TIPS Plus Transvenous Obliteration for Gastric Varices
TIPS Plus Transvenous Obliteration for Gastric Varices
Variceal hemorrhage (VH) from gastric varices (GVs) results in significant morbidity and
 mortality among patients with liver cirrhosis. In cases of acute bleeding, refractory
 bleeding, or high risk GVs, the transjugular intrahepatic portosystemic shunt (TIPS) creation
 and transvenous variceal obliteration procedures have used to treat GVs. While these
 techniques are effective, each is associated with limitations, including non-trivial
 rebleeding and hepatic encephalopathy rates for TIPS and aggravation of esophageal varices,
 development of new or worsening ascites, and formation of difficult to treat ectopic varices
 for transvenous obliteration. Increasingly, however, TIPS and transvenous obliteration are
 viewed as complimentary procedures that can be combined to reduce bleeding risk and
 ameliorate sequelae of portal hypertension. Yet, despite a strong mechanistic basis for their
 combination, there are few studies investigating the combined effectiveness of TIPS plus
 transvenous obliteration. Thus, the aim of this single center prospective pilot study is to
 assess the effectiveness and safety of combined TIPS creation plus transvenous obliteration
 for the treatment of GVs, with the overall goal of improving the clinical outcomes of
 patients with VH related to GVs. The work proposed could lead to important advances in the
 treatment of bleeding complications due to liver cirrhosis.
Liver cirrhosis-or scarring of the liver-occurs with a worldwide prevalence approximating
 4.5-9.5%, affecting hundreds of millions of people. Cirrhosis results in 2% of all global
 mortality, approximating 1 million deaths per year, and affects more than 600,000 persons in
 the United States. Variceal hemorrhage (VH) from gastroesophageal varices (GEVs) is a leading
 cause of mortality in patients with liver cirrhosis. Gastric varices (GVs) occur in 5-33% of
 patients with cirrhotic liver disease and have a bleeding incidence of 25% within 2-years of
 development, 36% within 3-years, and 44% within 5-years. GVs are associated with high
 mortality rates approximating 25% at 2-years. First-line therapy in patients who have not
 bled includes preventative pharmaceuticals, while acute bleeding is typically treated with
 vasoconstrictive agents and endoscopic variceal ligation or sclerotherapy. In cases of acute
 hemorrhage, refractory bleeding, or high risk GVs, Interventional Radiology (IR) guided
 transjugular intrahepatic portosystemic shunt (TIPS) creation is recommended to decompress
 varices and divert blood flow through a controlled synthetic conduit. In the modern era, TIPS
 is associated with initial GV bleeding control in greater than 90% of cases. However, GV
 rebleeding rates after TIPS are non-trivial, widely ranging between 13-53%. Moreover, GVs are
 widely thought to remain patent and sustain bleeding at low portosystemic pressure gradients
 (PSGs), as is the case after TIPS. In addition, TIPS can also contribute to high rates
 hepatic encephalopathy (HE) due to increased portosystemic shunting. Recently, transvenous
 obliteration techniques-including balloon-occluded retrograde (BRTO) and antegrade (BATO)
 transvenous obliteration as well as more recent adaptations including coil- (CARTO) and
 plug-assisted (PARTO) retrograde transvenous obliteration-have been developed with the intent
 of directly eradicating GVs. While obliteration techniques are associated with high technical
 success rates approximating 91-100% and low rebleeding incidence less than 5%, the worsened
 portal hypertension that follows from GV closure results in adverse side effects, including
 aggravation of esophageal varices (EVs) in 33% of patients, development of new or worsening
 of ascites in 10% of patients, and formation of difficult to treat ectopic varices.

 Traditionally, TIPS and transvenous obliteration have evolved in relative isolation as
 different philosophical strategies to address VH. TIPS is more commonly utilized in North
 America and Europe, where portal decompression with or without adjunctive embolization of
 varices has been a mainstay of endovascular strategy. Conversely, transvenous obliteration
 evolved in Asia as a direct treatment of VH by obliterating GEVs (particularly GVs) via
 sclerosis. These approaches were previously viewed as in conflict with one another as
 obliteration closes GVs but aggravates portal hypertension, whereas TIPS is designed to
 reduce portal hypertension. Increasingly, however, TIPS and transvenous obliteration are
 viewed as complimentary procedures that can be combined to reduce bleeding risk and
 ameliorate sequelae of portal hypertension. Performed together, TIPS and transvenous
 obliteration result in the elimination of high flow GVs that are at risk for life threatening
 hemorrhage, with replacement by a man-made endovascular created portosystemic shunt that is
 not at risk for rupture as well as reduction the risk for post-obliteration EV aggravation,
 ascites formation, or development of ectopic varices.

 Yet, despite a strong mechanistic basis for their combination, there are few studies
 investigating the effectiveness of combined TIPS plus transvenous obliteration. Thus, the
 overarching goal of this single center prospective pilot study is to assess the effectiveness
 and safety of combined TIPS creation plus transvenous obliteration for the treatment of GVs.
Inclusion Criteria:

 -  Aged ≥ 18 years

 -  Ability to provide written consent

 -  Endoscopically proven acute or recurrent VH from GVs, or high risk GVs

 Exclusion Criteria:

 -  Prior indwelling TIPS

 -  Prior endovascular obliteration procedure

 -  Elevated heart pressures (left or right)

 -  Heart failure or severe valvular insufficiency

 -  Severe pulmonary hypertension

 -  Rapidly progressive liver failure

 -  Severe or uncontrolled hepatic encephalopathy

 -  Uncontrolled systemic infection or sepsis

 -  Unrelieved biliary obstruction

 -  Polycystic liver disease

 -  Extensive primary or metastatic hepatic malignancy

 -  Severe uncontrolled coagulopathy

 -  Pregnancy