Is Transient Elastography Needed for Noninvasive Assessment of High-Risk Varices? The REAL Experience

Abstract

INTRODUCTION: The Baveno VI consensus guidelines and an expanded algorithm suggest that transient elastography (TE) and platelet (PLT) count can be used to identify patients with cirrhosis who can avoid esophagogastroduodenoscopy (EGD). The primary aims of this study were to assess the ability of a simple algorithm, which uses only laboratory parameters, to predict medium/large esophageal varices (EV) in patients with hepatitis C virus (HCV) and cirrhosis from the Rete Sicilia Selezione Terapia–HCV (RESIST-HCV) cohort and to compare the performance of the algorithm with Baveno VI and Expanded Baveno VI criteria. The secondary aim was to assess the role of TE in ruling out large EV. METHODS: In total, 1,381 patients with HCV-associated cirrhosis who had EGD and TE within 1 year of starting treatment with direct-acting antivirals were evaluated. Using multivariate logistic analysis, laboratory variables were selected to determine which were independently associated with medium/large EV to create the RESIST-HCV criteria. These criteria were tested in a training cohort with patients from a single center (Palermo) and validated with patients from the 21 other centers of the RESIST-HCV program (validation cohort). RESULTS: In the entire cohort, medium/large EV were identified in 5 of 216 patients (2.3%) using the Baveno VI criteria and 13 of 497 patients (2.6%) using the Expanded Baveno VI criteria. PLT count and albumin level were independently associated with medium/large EV. The best cut-off values were a PLT count greater than 120 × 109 cells/μL and serum albumin level greater than 3.6 g/dL; negative predictive values (NPVs) were 97.2% and 94.7%, respectively. In the training cohort of 326 patients, 119 (36.5%) met the RESIST-HCV criteria and the NPV was 99.2%. Among 1,055 patients in the validation cohort, 315 (30%) met the RESIST-HCV criteria and the NPV was 98.1%. Adding TE to the RESIST-HCV criteria reduced the avoided EGDs for approximately 25% of patients and the NPV was 98.2%. DISCUSSION: The “easy-to-use” RESIST-HCV algorithm avoids EGD for high-risk EV screening for more than 30% of patients and has the same performance criteria as TE. Using these criteria simplifies the diagnosis of portal hypertension.

Validation of the Combined Model Based on Platelet Count and Albumin to Rule out High-Risk Varices in Liver Cirrhosis

“…Most studies that attempted to noninvasively rule out HRV, however, were retrospective and did not include an assessment of EV size [ 23 ]. Reassuringly, the diagnostic performance of the RESIST-HCV criteria was consistent with the performance reported in the recently published study [ 13 ]. Second, LSM measured by TE is useful for the assessment of HRV.…”

“…In the present study, we validated the recently published RESIST-HCV criteria [ 13 ] that use only platelet count and serum albumin level to identify patients who are at low risk of HRV and can safely avoid endoscopic screening, saving time and reducing costs. This is the first validation performed in Chinese patients.…”

“…The development of noninvasive criteria that do not include TE is desirable. Therefore, an easy-to-use Rete Sicilia Selezione Terapia hepatitis C virus (RESIST-HCV) criteria, which uses only platelet count and serum albumin, have been proposed to exclude HRV in compensated cirrhosis by Calvaruso et al [ 13 ]. By using these criteria, the spared EGD rate and the missed HRV rate were 31.4% and 1.6%, respectively [ 13 ].…”

Baveno Criteria Safely Identify Patients With Compensated Advanced Chronic Liver Disease Who Can Avoid Variceal Screening Endoscopy: A Diagnostic Test Accuracy Meta-Analysis

“…Augustin et al proposed that the expanded Baveno criteria (LS < 25 kPs and platelet count > 110,000/μl) may outperform the original Baveno criteria since it spares 40% of variceal screening endoscopies with a missing VNT rate of 1.6% (Augustin et al, 2017). Since, multiple studies attempted to validate these criteria with various success (Petta et al, 2018; Calvaruso et al, 2019; Dajti et al, 2019; Moctezuma-Velazquez et al, 2019; Tosetti et al, 2019a). However we must be aware that the higher SER with the application of the expanded Baveno criteria may be associated with an increased number of missed VNTs (i.e., false negative cases in the 2 × 2 diagnostic table) because the negative predictive value of the criteria is dependent on the pre-test probability of VNTs (i.e., a more severe liver disease with higher VNT rate will be associated with a lower negative predictive value of the criteria).…”

Multimodal Ultrasound Model Based on the Left Gastric Vein in B-Viral Cirrhosis: Noninvasive Prediction of Esophageal Varices

“…Thrombocytopenia may be due to hypersplenism caused by PH and an impaired immune system ( 34 – 36 ). Calvaruso et al ( 37 ) reported that PLT was superior to LS in predicting large EV; however, both showed low AUROCs. The study reported that these noninvasive tests did not accurately detect small EV.…”