Blood cell differential count discretisation modelling to predict survival in adults reporting to the emergency room: a retrospective cohort study.

OBJECTIVES: To assess the survival predictivity of baseline blood cell differential count (BCDC), discretised according to two different methods, in adults visiting an emergency room (ER) for illness or trauma over 1 year. DESIGN: Retrospective cohort study of hospital records. SETTING: Tertiary care public hospital in northern Italy. PARTICIPANTS: 11 052 patients aged >18 years, consecutively admitted to the ER in 1 year, and for whom BCDC collection was indicated by ER medical staff at first presentation. PRIMARY OUTCOME: Survival was the referral outcome for explorative model development. Automated BCDC analysis at baseline assessed haemoglobin, mean cell volume (MCV), red cell distribution width (RDW), platelet distribution width (PDW), platelet haematocrit (PCT), absolute red blood cells, white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets. Discretisation cut-offs were defined by benchmark and tailored methods. Benchmark cut-offs were stated based on laboratory reference values (Clinical and Laboratory Standards Institute). Tailored cut-offs for linear, sigmoid-shaped and U-shaped distributed variables were discretised by maximally selected rank statistics and by optimal-equal HR, respectively. Explanatory variables (age, gender, ER admission during SARS-CoV2 surges and in-hospital admission) were analysed using Cox multivariable regression. Receiver operating curves were drawn by summing the Cox-significant variables for each method. RESULTS: Of 11 052 patients (median age 67 years, IQR 51-81, 48% female), 59% (n=6489) were discharged and 41% (n=4563) were admitted to the hospital. After a 306-day median follow-up (IQR 208-417 days), 9455 (86%) patients were alive and 1597 (14%) deceased. Increased HRs were associated with age >73 years (HR=4.6, 95% CI=4.0 to 5.2), in-hospital admission (HR=2.2, 95% CI=1.9 to 2.4), ER admission during SARS-CoV2 surges (Wave I: HR=1.7, 95% CI=1.5 to 1.9; Wave II: HR=1.2, 95% CI=1.0 to 1.3). Gender, haemoglobin, MCV, RDW, PDW, neutrophils, lymphocytes and eosinophil counts were significant overall. Benchmark-BCDC model included basophils and platelet count (area under the ROC (AUROC) 0.74). Tailored-BCDC model included monocyte counts and PCT (AUROC 0.79). CONCLUSIONS: Baseline discretised BCDC provides meaningful insight regarding ER patients' survival.

Eosinopenia is a reliable marker of severe disease and unfavourable outcome in patients with COVID-19 pneumonia.

BACKGROUND AND AIM: Viral pneumonia is the most relevant clinical presentation of COVID-19 which may lead to severe acute respiratory syndrome and even death. Eosinopenia was often noticed in patients with COVID-19 pneumonia, but its role is poorly investigated. The aim of the present study was to investigate the characteristics and clinical outcomes of patients with COVID-19 pneumonia and eosinopenia. METHODS: We revised the records of consecutive patients with COVID-19 pneumonia admitted to our ER-COVID-19 area in order to compare clinical characteristics and outcomes of patients with and without eosinopenia. We considered the following clinical outcomes: 4-weeks survival; need for intensive respiratory support; and hospital discharge. RESULTS: Out of first 107 consecutive patients with pneumonia and a positive COVID-19 nasopharyngeal swab, 75 patients showed undetectable eosinophil count (absolute eosinopenia). At 4 weeks, 38 patients (38.4%) had required intensive respiratory treatment, 25 (23.4%) deceased and 42 (39.2%) were discharged. Compared with patients without absolute eosinopenia, patients with absolute eosinopenia showed higher need of intensive respiratory treatment (49.3% vs 13.3%, P < .001), higher mortality (30.6% vs 6.2%, P .006) and lower rate of hospital discharge (28% vs 65.6%, P < .001). Binary logistic regression analyses including neutrophil, lymphocyte, eosinophil, basophil and monocyte counts showed that absolute eosinopenia was an independent factor associated with 4-weeks mortality, need for intensive respiratory support and hospital discharge. CONCLUSIONS: Absolute eosinopenia is associated with clinical outcomes in patients with COVID-19 pneumonia and might be used as a marker to discriminate patients with unfavourable prognosis.

Urgent pulmonary lobectomy for blunt chest trauma: report of three cases without mortality.

BACKGROUND: The majority of patients with severe blunt chest trauma is successfully treated with supportive measures and thoracostomy tube; only few cases need urgent thoracotomy. Lung-sparing techniques are treatments of choice but major pulmonary resections are necessary in case of injuries involving hilar vessels or bronchi. Currently the mortality associated with pulmonary lobectomy performed for chest trauma is 40%. METHODS: Over a 2-year period [2013-2014], 210 patients with chest trauma were hospitalized at our Institution. Mechanism of injury was blunt in 204 (97.1%) patients and penetrating in 6 (2.9%). In 48 (22.8%) patients was necessary a ventilatory support and 37 (17.6%) patients were treated with thoracostomy tube. Nineteen (9%) patients needed urgent thoracotomy: 4 (1.9%) cases for penetrating injury and 15 (7.1%) cases for blunt trauma. Three (1.4%) patients treated with urgent thoracotomy required concomitant laparotomy for intra-abdominal injuries. The overall mortality rate was 1.4%. RESULTS: We report three cases of urgent lobectomies for chest trauma without mortality and with postoperative complete restoration of respiratory function. The anatomical lobectomies were performed for: massive hemothorax with bronchial disruption, expanding pulmonary hematoma with hypovolemic shock, and massive hemothorax in deep parenchymal laceration. CONCLUSIONS: Mortality rate after major pulmonary resections for trauma is very high and increases with the presence of multivisceral injuries, the severity of hypovolemic shock and extent of lung resection. Anterolateral thoracotomy was the approach employed in case of cardiac arrest. In hypovolemic patients a posterolateral incision with a double lumen intubation was performed. The absence of mortality in this series may be related to the prompt diagnosis, short operative time and absence of associated severe neurological or abdominal injuries.

Adherence to American Association for the Study of Liver Diseases guidelines for the management of hepatocellular carcinoma: results of an Italian field practice multicenter study.

AIM: Adherence to and the applicability of practice guidelines for the management of hepatocellular carcinoma (HCC) in field practice have not been fully addressed. We designed a multicenter field practice prospective study to evaluate the adherence to the 2005 American Association for the Study of Liver Diseases guidelines in Italy. MATERIALS & METHODS: The study began in September 2008 and consecutively enrolled cirrhotic patients with newly diagnosed HCC from 30 local, nonreference centers in Italy. Patients were stratified according to Child-Pugh, the model for end-stage liver disease, tumor-node metastasis, performance status and the Barcelona Clinic Liver Cancer (BCLC) classifications. The diagnostic and therapeutic strategies adopted in each individual patient were recorded. Statistical analysis was carried out on 536 patients using all of the valuable data. RESULTS: A total of 286 (54.5%) patients were ≥70 years old. Comorbidities, recorded in 397 (74%) patients, were classified as moderate to severe in 170 patients (43%). Overall, 174 (59%) patients with early-stage BCLC were ≥70 years; 104 (35%) of these had moderate-to-severe comorbidities and 54% were under a regular US surveillance program. Diagnosis was performed by computed tomography in 93% of patients, contrast-enhanced ultrasound in 62% and MRI in 17%. In patients with nodules of ≤2 cm, adherence to noninvasive diagnostic criteria was 56%. Adherence to the BCLC classification was shown to be suboptimal overall, particularly regarding allocation to surgical procedures, and a total of 119 patients (40%) with BCLC stage A did not receive curative therapies. CONCLUSIONS: This multicenter survey showed that, in the 'real world', adherence to the both the diagnostic and therapeutic American Association for the Study of Liver Diseases 2005 algorithms was low, particularly in patients with early-stage HCC. Difficulties in applying the algorithms in routine clinical practice and the high prevalence of older patients with relevant comorbidities may account for our findings. Strategies to help improve adherence to international guidelines for HCC in field practice are required.

Diagnosis, treatment and survival of patients with hepatorenal syndrome: a survey on daily medical practice.

BACKGROUND & AIMS: Hepatorenal syndrome (HRS) is a severe complication of cirrhosis with ascites. The International Ascites Club recommended strict diagnostic criteria and treatment with vasoconstrictors and albumin. Aim of this prospective cohort study was to investigate the prevalence of HRS, diagnostic criteria, treatment and 3-month outcome in the daily-clinical-practice. METHODS: Two-hundred-fifty-three patients with cirrhosis and renal failure consecutively admitted to 21 Italian hospitals were recruited. RESULTS: The prevalence of HRS was 45.8% (30% type-1 and 15.8% type-2). In 36% of cases HRS was presumed because not all diagnostic criteria could be fulfilled. In 8% of cases HRS was superimposed on an organic nephropathy. Patients with HRS type-1 were younger and showed higher leukocyte count, higher respiratory rates, and worse liver function scores. Sixty-four patients with HRS type-1 received vasoconstrictors (40 terlipressin and 24 midodrine/octreotide). A complete response was obtained in 19 cases (30%) and a partial response in 13 (20%). Age was the only independent predictor of response (p=0.033). Three-month survival of patients with HRS type-1 was 19.7%. Survival was better in patients who responded to therapy. Age (p=0.017), bilirubin (p=0.012), and creatinine increase after diagnostic volume expansion (p=0.02) independently predicted death. The mortality rate was 97% among patients with at least two negative predictors. CONCLUSIONS: The diagnostic criteria of HRS in our daily-clinical-practice could not be completely fulfilled in one third of cases. The treatment with vasoconstrictors and albumin was widely implemented. Mortality was strongly predicted by simple baseline variables.

Therapeutic strategies and emergence of multiresistant bacterial strains.

Spontaneous bacterial peritonitis (SBP) is one of the most serious complications occurring in cirrhotic patients with ascites. Therefore, an effective therapy is always required starting immediately after diagnosis. There are three aims of therapy: (1) to eradicate the bacterial strain responsible of the infection; (2) to prevent renal failure; and (3) to prevent SBP recurrence. The first end point is achievable by means of a large-spectrum antibiotic therapy. Empirical antibiotic therapy can be started with a third-generation cephalosporin, amoxicillin-clavulanate or a quinolone. The effectiveness of antibiotics should be verified by determining the percent reduction of polymorphonuclear cells count in the ascitic fluid. If bacteria result to be resistant to the empirical therapy, a further antibiotic must be given according to the in vitro bacterial susceptibility. In most cases, a 5-day antibiotic therapy is enough to eradicate the bacterial strain. Severe renal failure occurs in about 30% of patients with SBP, independently of the response to antibiotics, and it is associated with elevated mortality. The early administration of large amount of human albumin showed to be able to reduce the episodes of renal failure and to improve survival. After the resolution of an episode of SBP, the recurrence is frequent. Therefore, an intestinal decontamination with oral norfloxacin has been shown to significantly reduce this risk and is widely practised. However, such a long-term prophylaxis, as well as the current increased use of invasive procedures, favours the increase of bacterial infections, including SBP, contracted during the hospitalization (nosocomial infections) and sustained by multi-resistant bacteria. This involves the necessity to use a different strategy of antibiotic prophylaxis as well as a more strict surveillance of patients at risk.

Point-of-care coagulation monitors calibrated for the international normalized ratio for cirrhosis (INRliver) can help to implement the INRliver for the calculation of the MELD score.

BACKGROUND/AIMS: The MELD defines a score used to prioritize patients awaiting liver transplantation and includes results for bilirubin, creatinine and PT expressed as INR. It is assumed that the MELD for individual patients is the same regardless of the laboratory method used for testing, thus ensuring parity of organ allocation. Previous studies showed that the INR calibrated for patients on vitamin K antagonists (INR(vka)) does not normalize results across thromboplastins, whereas an alternative calibration called INR(liver) does. However, implementation of INR(liver) calibration for thromboplastins is difficult in practice. This study aimed to assess whether easy-to-run whole-blood coagulation monitors (widely used for patients on VKA) can be calibrated to measure efficiently the INR(liver) and minimize the interlaboratory variability. METHODS: PT values for 61 cirrhotic patients were measured on native-blood with 2 monitors calibrated in terms of INR(vka). PTs for these subjects were also measured with a WHO-standard for thromboplastin. Paired-PTs with the monitors and the standard were subsequently used to calibrate the monitors in terms of INR(liver). INR(vka) and INR(liver) were then compared to assess for statistical significance. RESULTS: The mean INR(vka) obtained with the monitors and the standard were significantly different (p<0.001). Conversely, the corresponding INR(liver) were not. CONCLUSIONS: The INR(liver) calibration as previously described for thromboplastins works also for the easy-to-run whole-blood coagulation monitors. Once the monitors are calibrated by the manufacturer in terms of INR(liver) they could be used as near-patient-testing devices directly by the personnel of liver units making the determination of the INR for patients awaiting liver transplantation much easier and standardized.

The systemic inflammatory response syndrome in cirrhotic patients: relationship with their in-hospital outcome.

BACKGROUND/AIMS: Some evidence suggests that the systemic inflammatory response syndrome (SIRS) contributes to the poor outcome of cirrhotic patients. We studied 141 cirrhotic patients consecutively admitted to a tertiary referral centre assessing prevalence of SIRS and its relationship with in-hospital outcome. METHODS: Presence of SIRS was assessed on admission and during hospital stay. Main clinical outcomes were death and development of portal hypertension-related complications. RESULTS: Thirty-nine patients met SIRS criteria. SIRS was present on admission in 20 of 141 patients (14.1%), whereas it occurred during hospital stay in 19 of 121 (15.7%). SIRS was correlated with bacterial infection at admission (p=0.02), jaundice (p=0.011), high serum creatinine levels (p=0.04), high serum bilirubin levels (p=0.002), high international normalized ratio (p=0.046), high model of end-stage liver disease (MELD) score (p=0.001), and high SOFA score (p=0.003). During a follow-up of 14+/-8 days, 16 patients died (11%), 7 developed portal hypertension-related bleeding (5%), 16 hepatic encephalopathy (11%), and 5 hepatorenal syndrome type-1 (3.5%). SIRS was correlated both to death (p<0.001) and to portal hypertension-related complications (p<0.001). On multivariate analysis, SIRS and MELD were independently associated with death. CONCLUSIONS: SIRS frequently occurs in patients with advanced cirrhosis and is associated with a poor outcome.

The use of E/A ratio as a predictor of outcome in cirrhotic patients treated with transjugular intrahepatic portosystemic shunt.

OBJECTIVES: The clinical significance of diastolic dysfunction in cirrhosis, a feature of cirrhotic cardiomyopathy, is unclear. The aim of this study was to assess the utility of E/A ratio, an indicator of diastolic dysfunction, to predict ascites clearance and mortality after transjugular intrahepatic portosystemic stent shunt (TIPS) insertion. METHODS: A total of 101 cirrhotic patients who received TIPS had pre-TIPS assessments of demographics, severity of liver dysfunction (Child-Pugh and Model for End-Stage Liver Disease (MELD) scores), renal function, hemodynamics, and cardiac function (two-dimensional echocardiography). An E/A ratio of < or =1 was used to indicate diastolic dysfunction. Patients were followed-up for a mean period of 24.6+/-2.4 months post TIPS. RESULTS: A total of 41 patients with an E/A ratio of < or =1 (group A), and 60 patients with an E/A ratio of >1 (group B) were studied. Group A had significantly higher MELD scores (14.0+/-1.0 vs. 11.4+/-0.8; P=0.03), because of higher serum creatinine levels (107+/-5 vs. 86+/-6 micromol/l; P<0.01). There was no difference in pre-TIPS systemic hemodynamics, systolic function, or portal pressure between the two groups. After TIPS, more patients in group B had ascites clearance (log rank, P=0.038), and the same patients had a higher probability of survival (log rank, P=0.046). There were three post-TIPS cardiac deaths in group A only. A multivariate analysis showed that an E/A of ratio < or =1 was predictive of slow ascites clearance (hazard ratio=7.3, 95% confidence interval=1.3-40.7, P=0.021) and death after TIPS (hazard ratio=4.7, 95% confidence interval=1.1-20.2, P=0.035). CONCLUSIONS: Diastolic dysfunction, indicated by reduced E/A ratio, is prevalent in advanced cirrhosis and is associated with reduced ascites clearance and increased mortality post TIPS, possibly related to worsening of hemodynamic dysfunction in the post-TIPS period.

Prediction of asymptomatic cirrhosis in chronic hepatitis C patients: accuracy of artificial neural networks compared with logistic regression models.

OBJECTIVE: Models based on logistic regression analysis are proposed as noninvasive tools to predict cirrhosis in chronic hepatitis C (CHC) patients. However, none showed to be sufficiently accurate to replace liver biopsy. Artificial neural networks (ANNs), providing a prediction based on nonlinear algorithms, can improve the diagnosis of cirrhosis, a syndrome characterized by complex, nonlinear biological alterations. We compared ANNs with two logistic regression analysis-based models in predicting CHC histologically proven cirrhosis. METHODS: Liver biopsy was obtained in CHC patients of two different cohorts (an internal cohort including 244 patients and an external cohort including 220 patients). One hundred and forty-four patients from the internal cohort served as a training set to construct ANNs and a logistic regression model (LOGIT). These two models and the aspartate aminotransferase-to-platelet ratio index (APRI) were tested in the remaining 100 patients (internal validation set) and in the external cohort (external validation set). Diagnostic performances were evaluated by standard indices of accuracy. RESULTS: In the internal validation set, ANNs, LOGIT, and APRI showed similar discrimination powers (0.88, 0.87, and 0.87 respectively). However, ANNs showed the best positive predictive value (0.86 vs. 0.67 and 0.56) and positive likelihood ratio (40.2 vs. 13.4 and 8.4). In the external validation set, the discrimination power of ANNs (0.76) was significantly higher than those of LOGIT (0.67) and APRI (0.67). CONCLUSION: Compared to conventional models, ANNs performance in predicting CHC cirrhosis is slightly better and more reproducible.

Usefulness of simplified acute physiology score II in predicting mortality in patients admitted to an emergency medicine ward.

The Objective of this prospective observational study was to evaluate the applicability of the simplified acute physiology score (SAPS II) in patients admitted to an Emergency Medicine Ward in the Emergency Medicine Ward of a tertiary university hospital. We studied consecutive patients admitted to an Emergency Medicine Ward from the emergency department. The SAPS II was assessed in predicting overall in-hospital mortality in terms of sensitivity, specificity and receiver operating characteristic (ROC) curve. A total of 211 consecutive patients were admitted over a period of 2 months. Median SAPS II score was 28 (range 6-93), with a mean risk of in-hospital mortality of 0.17 (range 0.01-0.97) for the whole population, and an observed mortality of 15%. The area under the receiver operator curve (ROC) was 0.84 (0.77-0.91). Considering a cut-off value of SAPS II of 49, the sensitivity was 0.50 (95% CI 0.42-0.56), the specificity was 0.95 (0.92-0.98), the positive predictive value (PPV) was 0.64 (0.58-0.71), and the negative predictive value (NPV) was 0.91 (0.87-0.95), the positive likelihood ratio (pLH) was 9.9, and the negative likelihood ratio (nLH) was 0.5. If contrarily a cut-off value of SAPS II of 22 were used, the sensitivity would be 1.0, the specificity would be 0.21 (0.16-0.26), the PPV would be 0.18 (0.13-0.23), the NPV would be 1.0, the pLH would be 1.3, and the nLH would be 0.0. In this preliminary study, SAPS II predicted in-hospital mortality in patients admitted to an Emergency Ward.

Increased flow-mediated vasodilation in cirrhotic patients with ascites: relationship with renal resistive index.

BACKGROUND: Peripheral vasodilation is the key factor in the development of hyperdynamic circulation, sodium retention and functional renal failure in patients with cirrhosis. Brachial artery flow-mediated dilation (FMD) after transient vascular occlusion is a non-invasive method to assess the shear stress-induced arterial vasodilation. AIMS: To evaluate FMD in cirrhotic patients with and without ascites and to assess the relationship between FMD and intrarenal resistances. METHODS: Flow-mediated dilation was determined in 32 cirrhotic patients (22 with ascites) and 12 healthy controls and correlated with the intrarenal resistive index (RI) assessed by Doppler exploration. RESULTS: Basal diameter of the brachial artery was similar in healthy controls and in cirrhotic patients, whereas FMD was significantly higher in patients with cirrhosis and ascites [29.5% (range 10.3-50%)] than in pre-ascitic patients [17.3% (range 2.4-48.5%)] and healthy control subjects [11.6% (range 5.1-17.8%)] (P<0.001). Intrarenal RI was significantly higher in patients with cirrhosis than in healthy subjects, and a direct relationship existed between FMD and intrarenal RI (r=0.66; P<0.00001). CONCLUSIONS: These findings in vivo demonstrate that cirrhotic patients with ascites have an enhanced shear stress-induced peripheral vasodilation, which is closely related to intrarenal vasoconstriction.

[Endovascular repair of aortic abdominal aneurysms in octagenarian patients: early and midterm results]. / Trattamento endovascolare di Aneurismi dell'aorta addominale in pazienti ottantenari. Risultati a medio termine.

AIM OF THE STUDY: This article summarizes our experience in endovascular repair of abdominal aortic aneurysm in octogenarian patients. MATERIAL AND METHODS: From January 2000 to December 2005 30 patients (mean age 84 years) underwent endovascular repair of abdominal aortic aneurysm; in 28 cases a loco-regional anaesthesia has been performed. Twenty-eight bifurcated graft, one straight graft and one aorto-iliac graft have been used. RESULTS: No operative mortality or early endoleak have been observed; during the follow-up period (20 months) 7 endo-leaks (3 cases type I; 4 cases type II) have been reported; all patients with type I EL underwent endovascular repair; in two patients with type II EL we observed spontaneous regression; the other cases are still monitored in absence of sac enlargement. Four graft occlusions have been observed; one early thrombosis has been treated with surgical thrombectomy, two of the three late occlusions required other procedures. Five patients died during the follow-up period, three of them during the first year. No death has been aneurysm related. DISCUSSION: In accord with other recent studies, our analysis confirms the positive impact on intra-operative and early post-procedural mortality of the endovascular therapy for abdominal aortic aneurysm in octogenarian patients; no evidence of significative benefit on late survival has been observed. CONCLUSION: In conclusion we consider endovascular option as the best approach in octogenarian patients even if a longer follow-up is mandatory.

Diastolic dysfunction is associated with poor survival in patients with cirrhosis with transjugular intrahepatic portosystemic shunt.

BACKGROUND: Transjugular intrahepatic portosystemic shunt (TIPS) is a treatment for portal hypertension-related complications. Accurate prediction of the outcome of patients treated with TIPS is important, because some patients have very short survival. Diastolic dysfunction is frequently observed in patients with cirrhosis. AIM: To investigate whether or not diastolic dysfunction can predict the outcome after TIPS. METHODS: Echocardiography with Doppler exploration was performed before and 28 days after TIPS insertion in 32 patients with cirrhosis. Several echocardiographic measures, including the early maximal ventricular filling velocity/late filling velocity (E/A) ratio as indicative of diastolic function, as well as laboratory, clinical and demographic variables were evaluated as predictors of survival. RESULTS: Univariate analysis revealed that the presence of diastolic dysfunction observed 28 days after TIPS (E/A ratio 1 survived. CONCLUSIONS: Diastolic dysfunction estimated using E/A ratio is a promising predictor of death in patients with cirrhosis who are treated with TIPS.

Evidence of normal thrombin generation in cirrhosis despite abnormal conventional coagulation tests.

The role played by coagulation defects in the occurrence of bleeding in cirrhosis is still unclear. This is partly due to the lack of tests that truly reflect the balance of procoagulant and anticoagulant factors in vivo. Conventional coagulation tests such as prothrombin time and activated partial thromboplastin time are inadequate to explore the physiological mechanism regulating thrombin, because they do not allow full activation of the main anticoagulant factor, protein C, whose levels are considerably reduced in cirrhosis. We used a thrombin generation test to investigate the coagulation function in patients with cirrhosis. Thrombin generation measured without thrombomodulin was impaired, which is consistent with the reduced levels of procoagulant factors typically found in cirrhosis. However, when the test was modified by adding thrombomodulin (i.e., the protein C activator operating in vivo), patients generated as much thrombin as controls. Hence, the reduction of procoagulant factors in patients with cirrhosis is compensated by the reduction of anticoagulant factors, thus leaving the coagulation balance unaltered. These findings help clarify the pathophysiology of hemostasis in cirrhosis, suggesting that bleeding is mainly due to the presence of hemodynamic alterations and that conventional coagulation tests are unlikely to reflect the coagulation status of these patients. In conclusion, generation of thrombin is normal in cirrhosis. For a clinical validation of these findings, a prospective clinical trial is warranted where the results of thrombin generation in the presence of thrombomodulin are related to the occurrence of bleeding.

Randomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites.

The transjugular intrahepatic portosystemic shunt (TIPS) has been shown to be effective in the control of refractory or recidivant ascites. However, the effect of TIPS on survival as compared with that of large-volume paracentesis plus albumin is uncertain. A multicenter, prospective, clinical trial was performed in 66 patients with cirrhosis and refractory or recidivant ascites (16 Child-Turcotte-Pugh class B and 50 Child-Turcotte-Pugh class C) randomly assigned to treatment with TIPS (n = 33) or with large-volume paracentesis plus human albumin (n = 33). The primary endpoint was survival without liver transplantation. Secondary endpoints were treatment failure, rehospitalization, and occurrence of complications. Thirteen patients treated with TIPS and 20 patients treated with paracentesis died during the study period, 4 patients in each group underwent liver transplantation. The probability of survival without transplantation was 77% at 1 year and 59% at 2 years in the TIPS group as compared with 52% and 29% in the paracentesis group (P = .021). In a multivariate analysis, treatment with paracentesis and higher MELD score showed to independently predict death. Treatment failure was more frequent in patients assigned to paracentesis, whereas severe episodes of hepatic encephalopathy occurred more frequently in patients assigned to TIPS. The number and duration of rehospitalizations were similar in the two groups. In conclusion, compared to large-volume paracentesis plus albumin, TIPS improves survival without liver transplantation in patients with refractory or recidivant ascites.