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Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis

Published:October 07, 2020DOI:https://doi.org/10.1016/j.jhep.2020.09.034

      Highlights

      • Largest prospective study validating the performance of Baveno VI criteria in patients with cirrhosis under HBV suppression.
      • SSM (≤46 kPa) for ruling out high-risk varices was well validated in patients with cirrhosis under viral suppression.
      • More unnecessary endoscopies (>50%) can be safely avoided by combining Baveno VI criteria and SSM model.

      Background & Aims

      There are no data validating the performance of spleen stiffness measurement in ruling out high-risk varices in patients with HBV-related cirrhosis under maintained viral suppression. Thus, we aimed to prospectively validate the performance of spleen stiffness measurement (cut-off 46 kPa) combined with Baveno VI criteria in ruling out high-risk varices in these patients.

      Methods

      Patients with cirrhosis were enrolled from April to December 2019 at the hepatology unit of the Nanfang Hospital, China. Liver and spleen transient elastography and esophagogastroduodenoscopy were performed at enrollment. Antiviral regimen(s) and virological responses, evaluated every 3-6 months, were recorded.

      Results

      Overall 341 patients with HBV-related cirrhosis under maintained viral suppression were enrolled, and the prevalence of high-risk varices was 20.5% (70/341). Baveno VI criteria spared 37.0% (126/341) esophagogastroduodenoscopies and no high-risk varices were missed (0/70). Eight cases of high-risk varices (8/70, 11.4%) were misclassified in patients (208/341, 61.0%) within the expanded Baveno VI criteria. The spleen stiffness measurement cut-off (≤46.0 kPa) was shown to safely rule out high-risk varices in these patients (the percentage of missed high-risk varices was 4.3%). Over half (61.6%, 210/341) of patients met the combined model (Baveno VI criteria and spleen stiffness measurement cut-off ≤46 kPa) and 4.3% (3/70) of high-risk varices cases were misclassified. This combined model exhibited a sensitivity of 95.71%, specificity of 76.38%, negative predictive value of 98.57%, and negative likelihood ratio of 0.06 for ruling out high-risk varices.

      Conclusions

      We validated the excellent performance of Baveno VI criteria combined with spleen stiffness measurement (cut-off 46 kPa) for safely ruling out high-risk varices in patients with HBV-related cirrhosis under viral suppression; more than half of esophagogastroduodenoscopy procedures were spared using this combination.

      Clinical trial number

      Lay summary

      Esophageal varices have important prognostic implications in patients with cirrhosis. Thus, their timely identification is important so that treatment can be initiated early. Herein, we validated the excellent performance of the combination of Baveno VI criteria with spleen stiffness measurement (cut-off 46 kPa) for ruling out high-risk esophageal varices in patients with HBV-related cirrhosis under maintained viral suppression (with antiviral treatment). This combined model was able to safely rule out high-risk varices (missed/total <5%) and over half (61.6%) of esophagogastroduodenoscopy procedures were spared.

      Graphical abstract

      Keywords

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      Linked Article

      • Reply to: “Small esophageal varices in compensated cirrhosis patients: To treat or not to treat?”
        Journal of HepatologyVol. 75Issue 2
        • Preview
          On behalf of my colleagues, we thank Dr Putera et al.1 for their interest in and comment on our study.2 According to the criteria proposed by the Baveno VI Consensus Conference,3 high-risk varices (HRVs) were defined as grade 1 esophageal varices (EVs) with red signs or grade ≥2 EVs which were deemed clinically significant and required treatment in standard clinical practice. Thus, low-risk varices were described as grade <2, including no EVs or grade 1 EVs without red signs, for which bleeding risk is considered low and prophylactic therapy is deemed unnecessary.
        • Full-Text
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      • Reply to: “Prospective validation of Baveno VI criteria in virally supressed HBV cirrhosis – more evidence is needed”
        Journal of HepatologyVol. 74Issue 3
        • Preview
          On behalf of my colleagues, we thank Drs Sharma and Agarwal for their interest and comment on our study.1 While guidelines2,3 recommend variceal screening by esophagogastroduodenoscopy (EGD) in all patients with cirrhosis, the screening scenario has changed much4 in patients with viral cirrhosis, owing to viral eradication of hepatitis C and viral suppression of hepatitis B, along with re-compensation in many decompensated patients. Thabut's5 and our study both validated that Baveno VI criteria are able to rule out high-risk varices (HRVs) safely in virally suppressed patients with cirrhosis.
        • Full-Text
        • PDF
      • Prospective validation of Baveno VI criteria in virally supressed HBV cirrhosis – more evidence is needed
        Journal of HepatologyVol. 74Issue 3
        • Preview
          We read with great interest the article by Wang et al. on the prospective validation of Baveno VI criteria and spleen stiffness measurement (SSM) in a cohort of patients with HBV-related cirrhosis and supressed viral levels.1 We would like to highlight a few important points:
        • Full-Text
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      • Small esophageal varices in compensated cirrhosis patients: to treat or not to treat?
        Journal of HepatologyVol. 75Issue 2
        • Preview
          We would like to congratulate Wang et al. for demonstrating that adding spleen stiffness measurement to the existing Baveno-VI criteria can spare more screening gastroscopy without missing more high-risk esophageal varices (EVs) compared to the Baveno-VI criteria.1 The definition of “low-risk varices” was potentially misleading as it also included patients without EVs. It would be interesting to also report the performance of this criteria in predicting the presence of small EVs.
        • Full-Text
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