Clinical evaluation of TIPS procedure guidance software

Purpose TIPS is an effective treatment for portal hypertension. Using fluoroscopic guidance, the target portal vein (PV) is only visible during a CO2 portogram, which cannot be used during PV access. Software has been developed to provide intra-procedural 3D needle guidance from 2 CO2 portograms. The purpose of this study was to demonstrate the utility of this software in creating TIPS shunts. Materials and Methods In 40 patients referred for TIPS (26M/14F, 58±13 yrs), 2 CO2 portograms were acquired at least 20 deg apart. The user then marked the hepatic vein (puncture origin) and PV (target) in each image using prototype software (Siemens Healthcare, Germany). A puncture path connecting these points was displayed on live fluoro and updated in real time with c-arm movement. Puncture attempts, fluoro time and x-ray dose were recorded. Results In 12 subjects the software could not be used: PV not visible on portogram (n=7), technical issues (3), high right heart pressure (2). In 21 of the remaining 28 cases (75%), the procedure was successful using the planned path. When the path was followed, all measured variables were significantly lower than when it was not: puncture attempts (4±5 vs 13±8 p Conclusion In conclusion, software has been developed which provides needle guidance during TIPS procedures. Use of the overlaid path results in significantly fewer puncture attempts and reduced x-ray exposure. Bending the needle according to the software determined angle increased the percentage of patients in whom the path could be followed reliably.