Weekend admissions with ascites are associated with delayed paracentesis: A nationwide analysis of the 'weekend effect'.

INTRODUCTION AND OBJECTIVES: Weekend admissions has previously been associated with worse outcomes in conditions requiring specialists. Our study aimed to determine in-hospital outcomes in patients with ascites admitted over the weekends versus weekdays. Time to paracentesis from admission was studied as current guidelines recommend paracentesis within 24h for all patients admitted with worsening ascites or signs and symptoms of sepsis/hepatic encephalopathy (HE). PATIENTS: We analyzed 70 million discharges from the 2005-2014 National Inpatient Sample to include all adult patients admitted non-electively for ascites, spontaneous bacterial peritonitis (SBP), and HE with ascites with cirrhosis as a secondary diagnosis. The outcomes were in-hospital mortality, complication rates, and resource utilization. Odds ratios (OR) and means were adjusted for confounders using multivariate regression analysis models. RESULTS: Out of the total 195,083 ascites/SBP/HE-related hospitalizations, 47,383 (24.2%) occurred on weekends. Weekend group had a higher number of patients on Medicare and had higher comorbidity burden. There was no difference in mortality rate, total complication rates, length of stay or total hospitalization charges between the patients admitted on the weekend or weekdays. However, patients admitted over the weekends were less likely to undergo paracentesis (OR 0.89) and paracentesis within 24h of admission (OR 0.71). The mean time to paracentesis was 2.96 days for weekend admissions vs. 2.73 days for weekday admissions. CONCLUSIONS: We observed a statistically significant "weekend effect" in the duration to undergo paracentesis in patients with ascites/SBP/HE-related hospitalizations. However, it did not affect the patient's length of stay, hospitalization charges, and in-hospital mortality.

Cost-Effectiveness of Transjugular Intrahepatic Portosystemic Shunt versus Large-Volume Paracentesis in Refractory Ascites: Results of a Markov Model Incorporating Individual Patient-Level Meta-Analysis and Nationally Representative Cost Data.

PURPOSE: To compare relative cost-effectiveness of serial large-volume paracentesis (LVP) and transjugular intrahepatic portosystemic shunt (TIPS) creation for treatment of refractory ascites. MATERIALS AND METHODS: A decisional Markov model was developed to estimate payer cost and quality-adjusted life-ears (QALYs) associated with LVP and TIPS treatment strategies for cirrhotic patients with refractory ascites. Survival estimates were derived from an individual patient-level meta-analysis of prospective randomized clinical trials. Health utilities for potential health states were derived from a prospective study of patients with cirrhosis. Cost data were derived from national representative claims databases (MarketScan and Medicare) and included reimbursement amounts for relevant procedures, hospitalizations, and outpatient pharmaceutical costs. One-way and probabilistic sensitivity analyses were performed. RESULTS: LVP resulted in 1.72 QALYs gained at a cost of $41,391, whereas TIPS resulted in 2.76 QALYs gained at a cost of $100,538. Incremental cost-effectiveness ratio of TIPS versus LVP was $57,003/QALY. At a willingness-to-pay ratio of $100,000/QALY, TIPS has a 62% probability of being acceptable compared with LVP. CONCLUSIONS: This study suggests that TIPS should be considered cost-effective in a country that places a relatively high value on health improvements but less so in countries with lower levels of health care resources.

Insufficient evidence of benefit regarding mortality due to albumin substitution in HCC-free cirrhotic patients undergoing large volume paracentesis.

BACKGROUND: Current guidelines for clinical practice recommend the infusion of human albumin after large volume paracentesis. After inspecting the current evidence behind this recommendation, we decided to conduct a systematic review and meta-analysis in order to address the effect of albumin on mortality and morbidity in the context of large volume paracentesis. METHODS: We performed a comprehensive search of large databases and abstract books of conference proceedings up to March 15th 2016 for randomized controlled trials, testing the infusion of human albumin against alternatives (vs no treatment, vs plasma expanders; vs vasoconstrictors) in HCC-free patients suffering from cirrhosis. We analyzed these trials with regard to mortality, changes in plasma renin activity (PRA), hyponatremia, renal impairment, recurrence of ascites with consequential re-admission into hospital and additional complications. We employed trial sequential analysis in order to calculate the number of patients required in controlled trials to be able to determine a statistically significant advantage of the administration of one agent over another with regard to mortality. RESULTS: We were able to include 21 trials totaling 1277 patients. While the administration of albumin prevents a rise in PRA as well as hyponatremia, no improvement in strong clinical endpoints such as mortality could be demonstrated. Trial sequential analysis showed that at least 1550 additional patients need to be recruited into RCTs and analyzed with regard to this question in order to detect or disprove a 25% mortality effect. CONCLUSIONS: There is insufficient evidence that the infusion of albumin after LVP significantly lowers mortality in HCC-free patients with advanced liver disease.

The benefit of paracentesis on hospitalized adults with cirrhosis and ascites.

BACKGROUND AND AIM: The aim of this study is to assess paracentesis utilization and outcomes in hospitalized adults with cirrhosis and ascites. METHODS: The 2011 Nationwide Inpatient Sample was used to identify adults, non-electively admitted with diagnoses of cirrhosis and ascites. The primary endpoint was in-hospital mortality. Variables included patient and hospital demographics, early (Day 0 or 1) or late (Day 2 or later) paracentesis, hepatic decompensation, and spontaneous bacterial peritonitis. RESULTS: Out of 8 023 590 admissions, 31 614 met inclusion criteria. Among these hospitalizations, approximately 51% (16 133) underwent paracentesis. The overall in-hospital mortality rate was 7.6%. There was a significantly increased mortality among patients who did not undergo paracentesis (8.9% vs 6.3%, P < 0.001). Patients who did not receive paracentesis died 1.83 times more often in the hospital than those patients who did receive paracentesis (95% confidence interval 1.66-2.02). Patients undergoing early paracentesis showed a trend towards reduction in mortality (5.5% vs 7.5%) compared with those undergoing late paracentesis. Patients admitted on a weekend demonstrated less frequent use of early paracentesis (50% weekend vs 62% weekday) and demonstrated increased mortality (adjusted odds ratio 1.12 95% confidence interval 1.01-1.25). Among patients diagnosed with spontaneous bacterial peritonitis, early paracentesis was associated with shorter length of stay (7.55 vs 11.45 days, P < 0.001) and decreased hospitalization cost ($61 624 vs $107 484, P < 0.001). CONCLUSION: Paracentesis is under-utilized among cirrhotic patients presenting with ascites and is associated with decreased in-hospital mortality. These data support the use of paracentesis as a key inpatient quality measure among hospitalized adults with cirrhosis. Future studies are needed to investigate the barriers to paracentesis use on admission.

Comparison of endoscopic evacuation, stereotactic aspiration, and craniotomy for treatment of basal ganglia hemorrhage.

BACKGROUND: The main surgical techniques for spontaneous basal ganglia hemorrhage include stereotactic aspiration, endoscopic aspiration, and craniotomy. However, credible evidence is still needed to validate the effect of these techniques. OBJECTIVE: To explore the long-term outcomes of the three surgical techniques in the treatment of spontaneous basal ganglia hemorrhage. METHODS: Five hundred and sixteen patients with spontaneous basal ganglia hemorrhage who received stereotactic aspiration, endoscopic aspiration, or craniotomy were reviewed retrospectively. Six-month mortality and the modified Rankin Scale score were the primary and secondary outcomes, respectively. A multivariate logistic regression model was used to assess the effects of different surgical techniques on patient outcomes. RESULTS: For the entire cohort, the 6-month mortality in the endoscopic aspiration group was significantly lower than that in the stereotactic aspiration group (odds ratio (OR) 4.280, 95% CI 2.186 to 8.380); the 6-month mortality in the endoscopic aspiration group was lower than that in the craniotomy group, but the difference was not significant (OR=1.930, 95% CI 0.835 to 4.465). A further subgroup analysis was stratified by hematoma volume. The mortality in the endoscopic aspiration group was significantly lower than in the stereotactic aspiration group in the medium (≥40-<80 mL) (OR=2.438, 95% CI 1.101 to 5.402) and large hematoma subgroup (≥80 mL) (OR=66.532, 95% CI 6.345 to 697.675). Compared with the endoscopic aspiration group, a trend towards increased mortality was observed in the large hematoma subgroup of the craniotomy group (OR=8.721, 95% CI 0.933 to 81.551). CONCLUSION: Endoscopic aspiration can decrease the 6-month mortality of spontaneous basal ganglia hemorrhage, especially in patients with a hematoma volume ≥40 mL.

No Increased Mortality After TIPS Compared with Serial Large Volume Paracenteses in Patients with Higher Model for End-Stage Liver Disease Score and Refractory Ascites.

PURPOSE: To compare survival after transjugular intrahepatic portosystemic shunt (TIPS) creation versus serial large volume paracenteses (LVP) in patients with refractory ascites and higher Model for End-Stage Liver Disease (MELD) scores. MATERIALS AND METHODS: In this retrospective study, from 1/1/2013 to 10/1/2018, 478 patients (294 male; mean age 58, range 23-89) underwent serial LVP (n = 386) or TIPS (n = 92) for ascites. Propensity-matched cohorts were constructed based on age, MELD, Charlson comorbidity index, varices, and hepatic encephalopathy. Survival was analyzed using a Cox proportional hazards model in which MELD score and TIPS were treated as time-dependent covariates. An interaction term was used to assess the impact of TIPS versus serial LVP on survival as a function of increasing MELD. RESULTS: In the overall patient sample, higher MELD score predicted worse survival after either serial LVP or TIPS [hazard ratio (HR) = 1.13; p < 0.001], but there was no significant interaction between TIPS and higher MELD score conferring worse survival (HR = 1.01; p = 0.55). In 92 propensity-matched serial LVP and 92 TIPS patients, higher MELD score predicted worse survival after either serial LVP or TIPS (HR = 1.19; p < 0.001), but there was no significant survival interaction between TIPS and higher MELD (HR = 0.97; p = 0.22). In 30 propensity-matched serial LVP patients and 30 TIPS patients with baseline MELD greater than 18, TIPS did not predict worse survival (HR = 0.97; p = 0.94). CONCLUSION: Higher MELD predicts poorer survival after either serial LVP or TIPS, but TIPS creation is not associated with worse survival compared to serial LVP in patients with higher MELD scores LEVEL OF EVIDENCE: Level 4, case series.

TIPS versus paracentesis for cirrhotic patients with refractory ascites.

BACKGROUND: Refractory ascites (ie, ascites that cannot be mobilized despite sodium restriction and diuretic treatment) occurs in 10 per cent of patients with cirrhosis. It is associated with substantial morbidity and mortality with a one-year survival rate of less than 50 per cent. Few therapeutic options currently exist for the management of refractory ascites. OBJECTIVES: To compare transjugular intrahepatic portosystemic stent-shunts (TIPS) versus paracentesis for the treatment of refractory ascites in patients with cirrhosis. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (January 2006), the Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 4, 2005), MEDLINE (1950 to January 2006), EMBASE (1980 to January 2006), CINAHL (1982 to August 2004), and Science Citation Index Expanded (1945 to January 2006). SELECTION CRITERIA: We included randomised clinical trials comparing TIPS and paracentesis with or without volume expanders for cirrhotic patients with refractory ascites. DATA COLLECTION AND ANALYSIS: We evaluated the methodological quality of the randomised clinical trials by the generation of the allocation section, allocation concealment, and follow-up. Two authors independently extracted data from each trial. We contacted trial authors for additional information. Dichotomous outcomes were reported as odds ratio (OR) with 95% confidence interval (CI). MAIN RESULTS: Five randomised clinical trials, including 330 patients, met the inclusion criteria. The majority of trials had adequate allocation concealment, but only one employed blinded outcome assessment. Mortality at 30-days (OR 1.00, 95% CI 0.10 to 10.06, P = 1.0) and 24-months (OR 1.29, 95% CI 0.65 to 2.56, P = 0.5) did not differ significantly between TIPS and paracentesis. Transjugular intrahepatic portosystemic stent-shunts significantly reduced the re-accumulation of ascites at 3-months (OR 0.07, 95% CI 0.03 to 0.18, P < 0.01) and 12-months (OR 0.14, 95% CI 0.06 to 0.28, P < 0.01). Hepatic encephalopathy occurred significantly more often in the TIPS group (OR 2.24, 95% CI 1.39 to 3.6, P < 0.01), but gastrointestinal bleeding, infection, and acute renal failure did not differ significantly between the two groups. AUTHORS' CONCLUSIONS: The meta-analysis supports that TIPS was more effective at removing ascites as compared with paracentesis without a significant difference in mortality, gastrointestinal bleeding, infection, and acute renal failure. However, TIPS patients develop hepatic encephalopathy significantly more often.

TIPS versus paracentesis for cirrhotic patients with refractory ascites.

BACKGROUND: Ten per cent of cirrhotic patients develop refractory ascites, which carries substantial morbidity and has a one-year survival of less than 50 per cent. Patients with refractory ascites may benefit from transjugular intrahepatic portosystemic stent-shunts (TIPS). OBJECTIVES: To compare TIPS versus paracentesis standard treatment in patients with refractory ascites due to cirrhosis with regard to overall short- and long-term mortality, treatment efficacy, and complications. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2003), The Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 1, 2003), MEDLINE (1966 to July 2003), EMBASE (1980 to July 2003), and CINAHL (1982 to July 2003). We supplemented the searches with reading through scientific citations, review of citations in relevant primary articles, and hand-searched abstracts from national meetings. SELECTION CRITERIA: We included randomised clinical trials comparing TIPS and paracentesis with or without volume expanders for cirrhotic patients with refractory ascites. DATA COLLECTION AND ANALYSIS: We evaluated the methodological quality of the randomised clinical trials by the generation of the allocation section, allocation concealment, and follow-up. Two independent observers extracted data from each trial. We contacted trial authors for additional information. Dichotomous outcomes were reported as odds ratio (OR) with 95% confidence interval (CI). MAIN RESULTS: Four randomised clinical trials, including 264 patients, met the inclusion criteria. Methodological quality was moderate. Thirty-day mortality (OR 1.00, 95% CI 0.10 to 10.06, P = 1.0) and 24-month mortality (OR 1.17, 95% CI 0.52 to 2.66, P = 0.70) did not differ significantly between TIPS and paracentesis treatment. TIPS significantly reduced ascites re-accumulation at three months (OR 0.07, 95% CI 0.03 to 0.18, P < 0.00001) and at 12 months follow-up (OR 0.14, 95% CI 0.06 to 0.28, P < 0.00001). Hepatic encephalopathy occurred significantly more often in the TIPS group (OR 2.11, 95% CI 1.22 to 3.66, P = 0.008). Gastrointestinal bleeding (OR 0.82, 95% CI 0.36 to 1.84, P = 0.63), acute renal failure (OR 0.64, 95% CI 0.15 to 2.72, P = 0.55), septicemia/infection (OR 1.05, 95% CI 0.22 to 4.94, P = 0.96), and disseminated intravascular coagulation (OR 0.82, 95% CI 0.26 to 1.84, P = 0.63) did not differ significantly between groups. REVIEWERS' CONCLUSIONS: TIPS removed ascites more effectively than paracentesis. After 12 months, the beneficial effects of TIPS on ascites was still present. Mortality, gastrointestinal bleeding, septicemia/infection, acute renal failure, and disseminated intravascular coagulation did not differ significantly between the two groups. Hepatic encephalopathy occurred significantly more often in the TIPS group.

Wrong-side thoracentesis: lessons learned from root cause analysis.

IMPORTANCE: Despite the recognized value of the Joint Commission's Universal Protocol and the implementation of time-outs, incorrect surgical procedures are still among the most common types of sentinel events and can have fatal consequences. OBJECTIVES: To examine a root cause analysis database for reported wrong-side thoracenteses and to determine the contributing factors associated with their occurrence. DESIGN, SETTING, AND PARTICIPANTS: We searched the National Center for Patient Safety database for wrong-side thoracenteses performed in ambulatory clinics and hospital units other than the operating room reported from January 1, 2004, through December 31, 2011. MAIN OUTCOMES AND MEASURES: Data extracted included patient factors, clinical features, team structure and function, adherence to bottom-line patient safety measures, complications, and outcomes. RESULTS: Fourteen cases of wrong-side thoracenteses are identified. Contributing factors included failure to perform a time-out (n=12), missing indication of laterality on the patient's consent form (n=10), absence of a site mark on the patient's skin within the sterile field (n=12), and absent verification of medical images (n=7). Complications included pneumothoraces (n=4), hemorrhage (n=3), and death directly attributable to the wrong-side thoracentesis (n=2). Teamwork and communication failure, unawareness of existing policy, and a deficit in training and education were the most common root causes of wrong-side thoracentesis. CONCLUSIONS AND RELEVANCE: Prevention of wrong-site procedures and accompanying patient harm outside the operating room requires adherence to the Universal Protocol and time-outs, effective teamwork, training and education, mentoring, and patient assessment for early detection of complications. The time-outs provide protected time and place for error detection and recovery.

The role of relative lymphocyte count as a biomarker for the effect of catumaxomab on survival in malignant ascites patients: results from a phase II/III study.

PURPOSE: We report the role of relative lymphocyte count (RLC) as a potential biomarker with prognostic impact for catumaxomab efficacy and overall survival (OS) based on a post hoc analysis of the pivotal phase II/III study of intraperitoneal catumaxomab treatment of malignant ascites. EXPERIMENTAL DESIGN: The impact of treatment and RLC on OS was evaluated using multivariate Cox models. Kaplan-Meier and log-rank tests were used for group comparisons. Survival analyses were performed on the safety population [patients with paracentesis plus ≥ 1 dose of catumaxomab (n = 157) and paracentesis alone (n = 88)]. Determination of the optimal cutoff value for RLC was based on five optimality criteria. RESULTS: OS was significantly longer with catumaxomab versus paracentesis alone (P = 0.0219). The 6-month OS rate with catumaxomab was 28.9% versus 6.7% with paracentesis alone. RLC had a positive impact on OS and was an independent prognostic factor (P < 0.0001). In patients with RLC > 13% (n = 159: catumaxomab, 100 and control, 59), catumaxomab was associated with a favorable effect on OS versus paracentesis alone (P = 0.0072), with a median/mean OS benefit of 41/131 days and an increased 6-month survival rate of 37.0% versus 5.2%, respectively. In patients with RLC ≤ 13% at screening (n = 74: catumaxomab, 50 and control, 24), the median (mean) OS difference between the catumaxomab and the control group was 3 (16) days, respectively (P = 0.2561). CONCLUSIONS: OS was significantly improved after catumaxomab treatment in patients with malignant ascites. An RLC > 13% at baseline was a significant prognostic biomarker.

The impact of preoperative hepatic hydrothorax on the outcome of adult liver transplantation.

INTRODUCTION: Hepatic hydrothorax is an uncommon, but severe complication of cirrhosis. Orthotopic liver transplantation (OLT) is the best option in case of end-stage liver disease. The impact of hepatic hydrothorax on pre-transplant and post-transplant courses has not been clearly investigated. PATIENTS AND METHODS: Eleven patients (group 1) with hepatic hydrothorax and end-stage liver disease out of 346 consecutive patients who underwent OLT between January 2002 and December 2006 were studied. First, pretransplant and posttransplant symptoms and management of hepatic hydrothorax were compared in this group. Second, postoperative complications and survival were compared with two control groups of 11 patients, matched for age, sex, year of transplant, and severity of cirrhosis. Group 2 included patients with tense ascites, but no hepatic hydrothorax. Group 3 included patients without ascites. RESULTS: In group 1, 73% of patients needed thoracentesis in the pre-transplant course (55% more than once) and none of the patients needed thoracenthesis in the post-transplant course. Comparing the postoperative period between the three groups, no significant differences in the duration of mechanical ventilation, intensive care unit stay, and in-hospital stay were observed. There were no significant differences in terms of incidence of sepsis and early postoperative death. One-year survival was also similar. CONCLUSION: Liver transplantation is a good definitive therapeutic option for cirrhotic patients with hepatic hydrothorax and end-stage liver disease. The need of thoracentesis decreases in the posttransplant course, and the presence of preoperative hepatic hydrothorax did not have a significant negative influence on postoperative outcome.