We excluded patients who did not have cirrhosis and patients with prior liver transplants, end‐stage renal disease on dialysis, and hepatocellular or other forms of cancer. In some cases, the first encounter was years before the TIPS procedure. We collected data from each patient's first encounter at our institution and every 6 months thereafter. We also included patients who were seen during this period with refractory ascites, as defined by the International Ascites Club criteria, 27 but had not received a TIPS. The study included all patients who had received a TIPS procedure at our institution between 19. This single‐center retrospective study was approved by the University of Iowa Institutional Review Board. 26 If mortality was higher than expected from the combination of the separate independent risks of MELD and of needing/receiving a TIPS procedure, the interaction effect would be positive. By comparing the mortality to be expected from combining these independent factors with the actual mortality observed in our patients, we determined the statistical interaction effect or effect modification. As no such randomized studies exist, we used Cox proportional hazards modeling to determine the risk attributable to needing/receiving TIPS and separately the risk attributable to a high MELD score. To definitively answer this question, a controlled study is needed in which patients with a high MELD score and an indication for TIPS were randomized to receive a TIPS procedure or to be managed without TIPS. 24, 25 The most important consequence of this is that patients with high MELD scores could be denied a potentially lifesaving procedure if the TIPS did not add to the risk over and above that accounted for by these two preexisting risk factors. We hypothesized that the increased mortality risk after TIPS in patients with high MELD scores is due to the intrinsic risks of having both a high MELD score and a complication necessitating a TIPS, the confounding by indication effect. However, the TIPS procedure is sometimes blamed for the increased risk of death in patients with high MELD scores. ![]() 21, 22, 23 It is impossible in retrospective studies to separate the risk of death due to the condition that is the indication for the TIPS (such as intractable ascites, hepatic hydrothorax, or variceal hemorrhage) and death caused by the TIPS procedure as the two are confounded. 1, 2, 3, 4, 5, 6, 7 This high death rate could be because patients with high MELD scores have a higher risk of death than those with low MELD scores, 8, 9, 10, 11 or because they have a life‐threatening complication, such as intractable ascites 12, 13, 14 or variceal bleeding, 15, 16, 17, 18, 19, 20 which increases their risk of dying, or because the TIPS procedure itself increases the risk of death. Patients with high model for end‐stage liver disease (MELD) scores who undergo a transjugular intrahepatic portosystemic shunt (TIPS) procedure are at a high risk of dying after the procedure. ![]() However, the risk of death after TIPS was progressively lower than expected as the MELD score increased. There was an 80% lower incremental risk of death among patients with a MELD score ≥18 (hazard ratio for TIPS, 0.20 95% confidence interval, 0.03‐1.23) 6 months after the TIPS procedure.Ĭonclusion: Risk of death is associated with underlying disease severity as shown by the MELD score and the need for TIPS, and both history of TIPS and high MELD score independently increased the risk of mortality. ![]() Patients with MELD scores ≥18 had a 51% lower incremental risk of death (lower risk than would be expected from the combined independent risks of MELD and needing/receiving TIPS) associated with TIPS than patients with MELD scores <18 (hazard ratio for TIPS, 0.49 95% confidence interval, 0.10‐2.45) in the first 6 months following TIPS. We found a negative interaction between a high MELD score and a history of TIPS, with potentially important effect sizes. We performed Cox proportional hazard regression, including both TIPS and MELD as time‐dependent covariates together with their interaction, to calculate the impact of TIPS on the risk of death associated with a high MELD score. We analyzed the interaction between TIPS and MELD in 106 patients with TIPS and 79 with intractable ascites without TIPS. We aimed to determine if TIPS increased the risk of death in these patients. Physicians often exclude patients with a model for end‐stage liver disease (MELD) score ≥ 18 from a transjugular intrahepatic portosystemic shunt (TIPS) procedure due to the concern for higher risk of death.
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