Italian Medicine Agency.

The occurrence of decompensation marks a crucial turning point in the course of cirrhosis. The purpose of this study was to assess the risk of mortality according to the clinical characteristics of fi rst decompensation, considering also the impact of acute-on-chronic liver failure (AoCLF). METHODS:We conducted a prospective nationwide inception cohort study in Italy. Decompensation was defi ned by the presence of ascites, either overt or detected by ultrasonography (UD), gastroesophageal variceal bleeding (GEVB), and hepatic encephalopathy (HE). AoCLF was defi ned according to the Asian Pacifi c Association for the Study of the Liver criteria. Multivariable Cox proportional hazards regression was used to analyze the risk of failure (death or orthotopic liver transplantation (OLT)). RESULTS:A total of 490 consecutive cirrhotic patients (314 males, mean age 60.9 ± 12.6 years) fulfi lled the study criteria. AoCLF was identifi ed in 59 patients (12.0 % ). Among the remaining 431 patients, ascites were found in 330 patients (76.6 % ): in 257 (77.8 % ) as overt ascites and in 73 (22.2 % ) as UD ascites. GEVB was observed in 77 patients (17.9 % ) and HE in 30 patients (7.0 % ). After a median follow-up of 33 months, 24 patients underwent OLT and 125 died. The cumulative incidence of failure (death or OLT) after 1, 2, and 3 years was, respectively, 28, 53, and 62 % in patients with AoCLF; 10, 18, and 25 % in patients with UD ascites; 17, 31, and 41 % in patients with overt ascites; and 8, 12, and 24 % in patients with GEVB ( P < 0.0001).CONCLUSIONS: AoCLF is responsible for a relevant proportion of fi rst decompensation in cirrhotic patients and is associated with the poorest outcome. Patients with UD ascites do not have a negligible mortality rate and require clinical monitoring similar to that of patients with overt ascites .SUPPLEMENTARY MATERIAL is linked to the online version of the paper at

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Overall, these results confirm the presence of a different biological characteristic between CD and UC patients and suggest sHLA-G production by PBMC as a noninvasive diagnostic tool in the early phases of the diseases.

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