Multicenter Cohort Analysis Research Articles

Outcomes of Children With Cystic Fibrosis Admitted to PICUs.

Data on outcomes of children with cystic fibrosis admitted to PICUs are limited and outdated. Prior studies cite PICU mortality rates ranging from 37.5% to 100%. Given the advances made in cystic fibrosis care, we expect outcomes for these patients to have changed significantly since last studied. We provide an updated report on PICU mortality and the factors associated with death among critically ill children with cystic fibrosis. Retrospective multicenter cohort analysis utilizing data from the Virtual Pediatric Systems database. Data were collected from 135 PICUs from January 1, 2009, to June 20, 2018. One-thousand six-hundred thirty-three children with cystic fibrosis accounting for 2,893 PICU admissions were studied. None. The primary outcome was mortality during PICU admission. Predictors included demographics, anthropometrics, diagnoses, clinical characteristics, and critical care interventions. Odds ratios of mortality were calculated in univariate and multivariable analyses to assess differences in mortality associated with predictor variables. Generalized estimating equation models were used to account for multiple admissions per patient. The overall PICU mortality rate was 6.6%. Factors associated with increased odds of mortality included hemoptysis/pulmonary hemorrhage, pneumothorax, gastrointestinal bleeding, bacterial/fungal infections, lower body mass index/malnutrition, and need for noninvasive or invasive respiratory support. Intubation/mechanical ventilation occurred in 26.4% of the 2,893 admissions and was associated with a 19.1% mortality rate. Of the nonsurvivors, 20.7% died without receiving mechanical ventilation. The mortality rate during PICU admissions for patients with cystic fibrosis is lower than has been reported in prior studies, both in the overall cohort and in the subset requiring invasive mechanical ventilation. These data provide updated insight into the prognosis for cystic fibrosis patients requiring critical care.

Survival in Lung Transplant Recipients on a Calcineurin Free Regimen: Is It Possible?

Calcineurin inhibitors (CNI) are the cornerstone of immunosuppression in lung transplantation. The International Heart and Lung Transplant registry data estimates that almost 99% of patients are on a CNI-based immunosuppression regimen. The population of lung transplant (LTx) recipients not on a calcineurin inhibitor is exceedingly rare and their outcomes have not been previously examined in a systematic way. An IRB-approved, retrospective, observational, cohort study of LTx recipients who received CNI-free, everolimus (EVR)-based immunosuppression at the University of Colorado from January 1, 1995 - October 1, 2019. The health system's electronic medical records was queried to identify and collect data on eligible LTx recipients. All continuous variables are presented as median(range). Seven of 12 were single LTx (ILD, COPD), five were bilateral LTx,(ILD, COPD, CF) and one was a re-transplant. The majority (8/12) of patients were transitioned to CNI-free, EVR-based immunosuppression due to renal insufficiency, 3/12 due to metastatic cancer, and 1/12 due to both renal failure and cancer. Five of 12 were maintained on three agents (EVR, corticosteroid, and either methotrexate or azathioprine) and the others were on corticosteroids with EVR alone. The median time to transition to CNI-free immunosuppression was 8.8 (2.3 to 21.3) years. Median age at CNI cessation was 67 years old (40-72 years old). Median survival on CNI-free immunosuppression for all comers was 1.6 years with median survival in the deceased cohort (n=8) of 1 year (4 days to 4.6 years) and median survival in the living cohort (n=4) of 2.1 years (1.2 years to 8.2 years). At least three patients were treated with high dose steroids for presumed acute rejection after stopping the CNI. This review demonstrates that in certain situations withdrawal of CNI and transition to CNI-free, EVR- based immunosuppression may result in durable patient survival. Larger multicenter cohort analysis may be the next step in understanding the safety, efficacy and role of CNI-free immunosuppression, as equipoise would be impossible to achieve in a randomized controlled trial.

Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin

BackgroundInotuzumab ozogamicin (InO) is an anti-CD22 monoclonal antibody–drug (calicheamicin) conjugate that has shown superior efficacy compared to conventional chemotherapy in relapsed/refractory (RR) B-cell acute lymphocytic leukemia (ALL) patients. We sought to find the safety and efficacy of InO in a real-world setting. Patients and MethodsA multicenter cohort analysis on 84 RR ALL patients who received InO outside of clinical trials was conducted to evaluate response and toxicity. ResultsThe median (range) age of patients at InO initiation was 50 (20-87) years. Forty patients (48%) had ≥ 3 therapies and 23 patients (27%) underwent allogeneic hematopoietic stem-cell transplantation (allo-HCT) before InO. The median (range) number of cycles of InO provided was 2 (1-6), and cumulative dose was 3.3 (1.8-9.3) mg/m2. Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. Twenty-three patients (27%) with response received allo-HCT. The median duration of response was 11.5 months and when censored at allo-HCT was not reached (51% in remission at 2 years). The median overall survival after InO was 11.6 months and when censored at time of allo-HCT was 13.6 months. The most common grade 3 or higher adverse events observed were transaminitis (16%), hyperbilirubinemia (5%), bleeding (4%), veno-occlusive disease (2%), and hyperglycemia (2%). In multivariate analysis, allo-HCT after InO did not retain favorable significance for duration of response (hazard ratio = 1.27; 95% confidence interval, 0.89-1.61; P = .2) or overall survival (hazard ratio = 1.10; 95% confidence interval, 0.37-3.25; P = .85). ConclusionInO was well tolerated and had significant efficacy in RR B-cell ALL patients.

Safety and efficacy of immune checkpoint inhibitors in advanced urological cancers with pre-existing autoimmune disorders: a retrospective international multicenter study

BackgroundThere is limited experience regarding the safety and efficacy of checkpoint inhibitors (CPI) in patients with autoimmune disorders (AD) and advanced urological cancers as they are generally excluded from clinical...

Trends in incidence and outcomes of necrotizing enterocolitis over the last 12 years: A multicenter cohort analysis

ObjectiveWe sought to describe changes in the incidence and mortality of necrotizing enterocolitis (NEC) and associated surgical management strategies for very low birth weight (VLBW) infants. MethodsData were prospectively collected on VLBW infants (≤1500 g or < 29 weeks) born 2006 to 2017 and admitted to 820 U.S. centers. NEC was defined by the presence of at least one clinical and one radiographic finding. Trends analyses were performed to assess changes in incidence and mortality over time. ResultsOf 473,895 VLBW infants, 36,130 (7.6%) were diagnosed with NEC, of which 21,051 (58.3%) had medical NEC and 15,079 (41.7%) had surgical NEC. Medical NEC decreased from 5.3% to 3.0% (p < 0.0001). Surgical NEC decreased from 3.4% to 3.1% (p = 0.06). Medical NEC mortality decreased from 20.7% to 16.8% (p = 0.003), while surgical NEC mortality decreased from 36.6% to 31.6% (p < 0.0001). In the surgical cohort, the use of primary peritoneal drainage (PPD) versus initial laparotomy rose from 23.2% to 46.8%. ConclusionThe incidence and mortality of both medical and surgical NEC have decreased over time. Changes in surgical management during this time period included the increased utilization of primary peritoneal drainage. Type of studyPrognosis study. Level of evidenceLevel II.

Immune-Related Adverse Events and Immune Checkpoint Inhibitor Efficacy in Patients with Gastrointestinal Cancer with Food and Drug Administration-Approved Indications for Immunotherapy.

Immune-related adverse event (IRAE) onset may represent a clinical biomarker for anti-programmed cell death protein 1 (PD-1) antibody response based on emerging evidence from patients with various advanced malignancies. This phenomenon has not been previously reported in a multidisease cohort of patients with gastrointestinal (GI) cancer with Food and Drug Administration (FDA)-approved indications to receive immune checkpoint inhibitor therapy. The study was a multicenter retrospective cohort analysis of 76 patients with GI cancer who had received anti-PD-1 antibodies for FDA-approved indications. The primary and secondary outcomes of the study were progression-free survival (PFS) and overall survival (OS) in patients based upon IRAE presence, respectively. PFS and OS were estimated by the Kaplan-Meier method; a Cox proportional-hazards model adjusted for IRAE onset, patient age, and enrolling institution was used to analyze outcomes. Median PFS and OS were prolonged in patients who experienced IRAEs compared with those who did not experience them (PFS: not reached [NR] vs. 3.9 months [hazard ratio (HR) 0.13, 95% confidence interval (CI) 0.05-0.3, p < .001]; OS: NR vs. 7.4 months [HR 0.11, 95% CI 0.03-0.36, p < .001]). Among patients who experienced IRAEs, there were no significant differences in PFS and OS by either initial IRAE severity, management, or time to onset. Patients with gastrointestinal cancer who experienced IRAEs while on anti-PD-1 antibodies demonstrated significant improvements in PFS and OS compared with their counterparts who did not develop IRAEs. Although these findings add to results from studies in other tumor types, larger prospective studies are needed prior to clinical adoption of IRAE onset as a biomarker for immune checkpoint inhibitor response. Predictive clinical biomarkers for immune checkpoint inhibitor response have been understudied in the field of immuno-oncology. Immune-related adverse event onset appears to be one such biomarker. Across tumor types, immune-related adverse event onset has been associated with response to anti-programmed cell death protein 1 (PD-1) antibodies. The results of this study demonstrate this for the first time in patients with gastrointestinal cancer receiving anti-PD-1 antibodies. Before immune-related adverse event onset can be adopted clinically as a predictive biomarker for immune checkpoint inhibitor response, however, larger prospective studies are needed to better understand the nuances between immune-related adverse event characteristics (severity, site, management, timing of onset) and immune checkpoint inhibitor effectiveness.

Radiation therapy to the primary tumor for de novo metastatic breast cancer and overall survival in a retrospective multicenter cohort analysis

BackgroundThe impact of locoregional treatment (LRT) on overall survival (OS) in de novo metastatic breast cancer (dnMBC) is still under debate, with very few data available regarding exclusive radiotherapy (ERT) as a therapeutic modality. MethodsWe evaluated the impact of ERT, exclusive surgery, or a combination of surgery plus radiotherapy (bimodality therapy, BMT) on survival outcomes in a national real-life dnMBC cohort. The primary and secondary end points were OS and progression free survival (PFS) according to LRT (ERT, exclusive surgery, BMT) and no LRT. Sensitivity analyses were performed using propensity score matched analyses. ResultsFrom 2008 to 2014, 4507 dnMBC patients were identified. Only patients alive and free from progression under systemic therapy at least 1 year after diagnosis were included (n = 1965). Forty-five percent of patients (891/1965) underwent LRT: 41.1% (n = 366) ERT, 13.7% (n = 122) exclusive surgery, and 45.2% (n = 403) BMT. OS adjusted for major prognostic factors was significantly longer in the ERT and BMT group compared with no-LRT group, but not exclusive surgery (hazard ratio (HR) = 0.63, 95% confidence interval (CI) [0.49, 0.80], p < 0.001, HR = 0.61, 95%CI [0.47, 0.78], p < 0.001 and HR = 0.87, 95%CI [0.61, 1.26], p = 0.466 respectively). Results were similar after matching on a propensity score. ERT, surgery and BMT were all associated with a significantly better PFS in multivariable analysis. ConclusionERT was significantly associated with better OS in dnMBC, in the same magnitude as BMT, compared with no-LRT. However, even with statistical models adjusted for known prognostic factors and propensity score analysis, selection biases cannot be eliminated from observational studies.

A Comparison of Open and Laparoscopic-assisted Colectomy for Obstructive Colon Cancer.

We performed a retrospective multi-center cohort analysis to compare the outcomes of laparoscopic surgery vs. open surgery for obstructive colon cancer. A total of 455 patients with colon cancer with ileus underwent surgery at Yokohama City University Hospital and four related institutions from April 2000 to March 2016. There were 414 cases in the open surgery group and 41 cases in the laparoscopic surgery group with no marked differences in the gender or age. The postoperative complication rate, according to the Clavien-Dindo classification, was lower in the laparoscopic group compared to the open surgery group. The postoperative hospital stay was 16 days in the open surgery group and 9 days in the laparoscopic surgery group (p=0.004). Among the various factors examined, the operation approach was identified as a statistically significant independent risk factor for postoperative complications (p=0.015). Preoperative treatment for colon cancer with ileus and elective laparoscopic surgery are thought to be useful for achieving curative treatment, avoiding colostomy, and shortening the length of hospital stay.

Validation of a score chart to predict the risk of chronic mesenteric ischemia and development of an updated score chart.

Background and objectiveThe objective of this article is to externally validate and update a recently published score chart for chronic mesenteric ischemia (CMI).MethodsA multicenter prospective cohort analysis was conducted of 666 CMI-suspected patients referred to two Dutch specialized CMI centers. Multidisciplinary consultation resulted in expert-based consensus diagnosis after which CMI consensus patients were treated. A definitive diagnosis of CMI was established if successful treatment resulted in durable symptom relief. The absolute CMI risk was calculated and discriminative ability of the original chart was assessed by the c-statistic in the validation cohort. Thereafter the original score chart was updated based on the performance in the combined original and validation cohort with inclusion of celiac artery (CA) stenosis cause.ResultsIn 8% of low-risk patients, 39% of intermediate-risk patients and 94% of high-risk patients of the validation cohort, CMI was diagnosed. Discriminative ability of the original model was acceptable (c-statistic 0.79). The total score of the updated chart ranged from 0 to 28 points (low risk 19% absolute CMI risk, intermediate risk 45%, and high risk 92%). The discriminative ability of the updated chart was slightly better (c-statistic 0.80).ConclusionThe CMI prediction model performs and discriminates well in the validation cohort. The updated score chart has excellent discriminative ability and is useful in clinical decision making.

SC19 - Operative profile, safety and functional outcomes after Greenlight laser prostate surgery: Results from multicenter italian cohort analysis

SC19 - Operative profile, safety and functional outcomes after Greenlight laser prostate surgery: Results from multicenter italian cohort analysis

Evaluation and treatment of latent tuberculosis infection among healthcare workers in Korea: A multicentre cohort analysis.

ObjectiveHealthcare workers (HCWs) are one of the target groups for systematic testing and treatment of latent tuberculosis infection (LTBI) in a setting of low TB incidence. We performed this study to describe the testing of HCWs for LTBI and analyse the acceptance and completion of treatment of LTBI.MethodsThis retrospective cohort study was conducted in four university-affiliated hospitals between January 1 and December 31, 2018. HCWs with positive interferon-gamma release assay (IGRA) during LTBI screening were analysed. We assessed the acceptance and completion of LTBI treatment.ResultsOverall, 893 HCWs were IGRA positive. Among them, 609 HCWs visited the clinic for evaluation of LTBI. Of 609 HCWs who were evaluated, 302 (49.6%) were offered treatment for LTBI. The proportion of acceptance for treatment was 64.5% (195 of 302 HCWs). The treatment course was completed by 143 of 195 HCWs (73.3%). Three months of isoniazid and rifampin (3HR) was used in 137 HCWs (70.3%) and 4 months of rifampin (4R) in 58 (29.7%). 72 HCWs (36.9%) experienced at least one adverse drug events, but there was no different characteristics between completer and non-completer.ConclusionThe acceptance and completion of LTBI treatment were unsatisfactory. Subjective perspective regarding obstacles to treatment of LTBI needs to be explored to increase compliance to LTBI treatment.

Surgical treatment of vulvar cancer: Impact of tumor-free margin distance on recurrence and survival. A multicentre cohort analysis from the francogyn study group

ObjectiveIn vulvar cancer, it is admitted that tumor-free margin distance is one of the most important element for locoregional control. It is currently recommended to surgically remove the tumor with at least an 8 mm tumor-free margin. The aim of this study was to evaluate the impact of tumor-free margin distance on recurrence and survival in vulvar cancer. Material and methodsFrom 2005 to 2016, 112 patients surgically treated for a vulvar squamous cell cancer were included in a retrospective multicenter study. Overall, disease-free and metastasis-free survivals were analyzed according to tumor-free margin distance. ResultsPatients were divided into three groups: group 1 (margin <3 mm, n = 47); group 2 (margin ≥3 mm to < 8 mm, n = 48) and group 3 (margin ≥8 mm, n = 17). During the study, 26,8% patients developed recurrence (n = 30) after a median of 8 months (1-69). Analysis of 5-year overall survival, as well as disease-free and metastasis-free survivals, did not reveal a difference between groups. We performed a subgroup analysis in patients with a tumor-free margin <8 mm (group 1 and 2). It showed that histological lesions observed closest to the edge of the specimen were more often invasive or in situ carcinoma lesions in group 1 than in group 2, in which VIN lesions were mainly observed at this location. After re-excision, no patients in group 1 and 50% (n = 2) patients in group 2 developed recurrence. ConclusionThis study did not reveal a significant impact of tumor-free margin distance on recurrence and survival in vulvar cancer. Moreover, the benefit of re-excision seems stronger when tumor-free margins are positive or very close (<3 mm), cases in which invasive or in situ lesions are often present closest to the edge of the specimen.

Efficiency of using polyacrylic acid silver salt in decompression and stabilization surgery on the lumbar spine involving 1 to 3 segments

Objective. To determine possible effect of the preparation of an incomplete polyacrylic acid silver salt on the volume of intraoperative and postoperative blood loss in open posterior surgery on the spine involving up to three segments.Material and Methods. Study design: randomized prospective multicenter cohort analysis. Level of evidence – IIb. The study was based on 90 patients aged 27 to 65 years who underwent decompression and stabilization surgical interventions on the lumbar spine through posterior median approach using transpedicular fixation system with fixation of up to three vertebrae. A comparison of perioperative blood loss volume in patients with local application of polyacrylic acid silver salt and without it was performed.Results. The volume of inraoperative blood loss (the sample was described using the mean value and standard deviation M ± σ) in the study group was 258.1 ± 164.5 ml (min 90; max 890), in the control group – 405.5 ± 157.9 ml (min 190; max 950). The postoperative blood loss through drainage (M ± σ) was 81.500 ± 77.046 ml (min 20; max 400) in the study group, 151.560 ± 74.745 (min 20; max 600) in the control group. Comparison of both intraoperative and postoperative blood loss according to the Mann-Whitney U-test confirms the high statistical significance of differences (p &lt; 0.01), which suggests the effectiveness of the preparation.Conclusion. The use of incomplete polyacrylic acid silver salt in decompression and stabilization interventions on the lumbar spine involving 1 to 3 segments can effectively reduce the volume of blood loss both during surgery and in the postoperative period.

FP695Prevalence of Aortic stenosis in dialysis patients: baseline characteristics in a Japanese multicenter prospective cohort analysis

FP695Prevalence of Aortic stenosis in dialysis patients: baseline characteristics in a Japanese multicenter prospective cohort analysis

Serum triglyceride level dose dependently elevates the risk of local or systemic complications in acute pancreatitis. A multicenter international cohort analysis of 716 patients

Serum triglyceride level dose dependently elevates the risk of local or systemic complications in acute pancreatitis. A multicenter international cohort analysis of 716 patients

Adjuvant therapy is associated with improved overall survival only in the subgroup of patients with pancreatobiliary or mixed subtype ampullary cancer after pancreatoduodenectomy - A large multicenter cohort analysis of more than 200 patients

Operative pancreatic debridement (OPD) is the historic gold standard for treating necrotizing pancreatitis (NP). Recent success with minimally invasive NP treatment approaches have raised the question of which NP patients require OPD. We therefore sought to define contemporary outcomes of NP patients undergoing OPD.A retrospective analysis was performed of 116 consecutive NP patients undergoing OPD using a prospectively maintained institutional NP database between 2006 and 2018.86 (74%) patients underwent open pancreatic debridement (OD) and 30 (26%) underwent open transgastric debridement (TGD). Median follow-up was 16 months (interquartile range [IQR], 8–45 months). Median age was 51 years (IQR, 43–65 years); 73 (63%) were male. Pancreatitis etiology included biliary (53%), alcohol (22%), and idiopathic/other (25%). Median time from diagnosis to OPD was 64.5 days (IQR, 32–114.5 days). Mean APACHE-II score was: admission 8.5 (standard deviation [SD], 5.9); worst 12.6 (SD, 7.9); preoperatively 7.2 (SD, 4.6). 40 patients (34%) were initially managed with minimally invasive techniques (percutaneous drain only in 24, endoscopic only in 6, combination in 10). Median postoperative length of stay was 11 days (IQR, 7–19 days). 90-day morbidity and mortality were 70% and 2%, respectively.NP patients who require OPD are critically and chronically ill. OPD is associated with substantial morbidity, but acceptable mortality in an experienced center with multidisciplinary support. This large contemporary series demonstrates that in properly selected patients, OPD remains an important treatment for NP.

Comparison of Adalimumab Serum Drug Levels When Delivered by Pen Versus Syringe in Patients With Inflammatory Bowel Disease. An International, Multicentre Cohort Analysis.

Adalimumab is administered via a pre-filled syringe or spring-loaded pen. In a previous study in Crohn's disease, higher drug levels were observed in syringe users. The aim of this study was to evaluate the impact of delivery device on adalimumab drug levels in patients with Crohn's disease. Consecutive Crohn's disease patients treated with maintenance adalimumab [40 mg fortnightly] were recruited from five centres. The first recorded drug level with matched clinical and biochemical markers of disease activity was compared between pen and syringe users. Of 218 patients, 64% used pen, with a median faecal calprotectin 110 μg/g and serum C-reactive protein 4 mg/L. In comparison to pen, syringe users had higher albumin [39 vs 42 g/L; p = 0.016], lower Harvey-Bradshaw Index [2 vs 1; p = 0.017], and higher rates of concomitant immunomodulation [54% vs 71%; p = 0.014]. Drug levels were equivalent between pen and syringe users [median 5.3 vs 5.2 μg/ml; p = 0.584], even after controlling for disease activity and immunomodulation. Syringe users at Alfred Health had higher drug levels than pen [6.1 vs 4.5 μg/ml; p = 0.039]; a greater proportion achieved therapeutic levels [75% vs 44%; p = 0.045]. A higher proportion of pen users from Saint-Étienne had therapeutic levels [79% vs 42%; p = 0.027], yet no significant difference in drug levels [7.9 vs 4.5 μg/ml; p = 0.119]. Delivery device does not appear to significantly affect adalimumab drug levels. Given differences between study sites, studies evaluating administration education and technique are warranted.

Predictive factors of incomplete aneurysm occlusion after endovascular treatment with the Pipeline embolization device.

The Pipeline embolization device (PED) is a routine choice for the endovascular treatment of select intracranial aneurysms. Its success is based on the high rates of aneurysm occlusion, followed by near-zero recanalization probability once occlusion has occurred. Therefore, identification of patient factors predictive of incomplete occlusion on the last angiographic follow-up is critical to its success. A multicenter retrospective cohort analysis was conducted on consecutive patients treated with a PED for unruptured aneurysms in 3 academic institutions in the US. Patients with angiographic follow-up were selected to identify the factors associated with incomplete occlusion. Among all 3 participating institutions a total of 523 PED placement procedures were identified. There were 284 procedures for 316 aneurysms, which had radiographic follow-up and were included in this analysis (median age 58 years; female-to-male ratio 4.2:1). Complete occlusion (100% occlusion) was noted in 76.6% of aneurysms, whereas incomplete occlusion (≤ 99% occlusion) at last follow-up was identified in 23.4%. After accounting for factor collinearity and confounding, multivariable analysis identified older age (> 70 years; OR 4.46, 95% CI 2.30-8.65, p < 0.001); higher maximal diameter (≥ 15 mm; OR 3.29, 95% CI 1.43-7.55, p = 0.005); and fusiform morphology (OR 2.89, 95% CI 1.06-7.85, p = 0.038) to be independently associated with higher rates of incomplete occlusion at last follow-up. Thromboembolic complications were noted in 1.4% and hemorrhagic complications were found in 0.7% of procedures. Incomplete aneurysm occlusion following placement of a PED was independently associated with age > 70 years, aneurysm diameter ≥ 15 mm, and fusiform morphology. Such predictive factors can be used to guide individualized treatment selection and counseling in patients undergoing cerebrovascular neurosurgery.

Characteristics, risk factors and outcomes of Clostridium difficile infections in Greek Intensive Care Units

BackgroundClostridium difficile is one of the major causes of diarrhoea among critically ill patients and its prevalence increases exponentially in relation to the use of antibiotics and medical devices. We sought to investigate the incidence of C. difficile infection in Greek units, and identify potential risk factors related to C. difficile infection. MethodsA prospective multicenter cohort analysis of critically ill patients (3 ICUs from 1/1/2014 to 31/12/2014). ResultsAmong 970(100%) patients, 95(9.79%) with diarrhoea, were included. Their demographic, comorbidity and clinical characteristics were recorded on admission to the unit. The known predisposing factors for the infection were recorded and the diagnostic tests to confirm C. difficile were conducted, based on the current guidelines. The incidence of C. difficile infection was 1.3% (n = 13). All-cause mortality in patients with diarrhoea, C. difficile infection and attributable mortality in patients with C. difficile infection was 28%, 38.5% and 30.8% respectively. Sequential Organ Failure Assessment (SOFA) scores on admission were significantly lower and prior C. difficile infection was more common in patients with current C. difficile infection. Regarding other potential risk factors, no difference was found between groups. No factor was independently associated with C. difficile infection. ConclusionsC. difficile infection is low in Greek intensive care units, but remains a serious problem among the critically-ill. Mortality was similar to reports from other countries. No factor was independently associated with C. difficile infection.

Readmissions to the ICU Among Children With Tracheostomies Placed After Cardiac Arrest.

Describe clinical outcomes and risk factors for ICU readmissions in a cohort of children who underwent tracheostomy placement after cardiac arrest. A retrospective, multicenter cohort analysis of children <18 years old admitted to a Virtual Pediatric Systems, LLC-participating PICU from January 2009 to December 2016 and underwent tracheostomy after cardiac arrest. Among 394 index admissions, the median age was 16.8 months (interquartile range [IQR] 5.3-89.3), and Pediatric Risk of Mortality 3 scores (median 9 [IQR 4.75-16]) indicated severe illness. Baseline neurologic function was generally age appropriate (Pediatric Cerebral Performance Category score: median 2 [IQR 1-3]). The most common primary diagnosis categories were respiratory (31.0%), cardiac (21.6%), and injury and/or poisoning (18.3%). Post-tracheostomy mortality during the index admission was 9.3%. Among the 358 patients who survived to discharge, 334 had >180 days of available follow-up data. Two hundred and five (61.4%) patients were readmitted at least once for a total of 643 readmissions (range 0-30; median 1 [IQR 0-2]). We observed 0.54 readmissions per patient-year. The median time to first readmission was 50.3 days (IQR 12.8-173.7). Significant risk factors for readmission included a pre-existing diagnosis of chronic lung disease, congenital heart disease and/or heart failure, prematurity, and new seizures during the index admission. The most common indication for readmission was respiratory illness (46.2%). Mortality (3.3%) and procedural burden during readmission were consistent with general PICU care. ICU readmission among children who undergo postarrest tracheostomy is common, usually due to respiratory causes, and involves outcomes and resource use similar to other ICU admissions. Risk factors for readmission are largely nonmodifiable.