Clinical effects and complications of TIPS for portal hypertension due to cirrhosis: A single center

World J Gastroenterol. 2013 Nov 28;19(44):8085-92. doi: 10.3748/wjg.v19.i44.8085.

Qin JP, Jiang MD, Tang W, Wu XL, Yao X, Zeng WZ, Xu H, He QW, Gu M.

Jian-Ping Qin, Ming-De Jiang, Wen Tang, Xiao-Ling Wu, Xin Yao, Wei-Zheng Zeng, Hui Xu, Department of Digestion, Chengdu Military General Hospital, Chengdu 610083, Sichuan Province, China.

Abstract

AIM: To determine the clinical effects and complications of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension due to cirrhosis.

METHODS: Two hundred and eighty patients with portal hypertension due to cirrhosis who underwent TIPS were retrospectively evaluated. Portal trunk pressure was measured before and after surgery. The changes in hemodynamics and the condition of the stent were assessed by ultrasound and the esophageal and fundic veins observed endoscopically.

RESULTS: The success rate of TIPS was 99.3%. The portal trunk pressure was 26.8 ± 3.6 cmH2O after surgery and 46.5 ± 3.4 cmH2O before surgery (P < 0.01). The velocity of blood flow in the portal vein increased. The internal diameters of the portal and splenic veins were reduced. The short-term hemostasis rate was 100%. Esophageal varices disappeared completely in 68% of patients and were obviously reduced in 32%. Varices of the stomach fundus disappeared completely in 80% and were obviously reduced in 20% of patients. Ascites disappeared in 62%, were markedly reduced in 24%, but were still apparent in 14% of patients. The total effective rate of ascites reduction was 86%. Hydrothorax completely disappeared in 100% of patients. The incidence of post-operative stent stenosis was 24% at 12 mo and 34% at 24 mo. The incidence of post-operative hepatic encephalopathy was 12% at 3 mo, 17% at 6 mo and 19% at 12 mo. The incidence of post-operative recurrent hemorrhage was 9% at 12 mo, 19% at 24 mo and 35% at 36 mo. The cumulative survival rate was 86% at 12 mo, 81% at 24 mo, 75% at 36 mo, 57% at 48 mo and 45% at 60 mo.

CONCLUSION: TIPS can effectively lower portal hypertension due to cirrhosis. It is significantly effective for hemorrhage of the digestive tract due to rupture of esophageal and fundic veins and for ascites and hydrothorax caused by portal hypertension.

KEYWORDS: Cirrhosis, Complication, Portal hypertension, Therapeutic effect, Transjugular intrahepatic portosystemic shunt

PMID: 24307804 [PubMed - in process] PMCID: PMC3848158

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Early TIPS with covered stents in high-risk patients with cirrhosis presenting with variceal bleeding: are we ready to dive into the deep end of the pool?

Journal of Hepatology

Articles in Press

Dominique Thabuta, Marika Rudlera, Didier Lebrecbc

Received 24 February 2011; received in revised form 11 May 2011; accepted 12 May 2011. published online 27 June 2011.
Accepted Manuscript

Abstract

Background
Patients with cirrhosis in Child-Pugh class C or those in class B who have persistent bleeding at endoscopy are at high risk for treatment failure and a poor prognosis, even if they have undergone rescue treatment with a transjugular intrahepatic portosystemic shunt (TIPS). This study evaluated the earlier use of TIPS in such patients.

Methods
We randomly assigned, within 24 hours after admission, a total of 63 patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy to treatment with a polytetrafluoroethylene-covered stent within 72 hours after randomization (early-TIPS group, 32 patients) or continuation of vasoactive-drug therapy, followed after 3 to 5 days by treatment with propranolol or nadolol and long-term endoscopic band ligation (EBL), with insertion of a TIPS if needed as rescue therapy (pharmacotherapy-EBL group, 31 patients).

Results
During a median follow-up of 16 months, rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy-EBL group as compared with 1 patient in the early-TIPS group (P=0.001). The 1-year actuarial probability of remaining free of this composite end point was 50% in the pharmacotherapy-EBL group versus 97% in the early-TIPS group (P<0.001). Sixteen patients died (12 in the pharmacotherapy-EBL group and 4 in the early-TIPS group, P=0.01). The 1-year actuarial survival was 61% in the pharmacotherapy-EBL group versus 86% in the early-TIPS group (P<0.001). Seven patients in the pharmacotherapy-EBL group received TIPS as rescue therapy, but four died. The number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapy-EBL group than in the early-TIPS group. No significant differences were observed between the two treatment groups with respect to serious adverse events.

Conclusions
In these patients with cirrhosis who were hospitalized for acute variceal bleeding and at high risk for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure and in mortality. (Current Controlled Trials number, ISRCTN58150114.)

Abbreviations: TIPS, Transjugular intrahepatic portosystemic shunt, HVPG, hepatic venous pressure gradient

Keywords: Child-Pugh score

No full text is available. To read the body of this article, please view the PDF online.

a Université Pierre et Marie Curie, Service d’hépato-gastroentérologie, Hôpital de la Pitié-Salpêtrière (AP-HP), Paris, France
b INSERM, Unité 773, Centre de Recherche Biomédicale Bichat-Beaujon CRB3, Paris and Clichy, France Université Denis Diderot-Paris 7, site Bichat, Paris, France
c Service d’Hépatologie, Hôpital Beaujon, Clichy, France

PII: S0168-8278(11)00496-X
doi:10.1016/j.jhep.2011.05.013
© 2011 Published by Elsevier Inc.

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Gore Launches Study of Early TIPS Therapy for Ascites Patients

November 01, 2010 08:00 AM Eastern Daylight Time

Experts Call for Fresh Look at Transjugular Intrahepatic Portosystemic Shunt (TIPS) Therapy for Liver Disease Patients

FLAGSTAFF, Ariz. & BOSTON--(BUSINESS WIRE)--(The Liver Meeting)—W.L. Gore & Associates (Gore) today announced a new prospective, randomized, multi-center study at the Annual Meeting of the American Association for the Study of Liver Diseases. The hypothesis of the study is that early intervention with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival when compared to large volume paracentesis in patients with cirrhosis and difficult to treat ascites. The study is expected to be the largest and most rigorous multi-disciplinary collaboration with hepatologists and interventional radiologists looking at early TIPS therapy. Gore expects the study to involve 150 subjects at more than 20 sites. The lead co-investigators are Thomas Boyer, MD, Chief of the Arizona Liver Institute and Ziv Haskal, MD, Professor and Director of the Vascular & Interventional Radiology at the University of Maryland Medical Center. Gore is launching an informational website at clinical.goremedical.com/earlytips

The Gore study for ascites patients comes on the heels of a landmark study published in The New England Journal of Medicine comparing early TIPS intervention with the GORE VIATORR TIPS Endoprosthesis to pharmacotherapy / endoscopic band ligation in high risk variceal bleeding patients with positive results. Ascites is the build up of fluid in the abdomen and variceal bleeding involves the rupture of veins in the gastrointestinal system, both a result of liver disease.

TIPS therapy is a minimally invasive procedure done with closed surgery, as only a small puncture is made in the jugular vein for insertion of the TIPS device. A TIPS creates a new channel to route blood flow through the damaged liver and into the main blood vessels that lead blood back to the heart. With the TIPS procedure, alternative treatments such as medications and paracentesis for ascites, and the treatment of varices may not be needed as often.

The GORE VIATORR TIPS Endoprosthesis is the only covered stent that is indicated for TIPS creation and revision. Trial data shows that the device has changed the landscape in TIPS procedures and optimized primary patency rates in the process. According to Dr. Haskal, fundamental and significant improvements in TIPS therapy are seen when using a covered stent versus a bare metal stent.

“Unlike a bare metal stent, the GORE VIATORR TIPS Endoprosthesis improves patency to such a degree that nearly all repeated invasive procedures on TIPS patients have disappeared,” said Dr. Haskal. “New data concerning covered stents forced us to take a fresh look at all earlier randomized studies comparing bare metal TIPS to other treatments. The possibility that we may prolong patient lives is one of the most exciting new questions in TIPS therapy that we must answer.”

According to Dr. Sanyal, “TIPS therapy studies in the 1990s may have failed to demonstrate increasing life expectancy for patients because only end stage patients were included. Previous trials with bare metal stents showed TIPS was a bridge to transplant at best. By including patients in earlier stages of the disease course we hope to show there is an improvement in lifespan,” said Dr. Sanyal who is also on the steering committee for the new Gore Early TIPS for Ascites Study. “By capturing patients a little earlier we may be able to impact their quality of life, as TIPS therapy may improve the ascites and slow the disease progression.”

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 13th consecutive year. For more information, visit http://www.goremedical.com/.

Products listed may not be available in all markets. GORE® and VIATORR® are trademarks of W. L. Gore & Associates.

Contacts
College Hill Life Sciences for W. L. Gore & Associates
Erik Clausen or Kena Hudson, 510-908-0966
goremedical@collegehill.com

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Early use of TIPS in patients with cirrhosis and variceal bleeding

N Engl J Med. 2010 Jun 24;362(25):2370-9.

García-Pagán JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mössner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group.

Hepatic Hemodynamic Laboratory, Liver Unit, Institut de Malalties Digestives i Metaboliques, University of Barcelona, Barcelona, Spain. jcgarcia@clinic.ub.es

Comment in:

N Engl J Med. 2010 Sep 30;363(14):1375; author reply 1376.
N Engl J Med. 2010 Sep 30;363(14):1375; author reply 1376.
N Engl J Med. 2010 Sep 30;363(14):1375-6; author reply 1376.
N Engl J Med. 2010 Jun 24;362(25):2421-2.
Ann Intern Med. 2010 Oct 19;153(8):JC4-6.

Abstract

BACKGROUND: Patients with cirrhosis in Child-Pugh class C or those in class B who have persistent bleeding at endoscopy are at high risk for treatment failure and a poor prognosis, even if they have undergone rescue treatment with a transjugular intrahepatic portosystemic shunt (TIPS). This study evaluated the earlier use of TIPS in such patients.

METHODS: We randomly assigned, within 24 hours after admission, a total of 63 patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy to treatment with a polytetrafluoroethylene-covered stent within 72 hours after randomization (early-TIPS group, 32 patients) or continuation of vasoactive-drug therapy, followed after 3 to 5 days by treatment with propranolol or nadolol and long-term endoscopic band ligation (EBL), with insertion of a TIPS if needed as rescue therapy (pharmacotherapy-EBL group, 31 patients).

RESULTS: During a median follow-up of 16 months, rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy-EBL group as compared with 1 patient in the early-TIPS group (P=0.001). The 1-year actuarial probability of remaining free of this composite end point was 50% in the pharmacotherapy-EBL group versus 97% in the early-TIPS group (P<0.001). Sixteen patients died (12 in the pharmacotherapy-EBL group and 4 in the early-TIPS group, P=0.01). The 1-year actuarial survival was 61% in the pharmacotherapy-EBL group versus 86% in the early-TIPS group (P<0.001). Seven patients in the pharmacotherapy-EBL group received TIPS as rescue therapy, but four died. The number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapy-EBL group than in the early-TIPS group. No significant differences were observed between the two treatment groups with respect to serious adverse events.

CONCLUSIONS: In these patients with cirrhosis who were hospitalized for acute variceal bleeding and at high risk for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure and in mortality. (Current Controlled Trials number, ISRCTN58150114.)

2010 Massachusetts Medical Society

PMID: 20573925 [PubMed - indexed for MEDLINE]

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