The use of a polytetrafluoroethylene-covered stent graft for transjugular intrahepatic portosystemic shunt (TIPS): Long-term follow-up of 100 patients.

PURPOSE: To retrospectively evaluate results and clinical outcome of transjugular intrahepatic portosystemic shunt (TIPS) after implantation of a polytetrafluoroethylene (PTFE)-covered stent graft. MATERIAL AND METHODS: The stent graft was used in 112 patients with higher risk of primary (i.e. patients with Budd-Chiari syndrome) or secondary shunt failure (patients with occlusion of a previous uncovered stent), or a complicated TIPS procedure with an imminent technical complication requiring covered stent. Patients were scheduled at 3- to 6-month intervals for duplex-sonographic control of shunt function. Radiological revision was performed in patients with a decrease in shunt function by >25%, primary non-response, or relapse of the index symptom. RESULTS: Twelve patients were lost to follow-up, and 100 patients were followed for 22+/-15 months. The actuarial rates of shunt patency were 90, 84, and 74% at 1, 2, and 3 years of follow-up, respectively. Two patients developed early (within 1 month) and 14 patients late shunt failure. Except for one transient rise in liver enzymes due to outflow obstruction by the stent graft, no technical complications were seen. Primary response to treatment was seen in 97% of patients treated for variceal bleeding and 84% of patients treated for refractory ascites. A relapse of the index symptom was seen in 13% of bleeders and 9% of patients treated for refractory ascites. CONCLUSION: TIPS created with a PTFE-covered stent graft showed favorable long-term results.

Treatment of refractory hepatic hydrothorax with transjugular intrahepatic portosystemic shunt: long-term results in 40 patients.

BACKGROUND/AIMS: Hepatic hydrothorax is a complication of portal hypertension secondary to ascites. In this study, we investigated retrospectively the effects of the transjugular intrahepatic portosystemic shunt (TIPS) on hepatic hydrothorax refractory to diuretic treatment. METHODS: Forty patients (Child-Pugh class B, 24 patients; Child-Pugh class C, 16 patients) with hydrothorax refractory to diuretic treatment, pleurocenteses or pleurodesis were included. The TIPS implantation was successful in all patients, who were then followed for 16 +/- 14 months (range 1 day-54 months). RESULTS: TIPS reduced the portosystemic pressure gradient from 26 +/- 6 to 10 +/- 5 mmHg. In the 17 patients whom we followed for 12 months or longer, improvements were found for the Child--Pugh score (8.6 +/- 1.8 v. 6.7 +/- 1.5), serum albumin concentration (3.1 +/- 0.5 v. 3.6 +/- 0.5 g/l), and urinary sodium excretion (22 +/- 29 v. 89 +/- 43 mmol/24 h) (P< 0.05). Two patients developed severe hepatic encephalopathy requiring shunt occlusion. Hydrothorax improved in 82% of patients and resolved in 71% of patients. Fifty per cent of patients developed shunt insufficiency within 7 +/- 9 months, contributing to a probability of relapse-free 1-year survival of 35%. In these patients, shunt revision resulted in a secondary response rate of 82.3%. The 1-year survival was 64%. Both hydrothorax response and survival showed a significant inverse correlation with age over 60 years (P< 0.01 and P< 0.003, respectively) but not with other biomedical variables. CONCLUSION: TIPS is effective for hydrothorax refractory to diuretic treatment and other standard interventions to bridge the time to transplantation. Patients older than 60 years have a poor response and short survival.

Helicobacter pylori infection does not correlate with plasma ammonia concentration and hepatic encephalopathy in patients with cirrhosis.

BACKGROUND/AIMS: In patients with cirrhosis, infection of the stomach with Helicobacter pylori may increase ammonia production and, consequently, the incidence of hepatic encephalopathy. To test this hypothesis a retrospective analysis was performed in patients with a transjugular intrahepatic portosystemic shunt. These patients are regarded to be ideal candidates for such a study since they have a high bioavailability of gut-derived ammonia and many of them develop spontaneous hepatic encephalopathy. METHODOLOGY: In 132 patients (Child-Pugh class A: 24%, B: 49%, C: 27%) with stable transjugular intrahepatic portosystemic shunt function for more than 3 months (mean follow-up: 15.5 +/- 10.8 months) the diagnosis of H. pylori infection was established by a specific and sensitive immunoblot assay for IgG- and IgA-antibodies. During follow-up, hepatic encephalopathy was assessed by clinical examination and a structured questionnaire. Venous plasma ammonia concentration was measured at the time of antibody determination (end of study period). RESULTS: Eighty-four patients (64%) had negative and 48 patients (36%) had positive immunoblots for H. pylori. The groups were comparable with respect to age, gender, etiology of cirrhosis, Child-Pugh class, follow-up after transjugular intrahepatic portosystemic shunt, and shunt function. The ammonia concentrations of the patients without (group 1) and with antibodies against H. pylori (group 2) were 73 +/- 27 and 69 +/- 28 mumol/L (mean +/- SD), respectively. Hepatic encephalopathy occurred in 23 of 84 patients (27%) of group 1 and in 11 of 48 patients (23%) of group 2. CONCLUSIONS: A positive immunoblot for H. pylori antibodies neither correlates with plasma ammonia concentration nor with the incidence of hepatic encephalopathy in patients with cirrhosis of the liver and portosystemic shunt.

Severe veno-occlusive disease after allogeneic bone marrow or peripheral stem cell transplantation--role of transjugular intrahepatic portosystemic shunt (TIPS).

AIMS: Veno-occlusive disease of the liver is a severe complication of allogeneic bone marrow or peripheral stem cell transplantation with a high mortality. In its severe form, the portal vein is used as an outflow tract for the arterial hepatic perfusion. A portosystemic side-to-side shunt, e.g. a transjugular intrahepatic portosystemic shunt, may facilitate portal outflow thus increasing hepatic (i.e. arterial) perfusion. METHODS: The effect of a transjugular shunt on liver function and blood flow was studied in three patients receiving shunt treatment 0-2 days after the diagnosis of severe veno-occlusive disease occurring 28, 20, and 17 days after allogeneic transplantation for acute myeloid leukemia, Hodgkin's disease and chronic myeloid leukemia, respectively. RESULTS: The transjugular shunt reduced the portosystemic pressure gradient from 23 to 8, 18 to 5, and 33 to 13 mmHg in patients 1, 2, and 3, respectively, increased the stagnant portal vein flow to normal, and decreased the arterial resistive index, indicating an increase in the arterial perfusion of the liver. This was accompanied by rapid relief from abdominal pain and removal of ascites. The AST concentration dropped from 1230, 417, and 2930 U/l before to 93, 20, and 41 U/l and the PT-time ratio improved 3-7 days after shunt treatment while the bilirubin concentration continued to rise until the patients died 26, 42, and 33 days after transplantation from multiorgan failure (two patients) or intracerebral hemorrhage. CONCLUSIONS: The transjugular shunt may have improved abdominal and hepatic perfusion and prevented further necrosis of hepatocytes. It did not, however, affect jaundice or survival, which was limited by extrahepatic complications.

How much reduction in portal pressure is necessary to prevent variceal rebleeding? A longitudinal study in 225 patients with transjugular intrahepatic portosystemic shunts.

OBJECTIVES: This longitudinal study determines the risk of rebleeding in relation to the reduction of the portosystemic pressure gradient in patients with a transjugular intrahepatic portosystemic shunt (TIPS) for variceal bleeding. METHODS: The study included 225 patients in whom a TIPS revision was indicated by the endoscopic finding of varices with a high risk for rebleeding (n = 167) or a recent variceal rebleed (n = 58). The portosystemic pressure gradient was determined before and after TIPS placement and at revision performed after a mean of 10 +/- 15 months. RESULTS: The portosystemic pressure gradient at revision approached the index pressure gradient before TIPS implantation (23.1 +/- 5.5 mm Hg) by 8.4 +/- 31%. Rebleeding was inversely correlated with the reduction in index pressure gradient found at revision. Thus, 80% of rebleedings occurred with pressure gradients close to the index pressure gradient (< 25% reduction) or with gradients equal to or greater than the index pressure gradient. In contrast, only one patient (0.4%) and three patients (1.3%) rebled with a pressure gradient of < 12 mm Hg or a reduction of the index pressure gradient by > 50%, respectively. Kaplan-Meier analysis of rebleeding, which included the 225 patients at risk, showed a probability of rebleeding of 18%, 7%, and 1% for a reduction of the index pressure gradient by 0%, 25-50%, and > 50%, respectively. CONCLUSIONS: Most rebleedings occurred with pressure gradients similar to the index-pressure gradient measured at first bleeding. Accordingly, a graded reduction by 25-50% sufficiently prevents rebleeding. It can be assumed that, in comparison with the widely used threshold value of 12 mm Hg, a reduction by 25-50% may have a favorable benefit-to-risk ratio with respect to shunt-induced hepatic encephalopathy and liver failure. It should therefore be a goal in the decompressive treatment of portal hypertension and maintained during follow-up of patients with variceal bleeding.

[Pancreatic and biliary tract tumors--diagnosis: ultrasonic diagnosis--endosonography]. / Pankreas- und Gallenwegstumoren--Diagnostik: Ultraschall--Endosonographie.

Pancreaticobiliary tumors are mostly adenocarcinomas with a poor 5-year survival of less than 2%. Early diagnosis of resectable tumors improves outcome. Conventional ultrasound (US) is non-invasive and is the first modality employed on suspicion of these tumors. With adequate skills and equipment, pancreatic tumors from 1.5 cm in diameter can be detected. By contrast, US is less sensitive in the detection of lymph node involvement and infiltration of blood vessels. Depending on the location tumors of the biliary tract appear as a mass lesion intrahepatically or within the gallbladder. Perihilar and extrahepatic bile duct carcinomas cause proximal duct dilatation which is readily detected by US. Again, sensitivity in the detection of lymph node metastases or portal vein invasion is limited. Endoscopic ultrasound (EUS) has emerged as the method of choice in detecting small pancreatic tumors (e.g. < 2 cm in diameter). An accuracy of over 90% in T-staging and blood vessel infiltration can be achieved whereas lymph node metastases are correctly diagnosed in only 67% of cases. EUS-guided biopsy is readily performed using a curved array scanner. This technique enables neurolysis of the coeliac plexus in patients with heavy pain. EUS adds valuable information in cases of distal extrahepatic bile duct cancer. The role of EUS is limited in perihilar and intrahepatic cholangiocarcinoma. Staging and palliative therapy of perihilar carcinoma is still a domain of endoscopic retrograde cholangiography. Intraductal EUS is restricted to specialized centers and plays no role for routine purposes.

[Value of manometry]. / Stellenwert der Manometrie.

Manometry of the esophagus is essential in the diagnostic workup of patients with motility disorders of the esophagus. Before manometry organic diseases causing the symptoms should be excluded by a esophago-gastroscopy and/or a barium swallow meal. Indications for manometry are noncardiac chest pain, dysphagia of unknown origin, primary or secondary motility disorders of the esophagus and preoperative assessment before antireflux surgery.

A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.

BACKGROUND: In patients with cirrhosis and ascites, creation of a transjugular intrahepatic portosystemic shunt may reduce the ascites and improve renal function. However, the benefit of this procedure as compared with that of large-volume paracentesis is uncertain. METHODS: We randomly assigned 60 patients with cirrhosis and refractory or recurrent ascites (Child-Pugh class B in 42 patients and class C in 18 patients) to treatment with a transjugular shunt (29 patients) or large-volume paracentesis (31 patients). The mean (+/-SD) duration of follow-up was 45+/-16 months among those assigned to shunting and 44+/-18 months among those assigned to paracentesis. The primary outcome was survival without liver transplantation. RESULTS: Among the patients in the shunt group, 15 died and 1 underwent liver transplantation during the study period, as compared with 23 patients and 2 patients, respectively, in the paracentesis group. The probability of survival without liver transplantation was 69 percent at one year and 58 percent at two years in the shunt group, as compared with 52 percent and 32 percent in the paracentesis group (P=0.11 for the overall comparison, by the log-rank test). In a multivariate analysis, treatment with transjugular shunting was independently associated with survival without the need for transplantation (P=0.02). At three months, 61 percent of the patients in the shunt group and 18 percent of those in the paracentesis group had no ascites (P=0.006). The frequency of hepatic encephalopathy was similar in the two groups. Of the patients assigned to paracentesis in whom this procedure was unsuccessful, 10 received a transjugular shunt a mean of 5.5+/-4 months after randomization; 4 had a response to this rescue treatment. CONCLUSIONS: In comparison with large-volume paracentesis, the creation of a transjugular intrahepatic portosystemic shunt can improve the chance of survival without liver transplantation in patients with refractory or recurrent ascites.

Correlation of duplex sonography findings and portal pressure in 375 patients with portal hypertension.

OBJECTIVE: The purpose of this study was to determine the potential usefulness of duplex sonography in the grading of portal hypertension. SUBJECTS AND METHODS: Duplex sonography of the portal vein system and measurement of the portal pressure and portosystemic pressure gradient were performed in 375 patients before placement of transjugular intrahepatic portosystemic shunts. Subgroups included patients with recent variceal bleeding (n = 296) and patients with refractory ascites without previous variceal bleeding (n = 79). A matched cohort of 100 patients without portal hypertension was also examined. Differences between the groups in portal and splenic vein diameter, flow velocity, congestion index, and hepatic arterial resistive index were assessed using the Wilcoxon rank sum test. RESULTS: Compared with healthy individuals, our patients had an increased portal vein diameter (+30%, p < .001), decreased portal vein flow velocity (-44%, p < .001), and increased congestion index (+185%, p < .001). A portal vein diameter greater than 1.25 cm or a portal vein flow velocity less than 21 cm/sec indicated portal hypertension with a sensitivity and specificity of 80%. If the congestion index exceeded 0.1, portal hypertension was diagnosed with a 95% sensitivity and specificity. The portal pressure and gradient correlated only weakly (r < .2, p < .05) with sonographic variables. Using multivariate analysis, subgroups with variceal bleeding or refractory ascites did not show differences in hemodynamics, including pressures. CONCLUSION: Duplex sonography contributes to the diagnosis of portal hypertension but does not allow its grading. Similarity of portal hemodynamics between patients with variceal bleeding and patients with refractory ascites suggests that additional factors determine the respective clinical presentation.

Platelet aggregation and platelet-derived growth factor inhibition for prevention of insufficiency of the transjugular intrahepatic portosystemic shunt: a randomized study comparing trapidil plus ticlopidine with heparin treatment.

Intimal proliferation at the interface between prosthetic material and tissue is an intrinsic phenomenon of stenting and the major cause of insufficiency of the transjugular intrahepatic portosystemic shunt (TIPS). For its prevention, a randomized study was performed comparing standard heparin treatment with a combination of trapidil, a drug with anti-platelet-derived growth factor (PDGF) activity, and ticlopidine, a platelet aggregation inhibitor. Ninety patients with cirrhosis who received a transjugular shunt were randomized, and 84 patients completed the trial. Group 1 (n = 42) received a bolus of heparin (12 to 24 U/kg) at shunt placement, followed by 1 week of intravenous and 4 weeks of subcutaneous heparin treatment. Group 2 (n = 42) received the same heparin bolus, followed by a 1-day intravenous heparin treatment and a 6-month treatment with trapidil (400 mg/d) and ticlopidine (250 mg/d). Shunt function was assessed by duplex-sonography and angiography. Stenoses were classified according to their location as type 1 (within the stent) and type 2 (in the draining hepatic vein). The estimated rate of overall stenoses (intention-to-treat analysis) at 1 year showed a significant reduction in patients receiving trapidil and ticlopidine (group 2) as compared with heparin (33 vs. 57%; P =.047). There was no difference in the estimated 1-year rate of type 1 stenoses between the two groups, but there was a significant reduction in type 2 stenoses (group 1: 58%, group 2: 19%; P =.016). The treatment effect continued after withdrawal of the drugs and was accompanied by a decreased incidence of rebleeding. The study demonstrates that the incidence of type 2 stenosis of the transjugular shunt can be reduced by combined inhibition of platelet aggregation and PDGF activity. The findings may be of relevance not only for the transjugular shunt, but also for other stent applications, e.g., vascular and biliary, as well as for bypass and shunt surgery.

Risk factors and prevention of early infection after implantation or revision of transjugular intrahepatic portosystemic shunts: results of a randomized study.

The aim of this study was to evaluate the efficacy of a single dose of a second-generation cephalosporine to prevent postinterventional infection and to identify risk factors for postinterventional infection in patients receiving implantation or revision of a transjugular intrahepatic portosystemic shunt (TIPS). Eighty-four patients (105 transjugular interventions) were randomized receiving no antibiotic treatment (46 interventions) or 2 g cefotiam (56 interventions) given at the beginning of the procedure. Patients with overt infection or those receiving antibiotic treatment in the preceding two weeks were excluded. Groups were comparable with respect to biographic and medical data. Postinterventional infection was defined as an increase in WBC count (> or =15,000/microl), fever (> or =38.5 degrees C), or a positive blood culture. Infection occurred in 17% of the patients. Patients not receiving cefotiam had a slightly higher incidence of infection (20%) than patients treated with cefotiam (14%, NS). Multivariate analysis demonstrated prognostic relevance for multiple stenting and periprocedural use of a central venous line. The clinical outcome of the patients was unaffected by cefotiam treatment. In conclusion, a single dose of intrainterventional cefotiam does not prevent postinterventional infection. This may be due to the antimicrobial spectrum and short half-time of cefotiam. Strict adherence to aseptic conditions during intervention and early removal of central venous lines may reduce the rate of post interventional infection considerably. Antibiotic prophylaxis with cefotiam does not seem to be useful since it will not influence outcome and costs.

The first decade of the transjugular intrahepatic portosystemic shunt (TIPS): state of the art.

The transjugular intrahepatic portosystemic shunt (TIPS) is an interventional treatment resulting in decompression of the portal system by creation of a side-to-side portosystemic anastomosis. Since its introduction 10 years ago, more than 500 publications have appeared demonstrating rapid acceptance and increasing clinical use. This review summarizes the present knowledge of technical aspects and complications, follow-up of patients, and indications. With respect to the technique, the TIPS procedure is probably one of the most difficult interventions and, therefore, technical success and complications clearly depend on the skills of the operator. Thus, the number and kind of complications reported in this review do not necessarily relate to the procedural complications of an experienced center. The follow-up of the TIPS patient has to assess shunt patency, liver function and hepatic encephalopathy. Shunt patency can best be monitored by duplex-sonography. Routine radiological revision seems not to be helpful and does not improve results, i.e., rebleeding and survival. Short term patency may be improved by anticoagulation, while such a treatment does not influence long-term patency. With respect to the indications of TIPS, much is known about treatment of variceal bleeding. The nine randomized studies that are available to date show that survival is comparable between patients receiving TIPS or endoscopic treatment. The second group of patients is the group with refractory ascites and related complications, such as hepatorenal syndrome and hepatic hydrothorax. It has been demonstrated that TIPS improves these complications, but randomized studies are still lacking. In addition, TIPS has been applied successfully to patients with Budd-Chiari syndrome, portal vein thrombosis, before liver transplantation, and for the treatment of ectopic portal hypertensive bleeding.

[Treatment of portal hypertension by portosystemic shunts]. / Behandlung der portalen Hypertonie durch portosystemische Shunts.

The use of shunts for the treatment of portal hypertension has been revived after the introduction of the transjugular intrahepatic portosystemic shunt (TIPS) into clinical practice. This interventional procedure has mainly been used as rescue treatment for variceal bleeding resistant to endoscopic therapy and for ascites refractory to diuretic treatment and paracentesis. With respect to variceal bleeding TIPS has a low rate of "operative" mortality of < 1% and variceal rebleeding of 6 to 18%. In patients with refractory ascites the response to treatment is 50 to 92%. The major problems of the TIPS procedure are the increased incidence of hepatic encephalopathy and the high rate of shunt insufficiency of about 50%. Therefore, control of shunt function by duplex-sonography is essential to detect malfunction of the shunt. Radiological revision is then indicated if the clinical symptoms of portal hypertension (varices, ascites) reappear. The TIPS treatment has partially replaced the surgical shunting procedures. This decision is based on the potentially higher mortality of the surgical procedure. However, this has not been proven by randomized studies and, therefore, surgical shunts may also be indicated in selected patients with low operative mortality.

Transjugular intrahepatic portosystemic shunt (TIPS). Thrombogenicity in stents and its effect on shunt patency.

PURPOSE: To compare the thrombogenicity and patency of the Palmaz stent and the Wallstent, and to evaluate the effect of periprocedural heparin therapy in cirrhotic patients with maintained coagulation capacity who receive a transjugular intrahepatic portosystemic shunt (TIPS). MATERIAL AND METHODS: Twenty-four patients were randomized into 4 groups of 6 patients. Each received a Palmaz-stent or Wallstent TIPS with or without periprocedural heparin therapy. The groups receiving periprocedural heparin were given 24 U/kg b.w. just before stent placement, followed by 24 h therapeutic i.v. heparin. After 24 hours, all patients received i.v. heparin for 1 week followed by subcutaneous treatment with low-molecular-weight heparin (0.3 ml/day) for another 4 weeks. Stent thrombogenicity was determined scintigraphically after i.v. injection of 120-290 mBq of 99mTc-labeled platelets at the time of stent placement and expressed as the stent/heart ratio. Shunt patency was assessed by duplex sonography and confirmed radiologically. RESULTS: The aggregation ratio was highest 90 min after stent implantation. Wallstents showed a significantly higher ratio than Palmaz stents. Heparin reduced the ratio in patients with a Wallstent (-41%) but had no effect on Palmaz stents. Patients with a Wallstent without heparin had a higher rate of early shunt insufficiency (66.6%) than the other patients (0-16.6%). Primary assisted long-term patency was similar in the 4 groups. CONCLUSION: Wallstents were more thrombogenic than Palmaz stents and gave a significantly higher risk of early shunt insufficiency in cirrhotic patients with maintained coagulation capacity. Periprocedural heparin was effective in the prevention of shunt insufficiency and is therefore indicated in such patients.

The role of TIPS for the treatment of portal hypertension: effects and efficacy.

In patients with variceal bleedings TIPS is effective even if the portal pressure is reduced only partially and the reduction does not reach the threshold of 12 mmHg. Since the post-TIPS pressure gradient is closely correlated to the incidence of hepatic encephalopathy, higher gradients should be favoured in patients with a higher risk of hepatic encephalopathy, e.g. patients > age 65 years, Child-class C patients, and active alcoholics. An 8 mm diameter-shunt is probably the adequate size for most of these patients. Regarding patients with ascites, the effect of TIPS is partially due to an improvement of renal blood flow and function. The reasons for this are unknown. The systemic hemodynamic effects of the TIPS are probably not the cause since the shunt did not result in an improvement of the arterial filling and peripheral resistance. The experimentally proven hepatorenal baro-reflex may be an explanation.

Randomised trial of transjugular-intrahepatic-portosystemic shunt versus endoscopy plus propranolol for prevention of variceal rebleeding.

BACKGROUND: The transjugular-intrahepatic-portosystemic shunt is a new interventional treatment for portal hypertension. The aim of our study was to compare the transjugular shunt with endoscopic treatment for the prophylaxis of recurrent variceal bleeding. METHODS: Between March, 1993, and March, 1996, 126 patients with variceal bleeding were randomly assigned either transjugular shunt (n = 61) or endoscopic treatment (n = 65). Patients were followed up for a median of 14 (IQR 8-25) months and 13 (8-25) months, respectively. In 31 (51%) of the shunted patients, simultaneous transjugular-variceal embolisation was done at the time of shunt placement. Endoscopic treatment consisted of sclerotherapy and/or banding ligation and was combined with propranolol medication. FINDINGS: Technical success was achieved in all patients assigned to the shunt group. During follow-up, the cumulative 1-year variceal rebleeding rates in the shunted and endoscopically treated patients were 15% and 41% and the 2-year rates were 21% and 52% (p = 0.001), respectively. In nine (12%) patients from the endoscopic group treatment failed and the patients received the transjugular-shunt treatment. A total of 19 bleeding episodes from any source occurred in 15 patients in the shunt group compared with 100 episodes in 33 patients in the endoscopic group. There was no difference in survival with estimated 1-year survival rates for shunted and endoscopically treated patients of 90% and 89%, and 2-year survival rates of 79% and 82%, respectively. The incidence of clinically significant hepatic encephalopathy after 1 year was higher in the shunt group (36% vs 18%, p = 0.011). INTERPRETATION: These results suggest, that the transjugular shunt is more effective than endoscopic treatment in prevention of variceal rebleeding but has a considerable risk of hepatic encephalopathy. Survival is similar in the two groups.

The transjugular intrahepatic portosystemic stent-shunt procedure for refractory ascites.

BACKGROUND: Previous studies have suggested that the transjugular placement of an intrahepatic stent to establish a portosystemic shunt is an effective treatment of uncomplicated ascites accompanying variceal bleeding. We studied the stent shunt for use in patients with liver cirrhosis and ascites refractory to medical treatment. METHODS: Fifty of 62 consecutive patients with cirrhosis and refractory ascites (18 with Child-Pugh class B liver disease and 32 with class C) were treated with the stent shunt--an expandable stent of metallic mesh placed between a major branch of the portal vein and one of the hepatic veins. Patients were followed for a mean (+/- SD) of 426 +/- 333 days. Those with advanced cancer, severe heart failure, or severe liver failure were excluded. RESULTS: The stent shunt was successfully placed in all patients and reduced the pressure gradient between the portal vein and the inferior vena cava by an average of 63 percent. Thirty-seven patients (74 percent) had complete responses (total remission of ascites within three months), and nine patients (18 percent) had partial responses (ascites detected by ultrasound but with no need for paracentesis). Four patients did not respond, including two who died within two weeks of shunt placement. After the procedure, 25 patients had hepatic encephalopathy, as compared with 20 patients before the procedure; although encephalopathy improved in 3 patients, new encephalopathy developed in 8 patients. In the 28 of the 33 patients followed for more than six months who were evaluated, the mean serum creatinine concentration was 1.5 +/- 0.09 mg per deciliter (133 +/- 8 mumol per liter) before placement of the stent shunt, 1.5 +/- 1.6 mg per deciliter (133 +/- 141 mumol per liter) one week after the procedure, and 0.9 +/- 0.3 mg per deciliter (80 +/- 27 mumol per liter) after six months (P = 0.008 for the comparison of concentrations before and six months after the procedure). Renal function did not improve in the six patients with organic kidney disease. Procedure-related complications developed in 16 patients, including intraabdominal bleeding requiring blood transfusions in 2 patients. Thrombotic occlusion of the stent shunt occurred within two weeks in 5 patients, and later insufficiency of the shunt occurred in 16 patients, including 12 with recurrence of ascites after complete remission. During followup, an additional 29 patients died--10 of progressive liver disease and 19 of other causes. Survival for at least one year was associated with a patient's being under 60 years of age, having a serum bilirubin level before placement of the stent shunt of less than 1.3 mg per deciliter (22 mumol per liter), and having a complete response. CONCLUSIONS: Our findings in an uncontrolled prospective study suggest that the transjugular intrahepatic porto-systemic stent-shunt procedure was an effective treatment for many patients with liver cirrhosis and refractory ascites, but mortality from underlying diseases was substantial.