Inhibition of pseudointimal hyperplasia in swine TIPS models: The efficacy of local delivery of paclitaxel using a perforated balloon catheter

The aim of this study was to investigate the efficacy and feasibility of local delivery of paclitaxel to inhibit pseudointimal hyperplasia/intimal hyperplasia in swine transjugular intrahepatic portosystemic shunt (TIPS) models. TIPS were created in seven healthy domestic swine (15-20 kg). Before TIPS stent insertion, we performed a short-term infusion of paclitaxel (treatment group: n=4) and saline (control group: n=3) into the TIPS tract using a balloon catheter in which two 0.010 inch holes were created on opposite sides of the balloon. Paclitaxel or saline was given to all animals via the hepatic parenchymal and venous outflow tract. The animals were followed for up to two weeks and then killed. Gross and histological evaluations of the shunts were performed, and the maximum pseudointimal/intimal hyperplasia thicknesses were calculated for each animal. The average infusion time of paclitaxel or saline was 7.6 min (6-9 min). At gross and histological evaluation, considerable pseudointimal hyperplasia had formed in the control group and statistically significant differences were found upon microscopic evaluation in the maximum pseudointimal hyperplasia thickness between the control (2.41 mm, range 1.7-3.16 mm) and animals receiving paclitaxel (0.63 mm, range 0.42-0.98 mm, p<0.05). Local delivery of paclitaxel at the time of TIPS creation may have been effective in reducing pseudointimal/intimal hyperplasia in swine TIPS models.