and the effect of novel treatments on decision making.

Objectives: To evaluate the outcome of arterially enhancing nodules (AENs) measuring <20 mm detected on MRI in patients with cirrhosis., Methods: Prospective analysis of 54 patients with a total of 161 AENs <20 mm on MRI. Inclusion criteria included a minimum of 12 months of MRI follow-up or histological evaluation of the AEN. Key exclusions were patients with an AEN >20 mm or prior diagnosis of HCC. Two radiologists blinded to the clinical and pathological data reviewed serial MRIs and classified the AENs as no longer visible, stable, increasing, or decreasing in size., Results: A total of 161 AENs were identified and were followed by serial MRI for a mean of 24 months. Eighty (50%) AENs were no longer visible on repeat imaging, 42 (26%) remained stable, 1 of which was diagnosed as HCC on short-term follow-up, 8 (5%) increased in size and were subsequently diagnosed as HCC, and 24 (15%) decreased in size. In addition, 7 AENs (4%) were diagnosed on biopsy immediately following the initial MRI. Overall MR characteristics diagnostic of HCC were growth > or =2 mm and peripheral rim enhancement on initial MRI., Conclusions: The majority (90%) of AENs <20 mm in cirrhosis are benign. The presence of rim enhancement or interval growth of an AEN are suggestive of HCC.

The diagnosis of liver fibrosis has traditionally relied on liver biopsy. However, recent studies have suggested that there can be up to a 33 % error in the diagnosis of cirrhosis. In this article, we review the current status of liver biopsy as a gold standard for the diagnosis of liver fibrosis and discuss the radiological and serum tests that have been proposed as potential adjuncts or alternatives to biopsies. Indirect markers of liver fibrosis which reflect alterations in liver function and or inflammation are discussed as well as more direct markers of liver fibrosis. The limitations of utilization of these markers for both cross-sectional diagnosis of fibrosis and monitoring disease progression or regression are discussed.