title: Measuring the hemodynamic response to primary pharmacoprophylaxis of variceal bleeding: a cost-effectiveness analysis.
abstract: OBJECTIVE
  The hemodynamic response to ss-blockers alone or with nitrates is highly predictive of efficacy in prevention of variceal bleeding. Hemodynamic monitoring (HDM) requires catheterization of the hepatic vein and measurement of the hepatic venous pressure gradient, the difference between wedged and free hepatic venous pressure. The aim of this study was to compare HDM with no HDM in patients considered for primary pharmacoprophylaxis of esophageal variceal bleeding.
  
  
  METHODS
  A decision model was constructed to compare HDM with no HDM in cirrhotic patients with moderate to large esophageal varices. Patients intolerant to beta-blocker therapy would undergo endoscopic variceal ligation; those with an inadequate hemodynamic response (HDR) to beta-blocker therapy could have nitrates added before ligation was considered. Variceal bleeding was treated with ligation, with transjugular intrahepatic portosystemic shunt (TIPS) reserved for refractory bleeding. Probabilities of treatment responses as well as risks of bleeding and mortality were based on published literature. Only direct costs were considered during the 5-yr time horizon. Outcomes were cost in United States dollars, survival length in life-years, and proportions of patients who experienced variceal bleeding, TIPS insertion, and mortality from any cause.
  
  
  RESULTS
  In the base case analysis, HDM was either cost-saving ($2,523 US dollars /life-year gained) or cost-effective (incremental cost-effectiveness ratio of $5,200 US dollars/life-year saved) compared with no HDM, depending on whether nitrates were added to beta-blocker therapy. HDM reduced variceal bleeding by nearly 60% and had a small effect on all-cause mortality. In the sensitivity analysis, HDM was sensitive to the time horizon, as it was not cost-effective for a time horizon of <22 months and was not cost-saving before 49 months. The cost-effectiveness of HDM was not sensitive to reasonable variation in the probability of HDR to beta-blocker therapy, risk of bleeding, risk reduction with pharmacotherapy, or to the costs of HDM, bleeding, ligation, or TIPS. Probabilistic sensitivity analysis indicated that HDM was more effective and less costly 100% and 57% of the time, respectively.
  
  
  CONCLUSIONS
  Compared with the current standard of no HDM, measuring the hemodynamic response of primary pharmacoprophylaxis substantially reduces the number of bleeding episodes and is cost-effective or cost-saving over a wide range of sensitivity analyses. A randomized trial of HDM is needed to verify its efficacy in clinical practice.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Imperiale
authors.forename: Naga
authors.initials: N
authors.lastname: Chalasani
authors.forename: Robert W
authors.initials: RW
authors.lastname: Klein
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003663:Decision Trees; D004932:Esophageal and Gastric Varices / Q000517:prevention & control*; D004945:Esophagoscopy; D006439:Hemodynamics; D006801:Humans; D008026:Ligation; D008390:Markov Chains; D008991:Monitoring, Physiologic / Q000191:economics*; D009010:Monte Carlo Method; D009566:Nitrates / Q000627:therapeutic use; D019168:Portasystemic Shunt, Transjugular Intrahepatic; D012680:Sensitivity and Specificity
chemical_list: D000319:Adrenergic beta-Antagonists; D009566:Nitrates