Neighborhood socioeconomic status and length of stay after congenital heart disease surgery.

Background and Objectives: Socioeconomic factors are associated with health outcomes and can affect postoperative length of stay after congenital heart disease (CHD) surgery. The hypothesis of this study is that patients from neighborhoods with a disadvantaged socioeconomic status (SES) have a prolonged length of hospital stay after CHD surgery. Methods: Pre- and postoperative data were collected on patients who underwent CHD surgery at the University of Maryland Medical Center between 2011 and 2019. A neighborhood SES score was calculated for each patient using data from the United States Census Bureau and patients were grouped by high vs. low SES neighborhoods. The difference of patient length of stay (LOS) from the Society for Thoracic Surgeons median LOS for that surgery was the primary outcome measure. Linear regression was performed to examine the association between the difference from the median LOS and SES, as well as other third variables. Results: The difference from the median LOS was -4.8 vs. -2.2 days in high vs. low SES groups (p = 0.003). SES category was a significant predictor of LOS in unadjusted and adjusted regression analyses. There was a significant interaction between Norwood operation and SES-patients with a low neighborhood SES who underwent Norwood operation had a longer LOS, but there was no difference in LOS by SES in patients who underwent other operations. Conclusions: Neighborhood SES is a significant predictor of the LOS after congenital heart disease surgery. This effect was seen primarily in patients undergoing Norwood operation.

Cardiac MRI Findings of Myocarditis After COVID-19 mRNA Vaccination in Adolescents.

BACKGROUND. A possible association has been reported between COVID-19 messenger RNA (mRNA) vaccination and myocarditis. OBJECTIVE. The purpose of our study was to describe cardiac MRI findings in patients with myocarditis after COVID-19 mRNA vaccination. METHODS. This retrospective study included patients without known prior SARS-CoV-2 infection who underwent cardiac MRI between May 14, 2021, and June 14, 2021, for suspected myocarditis within 2 weeks of COVID-19 mRNA vaccination. Information regarding clinical presentation, hospital course, and events after hospital discharge were recorded. A cardiothoracic imaging fellow and cardiothoracic radiologist reviewed cardiac MRI examinations in consensus. Data were summarized descriptively. RESULTS. Of 52 patients without known prior SARS-CoV-2 infection who underwent cardiac MRI during the study period, five underwent MRI for suspected myocarditis after recent COVID-19 mRNA vaccination. All five patients were male patients ranging in age from 16 to 19 years (mean, 17.2 ± 1.0 [SD] years) who presented within 4 days of receiving the second dose of a COVID-19 mRNA vaccine. Troponin levels were elevated in all patients (mean peak troponin I value, 6.82 ± 4.13 ng/mL). Alternate possible causes of myocarditis were deemed clinically unlikely on the basis of medical history, physical examination findings, myocarditis viral panel, and toxicology screening. Cardiac MRI findings were consistent with myocarditis in all five patients on the basis of the Lake Louise criteria, including early gadolinium enhancement and late gadolinium enhancement (LGE) in all patients and corresponding myocardial edema in four patients. All five patients had a favorable hospital course and were discharged from the hospital in stable condition with improved or resolved symptoms after hospitalization (mean length of hospital stay, 4.8 days). Two patients underwent repeat cardiac MRI that showed persistent, although decreased, LGE. Three patients reported mild intermittent self-resolving chest pain after hospital discharge, and two patients had no recurrent symptoms after discharge. CONCLUSION. In this small case series, all patients with myocarditis after COVID-19 vaccination were male adolescents and had a favorable initial clinical course. All patients showed cardiac MRI findings typical of myocarditis from other causes. LGE persisted in two patients who underwent repeat MRI. These observations do not establish causality. CLINICAL IMPACT. Radiologists should be aware of a possible association of COVID-19 mRNA vaccination and myocarditis and recognize the role of cardiac MRI in the assessment of suspected myocarditis after COVID-19 vaccination.

Prevalence of Clinical and Subclinical Myocarditis in Competitive Athletes With Recent SARS-CoV-2 Infection: Results From the Big Ten COVID-19 Cardiac Registry.

Importance: Myocarditis is a leading cause of sudden death in competitive athletes. Myocardial inflammation is known to occur with SARS-CoV-2. Different screening approaches for detection of myocarditis have been reported. The Big Ten Conference requires comprehensive cardiac testing including cardiac magnetic resonance (CMR) imaging for all athletes with COVID-19, allowing comparison of screening approaches. Objective: To determine the prevalence of myocarditis in athletes with COVID-19 and compare screening strategies for safe return to play. Design, Setting, and Participants: Big Ten COVID-19 Cardiac Registry principal investigators were surveyed for aggregate observational data from March 1, 2020, through December 15, 2020, on athletes with COVID-19. For athletes with myocarditis, presence of cardiac symptoms and details of cardiac testing were recorded. Myocarditis was categorized as clinical or subclinical based on the presence of cardiac symptoms and CMR findings. Subclinical myocarditis classified as probable or possible myocarditis based on other testing abnormalities. Myocarditis prevalence across universities was determined. The utility of different screening strategies was evaluated. Exposures: SARS-CoV-2 by polymerase chain reaction testing. Main Outcome and Measure: Myocarditis via cardiovascular diagnostic testing. Results: Representing 13 universities, cardiovascular testing was performed in 1597 athletes (964 men [60.4%]). Thirty-seven (including 27 men) were diagnosed with COVID-19 myocarditis (overall 2.3%; range per program, 0%-7.6%); 9 had clinical myocarditis and 28 had subclinical myocarditis. If cardiac testing was based on cardiac symptoms alone, only 5 athletes would have been detected (detected prevalence, 0.31%). Cardiac magnetic resonance imaging for all athletes yielded a 7.4-fold increase in detection of myocarditis (clinical and subclinical). Follow-up CMR imaging performed in 27 (73.0%) demonstrated resolution of T2 elevation in all (100%) and late gadolinium enhancement in 11 (40.7%). Conclusions and Relevance: In this cohort study of 1597 US competitive athletes with CMR screening after COVID-19 infection, 37 athletes (2.3%) were diagnosed with clinical and subclinical myocarditis. Variability was observed in prevalence across universities, and testing protocols were closely tied to the detection of myocarditis. Variable ascertainment and unknown implications of CMR findings underscore the need for standardized timing and interpretation of cardiac testing. These unique CMR imaging data provide a more complete understanding of the prevalence of clinical and subclinical myocarditis in college athletes after COVID-19 infection. The role of CMR in routine screening for athletes safe return to play should be explored further.

Development of peripheral eosinophilia in inflammatory bowel disease patients on infliximab treated at a tertiary pediatric inflammatory bowel disease center is associated with clinically active disease but does not result in loss of efficacy or adverse outcomes.

INTRODUCTION: Inflammatory bowel disease (IBD) consisting of Crohn's disease (CD) and ulcerative colitis (UC) are inflammatory conditions affecting the gastrointestinal tract. Infliximab (IFX) is a chimeric anti-tumor necrosis factor antibody used to treat moderate to severe IBD. Eosinophils are commonly found in chronically inflamed tissues in IBD. Peripheral eosinophilia (PE) was previously implicated as a marker of disease severity at diagnosis. The main aim of this study was to investigate whether in IBD patients on IFX, development of PE is associated with adverse outcomes and poor IFX efficacy. METHODS: A comprehensive retrospective chart review of IBD patients on IFX (January 2006 to July 2015) treated at a tertiary pediatric IBD center was performed. Data was collected at time specified points over a 24 month period and included demographics, atopy, disease severity, development of PE, human antichimeric antibodies (HACA), infusion reactions, cancer, psoriasis, and loss of clinical response. RESULTS: One hundred twenty-one IBD patients starting IFX (67 male), mean age of 12.4 years (range 4-22 years old), met inclusion criteria. Of them, 36.3% had ≥1 PE episode (CD: 25 male, 11 female; UC: 6 male, 2 female). Mean absolute eosinophil count (AEC) did not change over time. PE was associated with clinically active disease. Among patients who developed PE, adverse outcomes were not significantly different versus those who did not have PE. CONCLUSIONS: In a cohort of primarily pediatric IBD patients on IFX, PE was associated with clinically active disease; however, PE was not related to increased incidence of adverse outcomes or loss of drug efficacy.

The impact of a new casino on the motor vehicle crash patterns in suburban Maryland.

BACKGROUND: Many states have legalized casino gambling, and casinos create increased vehicle traffic, but the strength of the association between casino construction and vehicle crashes is unknown. METHODS: Retrospective analyses of motor vehicle crashes (MVCs) occurring within Anne Arundel County, Maryland (2010-2014) were conducted. The ratio of crashes within one mile of the casino's location after it was opened were compared to the ratio occurring in the same area before it was opened to determine how the incidence of MVCs near the casino changed with time. Logistic regression was used to determine how crash characteristics may have influenced the incidence of MVCs near the casino after it opened. RESULTS: 101,860 persons were involved in 43,328 MVCs in Anne Arundel County during the study period; 29,476 (68.0 %) had an at-fault driver ≥21 years of age and complete data. MVCs proximal to the casino occurred most commonly during the day (N = 421, 76.6 %) and involved drivers <40 years of age (N = 366, 66.6 %) and male (N = 316, 57.4 %). After adjustment for impairment and day of the week, there was a significant association with crashes close to the casino after it opened (ORAdjusted = 1.23, 95 % CI: 1.04-1.46, p = 0.02). Crashes occurring close to the casino, after it opened, involved drivers <40 years of age (OR = 1.74, 95 % CI:1.45-2.08) and occurred on weekends (OR = 1.39, 95 %CI:1.15-1.67). CONCLUSIONS: In this single-site study the opening of a casino was associated with an increase in crashes nearby. The generalizability of this finding should be confirmed with analysis of MVC data near other gambling venues.

Evaluating for Differences by Race/Ethnicity in the Association Between Income and Gambling Disorder.

Multiple studies show an increased prevalence of gambling disorder among African Americans compared to whites. However, few studies take an analytic approach to understanding differences in risk factors by race/ethnicity. Income is inversely associated with gambling disorder; we hypothesized that this association would vary by race/ethnicity. The main objective was to evaluate whether the association between income and gambling disorder varies by race/ethnicity. With data from the baseline visit of a prospective cohort study, Prevention and Etiology of Gambling Addiction Study in the United States, we used multivariable logistic regression analysis to determine whether the association between income and gambling disorder varies by race/ethnicity. 1164 participants were included in the final analyses. Measures included: demographics (age, sex, race/ethnicity, education, employment, annual household income), veteran status, marital status, homelessness, smoking, substance abuse, alcohol abuse, marijuana use, and lifetime gambling disorder diagnosis as derived from Alcohol Use Disorder and Associated Disabilities Interview Schedule. There was no evidence of effect modification by race/ethnicity in the association between income and gambling disorder (global p value = 0.17). Income was associated with increased odds of gambling disorder, but only for those with low income (< $15,000; OR 2.27, 95% CI 1.46, 3.53). There was no evidence that the effect of income on gambling disorder varies by race/ethnicity. For all race/ethnicities combined, low income was associated with significantly increased odds of gambling disorder (OR 2.27, 95% CI 1.46, 3.53). Further research is needed to better understand racial/ethnic differences in gambling disorder.

Arch intervention following stage 1 palliation in hypoplastic left heart syndrome is associated with slower feed advancement: a report from the National Pediatric Quality Cardiology Improvement Collaborative.

INTRODUCTION: Infants undergoing stage 1 palliation for hypoplastic left heart syndrome may have post-operative feeding difficulties. Although the cause of feeding difficulties in these patients is multi-factorial, residual arch obstruction may affect gut perfusion, contributing to feeding intolerance. We hypothesised that undergoing arch reintervention following stage 1 palliation would be associated with post-operative feeding difficulties. METHODS: This was a retrospective cohort study. We analysed data from the National Pediatric Cardiology Quality Improvement Collaborative, which maintains a multicentre registry for infants with hypoplastic left heart syndrome discharged home following stage 1 palliation. Patients who underwent arch reintervention (percutaneous or surgical) prior to discharge following stage 1 palliation were compared with those who underwent non-aortic arch interventions after stage 1 palliation and those who underwent no intervention. Median post-operative days to full enteral feeds and weight for age z-scores were compared. Predictors of post-operative days to full feeds were identified. RESULTS: Among patients who underwent arch reintervention, post-operative days to full enteral feeds were greater than for those who underwent non-aortic arch interventions (25 versus 16, p = 0.003) or no intervention (median days 25 versus 12, p < 0.001). Arch intervention, multiple interventions, gestational age, and the presence of a gastrointestinal anomaly were predictors of days to full feeds. CONCLUSIONS: Repeat arch intervention is associated with a longer time to achieve full enteral feeding in patients with hypoplastic left heart syndrome after stage 1 palliation. Further investigation of this association is needed to understand the role of arch obstruction in feeding problems in these patients.

Social isolation proxy variables and prescription opioid and benzodiazepine misuse among older adults in the U.S.: A cross-sectional analysis of data from the National Survey on Drug Use and Health, 2015-2017.

BACKGROUND: Prescription drug misuse in older adults is a growing public health problem. It is important to understand factors which predispose older adults to misuse prescription drugs, and social isolation may play an important role. In this study, we examined the association between social isolation proxy variables (living alone, being unmarried, and not attending religious services) and prescription opioid/benzodiazepine misuse in older adults. METHODS: With pooled cross-sectional data from the National Survey on Drug Use and Health (2015-2017), we used multinomial multiple logistic regression models to analyze the association between each social isolation proxy variable and past-year prescription opioid/benzodiazepine misuse. We controlled for potentially confounding variables including sociodemographic, physical/mental health, and substance use variables. RESULTS: Being unmarried was associated with approximately three times increased odds of combined opioid and benzodiazepine misuse (OR 2.98, 95% CI 1.75, 5.08), a finding that persisted after adjusting for multiple potential confounders. Further analysis showed this finding persisted for divorced/separated and never married individuals, but not widowed. Not attending religious services was also associated with prescription opioid/benzodiazepine misuse, but only in unadjusted analyses. There was no association between living alone and opioid/benzodiazepine misuse. CONCLUSION: Increased odds of combined opioid and benzodiazepine prescription drug misuse was observed among unmarried older adults. Given the susceptibility of older adults to the harms of these medications, further exploration of the role of marital relationships and other forms of social connectedness in prescription drug misuse in this vulnerable population is indicated.

Comparison of cumulative dispersed energy (CDE) in femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification.

PURPOSE: To compare the amount of phacoemulsification ultrasound energy used between eyes undergoing femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification. METHODS: One eye of consecutive patients undergoing routine non-complicated phacoemulsification from January 2014 to December of 2015 was included in the analysis. FLACS was performed using the Alcon LenSx. Linear regression was used for analysis with type of surgery (FLACS versus conventional phacoemulsification) as the exposure and cumulative dispersed energy (CDE) as the outcome variable. Age, surgeon, eye side, and eye sequence (first versus second eye) were covariates. RESULTS: A total of 1159 surgeries met inclusion criteria. The average age of the cohort was 70.6 (SD 8.6) years, 590 cases (51%) were performed by surgeon 1, and 582 cases (50%) were right eyes. Overall, FLACS resulted in significantly lower CDE as compared to conventional phacoemulsification (ß = 0.89, 95% CI 0.83, 0.95). When stratified by eye side and surgeon, FLACS performed on left eyes operated on by surgeon 1 resulted in lower CDE as compared to conventional phacoemulsification (ß = 0.76, 95% CI 0.66, 0.87), but not for right eyes operated on by surgeon 1 (ß = 0.92, 95% CI 0.79, 1.07) or for eyes operated on by surgeons 2 or 3. CONCLUSIONS: The use of FLACS on the Alcon LenSx platform results in a small decrease in phacoemulsification energy as compared to conventional phacoemulsification in certain cases. Further study assessing optimal laser settings and surgical technique is necessary.

Cardiovascular Events Following Treatment Initiation with Atypical Antipsychotic Medications in Publicly Insured U.S. Youth.

OBJECTIVE: To assess the risk of incident cardiovascular events that led to hospitalizations or emergency department visits following atypical antipsychotic (AAP) treatment initiation in youth according to dose, duration of use, and concomitant use of leading psychotropic medication classes. METHODS: We used computerized Medicaid claims to conduct a retrospective cohort study of youth (5-20 years) who initiated AAP treatment. AAP use was operationalized in a time-dependent manner according to current vs. former use, average daily dose (in risperidone dose equivalents), and duration of use. In a secondary analysis, concomitant use of (1) stimulants and (2) serotonin-reuptake inhibitors (SSRI/SNRIs) with AAPs was also assessed. To account for confounding, disease risk score methodology was used in discrete time failure models. RESULTS: There were 74,700 youth who initiated AAP treatment (average follow-up = 24.8 months). During follow-up, the risk of cardiovascular events was significantly greater during current than former AAP use (RR = 1.55, 95% CI = 1.09-2.21). Furthermore, for current users of AAPs, the risk of cardiovascular events intensified with average daily dose (RR = 2.04, 95% CI = 1.11-3.77 for >3.75 mg/day vs. ≤1.25 mg/day). The risk of cardiovascular events did not significantly differ according to duration of AAP use. In AAP-treated youth, concomitant SSRI/SNRI use was associated with an increased risk of cardiovascular events (RR = 1.61, 95% CI = 1.01-2.57). By contrast, stimulant use concomitant with AAPs was not significantly associated with an increased risk of cardiovascular events. CONCLUSIONS: In publicly insured U.S. youth, current AAP use was associated with an increased risk of incident cardiovascular events, which intensified with increasing dose and with concomitant SSRI/SNRI use. Prudent interpretation of these findings suggests that further research is needed to identify youth subpopulations with the greatest risk of developing AAP treatment-emergent cardiovascular events.

Angiotensin converting enzyme inhibitors and interstage failure in infants with hypoplastic left heart syndrome.

INTRODUCTION: Angiotensin converting enzyme inhibitors are commonly prescribed medications after the Norwood procedure. There are little data that can be used to determine if angiotensin converting enzyme inhibitors improve interstage outcomes in children with single ventricle defects. The objective of this study was to investigate the relationship between angiotensin converting enzyme inhibitors and interstage failure among infants born with hypoplastic left heart syndrome. METHODS: We conducted a retrospective cohort study using data from the National Pediatric Cardiology Quality Improvement Collaborative database (collected between 2008 and 2015). We used logistic regression models to assess the exposure-outcome associations and propensity score matching to account for differences in baseline patient characteristics associated with use of angiotensin converting enzyme inhibitors. RESULTS: A total of 1 487 neonates participated in the study. Thirty-nine percent of patients were prescribed angiotensin converting enzyme inhibitors after the Norwood procedure; 11% experienced interstage failure (death, heart transplantation, and not being a candidate for the second-stage surgery). Before propensity score matching, patients receiving angiotensin converting enzyme inhibitors were significantly more likely to experience interstage failure, compared to patients not on angiotensin converting enzyme inhibitors (OR = 1.44; 95% CI: 1.04, 1.99; P = 0.03). Although there was an increased odds of interstage failure among patients receiving angiotensin converting enzyme inhibitors compared to patients not receiving angiotensin converting enzyme inhibitors in the propensity score-matched cohort, this association was not significantly different (adjusted OR = 1.29; 95% CI: 0.88, 1.95; P = 0.18). CONCLUSION: Angiotensin converting enzyme inhibitor therapy did not demonstrate a beneficial effect on interstage failure among infants with hypoplastic left heart syndrome, even when patient characteristics associated with the use of angiotensin converting enzyme inhibitors were considered.

Association of Antidepressant Medications With Incident Type 2 Diabetes Among Medicaid-Insured Youths.

Importance: Antidepressants are one of the most commonly prescribed classes of psychotropic medications among US youths. For adults, there is emerging evidence on the increased risk of type 2 diabetes in association with antidepressant use. However, little is known about the antidepressant treatment-emergent risk of type 2 diabetes among youths. Objective: To assess the association between antidepressant use and the risk of incident type 2 diabetes in youths by antidepressant subclass and according to duration of use, cumulative dose, and average daily dose. Design, Setting, and Participants: A retrospective cohort study was conducted using Medicaid claims data from 4 geographically diverse, large states of youths 5 to 20 years of age who initiated antidepressant treatment from January 1, 2005, to December 31, 2009. Exposures: Antidepressant use (selective serotonin reuptake inhibitors [SSRIs] or serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic or other cyclic antidepressants, and other antidepressants) was assessed using the following 4 time-varying measures: current or former use, duration of use, cumulative dose, and average daily dose. Main Outcomes and Measures: Incident type 2 diabetes was assessed using discrete-time failure models, adjusting for disease risk score estimated using more than 125 baseline and time-dependent covariates. Results: In this cohort of 119 608 youths aged 5 to 20 years who initiated antidepressant treatment (59 087 female youths and 60 521 male youths; 54.7% between 5 and 14 years of age) with a mean follow-up of 22.8 months, 79 285 [66.3%] had SSRI or SNRI exposure. The risk of type 2 diabetes was significantly greater during current use than former use of SSRIs or SNRIs (absolute risk, 1.29 per 10 000 person-months vs 0.64 per 10 000 person-months; adjusted relative risk [RR], 1.88; 95% CI, 1.34-2.64) and tricyclic or other cyclic antidepressants (absolute risk, 0.89 per 10 000 person-months vs 0.48 per 10 000 person-months; RR, 2.15; 95% CI, 1.06-4.36), but not of other antidepressants (absolute risk, 1.15 per 10 000 person-months vs 1.12 per 10 000 person-months; RR, 0.99; 95% CI, 0.66-1.50). Furthermore, for youths currently using SSRIs or SNRIs, the risk of type 2 diabetes increased with the duration of use (RR, 2.66; 95% CI, 1.45-4.88 for >210 days and RR, 2.56; 95% CI, 1.29-5.08 for 151-210 days compared with 1-90 days) and with the cumulative dose (RR, 2.44; 95% CI, 1.35-4.43 for >4500 mg and RR, 2.17; 95% CI, 1.07-4.40 for 3001-4500 mg compared with 1-1500 mg in fluoxetine hydrochloride dose equivalents). By contrast, neither the duration nor the cumulative dose of other antidepressants was associated with an increased risk of type 2 diabetes. The risk of type 2 diabetes increased significantly with the average daily dose among youths with more than 150 days of SSRI or SNRI use (RR, 2.39; 95% CI, 1.04-5.52 for >15.0 vs ≤15.0 mg/d) but not among youths with 1 to 150 days of SSRI or SNRI use. Conclusions and Relevance: In a large cohort of youths insured by Medicaid, the use of SSRIs or SNRIs-the most commonly used antidepressant subclass-was associated with an increased risk of type 2 diabetes that intensified with increasing duration of use, cumulative dose, and average daily dose.

Concomitant Use of Atypical Antipsychotics With Other Psychotropic Medication Classes and the Risk of Type 2 Diabetes Mellitus.

OBJECTIVE: More than half of youth treated with atypical antipsychotic (AAP) medications are also treated with concomitant antidepressants or stimulants. This study assessed the association between antidepressant or stimulant use concomitant with AAPs and the risk of incident type 2 diabetes mellitus (T2DM). METHOD: Medicaid Analytic eXtract data were used to conduct a retrospective cohort study of youth (aged 5-20 years) who initiated AAP treatment. In AAP-treated youth, concomitant antidepressant (selective serotonin reuptake inhibitors [SSRI]/serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic/other cyclic antidepressants [TCAs], and other antidepressants) or stimulant use was assessed. The risk of incident T2DM was estimated using discrete time failure models, adjusting for disease risk score estimated using >125 baseline and time-dependent covariates. RESULTS: Among 73,224 AAP initiators, 43.0% had concomitant antidepressant use (76.4% were SSRI/SNRIs) and 43.8% had concomitant stimulant use. The study cohort had an average follow-up of 24.8 months (median = 22.0 months, interquartile range [IQR] = 10.0-38.0 months). In current AAP-treated youth, concomitant SSRI/SNRI (relative risk [RR] = 1.84, 95% CI = 1.30-2.59) or TCA use (RR = 2.75, 95% CI = 1.28-5.87) was associated with an increased risk of T2DM. By contrast, concomitant use of other antidepressants or stimulants with AAPs was not associated with an increased risk of T2DM. In concomitant users of AAPs and SSRI/SNRIs, the risk of T2DM increased with the duration of SSRI/SNRI use (RR = 2.35, 95% CI = 1.15-4.83 for ≥180 days vs. 1-180 days) as well as with the cumulative SSRI/SNRI dose (RR = 1.99, 95% CI = 1.08-3.67 for >2,700 mg vs. 1-2,700 mg fluoxetine dose equivalents), after adjusting for the duration and cumulative dose of AAP use. By contrast, in concomitant users of AAPs and stimulants, neither duration nor cumulative dose of stimulants was associated with an increased risk of T2DM. CONCLUSION: In AAP-treated Medicaid-insured youth, concomitant SSRI/SNRI use was associated with a heightened risk of T2DM, which intensified with increasing duration and dose.

Interstage Weight Gain Is Associated With Survival After First-Stage Single-Ventricle Palliation.

BACKGROUND: Low birth and operative weight have been identified as risk factors for death after first-stage single-ventricle palliation. We hypothesize that weight gain after the first-stage operation is associated with transplant-free interstage survival to admission for the second-stage operation. METHODS: We used historical data from the National Pediatric Cardiology Quality Improvement Collaborative database to conduct a longitudinal study to assess the association between weight gain and transplant-free interstage survival. The primary predictor was weight gain. The primary outcome was transplant-free survival. We constructed a repeated-measures logistic regression model using the general estimating equation method to examine the association between weight gain and transplant-free interstage survival. RESULTS: The study population included 1,501 infants who were discharged alive from the first-stage single-ventricle palliation between June 2008 and January 2015. Patients who underwent a hybrid operation (n = 132) or were lost to follow-up (n = 11) were excluded. Transplant-free interstage survival was 90% (1,228 of 1,358). The mean weight gain was 2.5 (SD, 1.0) kg. Adjusted for age at the time of each measurement, the number of measurements, age at discharge from the first-stage operation, sex, diagnosis, postoperative arrhythmia, postoperative complications, and discharge antibiotic therapy, each 100-g increase in weight was associated with an odds ratio of transplant-free interstage survival of 1.03 (95% confidence limit, 1.01, 1.05). CONCLUSIONS: After first-stage single-ventricle palliation, interstage weight gain is significantly associated with transplant-free interstage survival.

FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.

BACKGROUND AND OBJECTIVES: In 2002, Congress mandated that the US Food and Drug Administration (FDA) monitor postmarketing pediatric adverse events and present safety reports to the FDA's Pediatric Advisory Committee (PAC). These safety reviews play a critical role in the postmarketing surveillance and identification of pediatric safety issues. This article follows a previous review ending in 2007 and summarizes 6 years of recent pediatric safety reporting, recommendations by the PAC, and actions by the FDA, including labeling changes. METHODS: An analysis of the FDA's PAC safety reviews performed from November 2007 through September 2013 was conducted. PAC recommendations for subsequent labeling changes, future studies, or other safety issues were reviewed. RESULTS: There were 6930 serious adverse event reports in 181 reviews. These findings resulted in 33 (18%) recommended labeling changes, and 21 (64%) of these changes were adopted. For 10 products, information was added to the Warning and Precautions section of the label. The PAC also discussed or recommended additional studies for certain products. CONCLUSIONS: This article highlights the importance of the FDA's ongoing pediatric postmarketing safety reviews of regulated products, advice from the PAC, and FDA actions in the best interest of pediatric patients. This mandated process facilitates detection of safety concerns that may not be identified in prelicensure clinical trials. It continues to identify critical safety concerns, including unlabeled adverse events, frequent off-label use, product misuse, and secondary exposures in children.