Author information
1
Division of Gastroenterology, Modena Hospital, University of Modena and Reggio Emilia, Modena, Italy. Electronic address: filippo.schepis@unimore.it.
2
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. Electronic address: filippo.schepis@unimore.it.
3
Division of Gastroenterology, Modena Hospital, University of Modena and Reggio Emilia, Modena, Italy; Yale University School of Medicine and VA CT Healthcare System, Department of Internal Medicine, Section of Digestive Diseases, New Haven, Connecticut, United States.
4
Department of Radiology, Modena Hospital, University of Modena and Reggio Emilia, Modena, Italy.
5
Department of Radiology, Careggi Hospital, Florence, Italy.
6
Division of Gastroenterology, Modena Hospital, University of Modena and Reggio Emilia, Modena, Italy.
7
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
8
Interventional Radiology Unit, Niguarda Ca' Granda Hospital, Milan, Italy.
9
Division of Hepatology and Gastroenterology, A.O. Niguarda Ca' Granda, Milan, Italy.
10
Department of Radiology, "Sapienza" University, Rome, Italy.
11
Radiology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Italy.
12
Interventional Radiology Unit, Papa Giovanni XXIII Hospital, Bergamo, Italy.
13
Unit of Interventional Radiology - Radiology Department, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
14
Radiology Service, Department of Diagnostic and Therapeutic Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Palermo, Italy.
15
Department of Infectious Diseases, University of Pavia, IRCCS Policlinico San Matteo, Pavia, Italy.
16
Division of Gastroenterology and Hepatology, Papa Giovanni XXIII Hospital, Bergamo, Italy.
17
HPB Surgery and Liver Transplantation Unit, Modena Hospital, University of Modena and Reggio Emilia, Modena, Italy.
18
Statistics Unit, Department of Clinical, Diagnostic and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
19
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Center for Research, High Education and Transfer DENOThe, University of Florence, Italy.
Abstract
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 (based on need for at least 1 large-volume paracentesis by 4 weeks after TIPS placement), 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 (46%) than controls (73%) 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).
CONCLUSION:
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.