Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness

Single arm pilot study of adults ≥18yo investigating changes in liver stiffness as measured
by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS.
Duration of participation is 30 days from TIPS creation. TIPS creation with Viatorr stent
graft will be in accordance with its FDA-approved indication for symptomatic portal
hypertension and per the manufacturer's instructions for use. Liver stiffness will be
measured on pre-TIPS and post-TIPS ultrasounds using Phillips Epiq Ultrasound systems
equipped with ElastPQ ultrasound shear wave elastography. Both ultrasounds will be performed
at times which are standard of care before and after TIPS creation. Primary objectives
include liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI)
before and after creation of TIPS. Secondary objectives include change in portosystemic
gradient, clinical success as measured by difference in frequency of repeat paracentesis
post-TIPS or freedom from recurrence of variceal bleeding and rate of hepatic encephalopathy.
Exploratory objectives include serum biomarkers of liver stiffness.

Inclusion Criteria:

- Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient
TIPS

- Age >18, Age <80

- Capable of giving informed consent

Exclusion Criteria:

- Coagulopathy defined as international normalized ration (INR) >2 which cannot be
corrected with fresh frozen plasma

- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion

- BMI >35 and/or cirrhosis due to non-alcoholic steatohepatitis (due to inaccurate
elastography measurements in patients with fatty liver)

- Urgent or emergent TIPS for bleeding

- Portal vein thrombosis with in the main, 1st, or 2nd order branches of the portal vein

- Hepatic vein thrombosis (ie no Budd Chiari syndrome)

- Excessive alcohol use defined as more than 2 oz in 24 hours on any individual day
within the last 30 days

- Inability to provide informed consent

- Pregnant or nursing women

- Enrollment in concurrent therapeutic trial for symptomatic portal hypertension