Part 1: Evidence and literature
Cook Medical recently sponsored a Webcast discussion between specialists in interventional radiology and hepatology on the need for early transjugular intrahepatic portosystemic shunt (TIPS) procedures in patients who suffer from portal hypertension.
The program was moderated by Prof. David Patch from the Royal Free Hospital in London and Prof. Otto M. van Delden from Amsterdam University Medical Center. Speakers included Prof. Bernhard Gebauer, director of the interventional radiology department at Charité Campus Virchow Clinic in Berlin; Dr. Virginia Hernández-Gea in the Liver Unit at Hospital Clínic-IDIBAPS in Barcelona; and Prof. Antonio Gaetano Rampoldi, from Niguarda Hospital in Milan.
The first study on preemptive TIPS for acute variceal bleeding (AVB) was published in 2004. In the article, titled “Influence of portal hypertension and its early decompression by TIPS placement on the outcome of variceal bleeding,” researchers (Monescillo, et al, J. Hepatol.) determined hemodynamically stable patients who have received standard care should receive TIPS implementation within 72 hours following a diagnostic endoscopy.
“These patients are at a high risk of recurrent bleeding,” Prof. Gebauer explained. “If you tried to implant TIPS under emergency conditions, then it might be very difficult to get a successful TIPS implementation in these patients.”
According to this study, failure of treatment for patients with a hepatic venous pressure gradient (HVPG) of greater than or equal to 20 mmHg who did not receive an early TIPS procedure was 50%, while for those who did receive TIPS, it was 12%.
Prof. Gebauer also pointed to a 2010 study titled “Early use of TIPS in patients with cirrhosis and variceal bleeding” (García Pagán, et al, NEJM) which showed that early TIPS had a better outcome than endoscopic band ligation.
Dr. Hernández-Gea discussed a 1981 study titled “The course of patients after variceal hemorrhage” (Graham and Smith, Gastroenterology) showing mortality due to bleeding concentrates in the first three days. This outcome was also confirmed in a recent meta-analysis (Nicoară-Farcău, et al, Gastroenterology).
“If we place the TIPS with the aim of preventing bleeding, preventing failure, and decreasing mortality, we have to prove that as soon as possible,” she said.
If we place the TIPS with the aim of preventing bleeding, preventing failure, and decreasing mortality, we have to prove that as soon as possible.
-Dr. Hernández-Gea
Dr. Hernández-Gea pointed to several randomized clinical trials and observational studies that evaluated the efficacy of preemptive TIPS. Almost all the studies used clinical criteria to identify patients at high risk, which is easy and allows any hospital to make this classification.
This high-risk population concentrates in patients with Child-Pugh C<14. Additionally, a survival benefit was observed in Child-Pugh B patients with active bleeding but not in those without active bleeding (Lv et al, J. Hepatol.).
According to Dr. Rampoldi, early TIPS is a concept often connected only to variceal bleeding, but literature has also demonstrated benefits from an early intervention in cases of refractory ascites. There are not clear guidelines yet on this, but, he said, we should already think about TIPS after the first paracentesis.
He explained that the literature indicates that ascites controlled following TIPS is more successful in cases of patients with low frequency of paracentesis. TIPS is also associated with improved survival.
TIPS for ascites may also help patients with nutritional deficits as well as sarcopenia. It is a complicated situation, according to Prof. Patch. He explained that, often, these patients are sarcopenic because of ascites, “so attempts to improve their sarcopenia are actually just delaying things when you need TIPS in order for them to eat and build up their muscle.” He explained a lack of muscle puts the patient at risk of developing encephalopathy.
Dr. Hernández-Gea added that it’s important to consider TIPS after the first instance of paracentesis and to perform the procedure once the refractory ascites has been assessed. “If we wait too much, the patient is going to be sarcopenic with bad nutritional status,” she said.
Dr. Patch fully agreed. “Early TIPS with bleeding, the definition of diuretic ascites, actually almost predefined a fairly sarcopenic patient. So we actually need to think of early TIPS for ascites as well as bleeding.”
…we actually need to think of early TIPS for ascites as well as bleeding.
-Dr. David Patch
Not all Child-Pugh B patients with active bleeding will benefit from preemptive TIPS. Learn more in Part 2, “Patient selection, referral pathway, and TIPS techniques.”
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All participants are paid consultants of Cook Medical.
References
- Garcia-Pagán JC, Di Pascoli M, Caca K, et al. Use of early-TIPS for high-risk variceal bleeding: results of a post-RCT surveillance study. J Hepatol. 2013;58(1):45-50. doi:10.1016/j.jhep.2012.08.020.
- Rudler M, Cluzel P, Corvec TL, et al. Early-TIPSS placement prevents rebleeding in high-risk patients with variceal bleeding, without improving survival. Aliment Pharmacol Ther. 2014;40(9):1074-1080. doi:10.1111/apt.12934.
- Deltenre P, Trépo E, Rudler M, et al. Early transjugular intrahepatic portosystemic shunt in cirrhotic patients with acute variceal bleeding: a systematic review and meta-analysis of controlled trials. Eur J Gastroenterol Hepatol. 2015;27(9):e1-e9. doi:10.1097/MEG.0000000000000403.
- Holster IL, Tjwa ET, Moelker A, et al. Covered transjugular intrahepatic portosystemic shunt versus endoscopic therapy + β-blocker for prevention of variceal rebleeding. Hepatology. 2016;63(2):581-589. doi:10.1002/hep.28318.
- Thabut D, Pauwels A, Carbonell N, et al. Cirrhotic patients with portal hypertension-related bleeding and an indication for early-TIPS: a large multicentre audit with real-life results. J Hepatol. 2017;68(1):73-81. doi:10.1016/j.jhep.2017.09.002.
- Njei B, McCarty TR, Laine L. Early transjugular intrahepatic portosystemic shunt in US patients hospitalized with acute esophageal variceal bleeding. J Gastroenterol Hepatol. 2017 Apr;32(4):852-858. doi: 10.1111/jgh.13593. PMID: 27624167; PMCID: PMC5350067.
- Hermie L, Dhondt E, Vanlangenhove P, Hoste E, Geerts A, Defreyne L. Model for end-stage liver disease score and hemodynamic instability as a predictor of poor outcome in early transjugular intrahepatic portosystemic shunt treatment for acute variceal hemorrhage. Eur J Gastroenterol Hepatol. 2018;30(12):1441-1446. doi:10.1097/MEG.0000000000001222.
- Lv Y, Zuo L, Zhu X, et al. Identifying optimal candidates for early TIPS among patients with cirrhosis and acute variceal bleeding: a multicentre observational study. Gut. 2019;68(7):1297-1310. doi:10.1136/gutjnl-2018-317057.
- Lv Y, Yang Z, Liu L, et al. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019;4(8):587-598. doi:10.1016/S2468-1253(19)30090-1.
- Hernández-Gea V, Procopet B, Giráldez Á, et al. Preemptive-TIPS Improves Outcome in High-Risk Variceal Bleeding: An Observational Study. Hepatology. 2019;69(1):282-293. doi:10.1002/hep.30182.
- Trebicka J, Gu W, Ibáñez-Samaniego L, et al. Rebleeding and mortality risk are increased by ACLF but reduced by pre-emptive TIPS. J Hepatol. 2020;73(5):1082-1091. doi:10.1016/j.jhep.2020.04.024.
- Dunne PDJ, Sinha R, Stanley AJ, et al. Randomised clinical trial: standard of care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding. Aliment Pharmacol Ther. 2020;52(1):98-106. doi:10.1111/apt.15797.
- Lv Y, Zuo L, Zhu X, et al. Identifying optimal candidates for early TIPS amongpatients with cirrhosis and acute variceal bleeding: A multicentre observational study. J. Hepatol. 2019;68:1297–1310.
- Nicoara-Farcau O, Han G, Rudler M, et al. Effects of early placement of transjugular portosystemic shunts in patients with high-risk acute variceal bleeding: A metaanalysis of individual patient data. Gastroenterology. 2021;160:193–205.
- Graham D, Smith L. The course of patients after variceal hemorrhage. Gastroenterology. 1981;80:800-9.
- Monescillo A, Martínez-Lagares F, Ruiz-del-Arbol L, et al. Influence of portal hypertension and its early decompression by TIPS placement on the outcome of variceal bleeding. Hepatology. 2004;40(4):793-801. doi:10.1002/hep.20386.