HVPG for Rebleeding Risk Stratification
Condition: Liver Cirrhosis; Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Observational

Summary: 
      Background: In patients with cirrhosis on secondary prevention of variceal rebleeding with
      non-selective beta-blockers (NSBBs), the risk of rebleeding and death is markedly higher in
      those failing to achieve a good hemodynamic response (HVPG reduction ≥20% of baseline values
      or ≤12mmHg). However a substantial proportion of non-responders will never rebleed, thus
      appearing protected by NSBBs although non-detected by HVPG response. This low sensitivity
      hampers risk stratification and diminishes the cost-effectiveness of assessing the
      hemodynamic response to NSBBs. This is particularly relevant in prevention of rebleeding
      since in this scenario the risk of rebleeding and of other portal hypertension related
      complications is very high, which calls for early institution of effective therapy.

      Baseline HVPG bears prognostic significance with regards to risk of developing varices,
      decompensation, hepatocellular carcinoma and death1,2,7,8,18-27. However, no studies have
      investigated whether adding data from baseline HVPG may improve the sensitivity of the
      criteria defining a good or poor hemodynamic response.

      Hypothesis: Adding data from baseline HVPG may improve the sensitivity of the criteria
      defining a good or poor hemodynamic response.

      Objective: Exploring the prognostic value of basal HVPG that better discriminate those
      non-responders who do not re-bleed under prophylactic treatment with NSBBs.

      Methods: Observational cohort study. Training set: patients from two longitudinal studies
      conducted at the Hepatic Hemodynamic laboratory of the Hospital Clínic of Barcelona to assess
      the prognostic value of HVPG changes during continuous therapy with NSBBs for preventing
      variceal rebleeding. Validation set for chronic hemodynamic response: patients from two
      longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the Hospital de Sant
      Pau of Barcelona to assess the prognostic value of HVPG changes during continuous therapy
      with NSBBs for preventing variceal rebleeding; a third cohort composed of patients undergoing
      acute hemodynamic response to intravenous propranolol will be studied.

      All patients received a preplanned follow-up in the outpatient clinic at 1, 3, and 6 months,
      and every 6 months thereafter in the original studies.

      End-point: bleeding from portal hypertensive sources (esophago-gastric varices or portal
      hypertensive gastropathy) (defined according to Baveno criteria 32), death or liver
      transplantation.

      Ethical aspects: All patients have given their written informed consent to use their data in
      the original studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with liver cirrhosis who already experienced a esophageal variceal bleeding,
        requiring therapy with non-selective beta-blockers for their portal hypertension.