A Clinically Applicable Fiber-optic Imaging /in-plane IVUS–integrated Needle/balloon Catheter System for TIPS Creation in Normal Adult Pigs

Purpose: To utilize a clinically applicable fiber-optic imaging and/or in-plane intravascular ultrasound (IVUS)–integrated needle/balloon catheter system for TIPS creation in normal adult pigs, as a significant step toward clinical translation of this technique for TIPS.

Materials and Methods: At the 2025 annual SIR meeting, we presented our proof-of-principle study, using a lab-made 21G needle-integrated balloon catheter system for TIPS creation. We upgraded the system to a clinically applicable version with a few key improvements: (1) a 15-French, three-lumen balloon catheter with a 12mmx20 mm eccentric balloon was manufactured by a professional balloon catheter company and the eccentric balloon provides sufficient strength to facilitate the needle puncture into the portal vein; (2) a hemostasis valve is attached at the proximal end of the catheter to stabilize the intracardiac echocardiography (ICE) probe; (3) the redesigned handle significantly improved the ergonomics;(4) a 0.020-inch stainless steel sharp-tipped stylet can reinforce the needle, facilitate the intrahepatic puncture, and enhance the echogenicity for improved needle visibility. We tested the new system in 12 live pigs for creating the TIPS and compared puncture attempts, procedure time, and radiation dose with the prior prototype.

Results: The clinically applicable system allowed more accurate and efficient targeting of the portal vein. In 12 live pigs, a 100% success rate of optimal portal vein puncture was achieved using the following optimal parameters: an 8-cm curved needle tip, a 120°-135° needle-tip angle, 45° counterclockwise rotation of the balloon catheter in the hepatic vein, and a catheter depth of 4.5–5 cm within the hepatic vein. Compared with our lab’s proof-of-concept prototype tested last year, the current clinically applicable system significantly reduced needle puncture attempts (2 ± 1 vs. 5 ± 1), shortened procedure time (20 ± 5 vs. 32 ± 5 minutes), and lowered radiation dose (97 ± 11 vs. 180 ± 9 mGy).

Conclusion: The upgraded needle-integrated micropuncture balloon catheter system enables precise, safe, and reliable intrahepatic puncture for TIPS creation in live pigs, representing an important step toward clinical translation for challenging TIPS procedures.