A novel intravascular navigational ultrasound system for transjugular intrahepatic portosystemic shunt procedures.

BACKGROUND AND AIMS: Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method for reducing portal hypertension in patients with decompensated cirrhosis. However, portal vein puncture is associated with a steep learning curve. Conventional "blind" puncture methods are often imprecise, carry a high risk of complications, and require significant radiation exposure. To increase puncture accuracy, we developed an intravascular navigational ultrasound (IVNU) system. This study aimed to evaluate the feasibility, efficacy, and safety of IVNU for portal vein puncture during TIPS procedures. METHODS: In the in vitro experiment, we performed punctures using IVNU in four isolated porcine livers. Subsequently, in the in vivo animal study, eight Bama swine (Sus scrofa) were randomly assigned to undergo TIPS using either IVNU (experimental group) or conventional "blind" puncture with the RUPS100 COOK kit (control group). RESULTS: In our in vitro experiment, the IVNU system successfully punctured each lobe. In our in vivo study, all the procedures successfully established portosystemic shunts. The IVNU group exhibited significantly fewer punctures (1.8 ± 0.4 vs. 4.2 ± 1.1), shorter procedure times (32.5 ± 4.2 min vs. 58.7 ± 6.5 min), shorter fluoroscopy times (8.1 ± 1.3 min vs. 20.4 ± 2.1 min), and lower radiation doses (579.5 ± 45.9 mGy vs. 1305.7 ± 50.4 mGy) than the control group (all P < 0.01). Puncture-related complications were also significantly reduced in the IVNU group. CONCLUSIONS: These findings indicate that IVNU significantly improves portal vein targeting success, reduces the risk of puncture-related complications and radiation exposure, and decreases procedure time, offering clinicians an optimized solution for TIPS creation.