Refractory Ascites: : TIPS. Jayer Chung, MD Department of Surgery University of Colorado Health Sciences Center

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1 Refractory Ascites: : TIPS vs non-tips Jayer Chung, MD Department of Surgery University of Colorado Health Sciences Center

2 Overview Definition and epidemiology of refractory ascites (RA) Pathophysiology of ascites Description of the treatments for RA Why are other therapies better than TIPS? Transplant TIPS vs LVP- encephalopathy, QOL, cost, frequent occlusions TIPS vs peritoneovenous shunts Conclusion

3 Refractory ascites Definition- complication of portal hypertension; inability to mobilize ascites despite adequate Na restriction and maximal diuretic therapy DDx: cardiogenic, nephrogenic, malignant, or chylous ascites Transudate; < 2.5; SAAG > 1.1 for portal hypertension 1 Incidence/ Prevalence- ~ 10% of all patients with portal hypertension Mortality- 1- and 2- yr mortality: >50% and 80% respectively 2 SBP and hepatorenal syndrome, encephalopathy, & variceal hemmorrhage

4 Portal hypertension 2 Vasodilation and decrease in circulating blood volume Decrease oncotic pressure Activation of renin/ angiotensin system, SNS, and AVP + Increase pre-sinusoidal/ post-sinusoidal gradient Na and H 2 O retention Ascites

5 Transplant Treatments Transjugular Intrahepatic Portosystemic Shunt (TIPS) Large Volume Paracentesis (LVP; >5L) Peritoneovenous shunt (LaVeen, and Denver) Open portosystemic shunts

6 Large Volume Paracentesis (LVP) 2 Indications Tense ascites Complications Repeated complement and protein depletion, SBP, hypotension Colloid replacement (albumin) if > 5L removed

7 Transplant 4 Indications- Acute or chronic liver failure of any cause (Child s > 7, MELD > 10) Contraindications Morbid obesity, active extrahepatic malignancy, active sepsis, HIV, non-compliance, cholangiocarcinoma, HCC > 6cm

8 3

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10 (+) (-)

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12 4 Indications Refractory ascites, not eligible for LVP, transplantation, or TIPS Complications Shunt malfunction, occlusion, DIC, variceal bleeding, sepsis, SBO/ adhesions, electrolyte abnormalities, fluid leak, SVC thrombosis

13 Transplant is #1 therapy for RA Gold standard- 1-, 5-, 10-yr survival of 81%, 72% and 68% respectively 5 Only curative therapy for refractory ascites Improve health-related quality of life 6 Only problem is organ shortage : Candidacy by 8x, organs only by 2x 3 17,269 candidates on wait list, and only 5,906 donors for

14 Why is TIPS the same or worse than LVP? No overall change in survival vs LVP Complications- frequent stenoses/ occlusions, hepatic encephalopathy QOL Cost

15 No survival benefit vs LVP Authors N 8 Lebrec 9 25 Rossle Gines Sanyal Salerno Lower with TIPS Lower with paracentesis

16 Tripathi et al. N=472, 10 yr f/u. 50% requiring 12 months, 31% failing by 6 months

17 9 Authors N 8 Lebrec 9 25 Rossle Gines Sanyal Salerno Lower with TIPS Lower with paracentesis

18 QOL Campbell MS et al. 109 pts (52/57), PRCT, 1 yr f/u pts (57%) in TIPS arm vs 8 pts (24%) in LVP arm required re-hospitalization (p=0.006) SF-36 questionnaire showed no change, largely due to the increase in encephalopathy in the TIPS arm (49% vs 6 months) Due to the increased frequency of hospitalizations (secondary to further interventional procedures) and increased frequency of encephalopathy, there is no overall improvement in QOL despite improvements in ascites control.

19 Cost 11 Gines PRCT, N=70 (35/35) TIPS 103% more expensive than repeated LVP ($19,813 vs $9,765) Analysis of the cost of procedures only; hence, this analysis likely underestimates the cost of TIPS vs LVP

20 TIPS vs Peritoneovenous shunts Rosemurgy N=32(16/16), PRCT, 3 yr f/u 16 Denver shunts only Mortality 28.7 months vs 16.1 months median survival Ascites 54% control vs 80% 1 month 80% control vs 54% 1 yr Patency Median primary patency of 4.4 months vs 4 months, though assisted patency of 31.1 months vs 13.1 months Short term results comparable, though TIPS better long-term

21 Conclusions Transplant the gold standard, but organ shortage Short term results of TIPS and peritoneovenous shunts comparable TIPS only superior to LVP with respect to removal of ascites Similar or worse QOL Frequent hospitalizations and increased rates of encephalopathy No change in overall mortality Much more expensive $$$$

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23 References 1. Townsend CE, et al. Sabiston Textbook of Surgery: The Biological Basis of Modern Surgical Practice. 17 th edition, Zervos EE, et al. Management of medically refractory ascites. The American Journal of Surgery. 2001; 181: Trotter JF, et al. Adult-to-Adult Transplantation of the Right Hepatic Lobe from a Living Donor. NEJM. 2002; 346(14): Murray KF, et al. AASLD Practice Guidelines: Evaluation of the Patient for Liver Transplantation. Hepatology. 2005; 41: Boyer T, et al. AASLD Practice Guideline: The Role of Transjugular Intrahepatic Shunt in the Management of Portal Hypertension. Hepatology. 2005; 41: Orsi F, et al. Percutaneous Peritoneovenous Shunt Positioning: Technique and Preliminary Results. Eur Radiol. 2002; 12: Busuttil RW, et al. Analysis of Long-term Outcomes of 3200 Liver Transplantations Over Two Decades: A Single-Center Experience. Annals of Surgery. 2005; 241(6): Sainz-Barriga M, et al. Quality-of-Life-Assessment Before and After Liver Transplantation. Transplantation Proceedings. 2005; 37: United Network for Organ Sharing (UNOS): Data Resources Page. Retrieved January 25, 2006 from the UNOS website: Abillos A, et al. A meta-analysis of transjugular intrahepatic portosystemic shunt versus paracentesis for refractory ascites. Journal of Hepatology. 2005; 42: Lebrec, D et al. Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial. Journal of Hepatology. 1996; 25:

24 10. Rossle M, et al. A Comparison of Paracentesis and Transjugular Intrahepatic Portosystemic Shunting in Patients with Ascites. NEJM. 2005; 342(23): Gines P, et al. Transjugular Intrahepatic Portosystemic Shunting Versus Paracentesis Plus Albumin for Refractory Ascites in Cirrhosis. Gastroenterology. 2002; 123: Sanyal AJ, et al. The North American study for the Treatment of Refractory Ascites. Gastroenterology. 2003; 124: Salerno F, et al. Randomized Controlled Study of TIPS Versus Paracentesis Plus Albumin in Cirrhosis With Severe Ascites. Hepatology. 2004; 40: Tripathi D, et al. Ten Years follow-up of 472 patients following transjugular intrahepatic portosystemic stent-shunt insertion at a single centre. European Journal of Gastroenterology & Hepatology. 2004; 16: Campbell MS, et al. Quality of Life in Refractory Ascites: Transjugular Intrahepatic Portal- Systemic Shunting Versus Medical Therapy. Hepatology. 2005; 42: Rosemurgy A, et al. TIPS Versus Peritoneovenous Shunt in the Treatment of Medically Intractable Ascites: A Prospective Randomized Trial. Ann Surg. 2004; 239:

25 A= 5-6 (10%), B= 7-9 (31%), C= (76%)

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27 Non-selective Completely divert portal flow End-side (Eck s fistula) &side-side portacaval, mesocaval, and mesorenal, H- graft (8mm PTFE), splenorenal shunt Selective Distal spleno-renal (Warren)

28 Odds Ratio- probability of disease among exposed subjects/ probability of disease in unexposed subjects (ad/bc) Hepatorenal syndrome High M&M; avid Na retention, UNa<5mmol Hepatopulmonary syndrome R to L intrapulmonary shunt through dilated intrapulmonary vessels + ascites leads to hypoxia