Risk Factors for Hemorrhagic Adverse Events in Percutaneous Transhepatic Biliary Drainage: A Prospective Multicenter Study.

ABSTRACT

PURPOSE: To determine risk factors (RFs) for hemorrhagic adverse events (AEs) associated with percutaneous transhepatic biliary drainage (PTBD) and to develop a risk assessment model. MATERIALS AND METHODS: This was a multicenter, prospective, case control study between 2015 and 2020. Adults with an indication for PTBD were included. Patients who had undergone recent previous drainage procedures were excluded. Multiple variables were controlled. The exposure variables were the number of capsular punctures and passes (using the same puncture). A multivariate analysis was performed (logistic regression analysis). RESULTS: A total of 304 patients (mean age, 63 years ± 14 [range, 23-87 years]; female, 53.5%) were included. Hemorrhagic AEs occurred in 13.5% (n = 41) of the patients, and 3.0% (n = 9) of the cases were severe. Univariate analysis showed that the following variables were not associated with hemorrhagic AEs age, sex, bilirubin and hemoglobin levels, type of pathology, portal hypertension, location of vascular punctures, ascites, nondilated bile duct, intrahepatic tumors, catheter features, blood pressure, antiplatelet drug use, and tract embolization. Multivariate analysis showed that number of punctures (odds ratio [OR], 2.5; P = .055), vascular punctures (OR, 4.1; P = .007), fatty liver or cirrhosis (OR, 3.7; P = .021), and intrahepatic tumor obstruction (Bismuth ≥ 2; OR, 2.4; P = .064) were associated with hemorrhagic AEs. Patients with corrected coagulopathies had fewer hemorrhagic AEs (OR, -5.5; P = .026). The predictability was 88.2%. The area under the curve was 0.56 (95% confidence interval, 0.50-0.61). CONCLUSIONS: Preprocedural and intraprocedural RFs were identified in relation to hemorrhage with PTBD. AE risk assessment information may be valuable for prediction and management of hemorrhagic AEs.