Critical care therapies pre- and post-heart transplant and their impact: Analysis from the Pediatric Cardiac Critical Care Consortium.

BACKGROUND: Few studies highlighting the critical care management of patients after heart HTx (HTx) have been published to date. This analysis provides a contemporary representation of pre- and post-HTx critical care in various patient cohorts and outlines the impact of intensive care unit (ICU) therapies on outcomes. METHODS: Data from PC4 Collaborative Registry were analyzed for pediatric patients undergoing HTx between August 2014 and April 2022. RESULTS: A total of 1877 HTx in 1857 patients were reported from 42 centers; 56.5% had congenital heart disease (CHD). Patients with CHD were younger, smaller, more likely male, White race, and publicly insured. CHD patients had higher need for catheterization, increased likelihood of inotropic support and mechanical ventilation and lower VAD rates. Their operative courses were significant for longer bypass and cross-clamp times. Postoperatively, CHD patients required more CPR , utilized more ICU therapies and had higher hospital mortality (7.8% vs. 1.8% for non-CHD patients, p<0.0001). Longer cardiopulmonary bypass, longer deep hypothermic circulatory arrest times and delayed sternal closure were independent risk factors for hospital mortality. Lastly, center transplant volume but not surgical volume was associated with transplant outcomes. CONCLUSIONS: A diagnosis of CHD before HTx is associated with a greater use of ICU-specific therapies compared non-CHD cohort. Operative factors, particularly in patients with CHD, are independently associated with higher hospital mortality as was low transplant volume at the center. The study provides basis for further investigating ICU and operative factors that can be modified to improve transplant outcomes.

Clinical Presentation, Classification, and Outcomes of Cardiogenic Shock in Children.

BACKGROUND: Despite growing cardiogenic shock (CS) research in adults, the epidemiology, clinical features, and outcomes of children with CS are lacking. OBJECTIVES: This study sought to describe the epidemiology, clinical presentation, hospital course, risk factors, and outcomes of CS among children hospitalized for acute decompensated heart failure (ADHF). METHODS: We examined consecutive ADHF hospitalizations (<21 years of age) from a large single-center retrospective cohort. Patients with CS at presentation were analyzed and risk factors for CS and for the primary outcome of in-hospital mortality were identified. A modified Society for Cardiovascular Angiography and Interventions shock classification was created and patients were staged accordingly. RESULTS: A total of 803 hospitalizations for ADHF were identified in 591 unique patients (median age 7.6 years). CS occurred in 207 (26%) hospitalizations. ADHF hospitalizations with CS were characterized by worse systolic function (P = 0.040), higher B-type natriuretic peptide concentration (P = 0.032), and more frequent early severe renal (P = 0.023) and liver (P < 0.001) injury than those without CS. Children presenting in CS received mechanical ventilation (87% vs 26%) and mechanical circulatory support (45% vs 16%) more frequently (both P < 0.001). Analyzing only the most recent ADHF hospitalization, children with CS were at increased risk of in-hospital mortality compared with children without CS (28% vs 11%; OR: 1.91; 95% CI: 1.05-3.45; P = 0.033). Each higher CS stage was associated with greater inpatient mortality (OR: 2.40-8.90; all P < 0.001). CONCLUSIONS: CS occurs in 26% of pediatric hospitalizations for ADHF and is independently associated with hospital mortality. A modified Society for Cardiovascular Angiography and Interventions classification for CS severity showed robust association with increasing mortality.

Harnessing Non-Thermal Plasma to Supercharge Recovery in Abdominal Surgeries: A Pilot Study.

(1) Background: This study aims to evaluate the efficacy and safety of non-thermal plasma (NTP) therapy in accelerating wound healing in patients who have undergone laparoscopic and open surgeries. (2) Methods: NTP was applied using a needle-type reactor with an irradiance of 0.5 W/cm2 on the surgical wounds of fifty patients after obtaining informed consent. Three NTP treatments, each lasting three minutes, were administered hourly. (3) Results: The pilot study showed that NTP-treated surgical wounds healed completely without any signs of infection, dehiscence, pain, or itching. Notably, patients reported minimal pain after the NTP treatment. Visual assessments conducted twenty-four hours after surgery revealed no redness or fluid discharge. Comparisons with traditionally sutured wounds indicated that NTP-treated wounds healed at a rate equivalent to seven days. (4) Conclusions: The application of NTP in laparoscopic and open wounds proved safe and effective, expediting the wound healing process and eliminating clinical risks post-surgery. Significantly, NTP facilitated a healing rate within twenty-four hours, equivalent to seven days for suture-treated wounds, significantly reducing the hospitalization time to a single day. These findings highlight the potential of NTP to be a transformative approach for promoting postoperative recovery.

Innovative Curved-Tip Reactor for Non-Thermal Plasma and Plasma-Treated Water Generation: Synergistic Impact Comparison with Sodium Hypochlorite in Dental Root Canal Disinfection.

Non-thermal plasmas (NTPs), known as cold atmospheric plasmas (CAPs), hold great potential for diverse medical applications, including dentistry. However, traditional linear and rigid dielectric barrier discharge reactors used for NTP generation encounter limitations in accessing oral cavities and root canals. To address this issue, we have developed an innovative NTP reactor featuring an angled end for improved accessibility. The central copper electrode, with a 0.59 mm diameter and adjustable length for desired angulation, is coated with zircon powder (ZrSiO4) to ensure stable NTP generation. This central electrode is housed within a stainless steel tube (3 mm internal diameter, 8 mm external diameter, and 100 mm length) with a 27° angle at one end, making it ergonomically suitable for oral applications. NTP generation involves polarizing the reactor electrodes with 13.56 MHz radio frequency signals, using helium gas as a working medium. We introduce plasma-treated water (PTW) as an adjunctive therapy to enhance biofilm eradication within root canals. A synergistic approach combining NTP and PTW is employed and compared to the gold standard (sodium hypochlorite, NaOCl), effectively neutralizing Enterococcus faecalis bacteria, even in scenarios involving biofilms. Moreover, applying NTP in both gaseous and liquid environments successfully achieves bacterial inactivation at varying treatment durations, demonstrating the device's suitability for medical use in treating root canal biofilms. The proposed NTP reactor, characterized by its innovative design, offers a practical and specific approach to plasma treatment in dental applications. It holds promise in combatting bacterial infections in root canals and oral cavities.

Evaluation of factors leading to poor outcomes for pediatric acute lymphoblastic leukemia in Mexico: a multi-institutional report of 2,116 patients.

Background and aims: Pediatric acute lymphoblastic leukemia (ALL) survival rates in low- and middle-income countries are lower due to deficiencies in multilevel factors, including access to timely diagnosis, risk-stratified therapy, and comprehensive supportive care. This retrospective study aimed to analyze outcomes for pediatric ALL at 16 centers in Mexico. Methods: Patients <18 years of age with newly diagnosed B- and T-cell ALL treated between January 2011 and December 2019 were included. Clinical and biological characteristics and their association with outcomes were examined. Results: Overall, 2,116 patients with a median age of 6.3 years were included. B-cell immunophenotype was identified in 1,889 (89.3%) patients. The median white blood cells at diagnosis were 11.2.5 × 103/mm3. CNS-1 status was reported in 1,810 (85.5%), CNS-2 in 67 (3.2%), and CNS-3 in 61 (2.9%). A total of 1,488 patients (70.4%) were classified as high-risk at diagnosis. However, in 52.5% (991/1,889) of patients with B-cell ALL, the reported risk group did not match the calculated risk group allocation based on National Cancer Institute (NCI) criteria. Fluorescence in situ hybridization (FISH) and PCR tests were performed for 407 (19.2%) and 736 (34.8%) patients, respectively. Minimal residual disease (MRD) during induction was performed in 1,158 patients (54.7%). The median follow-up was 3.7 years. During induction, 191 patients died (9.1%), and 45 patients (2.1%) experienced induction failure. A total of 365 deaths (17.3%) occurred, including 174 deaths after remission. Six percent (176) of patients abandoned treatment. The 5-year event-free survival (EFS) was 58.9% ± 1.7% for B-cell ALL and 47.4% ± 5.9% for T-cell ALL, while the 5-year overall survival (OS) was 67.5% ± 1.6% for B-cell ALL and 54.3% ± 0.6% for T-cell ALL. The 5-year cumulative incidence of central nervous system (CNS) relapse was 5.5% ± 0.6%. For the whole cohort, significantly higher outcomes were seen for patients aged 1-10 years, with DNA index >0.9, with hyperdiploid ALL, and without substantial treatment modifications. In multivariable analyses, age and Day 15 MRD continued to have a significant effect on EFS. Conclusion: Outcomes in this multi-institutional cohort describe poor outcomes, influenced by incomplete and inconsistent risk stratification, early toxic death, high on-treatment mortality, and high CNS relapse rate. Adopting comprehensive risk-stratification strategies, evidence-informed de-intensification for favorable-risk patients and optimized supportive care could improve outcomes.

Longitudinal Follow-Up of Children With HLHS and Association Between Norwood Shunt Type and Long-Term Outcomes: The SVR III Study.

OBJECTIVE: In the SVR trial (Single Ventricle Reconstruction), newborns with hypoplastic left heart syndrome were randomly assigned to receive a modified Blalock-Taussig-Thomas shunt (mBTTS) or a right ventricle-to-pulmonary artery shunt (RVPAS) at Norwood operation. Transplant-free survival was superior in the RVPAS group at 1 year, but no longer differed by treatment group at 6 years; both treatment groups had accumulated important morbidities. In the third follow-up of this cohort (SVRIII [Long-Term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type]), we measured longitudinal outcomes and their risk factors through 12 years of age. METHODS: Annual medical history was collected through record review and telephone interviews. Cardiac magnetic resonance imaging (CMR), echocardiogram, and cycle ergometry cardiopulmonary exercise tests were performed at 10 through 14 years of age among participants with Fontan physiology. Differences in transplant-free survival and complication rates (eg, arrhythmias or protein-losing enteropathy) were identified through 12 years of age. The primary study outcome was right ventricular ejection fraction (RVEF) by CMR, and primary analyses were according to shunt type received. Multivariable linear and Cox regression models were created for RVEF by CMR and post-Fontan transplant-free survival. RESULTS: Among 549 participants enrolled in SVR, 237 of 313 (76%; 60.7% male) transplant-free survivors (mBTTS, 105 of 147; RVPAS, 129 of 161; both, 3 of 5) participated in SVRIII. RVEF by CMR was similar in the shunt groups (RVPAS, 51±9.6 [n=90], and mBTTS, 52±7.4 [n=75]; P=0.43). The RVPAS and mBTTS groups did not differ in transplant-free survival by 12 years of age (163 of 277 [59%] versus 144 of 267 [54%], respectively; P=0.11), percentage predicted peak Vo2 for age and sex (74±18% [n=91] versus 72±18% [n=84]; P=0.71), or percentage predicted work rate for size and sex (65±20% versus 64±19%; P=0.65). The RVPAS versus mBTTS group had a higher cumulative incidence of protein-losing enteropathy (5% versus 2%; P=0.04) and of catheter interventions (14 versus 10 per 100 patient-years; P=0.01), but had similar rates of other complications. CONCLUSIONS: By 12 years after the Norwood operation, shunt type has minimal association with RVEF, peak Vo2, complication rates, and transplant-free survival. RVEF is preserved among the subgroup of survivors who underwent CMR assessment. Low transplant-free survival, poor exercise performance, and accruing morbidities highlight the need for innovative strategies to improve long-term outcomes in patients with hypoplastic left heart syndrome. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT0245531.

Mortalidad de pacientes hospitalizados por Covid-19 en México, revisión sistemática / Mortality of patients hospitalized by Covid-19 in Mexico, systematic review

RESUMEN Introducción: Desde el inicio de la pandemia, México fue de los países que presentó tasas de mortalidad más altas por COVID 19. Objetivo: Determinar si la diabetes mellitus tipo 2, la hipertensión arterial y la obesidad incrementan la tasa de mortalidad en pacientes con diagnóstico de COVID-19 que requirieron hospitalización en México. Métodos: Revisión sistemática en Pubmed MeSH, Web of Science, Lilas, Scielo y Google Scholar con los términos MeSH "COVID-19", "SARS-COV2", "Coronavirus", y "México" durante los años 2020 y 2021, incluyendo artículos en inglés y español. Para el proceso de selección de artículos, dos revisores seleccionaron los estudios mientras que otros dos revisores adicionales participaron en el análisis de dichos estudios. Resultados: Se incluyeron 73 estudios realizados en México del 2020 al 2021 con información obtenida a través de las bases de datos del Sistema Nacional de Vigilancia Epidemiológica de México. Se incluyeron pacientes con un promedio de edad de 52,9 años ±13,27, el 64% de los pacientes incluidos fueron mujeres, se reportó una tasa de mortalidad de 6.76% (Min-Max 0.77-73.73%). El 71% de los estudios (52), no reportaron la mortalidad específica relacionada con las comorbilidades. La patología más prevalente fue la obesidad con un 24.23% (Min-Max 11.50-71.00%), seguida de la hipertensión arterial con un 22.23% (Min-Max 2.0-53.96%) y finalmente la diabetes mellitus tipo 2 con un 18.10% (Min-Max 1.83-40.00%). Conclusión: La comorbilidad más común entre los pacientes hospitalizados por COVID 19 en México fue la obesidad, seguida de la diabetes mellitus tipo 2 y por último la hipertensión.

ABSTRACT Introduction: Since the start of the pandemic, Mexico was one of the countries with the highest mortality rates from COVID 19. Objective: To determine if type 2 diabetes mellitus, arterial hypertension, and obesity increase mortality in patients diagnosed with COVID-19 who required hospitalization in Mexico. Methods: Systematic review in Pubmed MeSH, Web of Science, Lilas, Scielo, and Google Scholar with the terms MeSH COVID-19, SARS-COV2, Coronavirus, and Mexico for the years 2020 and 2021, in English or Spanish. Two reviewers selected the studies, two additional reviewers participated in the analysis of the studies. Results: Seventy three studies carried out in Mexico from 2020 to 2021 were included with information obtained from the databases of the National Epidemiological Surveillance System of Mexico. With an average age of 52.9 ± 13.27 years, 64% of the included patients were women, in general, a mortality rate of 16.76% (Min-Max 0.77-73.73%) was reported. 71% of the studies (52) did not report specific mortality related to comorbidities the most prevalent pathology was obesity with 24.23% (Min-Max 11.50-71.00%), followed by arterial hypertension 22.23% (Min-Max 2.0-53.96%) and finally Diabetes mellitus with 18.10% (Min-Max 1.83-40.00%). Conclusion: The most common comorbidity among patients hospitalized for COVID in Mexico was obesity, followed by type 2 diabetes mellitus and hypertension.

External assessment and refinement of a population pharmacokinetic model to guide tacrolimus dosing in pediatric heart transplant.

STUDY OBJECTIVE: The immunosuppressant tacrolimus is a first-line agent to prevent graft rejection following pediatric heart transplant; however, it suffers from extensive inter-patient variability and a narrow therapeutic window. Personalized tacrolimus dosing may improve transplant outcomes by more efficiently achieving and maintaining therapeutic tacrolimus concentrations. We sought to externally validate a previously published population pharmacokinetic (PK) model that was constructed with data from a single site. DATA SOURCE: Data were collected from Seattle, Texas, and Boston Children's Hospitals, and assessed using standard population PK modeling techniques in NONMEMv7.2. MAIN RESULTS: While the model was not successfully validated for use with external data, further covariate searching identified weight (p < 0.0001 on both volume and elimination rate) as a model-significant covariate. This refined model acceptably predicted future tacrolimus concentrations when guided by as few as three concentrations (median prediction error = 7%; median absolute prediction error = 27%). CONCLUSION: These findings support the potential clinical utility of a population PK model to provide personalized tacrolimus dosing guidance.

Evaluation of the MDR Direct Flow Chip Kit for the Detection of Multiple Antimicrobial Resistance Determinants.

The objective of this study was to evaluate the accuracy of the MDR Direct Flow Chip Kit for the detection of antimicrobial resistance (AMR) determinants from bacterial colonies. Ninety-two clinical isolates with known AMR determinants genotypically characterized were used. The MDR Direct Flow Chip Kit is a microarray-based assay that included 55 AMR determinants for beta-lactams (23), quinolones (13), aminoglycosides (5), macrolides (5), sulfonamides (3), colistin (2), vancomycin (2), chloramphenicol (1), and linezolid (1). The MDR Direct Flow Chip Kit correctly detects 52 of 53 AMR determinants tested. The cfr gene (linezolid resistance) was not detected. The global sensibility, specificity, positive predictive value, and the negative predictive value calculated were 98%, 100%, 100%, and 97%. The Cohen's Kappa coefficient calculated was 0.97 [95% Confidence Interval (0.90-1.03)]. In conclusion, the MDR Direct Flow Chip is an accurate assay for the detection of multiple AMR determinants in one simple reaction.

Impact of race and health coverage on listing and waitlist mortality in pediatric cardiac transplantation.

BACKGROUND: Social factors like race and insurance affect transplant outcomes. However, little is known in pediatric heart transplantation. We hypothesized that race and insurance coverage impact listing and waitlist outcomes across eras. METHODS: Data from the Pediatric Heart Transplant Society multi-center registry prospectively collected between January 1, 2000-December 31, 2019 were analyzed. Patients were divided by race as Black, White and other and by insurance coverage at listing (US governmental, US private and non-US single payer systems (UK, Canada). Clinical condition at listing and waitlist outcomes were compared across races and insurance coverages. Categorical variables were compared using a chi-square test and continuous variables using the Wilcoxon rank sum test. Risk factors for waitlist mortality were examined using multiphase parametric hazard modeling. A sensitivity analysis using parametric hazard explored the interaction between race and insurance. RESULTS: At listing, compared to Whites (n = 5391) and others (n = 1167), Black patients (n = 1428) were older, more likely on US governmental insurance and had cardiomyopathy as the predominant diagnosis (p < 0.0001). Black patients were more likely to be higher status at listing, in hospital, on inotropes or a ventricular assist device (p < 0.0001). Black patients had significantly shorter time on the waitlist compared to other races (p < 0.0001) but had higher waitlist mortality (p = 0.0091), driven by the earlier era (2000-2009) (p = 0.0005), most prominently within the US private insurance cohort (p = 0.015). Outcomes were not different in other insurance cohorts or in the recent era (2010-2019). CONCLUSION: Black children are older and sicker at the time of listing, deteriorate more often and face a higher wait list mortality, despite a shorter waitlist period and favorable clinical factors, with improvement in the recent era associated with the recent US healthcare reforms. The social construct of race appears to disadvantage Black children by limiting referral, consideration or access to pediatric cardiac transplantation.

Healing of Recurrent Aphthous Stomatitis by Non-Thermal Plasma: Pilot Study.

Recurrent aphthous stomatitis (RAS) is a common disease in the oral cavity characterized by recurrent ulcers (RU). Usually, these cause acute pain without definitive treatment. The present study determines the efficacy of non-thermal plasma (NTP) for treating RU. NTP is applied to the patient's RU using a radiofrequency generator connected to a point reactor. The power density applied to the ulcer is 0.50 W/cm2, less than 4 W/cm2, which is the maximum value without biological risk. Each patient received two treatments of three minutes each and spaced 60 min apart at a distance of 5 mm from the RU. From a sample of 30 ulcers in patients treated for RU with an average age of 37 years, they stated that the pain decreased considerably and without the need for ingestion of analgesics and antibiotics. Regeneration took place in an average of three days. The NTP proved to be an excellent therapeutic alternative for the treatment of RU since it has a rapid effect of reducing pain and inflammation, as well as adequate tissue regeneration.

Securing access to a comprehensive diagnostic panel for children with suspected acute lymphoblastic leukemia: Results from the Mexico in Alliance with St. Jude "Bridge Project".

Background: The "Bridge Project" is a Mexico in Alliance with St. Jude (MAS) initiative developed in 2019 to improve access, accuracy, and timeliness of specialized diagnostic studies for patients with suspected acute lymphoblastic leukemia (ALL). The project strategy relies on service centralization to improve service delivery, biological characterization, risk-group classification, and support proper treatment allocation. Methods: This is an ongoing prospective multisite intersectoral quality improvement (QI) project available to all patients 0-18 years of age presenting with suspected ALL to the 14 actively participating institutions in 12 Mexican states. Institutions send specimens to one centralized laboratory. From a clinical standpoint, the project secures access to a consensus-derived comprehensive diagnostic panel. From a service delivery standpoint, we assess equity, timeliness, effectiveness, and patient-centeredness. From an implementation science standpoint, we document feasibility, utility, and appropriateness of the diagnostic panel and centralized approach. This analysis spans from July 2019 to June 2023. Results: 612 patients have accessed the project. The median age was 6 years (IQR 3-11), and 53% were males. 94% of the specimens arrived within 48 hours, which documents the feasibility of the centralized model, and 100% of the patients received precise and timely diagnostic results, which documents the effectiveness of the approach. Of 505 (82.5%) patients with confirmed ALL, 463/505 (91.6%) had B-cell ALL, and 42/505 (8.3%) had T-cell ALL. High-hyperdiploidy was detected by DNA index in 36.6% and hypodiploidy in 1.6%. 76.6% of the patients had conclusive karyotype results. FISH studies showed t(12;21) in 15%, iAMP21 in 8.5%, t(1;19) in 7.5%, t(4;11) in 4.2%, t(9;22) in 3.2%, del(9)(p21) in 1.8%, and TRA/D (14)(q11.2) rearrangement in 2.4%. Among B-cell ALL patients, 344/403 (85.1%) had Day 15 MRD<1% and 261/305 (85.6%) Day 84 MRD<0.01. For T-cell ALL patients 20/28 (71.4%) had Day 29 MRD<0.01% and 19/22 (86.4%) Day 84 MRD<0.01%. Conclusions: By securing access to a standardized consensus-derived diagnostic panel, the Bridge Project has allowed better characterization of childhood ALL in Mexico while producing unprecedented service improvements and documenting key implementation outcomes. We are using these results to inform iterative changes to the diagnostic panel and an associated treatment guideline (MAS-ALL18).

Brain natriuretic peptide and N-terminal brain natriuretic peptide for the diagnosis of haemodynamically significant patent ductus arteriosus in preterm neonates.

BACKGROUND: Echocardiogram is the reference standard for the diagnosis of haemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. A simple blood assay for brain natriuretic peptide (BNP) or amino-terminal pro-B-type natriuretic peptide (NT-proBNP) may be useful in the diagnosis and management of hsPDA, but a summary of the diagnostic accuracy has not been reviewed recently. OBJECTIVES: Primary objective: To determine the diagnostic accuracy of the cardiac biomarkers BNP and NT-proBNP for diagnosis of haemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates. Our secondary objectives were: to compare the accuracy of BNP and NT-proBNP; and to explore possible sources of heterogeneity among studies evaluating BNP and NT-proBNP, including type of commercial assay, chronological age of the infant at testing, gestational age at birth, whether used to initiate medical or surgical treatment, test threshold, and criteria of the reference standard (type of echocardiographic parameter used for diagnosis, clinical symptoms or physical signs if data were available). SEARCH METHODS: We searched the following databases in September 2021: MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science. We also searched clinical trial registries and conference abstracts. We checked references of included studies and conducted cited reference searches of included studies. We did not apply any language or date restrictions to the electronic searches or use methodological filters, so as to maximise sensitivity. SELECTION CRITERIA: We included prospective or retrospective, cohort or cross-sectional studies, which evaluated BNP or NT-proBNP (index tests) in preterm infants (participants) with suspected hsPDA (target condition) in comparison with echocardiogram (reference standard). DATA COLLECTION AND ANALYSIS: Two authors independently screened title/abstracts and full-texts, resolving any inclusion disagreements through discussion or with a third reviewer. We extracted data from included studies to create 2 × 2 tables. Two independent assessors performed quality assessment using the Quality Assessment of Diagnostic-Accuracy Studies-2 (QUADAS 2) tool. We excluded studies that did not report data in sufficient detail to construct 2 × 2 tables, and where this information was not available from the primary investigators. We used bivariate and hierarchical summary receiver operating characteristic (HSROC) random-effects models for meta-analysis and generated summary receiver operating characteristic space (ROC) curves. Since both BNP and NTproBNP are continuous variables, sensitivity and specificity were reported at multiple thresholds. We dealt with the threshold effect by reporting summary ROC curves without summary points. MAIN RESULTS: We included 34 studies: 13 evaluated BNP and 21 evaluated NT-proBNP in the diagnosis of hsPDA. Studies varied by methodological quality, type of commercial assay, thresholds, age at testing, gestational age and whether the assay was used to initiate medical or surgical therapy. We noted some variability in the definition of hsPDA among the included studies. For BNP, the summary curve is reported in the ROC space (13 studies, 768 infants, low-certainty evidence). The estimated specificities from the ROC curve at fixed values of sensitivities at median (83%), lower and upper quartiles (79% and 92%) were 93.6% (95% confidence interval (CI) 77.8 to 98.4), 95.5% (95% CI 83.6 to 98.9) and 81.1% (95% CI 50.6 to 94.7), respectively. Subgroup comparisons revealed differences by type of assay and better diagnostic accuracy at lower threshold cut-offs (< 250 pg/ml compared to ≥ 250 pg/ml), testing at gestational age < 30 weeks and chronological age at testing at one to three days. Data were insufficient for subgroup analysis of whether the BNP testing was indicated for medical or surgical management of PDA. For NT-proBNP, the summary ROC curve is reported in the ROC space (21 studies, 1459 infants, low-certainty evidence). The estimated specificities from the ROC curve at fixed values of sensitivities at median (92%), lower and upper quartiles (85% and 94%) were 83.6% (95% CI 73.3 to 90.5), 90.6% (95% CI 83.8 to 94.7) and 79.4% (95% CI 67.5 to 87.8), respectively. Subgroup analyses by threshold (< 6000 pg/ml and ≥ 6000 pg/ml) did not reveal any differences. Subgroup analysis by mean gestational age (< 30 weeks vs 30 weeks and above) showed better accuracy with < 30 weeks, and chronological age at testing (days one to three vs over three) showed testing at days one to three had better diagnostic accuracy. Data were insufficient for subgroup analysis of whether the NTproBNP testing was indicated for medical or surgical management of PDA. We performed meta-regression for BNP and NT-proBNP using the covariates: assay type, threshold, mean gestational age and chronological age; none of the covariates significantly affected summary sensitivity and specificity. AUTHORS' CONCLUSIONS: Low-certainty evidence suggests that BNP and NT-proBNP have moderate accuracy in diagnosing hsPDA and may work best as a triage test to select infants for echocardiography. The studies evaluating the diagnostic accuracy of BNP and NT-proBNP for hsPDA varied considerably by assay characteristics (assay kit and threshold) and infant characteristics (gestational and chronological age); hence, generalisability between centres is not possible. We recommend that BNP or NT-proBNP assays be locally validated for specific populations and outcomes, to initiate therapy or follow response to therapy.

Evaluación clínica de un nuevo método molecular para la detección de microorganismos multirresistentes / Clinical evaluation of a new molecular method for the detection of multidrug-resistant microorganisms

Introducción: El objetivo fue realizar la validación clínica del sistema molecular AMR Direct Flow Chip® para la detección de genes de resistencia a antimicrobianos partiendo de aislados bacterianos en cultivo, así como de hisopos de muestras nasales o rectales. Métodos: El ensayo AMR es una PCR multiplex seguida de hibridación reversa tipo dot blot en arrays de ADN completamente automatizada mediante la plataforma HS24, con un tiempo de realización de 3h. Se realizó la validación preclínica con 104 cepas bacterianas caracterizadas y posteriormente se analizaron 210 muestras de hisopos nasales o rectales. Resultados: La sensibilidad y la especificidad del ensayo preclínico fueron del 100%, identificando correctamente las 104 cepas. En la validación clínica, la sensibilidad fue del 100% y la especificidad fue del 100% en muestras rectales y del 97% en hisopos nasales. Conclusiones: El sistema AMR Direct Flow Chip® es un sistema rápido y eficaz para la detección de microorganismos multirresistentes a partir de muestras rectales y nasales.(AU)

Introduction The main objective of this work is to carry out the clinical validation of the trial with the AMR Direct Flow Chip® starting from either nasal swabs, rectal swabs directly or from isolated strains to detect antibiotic resistance genes. Methods: We developed the preclinical validation of the assay with 104 known bacterial isolates. A total of 210 nasal or rectal swab samples were analyzed. The AMR assay is based on multiplex PCR followed by reverse dot blot hybridization on DNA arrays fully automated by using the HS24 platform. The completion time of the full analysis is 3 hours. Results :Both the sensitivity and specificity of the preclinical assay were 100%, with the 104 samples correctly identified. In the clinical validation, the sensitivity was 100% and the specificity was between 100% in rectal swabs and 97% in nasal swabs. Conclusions: The AMR Direct Flow Chip® is a rapid and effective assay for the detection of multidrug-resistant microorganisms from nasal and rectal swab samples.(AU)

Clinical evaluation of a new molecular method for the detection of multidrug-resistant microorganisms.

INTRODUCTION: The main objective of this work is to carry out the clinical validation of the trial with the AMR Direct Flow Chip starting from either nasal swabs, rectal swabs directly or from isolated strains to detect antibiotic resistance genes. METHODS: We developed the preclinical validation of the assay with 104 known bacterial isolates. A total of 210 nasal or rectal swab samples were analyzed. The AMR assay is based on multiplex PCR followed by reverse dot blot hybridization on DNA arrays fully automated by using the HS24 platform. RESULTS: Both the sensitivity and specificity of the preclinical assay were 100%, with the 104 samples correctly identified. In the clinical validation, the sensitivity was 100% and the specificity was between 100% in nasal swabs and 97% in rectal swabs. CONCLUSIONS: The AMR Direct Flow Chip® is a rapid and effective assay for the detection of multidrug-resistant microorganisms (MDR) from nasal and rectal swab samples.

Does Cardiac Catheterization Facilitate Hemodynamic Optimization of Pediatric Patients on Continuous-Flow Ventricular Assist Devices?

Understanding optimal ventricular assist device (VAD) parameters for pediatric patients is valuable given the inherent issue of patient-device size mismatch and heterogeneous cardiac anatomy in children. We evaluated our center's experience of continuous-flow VAD (CF-VAD) optimization using cardiac catheterization. We performed a retrospective analysis of all patients on CF-VAD support who underwent hemodynamic heart catheterization from 2013 to 2018. Fifteen patients had 16 hemodynamic catheterizations performed. The indications for hemodynamic optimization by catheterization included clinical signs of heart failure while on CF-VAD (9 of 16, 56%), pretransplant evaluation of pulmonary hypertension (2 of 16, 13%), or assessment of myocardial recovery (5 of 16, 31%). The median age at catheterization was 12 years (interquartile range: 8-16). Median baseline speed of device was 2333 ± 253 rotations per minute. The goal was to find the speed at which optimal hemodynamics were achieved, defined by low wedge pressure with an acceptable central venous pressure. Of the 16 catheterizations, there were 9 (56%) speed increases to achieve optimal hemodynamics and 5 (33%) speed decreases for hemodynamic optimization or for potential explant. The speed was not changed in 2 (13%) catheterizations as the patients were determined to be at an optimal hemodynamic state. Overall, VAD settings were optimized in 75% (14 of 16) of hemodynamic catheterizations. There were no adverse events related to catheterization. Thus, we conclude that catheterization-based hemodynamic assessment is safe and effective for optimizing VAD speed and provides guidance on medical management in children supported on CF-VAD.

Topical use of hyperoxygenated fatty acids decreases surgical site infection in patients following laparoscopic cholecystectomy. A randomized controlled trial.

BACKGROUND: To date, the topically effect of hyperoxygenated fatty acids (HOFA) on the control of surgical site infection (SSI) is still unclear. OBJECTIVE: To assess the effect of topical application of a HOFA solution on the umbilical trocar site after laparoscopic cholecystectomy on SSI. The occurrence of trocar site incisional hernia (TSIH) was also analyzed. METHODS: A prospective, double-blind, randomized trial was conducted in patients undergoing laparoscopic cholecystectomy, who also presented at least one of the following associated risk factors for SSI and TSIH such as Body Mass Index (BMI) above 30 kg/m2, Diabetes Mellitus (DM), age over 65 years and Chronic Obstructive Pulmonary Disease (COPD). Patients were randomly allocated to topical application of a HOFA solution (HOFA arm) or saline physiological solution (non-HOFA arm) during closure of the umbilical trocar site with a polypropylene mesh. SSI was the primary outcome. TSIH was also assessed as a secondary outcome. RESULTS: 103 patients were included, 51 (49.5%) in the HOFA group and 52 (50.5%) in the non-HOFA group. SSI rate was significantly lower in the HOFA group in comparison with the non-HOFA group (19.6% vs. 3.8%; p = 0.028). TSIH rates were similar in both groups (3.8% vs. 2%). Multivariate analyses showed that only HOFA decreased significantly SSI rate. CONCLUSION: Topical application of a HOFA solution at the umbilical trocar site after laparoscopy cholecystectomy decreased SSI rate.

Simultaneous pediatric heart-kidney transplant outcomes in the US: A-25 year National Cohort Study.

BACKGROUND: Pediatric sHKTx remains uncommon in the US. We examined outcomes of pediatric sHKTx compared to PHTx alone. Our objective was to identify a threshold eGFR that justified pediatric sHKTx. METHODS: Data from the SRTR heart and kidney databases were used to identify 9245 PHTx, and 63 pediatric sHKTx performed between 1992 and 2017 (age ≤21 years). RESULTS: The median age for sHKTx was 16 years, and included 31 males (31/63 = 49%). Over half of sHKTx (36/63 = 57%) were performed in cases where pretransplant dialysis was initiated. Among patients who required pretransplant dialysis, the risk of death in sHKTx recipients was significantly lower than PHTx alone (sHKTx vs. PHTx: HR 0.4, 95% CI [0.2, 0.9], p = .01). In those without pretransplant dialysis, there was no improvement in survival between sHKTx and PHTx (p = .2). When stratified by eGFR, PHTx alone recipients had worse survival than sHKTx in the group with eGFR ≤35 ml/min/1.73 m2 (p = .04). The 1- and 5-year actuarial survival rates in pediatric sHKTx recipients were 87% and 81.5% respectively and was similar to isolated PHTx (p = .5). One-year rates of treated heart (11%) and kidney (7.9%) rejection were similar in sHKTx compared to PHTx alone (p = .7) and pediatric kidney transplant alone (p = .5) respectively. CONCLUSION: Pediatric sHKTx should be considered in HTx candidates with kidney failure requiring dialysis or eGFR ≤35 ml/min/1.73 m2 . The utility of sHKTx in cases of kidney failure not requiring dialysis warrants further study.