Transjugular intrahepatic portosystemic shunt effective in preventing recurrent variceal hemorrhage [Classics Series]

1. In patients with recurrent variceal bleeding secondary to portal hypertension, the use of transjugular intrahepatic portosystemic shunt (TIPS) demonstrated high efficacy in preventing variceal re-bleeds.

2. The major complications associated with TIPS are stent occlusion and stenosis as well as an increased incidence of hepatic encephalopathy.

Original Date of Publication: January 1994

This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials, 2e (The Classics Series).

Study Rundown: In patients with advanced liver disease and cirrhosis, variceal bleeding resulting from increased portal pressure is a potentially-life threatening complication. Each variceal bleeding episode is associated with a 30% mortality rate and a 70% risk of recurrent bleeding within 1 year. In patients refractory to medical and endoscopic management, surgical portacaval shunts were historically the mainstay of therapy in selected patients. The advent of TIPS, which involves creating a low-resistance channel between the hepatic and portal vein via percutaneous vascular access, provided a less invasive alternative to reducing portal hypertension. The purpose of this landmark prospective trial was to report the safety and efficacy of TIPS in the treatment of recurrent variceal bleeds secondary to liver cirrhosis.

The prospective trial reported the outcomes of 100 patients with cirrhosis and recurrent variceal bleeding. The majority of patients had failed previous endoscopic sclerotherapy. Outcomes of interest included frequency of technical success, evidence of decreased portal pressure via duplex sonography, variceal re-bleeding rates post-procedure, and rates of complication. At the conclusion of the trial, TIPS was successfully performed in nearly all patients in the cohort resulting in a significant reduction of portal venous pressure gradient. Subsequently, over 90% of patients were free of variceal bleeds at 6 month follow-up. The major complications included stent restenosis and occlusion, which occurred in 30% of patients. All patients experiencing complications were successfully managed with re-stent or dilatation. TIPS was associated with an increase in hepatic encephalopathy, although this was comparable to the rates observed in surgical shunts. This trial is limited by the observational nature of the trial and the lack of comparison groups to endoscopic sclerotherapy or surgical shunts. However, this was the first large trial to describe the successful use of TIPS. Future randomized trials have confirmed the conclusions of this trial and have established TIPS as a viable treatment method for patients with recurrent variceal bleeds.

Please click to read study in NEJM

In-Depth [prospective cohort]: This was a prospective study of 112 consecutive patients that underwent TIPS for recurrent variceal bleeding secondary to liver cirrhosis. Twelve patients were excluded due to the presence of either portal vein thrombosis, severe hepatic encephalopathy, stenosis of celiac trunk, or another primary liver malignancy. Overall, 90 patients in the cohort had TIPS inserted electively while 10 patients were treated emergently for acute variceal bleeds. The majority (92%) of patients had previous unsuccessful endoscopic sclerotherapy treatment. After insertion of TIPS, patients were followed at 1 month and then at 3 month intervals for sonographic assessment of stent patency and clinical assessment of hepatic encephalopathy. At the conclusion of the trial, TIPS were successfully inserted in 93 of 100 patients in the cohort. The mean duration of each procedure was 1.2 hours (range 30 minutes to 3 hours). There was significant reduction of portal pressure gradient associated with a significant elevation of portal blood flow post-TIPS. Major complications occurred in 15 patients and consisted of intraperitoneal and biliary hemorrhage as well as hematoma of the liver capsule. Two patients had migration of the stent to the pulmonary arteries.

At clinical follow-up, the proportion of patients that remained free of variceal bleeding at 6 months and 1 year post-TIPS was 92% and 85%, respectively. The 1 year survival in this cohort was 85%. The incidence of hepatic encephalopathy increased from 10% to 25% post-treatment. Older patients and larger diameter of shunt used were significantly associated with development of hepatic encephalopathy. Additionally, 31 patients developed stent occlusion or stenosis. Of these, 10 patients developed recurrent variceal bleeding at 1 year follow-up. Smaller stent diameter was a significant risk factor for stent occlusion/stenosis. All patients experiencing stent occlusion/stenosis were successfully treated with re-stent, thrombolysis, or stent dilation.

Rossle M, Haag K, Ochs A, Sellinger M, Noldge G, Perarnau J-M, et al. The Transjugular Intrahepatic Portosystemic Stent-Shunt Procedure for Variceal Bleeding. New England Journal of Medicine. 1994 Jan 20;330(3):165–71.

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