Development and validation of SCAISS, a tool for semi-automated quantification of sacroilitis by magnetic resonance in spondyloarthritis.

To develop a semi-automated method to quantify inflammation in sacroiliac (SI) joints by measuring bone marrow edema (BME) on MRI. The SCAISS was designed as an image-processing software. Validation followed: (1) three readers evaluated SI images of 23 patients with axial SpA and various levels of BME severity with the SCAISS, and two non-automated methods, SPARCC and Berlin; (2) 20 readers evaluated 12 patients images, also with the three methods; (3) 203 readers evaluated 12 patient images with the Berlin and the SCAISS. Convergent validity, reliability and feasibility were estimated in the first two steps and reliability was confirmed with the third. The interobserver reliability (ICC and 95% CI) in the three observers' study was similar across methods: SCAISS = 0.770 (0.580-0.889); Berlin = 0.725 (0.537-0.860); and SPARCC = 0.824 (0.671-0.916). In the 20 observers' study, ICC was: SCAISS = 0.801 (0.653-0.927); Berlin = 0.702 (0.518-0.882); and SPARCC = 0.790 (0.623-0.923). In the 203 observers' study, ICC were: SCAISS = 0.810 (0.675-0.930), and Berlin = 0.636 (0.458-0.843). SCAISS showed good convergent validity (r with SPARCC = 0.760). Median time (interquartile range) employed in the reading procedure was 28 (27) seconds for the SCAISS, 14 (9) for the Berlin score, and 94 (68) for the SPARCC. The SCAISS permits a valid, reliable, and fast calculation of overall BME lesion at the SI joint on MRI images not dependent on readers' experience.

Prognostic value of hepatic venous pressure gradient in patients with compensated chronic hepatitis C-related cirrhosis.

BACKGROUND AND AIM: Hepatic venous pressure gradient (HVPG) is the main predictor of clinical decompensation in cirrhotic patients with compensated disease of any etiology without varices. However, the predictive factors of decompensation are not so well known in patients with hepatitis C-related compensated cirrhosis, in whom etiology-based therapy is difficult. The aim of this study was to identify predictors of decompensation in patients with compensated chronic hepatitis C (CHC)-related cirrhosis with and without esophageal varices (Baveno stages 1 and 2). METHODS: The study population was a cohort of 145 of such consecutive patients who received hepatic hemodynamic study. All patients were similarly followed every 6 months. Through multivariate Cox regression and bootstrap analyses, a prognostic index (PI) was developed and tested in an external cohort (n = 38). RESULTS: Forty-two patients (29%) suffered a first decompensation episode after a median follow-up of 27 months (2-110). Cox regression analysis identified HVPG (hazard ratio (HR) 1.11; 95% confidence interval (CI): 1.05-1.17) and albumin (HR 0.42; 95% CI: 0.22-0.82) as independent predictors of decompensation. Bootstrapping confirmed that HVPG (95% CI: 1.05-1.18) and albumin (95% CI: 0.12-0.74) were the most robust predictive variables. Using a cut-off level of 2.5, the PI [4 + (0.11 × HVPG - 0.8 × albumin)] was able to distinguish two populations of patients with very different risks of decompensation in both the exploratory and validation cohorts. A time-dependent ROC curve identified HVPG as the best predictive variable. CONCLUSION: HVPG and albumin are independent predictors of clinical decompensation in patients with compensated CHC-related cirrhosis irrespective of the existence of varices.

Meta-analysis: Combination endoscopic and drug therapy to prevent variceal rebleeding in cirrhosis.

BACKGROUND: Combining endoscopic therapy and beta-blockers may improve outcomes in patients with cirrhosis and bleeding esophageal varices. PURPOSE: To assess whether a combination of endoscopic and drug therapy prevents overall and variceal rebleeding and improves survival better than either therapy alone. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and conference proceedings through 30 December 2007. STUDY SELECTION: Randomized trials comparing endoscopic plus beta-blocker therapy with either therapy alone, without language restrictions. DATA EXTRACTION: Two reviewers independently extracted data on interventions and the primary study outcomes of overall rebleeding and mortality. Metaregression and stratified analysis were used to explore heterogeneity. DATA SYNTHESIS: 23 trials (1860 patients) met inclusion criteria. Combination therapy reduced overall rebleeding more than endoscopic therapy alone (pooled relative risk, 0.68 [95% CI, 0.52 to 0.89]; I(2) = 61%) or beta-blocker therapy alone (pooled relative risk, 0.71 [CI, 0.59 to 0.86]; I(2) = 0%). Combination therapy also reduced variceal rebleeding and variceal recurrence. Reduction in mortality from combination therapy did not statistically significantly differ from that from endoscopic (Peto odds ratio, 0.78 [CI, 0.58 to 1.07) or drug therapy (Peto odds ratio, 0.70 [CI, 0.46 to 1.06]). Effects were independent of the endoscopic procedure (injection sclerotherapy or banding). No trial-level variable associated with the effect was identified through metaregression or stratified analysis. LIMITATION: Statistically significant heterogeneity in trial quality and evidence for selective reporting and publication bias were found. CONCLUSION: A combination of endoscopic and drug therapy reduces overall and variceal rebleeding in cirrhosis more than either therapy alone.

Value of the hepatic venous pressure gradient to monitor drug therapy for portal hypertension: a meta-analysis.

OBJECTIVES: The use of the hepatic venous pressure gradient (HVPG) to assess the efficacy of the pharmacological treatment of portal hypertension in cirrhosis is controversial. Our aim was to establish whether target HVPG reduction predicts variceal bleeding in cirrhotic patients receiving variceal bleeding prophylaxis. METHODS: Data sources were MEDLINE, EMBASE, Cochrane Controlled Trials Register, citation lists, and abstracts (most recent search March 2006). Cohorts of patients on drug therapy from randomized and nonrandomized studies correlating variceal bleeding and HVPG change were used. Heterogeneity was explored by metaregression analysis. RESULTS: Ten studies totaling 595 patients undergoing two HVPG measurements were identified. The RR of bleeding was lower in patients achieving an overall (HVPG or=20%) (0.27, 95% CI 0.14-0.52), complete (HVPG or=20%) (0.41, CI 0.20-0.81) response, with significant heterogeneity. Regression analysis identified the interval between the HVPG measurements significantly associated with the RR of bleeding. Heterogeneity was no longer significant after exclusion of an outlier trial, which showed the longest interval to HVPG remeasurement and the lowest quality score. Even considering nonvaluable patients because of bleeding as HVPG responders, the RR of bleeding was lower in overall responders than in nonresponders (0.66, CI 0.51-0.86). Overall response was associated with lower liver-related mortality (RR 0.58, CI 0.37-0.91). CONCLUSIONS: Current evidence supports the validity of HVPG end points to monitor drug therapy efficacy for variceal bleeding prophylaxis. HVPG monitoring also provides valuable prognostic information.

A meta-analysis of transjugular intrahepatic portosystemic shunt versus paracentesis for refractory ascites.

BACKGROUND/AIMS: Meta-analysis designed to provide evidence-based guidance on the effect of TIPS and paracentesis on mortality and encephalopathy in cirrhotic patients with refractory ascites. METHODS: Five randomized trials published between 1989 and 2005 were identified. RESULTS: The five trials involved 330 patients, and none included patients >76 years, with bilirubin >5-10 mg/dl or creatinine >3 mg/dl. Ascites recurrence was lower in the TIPS arm (RR 0.56; 95% CI 0.47-0.66). TIPS was associated with a greater risk of encephalopathy (RR 1.36; 95% CI 1.1-1.68) and severe encephalopathy (RR 1.72; 95% CI 1.14-2.58). TIPS did not affect mortality, as estimated by the RR (0.93; 95% CI 0.67-1.28, random effect model) and pooled hazard ratio (RR 1.09; 95% CI 0.84-1.88). Analysis of this outcome measure was limited by significant heterogeneity among trials. Liver-related mortality was homogenous and similar in both arms. Results were unaffected by excluding trials of lower quality or with a greater number of alcoholics. Meta-analysis of trials including patients with recidivant ascites revealed a lower mortality in the TIPS arm (RR 0.68; 95% CI 0.49-0.93). CONCLUSIONS: In patients with refractory ascites, a better control of ascites by TIPS does not translate into improved survival and worsens encephalopathy.

Influence of hepatic venous pressure gradient on the prediction of survival of patients with cirrhosis in the MELD Era.

Measurements of portal pressure, usually obtained via the hepatic venous pressure gradient (HVPG) may be a prognostic marker in cirrhosis. The aim of this study was to evaluate the impact of HVPG on survival in patients with cirrhosis in addition to the Model for End-Stage Liver Disease (MELD) score. We also examined whether inclusion of HVPG in a model with MELD variables improves its prognostic ability. Retrospective analyses of all patients who had HVPG measurements between January 1998 and December 2002 were considered. Proportional hazards Cox models were developed. Prognostic calibrative and discriminative ability of the model was evaluated. In this period, 693 patients had a hepatic hemodynamic study, and 393 patients were included. Survival was significantly worse in those patients with greater HVPG value (univariate HR, 1.05; 95% CI, 1.02-1.08; P = .001). HVPG remained as an independent variable in a model adjusted by MELD, ascites, encephalopathy, and age (multivariate HR, 1.03; 95% CI, 1.00-1.06; P = .05) so that each 1-mmHg increase in HVPG had a 3% increase in death risk. In addition, HVPG as well as MELD score variables and age, significantly contributes to the calibrative predictive capacity of the prognostic model; however, discriminative ability improved only slightly (overall C statistic [95% CI]; MELD score variables: 0.71 [0.62-0.80], MELD score variables, age, and HVPG 0.76: [0.69-0.83]). In conclusion, HVPG has an independent effect on survival in addition to the MELD score. Although inclusion of HVPG and age in a survival predicting model would improve the calibrative ability of MELD, its discriminative ability is not significantly improved.

Endoscopic treatment versus endoscopic plus pharmacologic treatment for acute variceal bleeding: a meta-analysis.

Endoscopic therapy, involving either injection sclerosis or band ligation, is considered the intervention of first choice for acute variceal bleeding (AVB). Pharmacologic agents have also been shown to be highly effective in the control of the bleeding episode. The purpose of this meta-analysis was to assess whether vasoactive drugs may improve the efficacy of endoscopic therapy (injection sclerosis or band ligation) in the control of AVB and thus increase survival rates. Computer databases and scientific meeting abstracts from 1994 to 2001 were used to search for randomized trials that compared the combined use of endoscopic and drug therapy with endoscopic therapy alone in the control of AVB. Eight trials involving 939 patients fulfilled the selection criteria and the following evaluated by standard meta-analysis methods: initial hemostasis, 5-day hemostasis, 5-day mortality, and adverse events. Combined treatment improved initial control of bleeding (relative risk [RR], 1.12; 95% confidence interval (CI), 1.02-1.23), and 5-day hemostasis (RR, 1.28; 95% CI, 1.18-1.39), with numbers of patients needed to treat (NNT) of 8 and 5, respectively. The difference in favor of combined treatment remained significant when trials that used drugs other than octreotide or that included a low proportion of alcoholic patients (<40%) or high-risk cirrhotic patients (<35%) were excluded. Mortality was not significantly decreased by combined therapy (RR, 0.73; 95% CI, 0.45-1.18). Severe adverse events were similar in both groups. In conclusion, in patients with AVB, pharmacologic agents improve the efficacy of endoscopic therapy to achieve initial control of bleeding and 5-day hemostasis, yet fail to affect mortality.