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## Complete Summary

#### GUIDELINE TITLE

The role of transjugular intrahepatic portosystemic shunt in the
management of portal hypertension.

#### BIBLIOGRAPHIC SOURCE(S)

Boyer TD, Haskal ZJ. The role of transjugular intrahepatic portosystemic
shunt in the management of portal hypertension. Hepatology 2005
Feb;41(2):386-400. \[117 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15660434)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Complications of portal hypertension including:

-   Development of esophago-gastric varices

-   Esophageal variceal rebleeding

-   Bleeding from gastric varices

-   Portal hypertensive gastropathy

-   Ascites

-   Refractory hepatic hydrothorax

-   Hepatorenal syndrome

-   Hepatic encephalopathy

-   Porto-pulmonary hypertension

-   Hepatopulmonary syndrome

#### GUIDELINE CATEGORY

Evaluation\
Management\
Prevention

#### CLINICAL SPECIALTY

Family Practice\
Gastroenterology\
Internal Medicine\
Radiology

#### INTENDED USERS

Advanced Practice Nurses\
Physician Assistants\
Physicians

#### 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

1.  Pre-transjugular intrahepatic portasystemic shunt (TIPS) evaluation,
    including routine tests of liver and kidney function, as well as
    Doppler ultrasound of the portal venous system, contrast-enhanced
    abdominal computed tomography, or magnetic resonance imaging of the
    liver

2.  Creation and placement of TIPS

3.  Post-TIPS monitoring by Doppler ultrasound and clinic visits to look
    for the development of TIPS dysfunction

#### MAJOR OUTCOMES CONSIDERED

-   Rate of success, major procedural complications, and the risk of
    rebleeding following transjugular intrahepatic portosystemic shunt
    (TIPS)

-   Mortality following TIPS

-   Optimal hepatic venous pressure gradient (HVPG) for the prevention
    of rebleeding from varices and for control of refractory ascites
    associated with cirrhosis

-   Complications of TIPS

-   Sensitivity, specificity, and predictive value of Doppler ultrasound

-   The rates of primary patency in polytetrafluoroethylene
    (PTFE)-covered and bare stent groups of patients

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT 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 on papers published between 1966 and
2004. Nine hundred eight papers were found under the subject heading
\"transjugular intrahepatic portosystemic shunt.\" Controlled trials and
large series were sought. Recently published papers were also used as a
source of references missed by the MEDLINE search, as were the personal
files of the two authors.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting 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-Analyses\
Systematic 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

The literature was critically reviewed by the authors and the members of
the practice guidelines committee who then provided a consensus opinion.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

The guideline developers reviewed a published cost-analysis.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

This guideline was commissioned and approved by the American Association
for the Study of Liver Diseases (AASLD) and the Society of
Interventional Radiology.

### 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**

1.  Transjugular intrahepatic portosystemic shunt (TIPS) should only be
    performed by experienced interventional radiologists (or specially
    trained physicians). Success and complication rates should be
    monitored; if they fail to meet expected rates, review of the
    program should be considered **(Grade III)**.

2.  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)**.

3.  Preceding creation of a TIPS, tests of liver and kidney function
    should be performed in addition to cross-sectional imaging of the
    liver to assess portal system patency and exclude liver masses
    **(Grade III)**.

4.  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)**.

5.  The degree of reduction in HVPG to control ascites is unclear, but
    at present a gradient of 8 mm Hg or less has been suggested to be a
    reasonable goal **(Grade II-2)**.

6.  Patients with high predicted 30-day mortalities should be informed
    of their prognosis, and TIPS should be performed only in the absence
    of other options **(Grade II-2)**.

7.  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**

8.  Physicians who perform TIPS need to be aware of both the procedural
    complications and the complications due to portal diversion and must
    be experienced in their management **(Grade II-3)**.

9.  Each center performing TIPS should have an established program of
    TIPS surveillance, and although there are no established guidelines,
    Doppler ultrasound should be performed before the patient is
    discharged from the hospital and at specified intervals following
    the procedure and the yearly anniversary of the TIPS thereafter
    **(Grade II-1)**.

10. 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)**.

11. TIPS stenosis is common, 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 performed at the 1-year
    anniversary of placement, especially in those patients who bled from
    varices **(Grade II-3)**.

**[Indications]{.underline}**

**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 and Gastric Antral Vascular Ectasia**

12. 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)**.

13. TIPS is effective in controlling acute bleeding from varices that is
    refractory to medical therapy and is preferred to surgery in this
    situation **(Grade II-3)**.

14. TIPS should not be used for the prevention of rebleeding in patients
    who have bled only once from esophageal varices, and its use should
    be limited to those who fail pharmacological and endoscopic therapy
    **(Grade I)**.

15. 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)**.

16. Pending further studies, 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 II-2)**.

17. 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)**.

18. The use of TIPS in the management of portal hypertensive gastropathy
    (PHG) should be limited to those who have recurrent bleeding despite
    the use of beta-blockers **(Grade II-3)**.

19. TIPS is ineffective in controlling bleeding from gastric antral
    vascular ectasia (GAVE) in patients with cirrhosis and should not be
    used in this situation **(Grade II-3)**.

**Ascites Associated With Cirrhosis; Refractory Hepatic Hydrothorax;
Hepatorenal Syndrome (HRS)**

20. Although TIPS will decrease the need for repeated large-volume
    paracentesis in patients with refractory ascites associated with
    cirrhosis, it should be used only in those patients who are
    intolerant of repeated large-volume paracentesis **(Grade I)**.

21. TIPS is effective in the control of hepatic hydrothorax, but it
    should be used only in patients whose effusion cannot be controlled
    by diuretics and sodium restriction **(Grade II-3)**.

22. TIPS is not recommended for the treatment of HRS, especially type 1
    HRS, pending the publication of controlled trials **(Grade II-3)**.

**Budd-Chiari Syndrome (BCS); Veno-occlusive Disease or Sinusoidal
Obstruction Syndrome; Hepatopulmonary Syndrome**

23. The decision to create a TIPS in a patient with BCS should be based
    on the severity of disease, and only patients with moderate disease
    appear to be reasonable candidates for a TIPS **(Grade II-3)**.

24. Patients with BCS 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)**.

25. The use of TIPS to treat sinusoidal obstruction syndrome cannot be
    recommended **(GradeII-3)**.

26. The use of TIPS to treat hepatopulmonary syndrome cannot be
    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, or magnetic resonance
imaging 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
may reduce 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 or is intolerant of 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,
it is unclear whether a surgical shunt or TIPS is the better form of
therapy pending the publication of additional controlled trials. Which
patients with BCS are best managed by TIPS remains undefined, although
creation of a TIPS in select patients may be of benefit. Creation of a
TIPS for the treatment of HRS or hepatopulmonary syndrome is of unproven
benefit and should be considered investigatory.

**[Definitions]{.underline}**:

**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

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence is specifically stated for each recommendation (see
the \"Major Recommendations\" field).

### 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 is 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

### 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/cm^3^

-   Moderate pulmonary hypertension

### 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 to be followed in every case.

-   In patients with good liver function and recurrent bleeding from
    varices despite medical treatment, it is unclear whether a surgical
    shunt or transjugular intrahepatic portosystemic shunt (TIPS) is the
    better form of therapy pending the publication of additional
    controlled trials.

-   Which patients with Budd-Chiari syndrome (BCS) are best managed by
    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.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Boyer TD, Haskal ZJ. The role of transjugular intrahepatic portosystemic
shunt in the management of portal hypertension. Hepatology 2005
Feb;41(2):386-400. \[117 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15660434)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005 Feb

#### GUIDELINE DEVELOPER(S)

American Association for the Study of Liver Diseases - Private 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, Department of
Radiology, Columbia University College of Physicians and Surgeons, New
York, NY

*Committee Members*: K. Rajender Reddy, MD (*Chair*); Robert L.
Carithers Jr., MD; Stanley M. Cohen, MD; Thomas W. Faust, MD; Steven L.
Flamm, MD; Gregory J. Gores, MD; Elizabeth Hespenheide, RN, BSN; Michael
R. Lucey, MD; David R. Nelson, MD; F. Fred Poordad, MD; Margaret C.
Shuhart, MD, MS; Brent A. Tetri, MD; Zobair M. Younossi, MD, MPH; Nizar
N. Zein, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Drs. Boyer and Haskal are paid consultants for W. L. Gore and
Associates, Inc., the manufacturer of a polytetrafluoroethylene-covered
stent used for transjugular intrahepatic portosystemic shunt (TIPS).

#### ENDORSER(S)

Society of Interventional Radiology - Medical Specialty Society

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Association for the Study of Liver Diseases Web
site](https://www.aasld.org/eweb/docs/practiceguidelines/tip.pdf).

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](http://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 from
[www.apprisor.com](http://www.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.

#### 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.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008