New York (Reuters Health) – Variceal embolization during transjugular intrahepatic portosystemic shunt (TIPS) placement does not reduce patients’ risk of recurrent variceal bleeding, new data show.
Dr. Yong Lv et al from the Xijing Hospital of Infectious Diseases, Xi’an, China and colleagues randomly assigned 134 adults with liver cirrhosis and gastro-esophageal bleeding to undergo either TIPS plus embolization (n=69) or TIPS alone (n=65). There was no difference between the two groups in terms of location of varices; in both groups the incidence of type 2 gastroesophageal varices was low (17%). Tips or TIPs plus embolization was performed successfully in all cases.
The 2-year actuarial probability of variceal rebleeding was similar between the two groups (TIPS plus embolization, 11.6%, 95% CI 4.0-19.1, vs TIPS alone, 13.8%, 95% CI 5.4-22.2; hazard ratio 0.82, 95% CI 0.42-1.61; p=0·566).
Patients ages 18 to 75 were eligible for the study if they had variceal bleeding within the past 6-42 days despite endoscopic treatment plus non-selective β-blockers for secondary prophylaxis. The interval from bleeding to randomization averaged 13 days in the TIPS plus embolization group and 14 in the TIPS-only group. Approximately one in four patients in each group underwent the procedures more than 21 days after the index bleeding.
The main cause of cirrhosis was hepatitis B (n=100, 75%); the median Model for End-Stage Liver Disease (MELD) score was 9.7 (QR 7.6-11.8).
The mean portacaval pressure gradient (PPG) went from 25.1 mmHg to 8.0 mmHg in patients with TIPS plus embolization, and from 24 mmHg to 7.7 mmHg in patients who underwent TIPS alone. In four patients in each group, the procedures resulted in a greater than 25% reduction in PPG, but the final PPG was greater than 12 mmHg.
During median follow-up periods of 61.8 months and 63.1 months in the groups with and without embolization, respectively, rebleeding occurred in 16 (23%) and 21 (32%) patients, respectively (p=0.32).
Recurrent bleeding was due to variceal rupture in all 16 patients in the TIPS plus embolization group and in 18 (86%) of the TIPS-only group.
Eleven (69%) patients in the TIPS plus embolization group and 12 (57%) in the TIPS-only group underwent TIPS revision. Mean PPG in patients undergoing TIPS revision was 20.5 mmHg; PPG was above 12 mmHG in all cases and fell to a mean of 9.4 mmHG after revision. The others were managed by endoscopic treatment and medication. Of the patients who did not initially achieve a PPG pressure of less than 12 mmHg, two rebled in the TIPS group and one rebled in the TIPS plus embolization group.
Complication rates were similar in each group. The main complication, overt encephalopathy, was seen in 25 of 69 (36%) patients undergoing TIPS plus embolization and in 30 of 65 (46%) who underwent TIPS alone (p=0.32) . There were no significant differences between the groups in the development of ascites, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatic hydrothorax or hepatocellular carcinoma.
Twenty four patients (35%) died during follow up in the TIPS plus embolization group and 25 patients died in the TIPS alone group (38%). Causes of death did not differ between the groups, with the main cause of death being liver failure. Two patients in the TIPs plus embolization group and one in the TIPS-along group underwent liver transplantation.
The authors say their study found no “evidence of an advantage of adding gastro-esophageal variceal embolization to TIPS for the prevention of variceal rebleeding.” However, they add, the “risk-benefit ratio of variceal embolization deserves individual consideration in certain subsets of patients, such as those with an insufficient fall in PPG after TIPS and those with gastric cardiofundal varices.”
In an editorial, Oana Nicoara-Farcau from Barcelona, Spain and Anna Baiges from Cluj-Napoca, Romania say the debate over gastric varices warrants further attention. They point out that having only a small percentage of patients with type 2 gastroesophageal varices and no patient with isolated gastric varices diminishes the strength of the study. They add that in 20% of the patients in each group, the time between index bleeding and randomization was greater than 21 days, which may represent a group with a lower rebleeding risk. Finally, they note, the rate of rebleeding was relatively high and they would have liked to see more post procedural data such as direction of flow, and the confirmation of the obliteration of varices.
“The study by Yong Lv and colleagues represents an important effort to improve the management of gastric varices; however, we need more specific and detailed data before we can draw strong conclusions and reach a consensus,” the editorial concludes.
SOURCE: https://bit.ly/3wFnq2U and https://bit.ly/38IXo7g The Lancet Gastroenterology and Hepatology, online May 17, 2022.
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