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LIVER ASSOCIATION GUIDANCE RECOMMEND EARLIER TIPS

The American Association for the Study of Liver Diseases (AASLD), the Advancing Liver Therapeutic Approaches group (ALTA) and European Association for the Study of the Liver (EASL) suggest TIPS earlier in the treatment algorithm and a multidisciplinary approach that includes gastroenterology and hepatology.1-3

HIGHER

transplant-free survival at one year

93% TIPS vs. 52% LVP+A (P = .003)

LESS

recurrence of ascites

32 TIPS vs. 320 LVP+A (P < .001) total number of paracenteses (TIPS n = 29, LVP+A n = 33)

FEWER

complications

0% TIPS vs. 18% LVP+A (P = .01) portal hypertension-related bleeding and hernia-related complications

FEWER

hospitalization days

Patients treated with TIPS averaged 17 days vs. 35 for those treated with LVP+A

NO DIFFERENCE

in hepatic encephalopathy

65% TIPS vs. 65% LVP+A (P = .868) probability of remaining free of hepatic encephalopathy


Earlier TIPS procedure for variceal bleeding

Evidence shows that early TIPS can significantly improve outcomes in select liver disease patients.*,3

HIGHER survival

in Child-Pugh C patients at one year

78% TIPS vs. 53% pharmacotherapy+EBL (P = .002)

GREATER freedom

from rebleeding and treatment failure

92% TIPS vs 74% pharmacotherapy+EBL (P = .017) freedom from failure to control bleeding or prevent rebleeding in Child-Plug B+AB (active bleeding) and C patients

LESS frequent

de novo ascites or worsening of previous ascites

9.1% TIPS vs. 47.6% pharmacotherapy+EBL (P < .001) in Child-Pugh B+AB and C patients

NO DIFFERENCE

in hepatic encephalopathy

42.4% TIPS vs. 37.7% pharmacotherapy+EBL (P = .683) experienced hepatic encephalopathy

Some patients with portal hypertension never experience esophageal variceal bleeding or are able to control their symptoms by taking medication. However, for other patients, medication and minimally invasive therapy fail to stop a bleeding episode or prevent recurrent bleeding episodes. For these patients with a high-risk of rebleeding, multiple studies have shown that the TIPS procedure is more effective at controlling and preventing esophageal variceal bleeding than continued treatment with medication and minimally invasive therapy.3-5

These studies have also shown that the TIPS procedure can increase survival in select patients.3 In several of these studies, the risk of hepatic encephalopathy was similar in patients who underwent the TIPS procedure and patients that continued with medication and minimally invasive therapy.3-5 The timing of when your TIPS procedure is performed is important, and the studies described focus on “early” TIPS where patients undergo a TIPS procedure within 72 hours of an acute esophageal bleeding episode. To determine whether the TIPS procedure can help control your esophageal variceal bleeding and increase your survival, ask your doctor if you are a good candidate for the TIPS procedure.

Read the study from New England Journal of Medicine

Read the study from HEPATOLOGY by AASLD

Early TIPS improves survival and control of bleeding compared to repeat endoscopic procedures with medical management.

Trial or studySurvival at one yearPrevention of rebleedingIncidence of hepatic encephalopathy
compared to pharmacotherapy 
combined with endoscopic therapy
Randomized Control Trial (RCT)486%97%§No significant difference
Post-RCT Surveillance Study586%93%IINo significant difference
Observational Study378%92%No significant difference
Early TIPS procedure with controlled expansion endoprosthesis

GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion combines the legacy of proven patency6 with diameter control to reach a targeted portal pressure gradient. The innovations include:

  • Control the diameter — Designed to reach a targeted portal pressure gradient
  • Lasting diameter control** — Size and set the diameter to stay
  • Engineered for flexibility — Conformability to tortuous anatomy

    GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion specifications

    Image
    GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion specifications
    The GORE® VIATORR® TIPS Device

    For your patients with portal hypertension, the GORE® VIATORR® TIPS Endoprosthesis maintains significantly increased patency compared to bare metal stent alternatives. Highly effective in lowering portal pressure gradients in patients with refractory ascites and variceal bleeding, the GORE® VIATORR® TIPS Endoprosthesis offers an effective treatment option for patients over a longer period of time.†† The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion allows doctors to adjust the diameter of the device during implantation based on the patient’s needs and portal pressure.

    Two clinical studies were conducted in the United States to evaluate the GORE® VIATORR® TIPS Endoprosthesis and the BOSTON SCIENTIFIC WALLSTENT Endoprosthesis Stent for use in de novo TIPS and TIPS revision. These studies demonstrated that primary patency of the GORE® VIATORR® Device group was superior to that of the BOSTON SCIENTIFIC WALLSTENT Device group (P < .001) at six months, with no significant differences in mortality or risk of encephalopathy.††


    a Levels of Evidence for Therapeutic Studies. From the Centre for Evidence-Based Medicine, http://www.cebm.net
    b Sarcopenia is a risk for patients with liver disease and not an indication for a TIPS procedure.

    1. Boike, Justin R. et al. North American practice-based recommendations for transjugular intrahepatic portosystemic shunts in portal hypertension. Clinical Gastroenterology and Hepatology, Volume 20, Issue 8, 1636 - 1662.e36.
    2. European Association for the Study of the Liver. EASL clinical practice guidelines on TIPS. Journal of Hepatology 2025;83(1):177-210.
    3. Lee EW, Eghtesad B, Garcia-Tsao G, et al. AASLD practice guidance on the use of TIPS, variceal embolization, and retrograde transvenous obliteration in the management of variceal hemorrhage. Hepatology 2024;79(1):224-250.
    4. Kaplan D, Ripoll C, Thiele M, et al. AASLD Practice Guidance on risk stratification and management of portal hypertension and varices in cirrhosis. Hepatology 2024;79(5):1180-1211.
    5. Biggins SW, Angeli P, Garcia-Tsao G, Ginès P, Ling SC, Nadim MK, Wong F, Kim WR. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology 2021;74(2):1014-1048. Erratum in: Hepatology. 2024;80(5):E89.
    6. Lai JC, Tandon P, Bernal W, Tapper EB, Ekong U, Dasarathy S, Carey EJ. Malnutrition, frailty, and sarcopenia in patients with cirrhosis: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology 2021;74(3):1611-1644. Erratum in: Hepatology. 2021;74(6):3563.

    This information is intended for education and awareness only. Patients should consult their physician for information on the risks associated with the devices and surgical procedures discussed in this website. All surgical procedures carry potential health risks. Not all patients will be candidates for treatment with these devices, and individual outcomes may vary. Always follow physician advice on your post-surgery care and recovery.

    IFU Consult instructions

    Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

    INDICATIONS FOR USE IN THE U.S.: The GORE® VIATORR® TIPS Endoprosthesis is indicated for use in the de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, ascites which recurs despite conventional treatment, and/or hepatic hydrothorax. 

    CONTRAINDICATIONS: There are no known contraindications for this device.