Search

Fibroscan is a well-established NIT for the diagnosis of advanced fibrosis (F>2) in patients with NAFLD, recently defined as compensated advanced chronic liver disease (cACLD). EASL Guidelines proposed 8 and 12 kPa, respectively, as rule-out and rule-in cut-offs for cACLD. Patients with Fibroscan measurement between 8 and 12 fall in a grey zone where further investigations are recommended. We recently proposed the cACLD Risk Score to further stratify this population. The main aim of this study was to test the diagnostic performance of the main NITs in a two European cohorts of patients with histological diagnosis of NAFLD. Secondly, we assessed the performance of the cACLD risk score to further stratify patients in the Fibroscan's grey zone. This is a retrospective observational study. We enrolled consecutive patients with histological diagnosis of NAFLD/NASH from January 2014 to December 2021 at two tertiary liver units in UK (the Royal Free Hospital, London - RFH) and Italy (Fondazione Universitaria Policlinico A. Gemelli IRCCS, Rome – FPG). We excluded patients who did not perform at least one of these NITs at time of biopsy (± 6 months): FIB4, NAFLD Fibrosis score (NFS), Fibroscan, APRI, AGILE3+, cACLD Risk Score. We performed a ROC analysis to explore the diagnostic performance of NITs for cACLD (F>2). Secondly, in patients with intermediate Fibroscan results (between 8-12 kPa), we tested the diagnostic performance of cACLD Risk Score. We included 536 patients;201 were female, median age was 53 years, and 44% had diabetes. Fibroscan and AGILE3+ score had the best diagnostic performances for cACLD with an AUROC of 0.81 and 0.83 respectively. (Fig. 1) EASL criteria showed a high sensitivity and high specificity for 8 kPa and 12 kPa cutoffs, respectively (Sens 84.3%; Spec 86.6%), wrong classification of 14.2% and 129 patients (24.1%) in the grey zone (between 8 and 12 kPa). Diagnostic performance of cACLD Risk Score in Fibroscan's grey zone was suboptimal (AUROC: 0.682). The use of Fibroscan+cACLD Risk Score vs Fibroscan alone showed a better overall accuracy (77.8% vs 61.7%) and a slight worsening of overall wrong classification rate (22.7% vs 14.2%) mainly due to a higher number of false negative than false positive. Among patients with intermediate Fibroscan (8-12 kPa), cACLD risk score correctly classify 64.4% of patients with a PPV of 72.0% and NPV of 62.5%. Our results suggest that cACLD Risk Score should be used in patients with indeterminate Fibroscan results in order to further stratify their risk of cACLD. The use of cACLD Risk Score improve the performance in identifying patients with cACLD (high PPV) although its false negative rate could lead to missed diagnosis (suboptimal NPV). Patients with intermediate fibroscan and low cACLD risk score should be still considered for further investigation (liver biopsy). [ABSTRACT FROM AUTHOR]