Formulation and Characterization of Intranasal Drug Delivery of Frovatriptan-Loaded Binary Ethosomes Gel for Brain Targeting.

Background: Frovatriptan succinate (FVT) is an effective medication used to treat migraines; however, available oral formulations suffer from low permeability; accordingly, several formulations of FVT were prepared. Objective: Prepare, optimize, and evaluate FVT-BE formulation to develop enhanced intranasal binary nano-ethosome gel. . Methods: Binary ethosomes were prepared using different concentrations of phospholipid PLH90, ethanol, propylene glycol, and cholesterol by thin film hydration and characterized by particle size, zeta potential, and entrapment efficiency. Furthermore, in-vitro, in-vivo, ex-vivo, pharmacokinetics, and histopathological studies were done. Results: Regarding FVT-loaded BE, formula (F9) demonstrated the best parameters from the other formulas; with the lowest particle size (154.1±4.38 nm), lowest PDI ( 0.213±0.05), highest zeta potential ( -46.94±1.05), and highest entrapment efficiency (89.34±2.37%). Regarding gel formulation, G2 showed the best gel formula with drug content ( 99.82±0.02 %) and spreadability (12.88 g/cm2). In-vitro study results showed that, in the first 30 minutes, around 22.3% of the medication is released, whereas, after 24 hours, about 98.56% is released in G2. Conclusion: Based on enhancing the bioavailability and sustaining the drug release, it can be concluded that the Frovatriptan-Loaded Binary ethosome Gel as nano-delivery was developed as a promising non-invasive drug delivery system for treating migraine.

Risk Factors for Extubation Failure After Pediatric Cardiac Surgery and Impact on Outcomes: A Multicenter Analysis.

IMPORTANCE: Extubation failure (EF) after pediatric cardiac surgery is associated with increased morbidity and mortality. OBJECTIVES: We sought to describe the risk factors associated with early (< 48 hr) and late (48 hr ≤ 168 hr) EF after pediatric cardiac surgery and the clinical implications of these two types of EF. DESIGN SETTING AND PARTICIPANTS: Retrospective cohort study using prospectively collected clinical data for the Pediatric Cardiac Critical Care Consortium (PC4) Registry. Pediatric patients undergoing Society of Thoracic Surgeons benchmark operation or heart transplant between 2013 and 2018 available in the PC4 Registry were included. MAIN OUTCOMES AND MEASURES: We analyzed demographics and risk factors associated with EFs (primary outcome) including by type of surgery. We identified potentially modifiable risk factors. Clinical outcomes of mortality and length of stay (LOS) were reported. RESULTS: Overall 18,278 extubations were analyzed. Unplanned extubations were excluded from the analysis. The rate of early EF was 5.2% (948) and late EF was 2.5% (461). Cardiopulmonary bypass time, ventilator duration, airway anomaly, genetic abnormalities, pleural effusion, and diaphragm paralysis contributed to both early and late EF. Extubation during day remote from shift change and nasotracheal route of initial intubation was associated with decreased risk of early EF. Extubation in the operating room was associated with an increased risk of early EF but with decreased risk of late EF. Across all operations except arterial switch, EF portrayed an increased burden of LOS and mortality. CONCLUSION AND RELEVANCE: Both early and late EF are associated with significant increase in LOS and mortality. Study provides potential benchmarking data by type of surgery. Modifiable risk factors such as route of intubation, time of extubation as well as treatment of potential contributors such as diaphragm paralysis or pleural effusion can serve as focus areas for reducing EFs.

Bivalirudin or heparin for systemic anticoagulation during pediatric extracorporeal membrane oxygenation: Multicenter retrospective study.

BACKGROUND: The objective of this study is to evaluate the outcomes of unfractionated heparin (UFH) compared to bivalirudin anticoagulation in pediatric ExtraCorporeal Membrane Oxygenation (ECMO). METHODS: A multicenter retrospective study, that included pediatric patients <18 years of age, who were supported on ECMO between June 2017 and May 2020. Patients treated with UFH were matched 2:1 by age and type of ECMO support to the bivalirudin group. RESULTS: The bivalirudin group (75 patients) were matched to 150 patients treated with UFH. Baseline characteristics and comorbidities of the two groups were similar. Veno-Arterial ECMO was the most common mode (141/225 [63 %]) followed by extracorporeal cardiopulmonary resuscitation (48/225 [21 %]). Bivalirudin treatment was associated with lower odds of bleeding events (aOR 0.23, 95%CI 0.12-0.45, p < 0.001) and lower odds of thrombotic events (aOR 0.48, 95%CI 0.23-0.98, p = 0.045). Patients who received bivalirudin had lesser odds for transfusion with fresh frozen plasma, and platelets (aOR 0.26, CI 0.12-0.57, p ≤0.001 and aOR 0.28, CI 0.15-0.53, p < 0.001, respectively). After adjusting for the type of ECMO support and adjusting for age, bivalirudin was associated with a decrease in hospital mortality by 50 % compared to the UFH group (aOR 0.50, 95%CI 0.27-0.93, p = 0.028). Similarly, for neurological disability at time of discharge, bivalirudin was associated with higher odds of intact neurological outcomes compared to UFH (OR 1.99 [95%CI 1.13-3.51], p = 0.017). CONCLUSIONS: This study demonstrated that effective anticoagulation can be achieved with bivalirudin, which was associated with lesser odds of bleeding events and utilization of blood products. Bivalirudin, in comparison with UFH, was associated with greater odds of hospital survival and intact neurological function at the time of discharge. A prospective randomized trial is required to validate the results of this study.

Analysis of Wholesale Drug Acquisition and Laboratory Assessment Costs Between Heparin Compared With Bivalirudin-Based Systemic Anticoagulation Strategies in Adult Extracorporeal Membrane Oxygenation.

OBJECTIVES: To assess the wholistic costs of systemic anticoagulation delivery in heparin versus bivalirudin-based maintenance of adult patients supported on extracorporeal membrane oxygenation (ECMO). DESIGN: Single-center retrospective cohort study. SETTING: Large academic ECMO center. PATIENTS: Adults on ECMO receiving heparin or bivalirudin for primary maintenance systemic anticoagulation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Electronic data were abstracted from a database maintained by our ECMO center, which transitioned to a preferred bivalirudin-based anticoagulation management in 2017. The pretransition group consisted of 126 patients (123 heparin and three bivalirudin), whereas the posttransition group included 275 patients (82 heparin and 193 bivalirudin). Drug costs were estimated using the wholesale acquisition cost, and laboratory assays costs were estimated using reimbursement fee schedules. Cost data were normalized to the duration of the ECMO run and reported in U.S. Dollar per ECMO day. Following the practice change, bivalirudin patients were less likely to receive AT supplementation (31.0 vs 12.4%; p < 0.0001) and had fewer coagulation assays ordered (6.1 vs 5.4 per ECMO day; p = 0.0004). After the transition, there was a dramatic decrease in costs related to AT assay assessments ($11.78 [interquartile range {IQR}, $9.48-$13.09] vs $1.03 [IQR, $0-$5.75]; p < 0.0001) and AT supplementation ($0 [IQR, $0-$312.82] vs $0 [IQR, $0-$0]; p < 0.0001) per ECMO day. Unadjusted survival at 28 days was higher posttransition (64.3 vs 74.9%; p = 0.0286). CONCLUSIONS: Antithrombin assays and supplementation compromise a significant proportion of heparin-based anticoagulation costs in ECMO patients and is substantially reduced when a bivalirudin-based anticoagulation strategy is deployed. A favorable association exists between the aggregate cost of administration of bivalirudin compared with heparin-based systemic anticoagulation in adults supported on ECMO driven by reductions in antithrombin activity assessments and the cost of antithrombin replacement.

Complementary and alternative medicine for children with sickle cell disease: A systematic review.

BACKGROUND: Complementary and alternative medicine (CAM) is a popular alternative to opioid and other analgesics in sickle cell disease (SCD). We review the effectiveness, prevalence, and factors associated with CAM use in the pediatric SCD population. METHODS: The review protocol was created based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A literature search was conducted in MEDLINE, Embase, Cochrane Library, PubMed, and Web of Science. RESULTS: Twenty-four studies were examined. The prevalence of CAM use in pediatric patients with SCD ranged from 36 to 84.5%. Common inpatient CAM interventions were yoga, virtual reality, and acupuncture, which decreased pain scale scores. Outpatient CAMs were consisted of cognitive behavioral therapy, massage therapy, and guided-imagery, which increased pain tolerability and decreased pain scale scores. CONCLUSIONS: CAM modalities can decrease pain scale scores. However, the impact of specific CAM modalities on emergency department visits, hospitalizations, and school absences were inconclusive.

Outcomes of complete surgical repair versus palliative intervention in neonates with Tetralogy of Fallot.

Using the US National Inpatient Sample dataset (2010 to 2018), we compared outcomes of neonates with Tetralogy of Fallot who had early primary surgical repair (1726 neonate) and those who had staged palliative intervention with transcatheter (1702 neonate) or surgical palliative shunt (2661 neonate).

A cross-sectional survey exploring the attitude, knowledge, and use of anesthesia teams toward evidence-based practice in Riyadh Saudi Arabia.

Background: Evidence-based practice (EBP) plays a crucial role in improving the quality of healthcare services by ensuring the delivery of the highest and safest level of patient care since EBP helps in justifying treatment choices to patients. Studies that examine the levels of EBP knowledge, attitudes toward EBP, and use of the use of EBP within anesthetic teams' practice are lacking, hence it is necessary to explore this. Aim: To evaluate anesthesia teams' levels of knowledge, attitude toward and use of the evidence-based practice in a local hospital in Saudi Arabia. Method: In one hospital, a cross-sectional survey was conducted using a convenience sampling technique using a validated questionnaire instrument called the Evidence-Based Practice EBP Questionnaire. The questionnaire was distributed through an online method to 173 participants. Descriptive and inferential statistics Tests were utilized to analyse the retrieved data using the SPSS program. Results: One hundred and forty questionnaires were completed and returned, yielding a response rate of 80.9%. Overall, anesthesia teams showed a high positive attitude toward EBP but low levels of knowledge and use of EBP. Participants with higher levels of education and/or work experience exhibited significantly higher levels of knowledge and use of EBP than those who had lower education levels and/or work experience. Also, higher levels of education and/or work experience exhibited a significant positive association toward a higher level of knowledge and use of EBP. However, attitude levels toward EBP did not exhibit either significant or associated. Physicians showed significantly higher knowledge and use of EBP than non-physicians. Lack of knowledge and lack of time due to workload were the leading barriers encountered by anesthesia teams ATs. Conclusion: Education level, work experience and job position affect the knowledge, attitude, and use of EBP. Continuous education and minimizing barriers are recommended to enhance the knowledge, attitude, and use of EBP among anesthesia teams in Saudi Arabia.

Evaluation of Bivalirudin Dosing in Pediatric Extracorporeal Membrane Oxygenation with Renal Insufficiency or Renal Replacement Therapy.

Bivalirudin offers several important advantages of relevance to the management of extracorporeal membrane oxygenation (ECMO) patients. This multicenter retrospective analysis evaluated the bivalirudin dosing in pediatric ECMO and correlated these doses with the severity of renal dysfunction. A total of 75 patients were included in this analyses: estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73 m 2 (n = 29), eGFR 30-60 (n = 18), eGFR < 30 (n = 28), and of those 23 were on renal replacement therapy (RRT). The initial bivalirudin dose used to reach therapeutic anticoagulation in patients with eGFR > 60 was significantly higher than the dose required in those with renal impairment (0.25 mg/kg/hr in patients with eGFR > 60 and 0.19 mg/kg/hr in patients on RRT, 0.18 mg/kg/hr in patients with eGFR 30-60 and 0.13 mg/kg/hr in patients with eGFR < 30 with no RRT). Progressive dose escalations (two to threefold increase) were required to maintain therapeutic range over the initial 4 days of ECMO that coincided with improving renal creatinine clearance during that same time period. Establishing an initial starting dose of bivalirudin contingent upon eGFR is essential for the rapid achievement of target anticoagulation intensity. Further dose adjustments guided by laboratory monitoring is necessary given the dynamic changes in creatinine clearance following ECMO initiation.

Radiologic Diagnosis of Nasal Gliomas with an Illustrative Case Report.

Nasal gliomas are congenital masses of dysplastic neuroglial and fibrovascular tissue. However, other congenital nasal masses, including encephaloceles, hemangiomas, and dermoid cysts make clinical diagnosis difficult. Radiological examination is imperative to accurate diagnosis of nasal gliomas. We hereby present the diagnostic imaging features of these lesions, which necessitate inclusion into the differential diagnosis of a congenital nasal mass.

Survival outcomes of in-hospital cardiac arrest in pediatric patients in the USA.

We report on in-hospital cardiac arrest outcomes in the USA. The data were obtained from the National (Nationwide) Inpatient Sample datasets for the years 2000-2017, which includes data from participating hospitals in 47 US states and the District of Columbia. We included pediatric patients (< 18 years of age) with cardiac arrest, and we excluded patients with no cardiopulmonary resuscitation during the hospitalization. Primary outcome of the study was in-hospital mortality after cardiac arrest. A multivariable logistic regression was performed to identify factors associated with survival. A total of 20,654 patients were identified, and 8226 (39.82%) patients survived to discharge. The median length of stay and cost of hospitalization were significantly higher in the survivors vs. non-survivors (LOS 18 days vs. 1 day, and cost $187,434 vs. $45,811, respectively, p < 0.001). In a multivariable model, patients admitted to teaching hospitals, elective admissions, and those admitted on weekdays had higher survival (aOR=1.19, CI: 1.06-1.33; aOR=2.65, CI: 2.37-2.97; and aOR=1.17, CI: 1.07-1.27, respectively). There was no difference in mortality between patients with extracorporeal cardiopulmonary resuscitation (E-CPR) and those with conventional cardiopulmonary resuscitation. E-CPR patients were likely to have congenital heart surgery (51.0% vs. 20.8%).Conclusion: We highlighted the survival predictors in these events, which can guide future studies aimed at improving outcomes in pediatric cardiac arrest. What is Known: • In-hospital cardiac arrest occurs in 2-6% of pediatric intensive care admissions. • Cardiac arrests had a significant impact on hospital resources and a significantly high mortality rate. What is New: • Factors associated with higher survival rates in patients with cardiac arrest: admission to teaching hospitals, elective admissions, and week-day admissions. • The use of rescue extracorporeal cardiopulmonary resuscitation in refractory cardiac arrest has increased by threefold over the last two decades.

Hexokinase inhibition using D-Mannoheptulose enhances oncolytic newcastle disease virus-mediated killing of breast cancer cells.

BACKGROUND: Most cancer cells exhibit increased glycolysis and use this metabolic pathway cell growth and proliferation. Targeting cancer cells' metabolism is a promising strategy in inhibiting cancer cell progression. We used D-Mannoheptulose, a specific hexokinase inhibitor, to inhibit glycolysis to enhance the Newcastle disease virus anti-tumor effect. METHODS: Human breast cancer cells were treated by NDV and/or hexokinase inhibitor. The study included cell viability, apoptosis, and study levels of hexokinase enzyme, pyruvate, ATP, and acidity. The combination index was measured to determine the synergism of NDV and hexokinase inhibitor. RESULTS: The results showed synergistic cytotoxicity against breast cancer cells by combination therapy but no cytotoxic effect against normal cells. The effect was accompanied by apoptotic cell death and hexokinase downregulation and inhibition to glycolysis products, pyruvate, ATP, and acidity. CONCLUSIONS: The combination treatment showed safe significant tumor cell proliferation inhibition compared to monotherapies suggesting a novel strategy for anti-breast cancer therapy through glycolysis inhibition by hexokinase downregulation.

Newcastle disease virus suppress glycolysis pathway and induce breast cancer cells death.

Newcastle disease virus (NDV) can modulate cancer cell signaling pathway and induce apoptosis in cancer cells. Cancer cells increase their glycolysis rates to meet the energy demands for their survival and generate ATP as the primary energy source for cell growth and proliferation. Interfering the glycolysis pathway may be a valuable antitumor strategy. This study aimed to assess the effect of NDV on the glycolysis pathway in infected breast cancer cells. Oncolytic NDV attenuated AMHA1 strain was used in this study. AMJ13 and MCF7 breast cancer cell lines and a normal embryonic REF cell line were infected with NDV with different multiplicity of infections (moi) to determine the IC50 of NDV through MTT assay. Crystal violet staining was done to study the morphological changes. NDV apoptosis induction was assessed using AO/PI assay. NDV interference with the glycolysis pathway was examined through measuring hexokinase (HK) activity, pyruvate, and ATP concentrations, and pH levels in NDV infected and non-infected breast cancer cells and in normal embryonic cells. The results showed that NDV replicates efficiently in cancer cells and spare normal cells and induce morphological changes and apoptosis in breast cancer cells but not in normal cells. NDV infected cancer cells showed decreased in the HK activity, pyruvate and ATP concentrations, and acidity, which reflect a significant decrease in the glycolysis activity of the NDV infected tumor cells. No effects on the normal cells were observed. In conclusion, oncolytic NDV ability to reduce glycolysis pathway activity in cancer cells can be an exciting module to improve antitumor therapeutics.

Outcomes of truncus arteriosus repair and predictors of mortality.

OBJECTIVE: The objective of this study was to identify patient and hospitalization characteristics associated with in-hospital mortality in infants with truncus arteriosus. METHODS: We conducted a retrospective analysis of a large administrative database, the National Inpatient Sample data set of the Healthcare Cost and Utilization Project for the years 2002 to 2017. We also sought to evaluate the resource utilization in the subgroup of subjects with truncus arteriosus and 22q11.2 deletion syndrome. Neonates with truncus arteriosus were identified by ICD-9 and ICD-10 codes. Hospital and patient factors associated with inpatient mortality were analyzed. RESULTS: Overall, 3009 neonates met inclusion criteria; a total of 326 patients died during the hospitalization (10.8%). Extracorporeal membrane oxygenation utilization was 7.1%. Univariate and multivariate logistic regression analyses were used to identify risk factors for in-hospital mortality. Significant risk factors for mortality were prematurity (adjusted odds ratio [aOR] = 2.43; 95% confidence interval [CI]: 1.40-4.22; P = .002), diagnosis of stroke (aOR = 26.2; 95% CI: 10.1-68.1; P < .001), necrotizing enterocolitis (aOR = 3.10; 95% CI: 1.24-7.74; P = .015) and presence of venous thrombosis (aOR = 13.5; 95% CI: 6.7-27.2; P < .001). Patients who received extracorporeal membrane oxygenation support or had cardiac catheterization procedure during the hospitalization had increased odds of mortality (aOR = 82.0; 95% CI: 44.5-151.4; P < .001, and aOR = 1.65; 95% CI: 0.98-2.77; P = .060, respectively). CONCLUSION: 22q11.2 deletion syndrome was associated with an inverse risk of death despite having more noncardiac comorbidities; this patient subpopulation also had a higher length of stay and increased cost of hospitalization.

Evaluation of Bivalirudin As an Alternative to Heparin for Systemic Anticoagulation in Pediatric Extracorporeal Membrane Oxygenation.

OBJECTIVES: Heparin is the universal anticoagulant for patients receiving extracorporeal membrane oxygenation support. However, heparin has many disadvantages, especially in young children, who develop heparin resistance. Recently our center has used bivalirudin, a direct thrombin inhibitor, for systemic anticoagulation in pediatric extracorporeal life support. Bivalirudin binds directly to thrombin with no need for antithrombin III and it inhibits both circulating and clot-bound thrombin. In this study, we sought to evaluate our experience with bivalirudin in pediatric extracorporeal life support. DESIGN: Retrospective chart review study of patients receiving extracorporeal membrane oxygenation support between October 2014 and May 2018. SETTING: Tertiary, academic PICU. PATIENTS: Sixteen patients receiving heparin and 16 patients receiving bivalirudin on extracorporeal life support were included in the study. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients in the bivalirudin group had a median age of 31 months versus 59 months in the heparin group (p = 0.41). Recovery and extracorporeal membrane oxygenation decannulation were similar in both groups (56% in the heparin group and 62% in the bivalirudin group; p = 0.62). Time to reach goal therapeutic anticoagulation level was shorter in the bivalirudin group (11 vs 29 hr; p = 0.01). Bleeding events were fewer in the bivalirudin group, and there was no difference in the rate of thrombotic events between the two groups. Comprehensive cost analysis that includes anticoagulant, laboratories, and antithrombin III cost, showed that heparin anticoagulation therapy total cost was significantly higher than bivalirudin (1,184 dollars per day in heparin group vs 494 dollars per day in bivalirudin group; p = 0.03). Bivalirudin dose required to maintain target anticoagulation will increase over time, and this is associated with an increase in creatinine clearance and an increase in fibrinogen serum levels. CONCLUSIONS: This study showed that the use of bivalirudin in pediatric extracorporeal membrane oxygenation support is feasible, safe, reliable, and cost-effective in comparison to heparin. Further prospective randomized clinical trials are necessary to confirm our observations.

Impact of ventricular arrhythmias on outcomes in children with myocarditis.

Children affected with acute myocarditis may progress rapidly into profound ventricular dysfunction and ventricular arrhythmias. The objective of this study is to assess the impact of ventricular arrhythmias on in-hospital mortality and the use of mechanical circulatory support in patients with myocarditis. Pediatric patients (age 0-18 years) admitted with myocarditis were identified from the National Inpatient Sample dataset for the years 2002-2015. A total of 12,489 patients with myocarditis were identified. Of them, 1627 patients were with ventricular arrhythmias and 10,862 patients without ventricular arrhythmias. Mortality was higher in those with ventricular arrhythmias (19.5% vs. 2.8%, OR = 8.47; 95% CI 7.16-10.04; p < 0.001). The median length of stay and the median cost of hospitalization were higher in the ventricular arrhythmias group (9 days vs. 4 days, p < 0.001 and $121,826 vs. $37,658, p < 0.001, respectively). There was a substantial increase in the utilization of extracorporeal membrane oxygenation (ECMO) in patients with ventricular arrhythmias (25.4% vs. 2.7%, OR = 12.40; 95% CI 10.55-14.57; p < 0.001). The use of ventricular assist devices (VADs) was higher in patients with ventricular arrhythmias (4.5% vs. 1.3%, OR = 3.76; 95% CI 2.82-5.01; p < 0.001). An improvement in discharge survival was observed over the years of study in both VA and non-VA groups; associated with this decline in mortality, there was a rising trend of ECMO utilization.Conclusion: Development of ventricular arrhythmia in children with myocarditis is a strong predictor for mortality and ECMO utilization. What is Known: • The clinical presentation of pediatric myocarditis varies from no symptoms of myocardial dysfunction to a rapidly progressing severe congestive heart failure. • Little is known about the predictors of mortality in children with suspected myocarditis. What is New: • Development of ventricular arrhythmia in children with myocarditis is a strong predictor for mortality and ECMO utilization. • Improvement in discharge survival was observed over the years of study; associated with this decline in mortality, there was a rising trend of ECMO utilization.

Clinical Outcomes and Risk Factors for In-Hospital Mortality in Neonates with Hypoplastic Left Heart Syndrome.

The objective of this study was to identify patient and hospitalization characteristics associated with in-hospital mortality in infants with hypoplastic left heart syndrome (HLHS). We conducted a retrospective analysis of a large administrative database, the National Inpatient Sample dataset of the Healthcare Cost and Utilization Project for the years 2002-2016. Neonates with HLHS were identified by ICD-9 and ICD-10 codes. Hospital and patient factors associated with inpatient mortality were analyzed. Overall, 18,867 neonates met the criteria of inclusion; a total of 3813 patients died during the hospitalization (20.2%). In-hospital mortality decreased over the years of the study (27.0% in 2002 vs. 18.3% in 2016). Extracorporeal membrane oxygenation utilization was 8.1%. Univariate and multivariate logistic regression analyses were used to identify risk factors for in-hospital mortality in infants with hypoplastic left heart syndrome. Independent non-modifiable risk factors for mortality were birth weight < 2500 g (Adjusted odds ratio (aOR) 2.16 [1.74-2.69]), gestational age < 37 weeks (aOR 1.73 [1.42-2.10]), chromosomal abnormalities (aOR 3.07 [2.60-3.64]) and renal anomalies (aOR 1.34 [1.10-1.61]). Independent modifiable risk factors for mortality were being transferred-in from another hospital (aOR 1.15 [1.03-1.29]), use of extracorporeal membrane oxygenation (aOR 12.74 [10.91-14.88]). Receiving care in a teaching hospital is a modifiable variable, and it decreased the odds of mortality (aOR 0. 78 [0.64-0.95]). In conclusion, chromosomal anomalies, Extra Corporeal Membrane Oxygenation, gestational age < 37 weeks or birth weight < 2500 g were associated with increased odds of mortality. Modifiable variables as receiving care at birth center and in a hospital designated as a teaching hospital decreased the odds of mortality.

Outcomes of hypoplastic left heart syndrome: analysis of National Inpatient Sample Database 1998-2004 versus 2005-2014.

Neonates with hypoplastic left heart syndrome (HLHS) were identified from the National Inpatient Sample dataset for the years 1998-2014. These patients were stratified into two chronological groups, past group (1998-2005) and recent group (2006-2014). A total of 20,649 neonates with HLHS were identified. Of them, 9179 (44.5%) were born in the past group and 11,470 (55.5%) in the recent group. Median birth weight was significantly less in the recent group (2967 g vs. 3110 g, p = 0.005). The patients in the recent group had more patients with low birth weight ( < 2.5 kg) and prematurity (8.7% vs 7.6% and 12.7% vs. 4.3%., respectively). In addition, recent group had more comorbidities including chromosomal anomalies, total anomalous pulmonary venous return, and kidney anomalies (5.6% vs. 3.6%, 2.3% vs. 1.7%, and 5.6% vs. 3.6%, respectively, p < 0.001); these were associated with a higher rate of extracorporeal membrane oxygenation utilization (9.2% vs. 4.5%, p < 0.001). Consequently, median length of stay was longer in the recent group (8 vs. 6 days, p < 0.001).Conclusion: Despite the higher frequency of comorbidities in recent group, the mortality rates decreased by 20% (from 25.3% to 20.6%, p < 0.001). Balloon atrial septostomy was performed less frequently in the recent group (23.3% vs. 16.1%, p < 0.001).What is known:• Hypoplastic left heart syndrome has the highest mortality among congenital cardiac defects during the first year of life.• Limited studies on patients' comorbidities and mortality rates trends over last two decades.What is new:• The study utilized a national database to compare in-hospital mortality and length of stay between the two time periods 1998-2005 and 2006-2014.• The recent group had more comorbidities (prematurity, chromosomal anomalies, total anomalous pulmonary venous return, and kidney anomalies), and there was higher rate of ECMO and longer length of stay, while mortality rates decreased by 20%.

Prevalence and Outcomes of Balloon Atrial Septostomy in Neonates With Transposition of Great Arteries.

OBJECTIVES: Transposition of the great arteries is the most common cyanotic congenital heart defect. Surgical correction usually occurs in the first week of life; presence of restrictive interatrial communication and severe hypoxemia warrants urgent intervention with balloon atrial septostomy and medical stabilization prior to surgery. The main objective of this study is to compare the characteristics, outcomes, and mortality risks in patients with transposition of the great arteries who underwent balloon atrial septostomy during their hospitalization versus transposition of the great arteries patients who have not undergone this procedure. DESIGN: Retrospective analysis of administrative data. SETTING: Data from Kids' Inpatient Database complemented with the National Inpatient Sample dataset for the years 1998-2014, this includes data from participating hospitals in 47 U.S. States and the District of Columbia. PATIENTS: Neonates admitted with transposition of the great arteries. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 17,392 neonates with diagnosis of transposition of the great arteries were captured in the databases we used. Male-to-female ratio was 2:1. The rate of balloon atrial septostomy in patients with transposition of the great arteries was 27.7% without significant change over the years. There was no significant difference in mortality between balloon atrial septostomy and no balloon atrial septostomy (6.3% vs 6.7%; p = 0.29). Neonates with balloon atrial septostomy had a two-fold increase in their length of stay compared with no balloon atrial septostomy (16 d vs 7 d; p < 0.0001). Stroke was present in 1.1% of balloon atrial septostomy group versus 0.6% in those who did not have balloon atrial septostomy (odds ratio, 1.85; 95% CI, 1.29-2.65; p < 0.0001). Extracorporeal membrane oxygenation was used more in balloon atrial septostomy group (5.1% vs 3.1%; p < 0.0001). CONCLUSIONS: There was no difference in mortality rate between balloon atrial septostomy and no balloon atrial septostomy patients. The prevalence of the diagnosis of stroke in this study was higher in patients who underwent balloon atrial septostomy. Furthermore, comparison of in-hospital mortality in balloon atrial septostomy and no balloon atrial septostomy revealed increased mortality risk in no balloon atrial septostomy patients transferred from other institution, no balloon atrial septostomy patients supported with extracorporeal membrane oxygenation, and balloon atrial septostomy patients diagnosed with stroke. Finally, length of stay and charges were higher in balloon atrial septostomy patients.

Bivalirudin Anticoagulation for an Infant with Hyperbilirubinemia and Elevated Plasma-Free Hemoglobin on ECMO.

Heparin has been used for decades as an anticoagulant in patients on mechanical circulatory support, which includes extracorporeal membrane oxygenation (ECMO) and ventricular assist devices. Bivalirudin is a direct thrombin inhibitor that can be used as an alternative anticoagulant in neonates and infants demonstrating inaccurate heparin monitoring. We report a case of a 2-month-old male child who was placed on ECMO for severe acute respiratory distress syndrome. His ECMO course was complicated by severe hemolysis and hyperbilirubinemia, which precluded accurate monitoring of heparin activity. Bivalirudin was successfully used for anticoagulation in this patient.