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Boston, Massachusetts; Tuesday, November 2, 2004 -- Transjugular intrahepatic portosystemic shunts (TIPS) have become an important part of the therapeutic armamentarium in patients with advanced liver disease.[1] Although the indications for use of TIPS are evolving, TIPS are often used in patients with refractory ascites, recurrent esophageal hemorrhage, or in those with initial bleeding that is refractory to standard medical and endoscopic therapy.[1,2] Nonetheless, the major problem with TIPS is that they often become occluded. Indeed, the rate of stenosis after placement of TIPS is at least 80% after 2 years,[3,4] and this leads to significant morbidity and mortality, as well as to substantial incremental cost.
This report highlights some of the more key information on this clinically important issue, as presented during this year's meeting of the American Association for the Study of Liver Diseases (AASLD), and places it in relevant and appropriate context for the clinician.
Important new data presented at this year's AASLD meeting focused on the management of patients with cirrhosis and portal hypertension. The use of polytetrafluoroethylene (PTFE)-coated stents and standard stents was addressed in a study presented by Bureau and colleagues.[5]
This multicenter study examined whether the use of coated stents provides greater long-term patency than uncoated stents. The study group included patients with cirrhosis and portal hypertension with standard indications for TIPS. The patients were well matched for clinical parameters, including epidemiologic features and disease. The mean Child-Pugh-Turcotte (CPT) score was 9 (individual CPT scores were as follows: type C, 37; B, 32; A, 11) and mean age was 55 years. Subjects were randomized to either coated or uncoated TIPS and were followed at 1, 3, 6, 9, 12, 18, and 24 months after TIPS. At 6, 12, and 24 months, angiography and hepatic venous pressure gradients (HVPG) were performed to assess patency and function of TIPS. The main endpoint was shunt dysfunction, which was defined as > 50% stenosis of the TIPS or an HVPG of 12 mmHg. Forty-one subjects received an uncovered stent, while 39 subjects received a coated stent. The actuarial rates of primary TIPS patency were 76% (30 patients) vs 36% (15 patients) in the coated vs uncoated groups, respectively (P = .001). Four subjects in the uncoated group and 12 subjects in the coated group had a recurrent clinical complication of portal hypertension (P = .002). Survival was 58% in the coated-stent group compared with 45% in the uncoated-stent group. It was interesting to note that the rate of hepatic encephalopathy was lower in the PTFE-covered stent vs the noncovered-stent group (33% vs 49%; P < .05). It was postulated that the reason for the lower rate of hepatic encephalopathy in the PTFE group was because patients in this arm had a lesser need for revision.
The study authors concluded that the use of PTFE-coated stents improves the long-term patency of TIPS, prevents clinical relapse of complications of portal hypertension, and decreases the rate of hepatic encephalopathy. Two other studies[6,7] presented during these meeting proceedings also addressed the role of PTFE-coated stents. Each of these studies, although nonrandomized, indicated that PTFE-covered stents reduced the incidence of shunt dysfunction, and in 1 study improved survival. These data indicate that PTFE coating is clinically desirable, and that this type of shunt should be used in patients requiring TIPS.
The risk of recurrent bleeding in patients with esophageal varices who have had an index bleed is substantial (in some studies, as high as 80% within 2 years). Moreover, a significant number of these patients will have medically and endoscopically refractory bleeding (estimated to be 20% to 30%), which requires more aggressive intervention. Therapeutic options include TIPS and shunt surgery. The distal splenorenal shunt is favored over portocaval shunt because of its lower risk of hepatic encephalopathy. This issue was addressed in a study by Henderson and colleagues,[8] as presented during this year's meeting.
This multicenter randomized trial, presented as a late-breaking abstract, initiated in 1997 and enrolled a total of 149 subjects (73 to distal splenorenal shunt and 76 to TIPS). All patients had CPT A (41 in the distal splenorenal shunt group and 39 in the TIPS group) or B (60 patients, 32 in the distal splenorenal shunt group and 38 in the TIPS group) cirrhosis, and failed endoscopic and/or pharmacologic therapy. Their decompression procedure was performed within 5 days of randomization. Patients were well matched in terms of clinical entry parameters, including age, sex, and ethanol consumption. The median duration of follow-up was 42 months. Rates of rebleeding were 5.5% (4 patients) for distal splenorenal shunt and 9% (7 patients) for TIPS. However, the need for reintervention was 11% for the distal splenorenal shunt group and 82% for TIPS. There was no difference between the 2 groups in the rate of hepatic encephalopathy or mortality. Of note, the operative mortality was 6% for subjects undergoing distal splenorenal shunt. Although a number of further analyses are planned (ie, to examine cost-effectiveness, secondary endpoints, etc.), these data suggest that these 2 forms of therapy are equally effective. A cost-analysis is eagerly anticipated, as it may show that given the need for reintervention, distal splenorenal shunt is actually more cost-effective than TIPS.
The 2 studies highlighted here were carefully performed randomized controlled trials. Therefore, these data are important and should be considered in current clinical practice. It is clear that TIPS is an important component of our current clinical management for patients with portal hypertension -- it is this physician's belief that TIPS should be performed with PTFE-covered stents (it is not known whether coating with additional agents could further improve the performance). In terms of management of patients with refractory variceal bleeding, TIPS is clearly effective, and may be preferable compared with shunt surgery because it is less invasive. We eagerly await more data regarding associated costs.
