Transjugular Intrahepatic Portosystemic Shunt (TIPS) clinical trial under IRB approval. True 3D Viewer 1.0 is 510K cleared by FDA; development and 510K clearance in process for all other applications

Luminary Site: Cleveland Clinic

Principal Investigator: Mark Sands, MD. FACR. Vice Chairman of Quality and Clinical Operations & Section Head, Interventional Radiology. Vice Chairman, Imaging Institute at the Cleveland Clinic.

Clinical Problem 

A transjugular intrahepatic portosystemic shunt (TIPS) is a percutaneous method used to treat the complications of
portal hypertension. During the TIPS procedure a channel is created through the hepatic parenchyma that shunts blood
from the portal vein to a hepatic vein, reducing the portosystemic pressure gradient.The high rate of shunt obstructions seen with TIPS mandates optimum pre-surgical planning and navigation. However, mapping CT image data or rotational angiography onto fluoroscopy image planes is not only difficult to accomplish accurately, there is significant data lost in translation with a 2D map attempting to describe a 3D structure. 

Goals:

  1. Improve anatomic understanding. The  t3D-TIPS protocol can provide a better understanding of portal and hepatic vein spatial location and liver structure because it integrates all three dimensions and corresponding depth cues in a single view.
  2. Increase surgical sensitivity. The t3D-TIPSsolution can provide an improved visualization to facilitate navigation from the hepatic vein to the portal vein because the accurate depiction of depth information provided by t3D enhances the 3D structure that define the liver parenchyma. 
  3. Reduce radiation during surgery. The t3D-TIPS navigation strategy can significantly reduce error checking when evaluating fluoroscopic images to traverse the liver as it provides a virtual copy of the patient.