Purpose: To evaluate the safety and performance of a recently developed expanded polytetrafluoroethylene (ePTFE)-covered nitinol stent-graft to create transjugular intrahepatic portosystemic shunt (TIPS) in patients with portal hypertension and related complications.
Materials and methods: The ePTFE-covered nitinol stent-graft was used to create TIPS in 16 patients with recurrent variceal bleeding (n = 13) or refractory ascites (n = 3). Follow-up was performed with duplex ultrasonography, clinical assessment, and venography at 6 months. Technical success and portosystemic pressure gradients (PPGs) before and after stent-graft implantation and at follow-up were assessed. Two patients died during follow-up. Histopathologic follow-up data were available for one patient at autopsy and for the other after liver transplantation.
Results: The implantation technical success rate was 100%. Mean (+/- SD) PPG was reduced from 24 mm Hg +/- 5 to 9 mm Hg +/- 2. Histopathologic analysis of the explanted endoprostheses revealed no inflammatory response or neointima formation. The venographic follow-up data available for 10 patients demonstrated 100% in-graft patency (mean follow-up, 289 days +/- 26). Revisions with implantation of a new ePTFE-covered nitinol stent-graft or another commercially available stent in 10 patients were necessary because of hepatic vein stenosis above the grafted portion and/or relative diameter mismatch causing TIPS dysfunction.
Conclusion: The ePTFE-covered nitinol stent-graft was used successfully to create TIPS and has the potential to prolong TIPS patency upon complete coverage to the hepatocaval junction.