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Letter: does early transjugular intrahepatic porto‐systemic shunt really have no effect on survival in high‐risk patients with oesophageal variceal bleeding?

EDITORS, We read with interest the randomised controlled trial by Dunne et al1 about early transjugular intrahepatic porto-systemic shunt (TIPSS), which found no role for early TIPSS in improving survival, in contrast to previous studies.2-4 In this study, several questions need to be addressed. For the definition of early TIPSS according to the Baveno VI consensus,5 strict criteria of patient selection and time window should be followed before early-TIPSS. In this study, 29 patients were randomised to the early TIPSS group, but six did not receive TIPSS and 10 received TIPSS beyond the 72-hour window, which could be a source of bias that may have affected the overall results. Although the authors performed a per protocol analysis excluding these 16 patients, there may not be comparable baseline values between the remaining 13 patients and the 29 patients in the standard group. Moreover, the remaining 13 patients could not meet the sample size requirements that the authors had calculated. Although there was no statistical difference between the two groups for 1-year mortality (24.1% vs 20.7%), the 6-week mortality was significantly higher in the early TIPSS group (10.3% vs 3.4%). In the early TIPSS group, one patient died from GI bleeding, 2 from liver failure, 2 from sepsis and 1 from cardiovascular causes. This suggests that deaths may not always be associated with primary liver disease, and some patients may have died from complications related to TIPSS. High 6-week mortality in the early TIPSS group may be attributed to the fact that operators were not skilful enough to successfully complete every procedure. The reason why this study did not confirm a survival benefit in the early TIPSS group may be related to the low baseline portal pressure gradient (PPG) value (17 ± 5 mm Hg). Carvedilol can lower the hepatic venous pressure gradient (HVPG) by 18.6%-27.7%.6 If these patients received standard of care (carvedilol + endoscopic therapy), and even although their PPG value could not be reduced below 12 mm Hg, it could be lower than 16 mm Hg. The risk of mortality does not increase when HVPG is below 16 mm Hg.7,8 For patients with low baseline PPG value (<20 mm Hg), both carvedilol and TIPSS may be sufficient to reduce the PPG below 16 mm Hg and thus reduce the risk of death. In our previous study, for patients with higher PPG, TIPSS was effective in improving the survival when used as first-line therapy in secondary prophylaxis of variceal haemorrhage.9 HVPG-guided early TIPSS might be more accurate and effective than Child-Pugh classification-guided early TIPSS used in this study. Patients with HVPG ≥ 20 mm Hg could be considered potential candidates for early TIPSS.