Performances of Baveno VII AND AASLD 2024 criteria for detecting gastroesophageal varices in untreated patients with HDVrelated cirrhosis

Background and Aim: In patients with cirrhosis, gastroesophageal varices (EV) due to clinically significant portal hypertension (CSPH) are associated with an increased risk of liver decompensation. Non-invasive tests (NITs) are increasingly used in clinical practice for assessing the risk for CSPH with EV, but chronic hepatitis Delta (CHD) specific studies are missing. We investigated the performances of NITs-based criteria to predict EV in CHD patients.Methods: Untreated patients with HDV-related com- pensated cirrhosis and available liver stiffness measurement (LSM) and esophagogastroduodenoscopy (EGD) enrolled in the multicen- ter SAVE-D and D-SHIELD studies were included. In a subgroup of patients, spleen stiffness measurement (SSM) was also available. EGD and transient elastography (TE) were performed prior to Bulevirtide (BLV) start. Baveno VI/VII and AASLD criteria were applied to identify patients in which screening endoscopy could have been avoided (LSM < 20 kPa + platelets [PLT] count > 150 ×109/L). Regarding SSM, the Baveno VII criteria of SSM ≤40 kPa was im- plemented to identify patients who could have been spared of screening endoscopy. NITs’ performances were assessed calculating for each criteria Sensibility (Sn), Specificity (Sp), Positive Predictive Value (PPV), Negative Predictive Value (NPV), and accuracy. The diagnostic performance of the continuous LSM variable was evaluated using Receiver Operating Characteristic (ROC) curve analysis. Results: 347 patients were included in this analysis (median age 54, 56% males): 93 (27%) showed high risk varices (HRV). Avoiding screening endoscopy in patients with LSM < 20 and PLT > 150 ×109/L resulted in 4 (9%) missed high risk varices (HRV) (Sensitivity [Sn] 95.7%, Negative Predictive Value [NPV] 93.8%). In patients with available SSM, the rate of missed HRV dropped to 7%, while Sn was reduced 89.5% and NPV to 92.9%. ROC analysis to identify patients harboring varices retrieved an optimal LSM cut- off of 18.7 kPa, with an AUROC of 0.620 (0.550-0.690), Sn of 60.2% and a false positive rate (1 - Sp) of 0.319, corresponding to a Sp of approximately 68.1%. The corresponding PPV was 40.8%. Conclu- sions: In patients with untreated HDV-related cirrhosis, applying the Baveno VII criteria to identify patients who could avoid screening EGD reports a rate of missed HRV higher than the acceptable threshold. Avoiding screening endoscopy based on NITs in CHD pa- tients could lead to misclassify patients who have HRV and are at higher risk of decompensating events.