Contraindications Absolute Relative Primary prevention variceal bleeding HCC if centrally located Active congestive heart failure Obstruction all hepatic veins Thomas D. Boyer, M.D. University of Arizona Multiple hepatic cysts Portal vein thrombosis Uncontrolled sepsis or infection Severe coagulopathy (INR > 5) Unrelieved biliary obstruction Thrombocytopenia < 20,000 Severe pulmonary hypertension Moderate pulmonary hypertension Advanced liver disease Currently TIPS is considered second or third line therapy for: Acute variceal bleeding Recurrent variceal bleeding Refractory ascites Is this the way TIPS should be used? Indications Efficacious Efficacy unclear No efficacy Secondary prevention VB Hepatorenal syndrome (I & II) GAVE Refractory acute VB Hepato-pulmonary syndrome VOD Refractory cirrhotic ascites Portal hypertensive gastropathy Bleeding gastric varices Budd-Chiari syndrome Complications Intraperitoneal bleed 1-2% Hepatic infarction < 1% Hepatic encephalopathy New/worse 10-44% Chronic 5-20% Death Refractory hepatic hydrothorax 1
Risk of HE with covered stents 78 patients 35 of 78 developed HE HR p Age 1.086 0.000002 Creatinine 1.02 0.041 Albumin 0.352 0.001 Sodium 0.926 0.016 Refractory HE only serum creatinine Riggio et al Am J Gastro 2008;103:2738 Models Emory Variables Acute bleeding, bilirubin > 3.0, ALT > 100, pre- TIPS HE MELD Variables Bilirubin, creatinine, INR Risk stratification for HE Limited data Patients > 70 yo probably at increased risk Unclear how size of stent or degree of reduction in pressure affects risk More advanced liver disease at increased risk but role of TIPS unclear Based on current data no clear metric to deny TIPS creation because of risk of HE high risk Low risk Gastroenterology 2000;118:138 2
MELD score and surgical risk 30 days Emory MELD CPS 3 months 12 months 90 days x Am J Gastro 2003;98:1167 X X X Teh et al. Gastroenterology 2007;132:1261 Multivariates and survival following TIPS 30 days 90 days 360 days Variable OR p value RR p value RR p value Age > 70 2.2 0.1 3.1 0.0008 3.1 0.0004 MELD 16-20 4.9 0.0003 3.0 0.0008 1.7 0.03 > 20 18.2 <0.0001 9.7 >0.0001 5.5 >0.0001 Pan et al. J Vasc Interv Radiol 2008;19:1576 Low 1 year 80-90% Elective prevention variceal rebleeding MELD < 10 Total serum bilirubin < 2 mg/dl Child-Pugh class A/B+ Serum creatinine < 1.2 mg/dl Normal serum sodium Medium 1 year 50-80% Elective treatment refractory ascites MELD 11-18 Child-Pugh class B- Total serum bilirubin 3-4 mg/dl Serum sodium < 140 to 130 mmol/l High 1 year < 50% Emergent TIPS for bleeding varices MELD > 18 Child-Pugh C Total serum bilirubin > 4 mg/dl Serum sodium < 130 mmol/l Serum creatinine > 1.7 mg/dl Age > 70 yo MELD and survival after TIPS x < 15 x 16-20 > 20 When the risk is high should a TIPS not be performed despite benefit? Acute variceal bleeding Refractory ascites Variceal rebleeding Pan et al. J Vasc Interv Radiol 2008;19:1576 3
TIPS in acutely bleeding varices Control Rebleeding Mortality 94 ± 7% 12 ± 6% 36 ± 16% J Hepatology 2003;37:703 LR HVPG < 20 mmhg CPS 8.4 HR HVPG 20 mmhg CPS 9.2 Monescillo et al. Hepatology 40:793,2004 MELD = 15.5 bilirubin = 3.7 ± 4.8 MELD = 16.9 bilirubin = 4.4 ± 4.9 Garcia-Pagan NEJM 2010;362:2370 Criteria CPS class C or class B plus active bleeding Covered stents J Hepatol 2005;43:990-6 Garcia-Pagan NEJM 2010;362:2370. Criteria CPS class C or class B plus active bleeding Covered stents Gastroenterology 2007;133:825 4
TIPS vs LVP and 1 year mortality bare stents Cost of preventing rebleeding 90 80 25,000 Mortality % 70 60 50 40 30 20 10 0 TIPS Gastroenterology 2007;133:825 LVP MELD 10 MELD 15 MELD 19 Yearly cost ($) 20,000 15,000 10,000 5,000 0 Rubenstein et al. Am J Gastro. 2004;99,1274 Boyer et al. J Hepatololgy 2008;48:407 VBL + drug VBL No Rx TIPS DSRS Endo, TIPS and shunts in variceal rebleeding PTFE covered stents Rebleeding % Enceph % Death % Endo Shunt Endo Shunt Endo Shunt 50 12 9 17 29 29 Endo TIPS Endo TIPS Endo TIPS 47 19 19 34 27 27 Shunt vs. Endo-odds ratio 0.24 (0.18-0.3) 2.09 (1.2-3.6) 1.0 (0.82-1.2) % Survival 100 90 80 70 60 50 40 30 20 10 Survival following TIPS for bleeding Median ~MELD 10-12 P = 0.84 DSRS TIPS censored patient 0 0 12 24 36 48 60 Follow-up (Months) Henderson et al Gastroenterology 2006;130:1643 Bare vs covered stents % of patients 60% 50% 40% 30% 20% 10% 0% Gastroenterology 2004;126:469 dysf angio throm mortality HE coated bare 5
Conclusions TIPS is effective in the control Acute bleeding from varices and may be procedure of choice in high risk patients Recurrent bleeding from varices-as as effective as shunts with similar HE and cost Refractory cirrhotic ascites and may improve survival irrespective of MELD score Thank you Hepatologist Just do it and I will take care of patient. Vs. IR I I will not kill this patient. Let them bleed to death instead Conclusions-continued continued Are we disadvantaging our patients by using strict criteria for not doing TIPS? Risk must be balanced by benefit We need more studies comparing TIPS to alternative therapies to allow for better decision making=new trial of resistant ascites Use of covered stents may significantly alter outcomes 6