Objective: Our objective is to describe the results of a multicenter prospective trial on the safety and efficacy of transjugular intrahepatic portosystemic shunts (TIPS) using the Viatorr stent-graft.
Subjects and methods: From 2001 to 2003, 114 patients (75 men and 39 women; mean age, 59.3 years) with portal hypertension underwent TIPS with the Viatorr stent-graft. Indications for treatment were variceal bleeding (n = 49, 43.0%), refractory ascites (n = 52, 45.6%), hypertensive gastropathy (n = 10, 8.8%), Budd-Chiari syndrome (n = 1, 0.9%), and hepatorenal syndrome (n = 2, 1.7%). Eight patients (7.0%) had Child-Pugh class A cirrhosis; 60 (52.6%), Child-Pugh class B; and 46 (40.4%), Child-Pugh class C. Patients were monitored by color Doppler sonography and phlebography.
Results: The procedure was successful in 113 (99.1%) of 114 patients; in one patient, creation of the track was not feasible. The mean portosystemic pressure gradient decreased from 21.8 to 8.7 mm Hg. Three minor immediate complications (2.6%) occurred (two cases of self-limiting hemoperitoneum and one extrahepatic portal puncture requiring covered stenting). At a mean follow-up of 11.9 months, the overall mortality rate was 31.0% (35/113), with a 30-day mortality rate of 8.8% (10/113). Mortality was significantly higher in patients in Child-Pugh class C with refractory ascites and with post-procedural encephalopathy. Cumulative primary patency rates were 91.9%, 79.9%, and 75.9% at 6, 12, and 24 months' follow-up, respectively. Restenosis occurred in 15 patients (13.3%) within the stent (n = 8, 53.3%) or at the ends of the portal (n = 1, 6.7%) or hepatic (n = 6, 40%) veins and was solved by percutaneous transluminal angioplasty (n = 11), stenting (n = 3), or parallel TIPS (n = 1). The secondary patency rate was 98.2%. Post-procedural encephalopathy occurred in 27 patients (23.9%).
Conclusion: The Viatorr stent-graft is safe and effective in TIPS creation, with high primary patency rates. Covering the entire track up to the inferior vena cava can increase patency.