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Background & Aims: Portosystemic encephalopathy (PSE) is a major complication of trans-jugular intrahepatic porto-systemic shunt (TIPS) placement. Most devices are self-expandable polytetrafluoroethylene-covered stent grafts (PTFE-SGs) that are dilated to their nominal diameter (8 or 10 mm). We investigated whether PTFE-SGs dilated to a smaller caliber (under-dilated TIPS) reduce PSE yet maintain clinical and hemodynamic efficacy. We also studied whether under-dilated TIPS self-expand to nominal diameter over time., Methods: We performed a prospective, non-randomized study of 42 unselected patients with cirrhosis who received under-dilated TIPS (7 and 6 mm) and 53 patients who received PTFE-SGs of 8 mm or more (controls) at referral centers in Italy. After completion of this study, dilation to 6 mm became the standard and 47 patients were included in a validation study. All patients were followed for 6 months; Doppler ultrasonography was performed 2 weeks and 3 months after TIPS placement and every 6 months thereafter. Stability of PTFE-SG diameter was evaluated by computed tomography analysis of 226 patients with cirrhosis whose stent grafts increased to 6, 7, 8, 9, or 10 mm. The primary outcomes were incidence of at least 1 episode of PSE grade 2 or higher during follow up, incidence of recurrent variceal hemorrhage or ascites, incidence of shunt dysfunction requiring TIPS recanalization, and reduction in porto-caval pressure gradient., Results: PSE developed in a significantly lower proportion of patients with under-dilated TIPS (27%) than controls (54%) during the first year after the procedure (P = .015), but the proportions of patients with recurrent variceal hemorrhage or ascites did not differ significantly between groups. No TIPS occlusions were observed. These results were confirmed in the validation cohort. In an analysis of self-expansion of stent grafts, during a mean follow-up period of 252 days after placement, none of the PTFE-SGs self-expanded to the nominal diameter in hemodynamically relevant sites (such as portal and hepatic vein vascular walls)., Conclusions: In prospective, non-randomized study of patients with cirrhosis, we found under-dilation of PTFE-SGs during TIPS placement to be feasible, associated with lower rates of PSE, and effective., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Guidelines recommend variceal screening in patients with cirrhosis to identify varices at high risk of bleeding requiring primary prophylaxis. Non-invasive criteria to rule out high-risk varices will avoid unnecessary endoscopies. Recent Baveno VI criteria define patients with compensated cirrhosis in whom endoscopy can be avoided as those with a liver stiffness by transient elastography <20 kPa and a platelet count >150 000/mm 3. AIMS: To validate Baveno criteria in two cohorts with a different prevalence of high-risk varices and to determine whether alternate parameters not including liver stiffness would be equal/more accurate in ruling out high-risk varices., Methods: Retrospective study evaluating patients with liver stiffness >10 kPa who had liver stiffness and endoscopy within 1 year of each other., Results: This study included 161 patients from the US cohort (14 [9%] with high-risk varices) and 101 patients from an Italian cohort (17 [17%] with high-risk varices). Of patients meeting Baveno criteria (41 in the US, 16 in Italy), none had high-risk varices and therefore 26% (US) and 16% (Italy) endoscopies could have been avoided. Sensitivity and negative predictive value were 100%. A stepwise strategy using platelet count >150 000 and MELD=6, increased the number of endoscopies avoided to 54% (US) while maintaining a sensitivity and negative predictive value of 100%. Excellent sensitivity and negative predictive value were validated in the Italian cohort and in another cohort of patients with a clinical diagnosis of cirrhosis., Conclusions: This study validates Baveno VI criteria, particularly in sites with a low prevalence of high-risk varices and describes a new accurate strategy that does not include liver stiffness., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)