Stability of 4 Intravenous Drug Formulations in Prefilled Syringes Stored Frozen for Up to 60 Days.

Purpose: Prefilled drug syringe use may reduce the cost of routine antibiotic drug delivery. Storage of prefilled syringes frozen (-20°C) or refrigerated (4°C-5°C), can optimize the use of robotic syringe filling systems if acceptable stability data is gathered per USP 797 standards. Methods: Four intravenous (IV) drug formulations were prepared from bulk standard solutions and filled into 10 mL syringes using an Intellifill© IV Robot. Formulations were Piperacillin (2.0 g) and Tazobactam (0.25 g) as 2.25 g in 10 mL; Piperacillin (3.0 g) and Tazobactam (0.375 g) as 3.375 g in 10 mL; Cefuroxime as 1.5 g in 11 mL; and Vancomycin as 1.0 g in 10 mL. Concentrations were assayed at "zero time," and after 21, 45, and 60 days frozen. Syringes were warmed to room temperature (RT) by gently rolling in hands. Three syringes of each formulation were assayed by stability-indicating HPLC per USP procedures. Assay results are the average of 5 injections of samples from each syringe upon return to RT and repeated for 3 separate syringes maintained at RT for 24 hours. Results: All formulations were stable out to 60 days frozen. Both of the piperacillin/tazobactam formulations were also stable when kept at refrigerated temperature for 9 days. Conclusion: Piperacillin/Tazobactam formulations can be stored frozen (-20°C) for up to 60 days with no appreciable loss. Cefuroxime and Vancomycin formulations can be stored frozen for up to 60 days. Both Piperacillin/Tazobactam formulations can be refrigerated for up to 9 days. Implementation of larger batch compounding coupled with frozen syringe storage and delivery could result in enhanced uniformity of composition and significant manpower savings.

Biological versus mechanical prostheses for aortic valve replacement.

OBJECTIVES: Long-term real-world outcomes are critical for informing decisions about biological (Bio) or mechanical (Mech) prostheses for aortic valve replacement, particularly in patients aged between 50 and 65 years. The objective was to compare long-term survival and major adverse cardiac and cardiovascular events (ie, stroke, reoperation, and major bleeding) within this population. METHODS: This was a multicenter observational study including all patients aged between 50 and 65 years who underwent an aortic valve replacement because of severe isolated aortic stenosis between the years 2000 and 2018. A total of 5215 patients from 27 Spanish hospitals were registered with a follow-up of 15 years. Multivariable analyses, including a 2:1 propensity score matching (1822 Mech and 911 Bio) and competing risks analyses were applied. RESULTS: Bio prostheses were implanted in 19% of patients (n = 992). No significant differences were observed between matched groups in long-term survival (hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.88-1.47; P = .33). Stroke rates were higher for Mech prostheses, but not significant (HR, 0.72; 95% CI, 0.50-1.03; P = .07). Finally, higher rates of major bleeding were found in the Mech group (HR, 0.65; 95% CI, 0.49-0.87; P = .004), whereas reoperation was more frequent among the Bio group (HR, 3.04; 95% CI, 1.80-5.14; P < .001). Bio prostheses increased from 13% in the period from 2000 to 2008 to 24% in 2009 to 2018. CONCLUSIONS: Long-term survival was comparable among groups in patients between 50 and 65 years of age. Mech prostheses were associated with a higher risk of major bleeding, whereas Bio prostheses entailed higher reoperation rates. Bio prostheses seem a reasonable choice for patients between 50 and 65 years in Spain.

Inflammatory myofibroblastic tumor: A rare entity with a complex diagnosis.

Inflammatory myofibroblastic tumor is a neoplasm with uncertain behavior. We describe a case in a 66-year-old female who underwent resection of a left atrial tumor suspected to be a cardiac myxoma which was subsequently diagnosed as an inflammatory myofibroblastic tumor. After three years' follow-up the patient underwent a second operation to remove tumoral occurrence in the right atrium, diagnosed as an intimal sarcoma. It cannot be confirmed whether the tumoral recurrence with a different diagnosis (intimal sarcoma) was a progression from the primary tumor or the metachronous appearance of a spontaneous sarcoma.

Comparison of catheter-related bloodstream infection rates in pediatric patients receiving parenteral nutrition with soybean oil-based intravenous fat emulsion versus a mixed oil fat emulsion.

STUDY OBJECTIVE: To compare rates of catheter-related bloodstream infections (CR-BSI) in pediatric patients who received parenteral nutrition (PN) with either soybean oil-based intravenous fat emulsion (SO-IFE) or mixed oil-IFE (MO-IFE). We hypothesized that the use of MO-IFE would be independently associated with reduced infection rates compared with SO-IFE. DESIGN: Retrospective cohort study. SETTING: Tertiary referral children's hospital and its associated gastrointestinal rehabilitation clinic (01 January, 2015-31 July, 2019). PATIENTS: Days of IFE exposure were counted for patients aged <18 years on IFE initiated during the review period, who had a central venous catheter (CVC) placed for PN administration, received IFE at least three times weekly, and for at least 7 days. MEASUREMENTS: The primary outcome included total and categorical CR-BSI rates expressed as the average with standard error (SE) number of infections per 1000 fat emulsion days. The following categories were specified: Candida albicans, non-albicans Candida spp., coagulase-negative Staphylococcus (CoNS), Enterobacterales, methicillin-resistant S. aureus, methicillin-susceptible S. aureus, and Pseudomonadales. Average infection rate comparisons were quantified as incidence rate ratios (IRR) using generalized linear mixed modeling with a Poisson distribution. MAIN RESULTS: Seven hundred and forty-three SO-IFE and 450 MO-IFE exposures were reviewed from 1131 patients, totaling 37,599 and 19,796 days of therapy, respectively. From those found significantly different, the average rate of infections with CoNS was 3.58 (SE 0.5)/1000 days of SO-IFE and 1.39 (SE 0.45)/1000 days of MO-IFE (IRR [95% confidence interval, CI]: 0.27 [0.16-0.46]; p < 0.01). Total average rates of infection were 7.33 (SE 0.76)/1000 days of SO-IFE and 4.52 (SE 0.75)/1000 days of MO-IFE (IRR [95% CI]: 0.60 [0.44-0.81]; p < 0.01). Other factors associated with higher infection rates include female gender, neonatal age, and inpatient-only IFE exposure. CONCLUSIONS: Receipt of MO-IFE was associated with lower rates of CoNS and total CR-BSIs compared with SO-IFE in pediatric patients. These findings could have major implications on IFE selection for pediatric patients receiving PN.

Giant Circumflex Aneurysm With Arteriovenous Fistula Surgery Guided by Three-Dimensional Printing.

A giant coronary artery aneurysm is an infrequent anomaly encountered as an incidental finding. An even more rare condition is its association with a coronary artery fistula. We report the case of a 61-year-old woman that combines two of the rarest coronary anomalies: a 70-mm giant circumflex aneurysm with an arteriovenous fistula tract draining to the superior vena cava. Considering the unique display of anatomy, the surgery was guided with 3-dimensional printing technology. Direct fistula occlusion near its outflow union, orifice source closure, aneurysmal sac exclusion, and two coronary artery bypass grafts were surgically performed. The postoperative course was satisfactory.

Treatment of Hepatic Embryonal Undifferentiated Sarcoma With Cardiothoracic Involvement.

Thorough study is required to decide the appropriate management of hepatic tumors in children. We present a case report of a hepatic embryonal undifferentiated sarcoma with unfavorable prognosis in a nine-year-old girl. After undergoing a detailed cancer characteristics and extension study, a two-stage surgery approach was decided. The hepatic tumor resection was the first procedure to be performed. One week later, under cardiopulmonary bypass, deep hypothermia, and circulatory arrest, thrombectomy of the inferior vena cava and right atrium was accomplished, plus thromboendarterectomy of the right pulmonary artery. During a four-year follow-up, the patient continues to be disease-free.

Plasma Citrulline Concentrations in Neonates With or Without Gastrointestinal Disease During Periods of Parenteral and Enteral Nutrition.

INTRODUCTION: Citrulline is synthesized primarily in enterocytes. Retrospective work revealed higher plasma concentrations in patients without gastrointestinal (GI) disease than in those with GI disease, regardless of bowel resection, leading us to speculate whether it could be used as a marker of gut function prospectively. Our purpose was to analyze plasma citrulline in these patients, comparing a period of exclusive parenteral nutrition (PN) vs both PN and enteral nutrition (PN/EN). METHODS: Premature neonates were included in this study. Plasma samples were collected during 2 periods, PN and PN/EN. They were classified into groups: patients without GI disease (Group 1), patients with GI disease without resection (Group 2), and patients with GI disease and resection (Group 3). Plasma was analyzed by high-performance liquid chromatography and tandem mass spectrometry (LC-MS/MS). Data were described as median with ranges. RESULTS: Fifty patients were recruited for this study, from which 164 samples were obtained and analyzed by LC-MS. Median plasma citrulline concentrations were 12.3 (5.6-39.4) µmol/L, 14.9 (6.8-39.8) µmol/L, and 10.8 (2.0-23.6) µmol/L for Groups 1, 2, and 3, respectively. After Bonferroni correction, only Group 3 had a significantly different median from the others. No differences were observed within periods of nutrition (PN vs PN/EN). Postconceptual age (PCA), among others, was assessed to determine differences for which the former demonstrated significance. CONCLUSION: Premature neonates with bowel resection had lower plasma citrulline concentrations, confirming its role as gut mass marker, though without differences during transitional feeding. PCA may affect expression of this protein.

Calprotectin: Clinical Applications in Pediatrics.

As seen over the past 20 years, calprotectin has evolved as a novel, non-invasive biomarker of gastrointestinal (GI) inflammation. We present this review of calprotectin in pediatrics. This article will focus on studies using calprotectin concentrations from different body fluids to monitor inflammation in different disease states and conditions. The ultimate goal of our group is to lay down a foundation as we consider using calprotectin prospectively as a marker of intestinal inflammation that could lead to further testing and possibly a marker of preparedness for feeding. We surveyed all published studies in English of calprotectin in neonates, infants, children, and adolescents through February 2014. We will discuss calprotectin's basic properties and analysis such as characteristics, identification, presence in body fluids, and maturational development. In addition, calprotectin's use in inflammatory diseases exploring both GI and non-GI conditions will be evaluated and compared with other serum markers presently available. Finally, a summary of our findings and discussion of future work that could be undertaken in order to render calprotectin as a more useful monitoring tool to the medical research community will complete the review.

MMR Vaccine: When Is the Right Time for the Second Dose?

Outbreaks of measles have been reported over the past 5 years, particularly affecting children between the ages of 1 and 5 years. Most of these children are younger than the age recommended by the Advisory Committee on Immunization Practices for the second dose of measles-mumps-rubella (MMR) vaccine. Question may arise as to whether strict adherence to the scheduled second dose is required or whether there is opportunity for earlier immunization under special circumstances (e.g., traveling abroad, poor response as evidenced by titer levels). The history of measles, its characteristics, and its evolving past and current immunization policies will be reviewed, focusing on the original intent of the recommended schedule and presenting a case in which deviating from current practice could be justified.