AASLD practice guidelines: the role of transjugular intrahepatic portosystemic shunt (TIPS) in the management of portal hypertension.

AASLD practice guidelines: the role of transjugular intrahepatic portosystemic shunt (TIPS) in the management of portal hypertension

C/O: http://www.guideline.gov/content.aspx?id=15476

Bibliographic Source(s)

Boyer T, Haskal Z, American Association for the Study of Liver Disease (AASLD). AASLD practice guidelines: the role of transjugular intrahepatic portosystemic shunt (TIPS) in the management of portal hypertension. Hepatology. 2010 Jan;51(1):1-16. [127 references]

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Boyer TD, Haskal ZJ. The role of transjugular intrahepatic portosystemic shunt in the management of portal hypertension. Hepatology 2005 Feb;41(2):386-400.

Disease/Condition(s) Complications of portal hypertension: Esophageal and gastric variceal bleeding Portal hypertensive gastropathy Gastric antral vascular ectasia Cirrhotic ascites Refractory hepatic hydrothorax Hepatorenal syndrome Budd-Chiari syndrome Hepatic encephalopathy Hepatopulmonary syndrome Veno-occlusive disease or sinusoidal obstruction syndrome Guideline Category Assessment of Therapeutic EffectivenessEvaluationManagementPreventionRisk AssessmentTreatment Clinical Specialty Critical CareGastroenterologyInternal MedicineRadiology Intended Users Health Care ProvidersPhysician AssistantsPhysicians Guideline Objective(s) To provide a data-supported approach to the use of transjugular intrahepatic portosystemic shunt (TIPS) in the management of the complications of portal hypertension Target Population Patient with complications of portal hypertension Interventions and Practices Considered Pre-transjugular intrahepatic portasystemic shunt (TIPS) evaluation, including routine tests of liver and kidney function; cross-sectional imaging of the liver by Duplex ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI); and cardiac evaluation (only when indicated) Creation and placement of TIPS Post-TIPS monitoring by Doppler ultrasound and follow-up to monitor for TIPS dysfunction Major Outcomes Considered Success rate of transjugular intrahepatic portosystemic shunt (TIPS) Rebleeding rates/reoccurrence of problem for which TIPS was originally inserted Complications of TIPS Mortality

Back to top Methodology Methods Used to Collect/Select the Evidence Hand-searches of Published Literature (Primary Sources)Hand-searches of Published Literature (Secondary Sources)Searches of Electronic Databases Description of Methods Used to Collect/Select the Evidence A MEDLINE search was performed from 1966 to 2009. A total of 1143 articles were found under the subject heading "transjugular intrahepatic portosystemic shunt." Controlled trials and large series were sought during this search. Recently published papers were also used as a source of references missed by the MEDLINE search, and the personal files of the two authors were also used as a source of references. Number of Source Documents Not stated Methods Used to Assess the Quality and Strength of the Evidence Expert ConsensusWeighting According to a Rating Scheme (Scheme Given) Rating Scheme for the Strength of the Evidence Grade I: Randomized controlled trials Grade II-1: Controlled trials without randomization Grade II-2: Cohort or case-control analytic studies Grade II-3: Multiple time series, dramatic uncontrolled experiments Grade III: Opinions of respected authorities, descriptive epidemiology Methods Used to Analyze the Evidence Review of Published Meta-AnalysesSystematic Review with Evidence Tables Description of the Methods Used to Analyze the Evidence Not stated Methods Used to Formulate the Recommendations Expert Consensus Description of Methods Used to Formulate the Recommendations Not stated Rating Scheme for the Strength of the Recommendations Not applicable Cost Analysis A cost-effectiveness analysis of a randomized controlled trial comparing transjugular intrahepatic portosystematic shunt (TIPS) (bare metal Wallstents) to distal splenorenal shunt (DSRS) reported costs of both in- and out-patient care. The average yearly cost over a 5 year period were $16,363 for TIPS patients and $13,492 for the DSRS patients. These yearly costs are similar to what has been reported for pharmacologic and endoscopic management of patients with bleeding varices. TIPS was slightly more cost effective than DSRS at year five ($61,000 per life saved) but difference was felt not to be significant. Using covered rather than bare walls stents was estimated to increase the cost-effectiveness of TIPS only slightly. The authors conclude that TIPS is as effective as DSRS in the prevention of variceal rebleeding and may be slightly more cost-effective. Method of Guideline Validation External Peer ReviewInternal Peer Review Description of Method of Guideline Validation The Practice Guidelines Committee of the American Association for the Study of Liver Diseases (AASLD) provided extensive peer review of the manuscript. These recommendations are fully endorsed by the AASLD and the Society for Interventional Radiology.

Back to top Recommendations Major Recommendations Recommendations are followed by quality of evidence ratings (Grades I, II-1, II-2, II-3, III) which are defined at the end of the "Major Recommendations" field. The Procedure: Pre-TIPS Evaluation and Contraindications, Mortality Transjugular intrahepatic portosystemic shunt (TIPS) should only be performed by experienced interventional radiologists (or specially trained physicians). Success and complication rates should be monitored and if they fail to meet expected rates then review of the program should be considered (Grade III). The decision to perform a TIPS, especially in a high-risk patient, should be reached by a team consisting of a gastroenterologist/hepatologist, interventional radiologist, and, where appropriate, a transplant physician (Grade III). Preceding creation of a TIPS, tests of liver and kidney function should be performed as well as  cross-sectional imaging of the liver to assess portal system patency and exclude liver masses (Grade III). Reduction in hepatic venous pressure gradient (HVPG) to less than 12 mm Hg should be achieved when the indication is bleeding esophageal varices. Embolization of gastric varices may be required despite adequate decompression of the portal venous system (Grade II-2). The degree of reduction in HVPG to control ascites is unclear, but at present a gradient of at least 12 mm Hg or less has been suggested to be a reasonable goal (Grade II-2). Patients with high predicted 30-day mortalities (Model for End-Stage Liver Disease [MELD] > 15 to 18 or serum bilirubin > 4.0 mg/dL) should be informed of their prognosis, and TIPS performed only in the absence of other options (Grade II-2). In high-risk patients, the need for liver transplantation should be discussed before the performance of an elective TIPS(Grade III). Complications; TIPS in the Transplant Candidate Those performing TIPS need to be aware of both the procedural complications and  those due to portal diversion and be experienced in their management (Grade II-3). Each center performing TIPS should have an established program of TIPS surveillance, and although there are no established guidelines, Doppler ultrasound should be performed at specified intervals following the procedure and the yearly anniversary of the TIPS thereafter (Grade II-1). Ultrasonographic findings suggesting TIPS dysfunction or recurrence of the complication of portal hypertension that lead to the initial TIPS should lead to repeat shunt venography and intervention, as indicated. The recurrence of symptoms in the face of a "normal" ultrasound does not eliminate the need for TIPS venography (Grade II-2). TIPS stenosis is common when bare stents have been used, especially in the first year, and Doppler ultrasound lacks the sensitivity and specificity needed to identify many of these patients. Therefore, repeat catheterization of the TIPS or upper endoscopy should be considered at the 1-year anniversary of TIPS creation, especially in those patients who bled from varices (Grade II-3). Polytetrafluoroethylene (ePTFE)-covered stents are preferred to bare stents to lower the risk of shunt dysfunction.(Grade-I) As with any form of portosystemic diversion, the risk of developing hepatic encephalopathy is increased following TIPS creation. The prophylactic use of nonabsorbable disaccharides or antibiotics does not appear to lower this risk. (Grade-I) Indications Primary Prevention of Variceal Bleeding; Acutely Bleeding Esophageal Varices Refractory to Medical Treatment; Esophageal Variceal Rebleeding; Bleeding from Gastric Varices; Prevention of Bleeding From Portal Hypertensive Gastropathy (PHG) and Gastric Antral Vascular Ectasia (GAVE) The use of TIPS to prevent bleeding from varices that have never bled is contraindicated because of the risk of increasing morbidity and mortality (Grade III). TIPS is effective in controlling acute bleeding from varices that is refractory to medical therapy and TIPS should be used in preference to surgery (Grade II-3). Pending the development of tests that accurately predict the risk of rebleeding, TIPS should not be used for the prevention of rebleeding in patients who have bled only once from esophageal varices. Its use should be limited to those who fail pharmacological and endoscopic therapy (Grade I). TIPS is effective in the prevention of rebleeding from gastric and ectopic varices (including intestinal, stomal, and anorectal varices) and is the preferred approach for the prevention of rebleeding in this group of patients (Grade II-3). In patients with good liver function, either a TIPS or a surgical shunt are appropriate choices for the prevention of rebleeding in patients who have failed medical therapy (Grade I). In patients with poor liver function, TIPS is preferred to surgical therapy in the prevention of rebleeding in patients who have failed medical therapy (Grade III). The use of TIPS in the management of portal hypertensive gastropathy should be limited to those who have recurrent bleeding despite the use of beta-blockers (Grade II-3). TIPS is ineffective in controlling bleeding from gastric antral vascular ectasia in patients with cirrhosis and should not be used in this situation (Grade II-3). Cirrhotic Ascites; Refractory Hepatic Hydrothorax; Hepatorenal Syndrome (HRS) TIPS will decrease the need for repeated large-volume paracentesis in patients with refractory cirrhotic ascites. However, given the uncertainty as to the effect of TIPS creation on survival and the increased risk of encephalopathy, TIPS should be used in those patients who are intolerant of repeated large-volume paracentesis (Grade I). TIPS is effective in the control of hepatic hydrothorax, but it only should be used in patients whose effusion cannot be controlled by diuretics and sodium restriction (Grade II-3). TIPS is of investigatory use for the treatment of hepatorenal syndrome (HRS), especially type 1, pending the publication of controlled trials (Grade II-3). Budd-Chiari Syndrome (BCS); Veno-occlusive Disease or Sinusoidal Obstruction Syndrome (SOS); Hepatopulmonary Syndrome The decision to create a TIPS in a patient with Budd-Chiari syndrome should be based on the severity of disease, and only those with moderate disease and who have failed to respond to anticoagulation appear to be reasonable candidates for a TIPS (Grade II-3). Patients with Budd-Chiari syndrome and mild disease can be managed medically, whereas those with more severe disease or acute hepatic failure are best managed by liver transplantation (Grade II-3). The use of TIPS to treat sinusoidal obstruction syndrome (SOS) cannot be recommended (Grade II-3). The use of TIPS to treat hepatopulmonary syndrome is not recommended (Grade II-3). Conclusions TIPS is an important part of the current armamentarium used to treat the complications of portal hypertension. Most fellowship-trained interventional radiologists are capable of creating a TIPS in a patient with patent hepatic and portal veins. Creation of a TIPS ranks among the more complex procedures performed by interventional radiologists, and it is important that each physician monitor their success and complication rates. As with any complex intervention, the decision to create a TIPS should be reached by a gastroenterologist or hepatologist who is experienced in the management of these patients in concert with an interventional radiologist. Pre-TIPS evaluation includes routine tests of liver and kidney function as well as Doppler ultrasound, contrast-enhanced abdominal computed tomography (CT), or magnetic resonance imaging (MRI) of the liver. Once a TIPS is created, it cannot be forgotten. The patient requires frequent monitoring by Doppler ultrasound and clinic visits to look for the development of TIPS dysfunction. The use of polytetrafluoroethylene (PTFE)-covered stents reduces the risk of TIPS dysfunction, but this will not eliminate the need for continued surveillance. TIPS will effectively prevent rebleeding from varices and decrease the need for repeat thoracentesis in patients with hepatic hydrothorax or for large-volume paracentesis in patients with refractory ascites. However, TIPS will increase the incidence of hepatic encephalopathy and will not improve survival in any of these patients. Hence, TIPS should not be considered as primary therapy for any complication of portal hypertension with the exception of bleeding gastric or ectopic varices. In all other situations, TIPS should only be created when the patient has failed other forms of medical therapy (i.e., pharmacological or endoscopic therapy, diuretics, or repeated large-volume paracentesis or thoracentesis). In patients with good liver function and recurrent bleeding from varices despite medical treatment, a surgical shunt or TIPS appear to be equivalent therapies. Which patients with BCS are best managed by TIPS remains undefined, although creation of a TIPS in select patients appears to be of benefit. Creation of a TIPS for the treatment of hepatorenal syndrome (HRS) or hepatopulmonary syndrome is of unproven benefit and should be considered investigatory. Definitions: Quality of Evidence Grade I: Randomized controlled trials Grade II-1: Controlled trials without randomization Grade II-2: Cohort or case-control analytic studies Grade II-3: Multiple time series, dramatic uncontrolled experiments Grade III: Opinions of respected authorities, descriptive epidemiology Clinical Algorithm(s) None provided

Back to top Evidence Supporting the Recommendations Type of Evidence Supporting the Recommendations The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Back to top Benefits/Harms of Implementing the Guideline Recommendations Potential Benefits Appropriate selection of patients for and use of the transjugular intrahepatic portosystemic shunt (TIPS) in the treatment of complications of portal hypertension Control of acute bleeding from varices that are refractory to medical therapy Prevention of rebleeding from gastric and ectopic varices Decrease in the need for repeat thoracentesis in patients with hepatic hydrothorax or for large-volume paracentesis in patients with refractory ascites Potential Harms Complications of Transjugular Intrahepatic Portosystemic Shunt (TIPS) TIPS dysfunction (thrombosis, occlusion/stenosis) Transcapsular puncture Intraperitoneal bleed Hepatic infarction Fistulae Hemobilia Sepsis Infection of TIPS Hemolysis Encephalopathy Stent migration or placement into inferior vena cava or too far into portal vein

Back to top Contraindications Contraindications Absolute Contraindications to Placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) Primary prevention of variceal bleeding Congestive heart failure Multiple hepatic cysts Uncontrolled systemic infection or sepsis Unrelieved biliary obstruction Severe pulmonary hypertension Relative Contraindications to Placement of a TIPS Hepatoma, especially if central Obstruction of all hepatic veins Portal vein thrombosis Severe coagulopathy (international normalized ratio [INR] >5) Thrombocytopenia of less than 20,000/cm3 Moderate pulmonary hypertension

Back to top Qualifying Statements Qualifying Statements These recommendations suggest preferred approaches to the diagnostic, therapeutic, and preventive aspects of care. They are intended to be flexible, in contrast to standards of care, which are inflexible policies designed to be followed in every case. Which patients with Budd-Chiari syndrome (BCS) are best managed by transjugular intrahepatic portosystemic shunts (TIPS) remains undefined, although creation of a TIPS in select patients may be of benefit. Creation of a TIPS for the treatment of hepatorenal syndrome (HRS) or hepatopulmonary syndrome is of unproven benefit and should be considered investigatory.

Back to top Implementation of the Guideline Description of Implementation Strategy An implementation strategy was not provided. Implementation Tools Mobile Device Resources For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Back to top Institute of Medicine (IOM) National Healthcare Quality Report Categories IOM Care Need Getting BetterLiving with IllnessStaying Healthy IOM Domain EffectivenessSafety

Back to top Identifying Information and Availability Bibliographic Source(s) Boyer T, Haskal Z, American Association for the Study of Liver Disease (AASLD). AASLD practice guidelines: the role of transjugular intrahepatic portosystemic shunt (TIPS) in the management of portal hypertension. Hepatology. 2010 Jan;51(1):1-16. [127 references] Adaptation Not applicable: The guideline was not adapted from another source. Date Released 2005 Feb (revised 2010 Jan) Guideline Developer(s) American Association for the Study of Liver Diseases - Nonprofit Research Organization Source(s) of Funding American Association for the Study of Liver Diseases Guideline Committee Practice Guidelines Committee Composition of Group That Authored the Guideline Primary Authors: Thomas D. Boyer, Liver Research Institute, University of Arizona School of Medicine, Tucson, AZ; Ziv J. Haskal, Division of Vascular and Interventional Radiology, University of Maryland Medical School, Baltimore, MD Committee Members: Jayant A. Talwalkar, MD, MPH (Chair); Anna Mae Diehl, MD (Board Liaison); Jeffrey H. Albrecht, MD; Amanda DeVoss, MMS, PA-C; Jose Franco, MD; Stephen A. Harrison, MD; Kevin  Korenblat, MD; Simon C. Ling, MBChB; Lawrence U. Liu, MD; Paul Martin, MD; Kim M. Olthoff, MD; Robert S. O'Shea, MD; Nancy Reau, MD; Adnan Said, MD; Margaret C. Shuhart, MD, MS; and Kerry N. Whitt, MD Financial Disclosures/Conflicts of Interest Drs. Boyer and Haskal were paid consultants for W. L. Gore and Associates, Inc., the manufacturer of a polytetrafluoroethylene (PTFE)-covered stent used for transjugular intrahepatic portosystemic shunts (TIPS). Guideline Endorser(s) Society of Interventional Radiology - Medical Specialty Society Guideline Status This is the current release of the guideline. This guideline updates a previous version: Boyer TD, Haskal ZJ. The role of transjugular intrahepatic portosystemic shunt in the management of portal hypertension. Hepatology 2005 Feb;41(2):386-400. Guideline Availability Electronic copies: Available in Portable Document Format (PDF) from the American Association for the Study of Liver Diseases Web site . Print copies: Available from the American Association for the Study of Liver Diseases, 1729 King Street, Suite 200; Alexandria, VA 22314; Phone: 703-299-9766; Web site: www.aasld.org ; e-mail: aasld@aasld.org. Availability of Companion Documents This guideline is available as a Personal Digital Assistant (PDA) download via the APPRISOR™ Document Viewer fromwww.apprisor.com . Patient Resources None available NGC Status This summary was completed by ECRI on May 17, 2005. The information was verified by the guideline developer on June 13, 2005. This NGC summary was updated by ECRI Institute on February 28, 2010. The updated information was verified by the guideline developer on March 24, 2010. Copyright Statement This NGC summary is based on the original guideline, which is subject to the American Association for the Study of Liver Diseases' copyright restrictions.