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Vascular and Interventional Radiology |
1 From the Department of Diagnostic Imaging and Interventional Radiology, University of Tor Vergata, Viale Oxford 81, 00133 Rome, Italy. Received April 5, 2005; revision requested June 16; revision received October 5; accepted November 4; final version accepted December 1. Address correspondence to D.K. (e-mail: danielkonda{at}yahoo.com).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONADVANCES IN KNOWLEDGEReferences |
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Materials and Methods: Approval of study and treatment protocol and waiver of informed consent for the retrospective study were obtained from institutional review board. Informed consent was obtained from each patient before procedure. Four male and nine female consecutive patients (mean age, 35.7 years) with Budd-Chiari syndrome treated with TIPS from January 1994 to November 2003 were included. In six patients, TIPS creation was performed with bare stents (group A). After April 2001, TIPS creation was performed in seven patients with expanded PTFE-covered stent-grafts (group B). Follow-up (group A mean, 22.7 months ± 10.53 [standard deviation]; group B mean, 23.1 months ± 7.81) was performed at 7 days, 30 days, and 3 months and subsequently every 3 months. Liver function was evaluated every 3 months. Primary end points were 6- and 12-month TIPS patency rates. Secondary end points were reintervention rate and clinical outcome. Patency rates were estimated (Kaplan-Meier method) and compared (log-rank test). Continuous (Mann-Whitney U test) and categoric (
2 test) data were compared. Significant differences before and after treatment were determined (Wilcoxon test).
Results: Mean primary patency duration was 4.46 months ± 3.40 in group A and 22.29 months ± 8.15 in group B. In group B, a significant increase in primary patency rate (100% and 85.7% vs 16.7% and 0% at 6 and 12 months; P < .001, log-rank test) and a decrease in reintervention rate (0.29 ± 0.49 vs 6.17 ± 1.72, P < .001) were observed. Both groups had a significantly decreased Child-Pugh score; group B had a more persistent and significantly higher reduction.
Conclusion: Expanded PTFE-covered stent-grafts significantly increased primary patency rate of TIPS in patients with Budd-Chiari syndrome, with reduced reintervention rate and prolonged clinical improvement.
© RSNA, 2006
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONADVANCES IN KNOWLEDGEReferences |
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Depending on the rapidity of suprahepatic venous obstruction and on the presence of collateral veins, which decongest the hepatic sinusoids, Budd-Chiari syndrome can be classified into four categories: fulminant, acute, subacute, and chronic. In the less common fulminant form, patients develop hepatic encephalopathy within 8 weeks from the instauration of jaundice. The acute form, which is not associated with the development of collateral veins, is characterized by intractable ascites and hepatocellular necrosis. Patients with the most frequent subacute form have collateral veins and, thereby, have minimal ascites and hepatocellular necrosis. The only clinical manifestations of the chronic form are those related to the complications of cirrhosis (2).
In patients with Budd-Chiari syndrome, abdominal pain, hepatomegaly, and ascites usually manifest. Esophageal varices and splenomegaly are observed in the chronic form, and jaundice is usually present in the fulminant and acute forms. Medical treatment of Budd-Chiari syndrome includes anticoagulation therapy, maintenance of the international normalized ratio between 2.0 and 2.5, and treatment of ascites. Treatment that includes thrombolysis with urokinase or tissue plasminogen activator is used in patients who have the fulminant form.
In the past decades, surgical portosystemic derivation has represented the only therapeutic option for patients with Budd-Chiari syndrome that is refractory to medical treatment. Successful treatment of Budd-Chiari syndrome by using a transjugular intrahepatic portosystemic shunt (TIPS) was described in 1993 by Peltzer et al (3) and Ochs et al (4). TIPS creation with the use of bare stents is usually feasible in patients with Budd-Chiari syndrome; however, it is associated with a high rate of early occlusion that requires repeated revisions of the stent to maintain patency. TIPS creation with the use of bare stents significantly improves hepatic synthetic dysfunction and is best suited as a bridge to orthotopic liver transplantation (5,6). A significant improvement in the patency rates has been reported with the use of expanded polytetrafluoroethylene (PTFE)-covered stent-grafts for TIPS creation in patients with ascites and/or variceal bleeding (7). In a recent study (8), the researchers reported high 1-year primary patency rates and fewer reinterventions in patients with Budd-Chiari syndrome who were treated with TIPS by using expanded PTFE-covered stent-grafts.
The purpose of this study was to retrospectively compare primary patency and reintervention rates, clinical outcome, and improvement in hepatic dysfunction (Child-Pugh score) in patients with Budd-Chiari syndrome who underwent TIPS creation with bare stents or expanded PTFE-covered stents.
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONADVANCES IN KNOWLEDGEReferences |
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Patient Population
The diagnosis of Budd-Chiari syndrome was established by using ultrasonography (US) and computed tomography (CT) or magnetic resonance imaging. All patients had acute or subacute Budd-Chiari syndrome and were referred for treatment for medically intractable ascites. The cause of Budd-Chiari syndrome was polycythemia vera (patients 1, 4, 7, 8, and 11), osteomyelosclerosis (patients 5 and 9), paroxysmal nocturnal hemoglobinuria (patients 10 and 12), antithrombin III deficiency (patient 2), protein S deficiency (patient 3), or idiopathic disease (patients 6 and 13).
Serum bilirubin and albumin levels were assessed in all patients prior to intervention. Values for prothrombin time measured as a percentage of a reference sample (Normotest; Baxter Immuno, Vienna, Austria) were normal in four patients and below average in nine patients (Table 1).
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TIPS Creation
TIPS creation was performed by one author (R.G.) who had 3 and 10 years of experience with the procedure in 1994 and 2001, respectively.
In the first six (two male and four female) patients (mean age, 33.7 years ± 12.41 [standard deviation]) with Budd-Chiari syndrome who were treated at our institution, TIPS creation was performed with the use of uncovered self-expanding stents (Wallstent; Boston Scientific/Medi-tech, Natick, Mass) (group A). From April 2001, because of the poor initial results with bare stents, TIPS creation was performed in seven (two male and five female) patients (mean age, 37.4 years ± 13.48) by using expanded PTFE-covered self-expanding nitinol stent-grafts (Viatorr; W. L. Gore and Associates, Flagstaff, Ariz) (group B).
In both groups, TIPS creation was performed with direct puncture of a portal vein from the intrahepatic portion of the inferior vena cava by using a Rösch-Uchida TIPS puncture set (Cook, Bloomington, Ind). After puncture, portal anatomy was assessed by using portal venography, and the intrahepatic tract was dilated with a 10-mm-diameter balloon catheter. Stents were deployed and covered the entire intrahepatic tract.
In group A patients, two 10-mm-diameter and 6-cm-long Wallstents were deployed in a coaxial fashion. In group B, 10-mm-diameter Viatorr stent-grafts with an 8-cm-long expanded PTFE covered portion and a 2-cm-long uncovered portion were used. In six patients (patients 7, 8, and 10–13), two stent-grafts were deployed coaxially with the uncovered portion of the proximal stent-graft inserted into the covered portion of the distal stent-graft, thus leaving no bare segments in the TIPS. The uncovered portion of the distal stent-graft was placed in the portal confluence. In patient 9, a single stent-graft was used (Fig 1).
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Medication
Perioperative prophylaxis included intravenous administration of 2 mg/d of ceftriaxone (Rocephin; Hoffman-La Roche, Basel, Switzerland), which was started 72 hours before the procedure and continued for 48 hours afterward.
Patients received 5000 IU of heparin (Epsoclar; Biologici Italia Laboratories, Milan, Italy) intravenously after the portal vein was punctured, and heparin therapy was continued for 48 hours (1000 IU/h) after the procedure. Subsequently, anticoagulation therapy with warfarin (Coumadin; Bristol-Myers Squibb, New York, NY) at a 2.0–2.5 international normalized ratio was maintained for life.
Follow-up
Follow-up was performed with Doppler US at 7 days, 30 days, and 3 months after the procedure and subsequently every 3 months. Liver function was evaluated every 3 months.
Reduction of in-stent blood flow velocity at Doppler US or clinical relapse with recurrence of ascites was further investigated with a hemodynamic study for assessment of the portosystemic pressure gradient and venography. Indication for TIPS revision was considered to be a portosystemic pressure gradient higher than 12 mm Hg or stent occlusion.
TIPS Revision
TIPS revision was performed by one author (R.G.). TIPS recanalization was performed through a transjugular approach by using a 7-F-diameter 25-cm-long introducer sheath (Terumo, Tokyo, Japan), a stiff hydrophilic guide wire (Terumo), and a multipurpose (Torcon NB Advantage; William Cook Europe, Bjaeverskov, Denmark) or Cobra catheter (Radiofocus Glidecath; Terumo). Dilatation was performed by using 10-mm-diameter balloon catheters.
Revision with stents was performed in group A by using a 10-mm-diameter bare Wallstents (Fig 2). One revision in patient 6 was performed with a 10-mm-diameter expanded PTFE-covered Viatorr stent-graft.
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Study End Points
The primary end points of this study were the 6- and 12-month primary TIPS patency rates. In patients who did not undergo TIPS revision during follow-up, primary patency was assumed to be the duration of TIPS patency from its creation to the last US documentation.
Secondary end points were rate of reintervention and clinical outcome. Clinical outcome was defined as the number of clinical relapses in each group and improvement in the Child-Pugh score.
The mean reduction of the portosystemic pressure gradient at the time of TIPS creation also was evaluated for both patient groups.
Statistical Analysis
Adequacy of the sample sizes was determined by using an 
value of .05 and a statistical power of 95%. All data are expressed as the mean ± standard deviation. Categoric data are expressed as percentages. Actuarial rates of shunt patency were estimated by using the Kaplan-Meier method and were compared in the two patient groups by using the log-rank test.
The Mann-Whitney U test was used to compare continuous data, and the 2 test was used to compare categoric values. The Wilcoxon signed rank test was used to determine statistically significant differences before and after treatment. A statistically significant difference was established at P < .05.
Statistical analysis was performed by using software (SPSS, version 13.0; SPSS, Chicago, Ill). All statistical analyses were performed by one author (D.K.) and a statistician.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONADVANCES IN KNOWLEDGEReferences |
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Follow-up and TIPS Revision
Prompt clinical improvement with resolution of ascites was achieved in all patients. Patient 1 developed ascites 7 days after the procedure. Doppler US revealed an in-stent thrombosis that was treated with the coaxial insertion of an additional Wallstent.
All shunts with bare stents (group A) became dysfunctional, with a mean duration of primary patency of 4.46 months ± 3.40. Six- and 12-month primary patency rates for group A patients were 16.7% and 0%, respectively (Table 2, Fig 3). During a mean follow-up of 22.7 months ± 10.53, an overall number of 13 revisions with stents (mean, 2.2 ± 0.41) and 24 balloon dilatation procedures (mean, 4.0 ± 1.30) were performed (Table 3).
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In group B, during a mean follow-up of 23.1 months ± 7.81, a balloon angioplasty procedure was performed in only patients 10 and 11, with increased in-stent flow velocity at the 21- and 15-month, respectively, Doppler US follow-up. No revisions with stents were required (Table 3). Six- and 12-month primary patency rates for group B patients were 100% and 85.7%, respectively (Table 2, Fig 3).
No hepatic encephalopathy was observed periprocedurally and during follow-up, and no variceal bleeding occurred in patients with occluded stents.
Clinical Outcome
During follow-up, clinical relapses were observed in all group A patients (16 episodes). No clinical relapses occurred in group B patients. A significant decrease in the Child-Pugh score was observed in both groups after treatment. A more persistent and significantly higher reduction of the Child-Pugh score, however, was observed in group B patients (Table 4).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONADVANCES IN KNOWLEDGEReferences |
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Orthotopic liver transplantation, which is considered the only truly curative treatment for Budd-Chiari syndrome, is the first-line treatment in patients with the fulminant form of Budd-Chiari syndrome or end-stage chronic liver disease. Prognosis of patients who undergo orthotopic liver transplantation for Budd-Chiari syndrome is, however, less favorable than it is for other indications (11).
Researchers in several studies have demonstrated the effectiveness of the TIPS created by using bare stents in patients with Budd-Chiari syndrome in terms of improvement in hepatic function and reduction of symptoms. Because of the high rates of stenosis or occlusion and the need for repeated revisions, however, TIPS creation with bare stents is considered best suited as a bridge to orthotopic liver transplantation (5,6,12–14).
The use of expanded PTFE-covered Viatorr stent-grafts for TIPS creation in patients with ascites and/or variceal bleeding has been amply described, with a reported 1-year primary patency rate of 80%–84% (7,15,16).
The Viatorr stent-graft is a self-expanding high-radial-strength nitinol stent-graft that has a proximal region lined internally by a thin layer of expanded PTFE, which is impermeable to bile, and a distal uncovered region. This stent-graft, originally designed for the treatment of tracheobronchial strictures, is routinely employed for TIPS creation, where the uncovered region placed in the portal system allows normal blood flow at the portal confluence and the covered region placed intrahepatically provides an impermeable interface with the hepatic parenchyma owing to the expanded PTFE lining, which reduces in-stent neointimal hyperplasia (17,18). Moreover, PTFE is the least thrombogenic artificial graft material available. These characteristics of expanded PTFE and the Viatorr stent-graft make this endoprosthesis probably the most suitable stent for TIPS creation, especially in patients with Budd-Chiari syndrome where a high risk of in-stent thrombosis exists. The Viatorr stent-graft has been only recently approved for TIPS creation in the United States by the Food and Drug Administration.
To our knowledge, only one study (8) has been reported in the literature in which the incidence of TIPS dysfunction and outcome in patients with Budd-Chiari syndrome who underwent TIPS creation with bare and expanded PTFE-covered stents were analyzed and compared. That study showed a substantial benefit of the use of expanded PTFE-covered stents compared with bare stents for TIPS creation in the treatment of Budd-Chiari syndrome in 25 patients. The authors reported a 1-year primary patency rate of 19% for TIPS with bare stents and 67% for that with expanded PTFE-covered stents. In that series of patients, a lower TIPS dysfunction rate with the need for fewer revisions was observed for expanded PTFE-covered stents (8).
In patients with clinically manifest Budd-Chiari syndrome who were treated with expanded PTFE-covered Viatorr stent-grafts compared with patients who were treated with Wallstents, there was a significant increase in the primary patency rate (100% and 85.7% vs 16.7% and 0% at 6 and 12 months, respectively; P < .001), a decrease in the reintervention rate (0.29 ± 0.49 vs 6.17 ± 1.72, P < .001), and a more persistent and significantly greater improvement in hepatic function. Revision of a TIPS, which was originally created with a bare stent, by using an expanded PTFE-covered stent resulted in a drastic reduction in the number of further revisions required and a substantial increase in patency.
In our series of patients, TIPS creation was not performed by using the stump of the occluded hepatic vein. In our experience, the transcaval approach in patients with Budd-Chiari syndrome is technically more feasible. As a matter of fact, in Budd-Chiari syndrome, the liver is enlarged and the intrahepatic portion of the inferior vena cava is surrounded by liver parenchyma, and this condition provides stability to the transcaval puncture. Furthermore, in Budd-Chiari syndrome, liver parenchyma is soft, which is different from its condition in cirrhosis, and this advantage helps to make the transcaval puncture straightforward.
Although in our series of patients the direct transcaval approach was selected merely because it was considered safe and more feasible, and not because it was thought to improve TIPS patency, there are some indications that this approach might actually affect the latter favorably. As a matter of fact, dysfunction of TIPS created by using Viatorr stent-grafts with direct puncture of a portal vein from a suprahepatic vein frequently results from hepatic vein stenosis above the graft portion of the endoprosthesis (19). The direct transcaval approach, with coverage of the entire intrahepatic tract from the portal vein to the inferior vena cava, prevents this complication. Use of this approach for TIPS created by using expanded PTFE-covered stents may be one of the reasons for the higher patency rates (85.7% vs 67% at 1 year) and the lower number of revisions (0.29 ± 0.49 vs 0.6 ± 0.9; mean follow-up, 19.1 and 23.1 months) observed in our series of patients compared with the data in the only previously reported series of patients (8). Use of TIPS with expanded PTFE-covered endoprostheses also resulted in a marked clinical improvement.
The major limitations of our study were that it was a single-center study and it included a relatively small patient population. Longer follow-up periods are required for complete secondary patency data.
Our results suggest that expanded PTFE-covered stents can be considered for use with TIPS creation in patients with Budd-Chiari syndrome that is refractory to medical therapy. Although larger series of patients with longer follow-up periods are necessary, our preliminary data suggest that TIPS creation by using expanded PTFE-covered stent-grafts in patients with Budd-Chiari syndrome may result in a persistent clinical improvement in the long term, thus delaying orthotopic liver transplantation.
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ADVANCES IN KNOWLEDGE |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONADVANCES IN KNOWLEDGEReferences |
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FOOTNOTES |
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Abbreviations: PTFE = polytetrafluoroethylene • TIPS = transjugular intrahepatic portosystemic shunt
Authors stated no financial relationship to disclose.
Author contributions: Guarantors of integrity of entire study, R.G., G.S.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, all authors; clinical studies, all authors; statistical analysis, D.K., G.S.; and manuscript editing, all authors
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References |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONADVANCES IN KNOWLEDGEReferences |
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This article has been cited by other articles:
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  F. Boyvat, A. Harman, U. Ozyer, C. Aytekin, and Z. Arat Percutaneous Sonographic Guidance for TIPS in Budd-Chiari Syndrome: Direct Simultaneous Puncture of the Portal Vein and Inferior Vena Cava Am. J. Roentgenol., August 1, 2008; 191(2): 560 - 564. [Abstract] [Full Text] [PDF]
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 H. Hoppe, S. L. Wang, and B. D. Petersen Intravascular US-guided Direct Intrahepatic Portocaval Shunt with an Expanded Polytetrafluoroethylene-covered Stent-Graft Radiology, January 1, 2008; 246(1): 306 - 314. [Abstract] [Full Text] [PDF]
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