Publications by authors named "Jennifer S Li"

143 Publications

Individuals aged 1-64 years with documented congenital heart defects at healthcare encounters, five U.S. surveillance sites, 2011-2013.

Am Heart J 2021 May 3;238:100-108. Epub 2021 May 3.

Department of Epidemiology, Colorado School of Public Health, University of Colorado | Anschutz Medical Campus, Aurora, CO.

Background: Many individuals born with congenital heart defects (CHD) survive to adulthood. However, population estimates of CHD beyond early childhood are limited in the U.S.

Objectives: To estimate the percentage of individuals aged 1-to-64 years at five U.S. sites with CHD documented at a healthcare encounter during a three-year period and describe their characteristics.

Methods: Sites conducted population-based surveillance of CHD among 1 to 10-year-olds (three sites) and 11 to 64-year-olds (all five sites) by linking healthcare data. Eligible cases resided in the population catchment areas and had one or more healthcare encounters during the surveillance period (January 1, 2011-December 31, 2013) with a CHD-related ICD-9-CM code. Site-specific population census estimates from the same age groups and time period were used to assess percentage of individuals in the catchment area with a CHD-related ICD-9-CM code documented at a healthcare encounter (hereafter referred to as CHD cases). Severe and non-severe CHD were based on an established mutually exclusive anatomic hierarchy.

Results: Among 42,646 CHD cases, 23.7% had severe CHD and 51.5% were male. Percentage of CHD cases among 1 to 10-year-olds, was 6.36/1,000 (range: 4.33-9.96/1,000) but varied by CHD severity [severe: 1.56/1,000 (range: 1.04-2.64/1,000); non-severe: 4.80/1,000 (range: 3.28-7.32/1,000)]. Percentage of cases across all sites in 11 to 64-year-olds was 1.47/1,000 (range: 1.02-2.18/1,000) and varied by CHD severity [severe: 0.34/1,000 (range: 0.26-0.49/1,000); non-severe: 1.13/1,000 (range: 0.76-1.69/1,000)]. Percentage of CHD cases decreased with age until 20 to 44 years and, for non-severe CHD only, increased slightly for ages 45 to 64 years.

Conclusion: CHD cases varied by site, CHD severity, and age. These findings will inform planning for the needs of this growing population.
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http://dx.doi.org/10.1016/j.ahj.2021.04.007DOI Listing
May 2021

Weight-Related Behaviors of Children with Obesity during the COVID-19 Pandemic.

Child Obes 2021 Apr 26. Epub 2021 Apr 26.

Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.

During the coronavirus disease 2019 (COVID-19) pandemic, children and families have had to adapt their daily lives. The purpose of this study was to describe changes in the weight-related behaviors of children with obesity after the onset of the COVID-19 pandemic. Semistructured interviews ( = 51) were conducted from April to June 2020 with parents of children with obesity. Families were participants in a randomized trial testing a clinic-community pediatric obesity treatment model. During interviews, families described their experience during the COVID-19 pandemic, with a particular emphasis on children's diet, physical activity, sleep, and screen time behaviors. Rapid qualitative analysis methods were used to identify themes around changes in children's weight-related behaviors. The mean child age was 9.7 (±2.8) years and the majority of children were Black (46%) or Hispanic (39%) and from low-income families (62%). Most parent participants were mothers (88%). There were differences in the perceived physical activity level of children, with some parents attributing increases in activity or maintenance of activity level to increased outdoor time, whereas others reported a decline due to lack of outdoor time, school, and structured activities. Key dietary changes included increased snacking and more meals prepared and consumed at home. There was a shift in sleep schedules with children going to bed and waking up later and an increase in leisure-based screen time. Parents played a role in promoting activity and managing children's screen time. The COVID-19 pandemic has created unique lifestyle challenges and opportunities for lifestyle modification. Clinical Trials ID: NCT03339440.
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http://dx.doi.org/10.1089/chi.2021.0038DOI Listing
April 2021

Causes of Death in Infants and Children with Congenital Heart Disease.

Pediatr Cardiol 2021 Apr 22. Epub 2021 Apr 22.

Department of Pediatrics, Division of Pediatric Cardiology, Duke University Medical Center, Box 3090, Durham, NC, 27710, USA.

With improved surgical outcomes, infants and children with congenital heart disease (CHD) may die from other causes of death (COD) other than CHD. We sought to describe the COD in youth with CHD in North Carolina (NC). Patients from birth to 20 years of age with a healthcare encounter between 2008 and 2013 in NC were identified by ICD-9 code. Patients who could be linked to a NC death certificate between 2008 and 2016 were included. Patients were divided by CHD subtypes (severe, shunt, valve, other). COD was compared between groups. Records of 35,542 patients < 20 years old were evaluated. There were 15,277 infants with an annual mortality rate of 3.5 deaths per 100 live births. The most frequent COD in infants (age < 1 year) were CHD (31.7%), lung disease (16.1%), and infection (11.4%). In 20,265 children (age 1 to < 20 years), there was annual mortality rate of 9.7 deaths per 1000 at risk. The most frequent COD in children were CHD (34.2%), neurologic disease (10.2%), and infection (9.5%). In the severe subtype, CHD was the most common COD. In infants with shunt-type CHD disease, lung disease (19.5%) was the most common COD. The mortality rate in infants was three times higher when compared to children. CHD is the most common underlying COD, but in those with shunt-type lesions, extra-cardiac COD is more common. A multidisciplinary approach in CHD patients, where development of best practice models regarding comorbid conditions such as lung disease and neurologic disease could improve outcomes in this patient population.
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http://dx.doi.org/10.1007/s00246-021-02612-2DOI Listing
April 2021

Medium-Term Complications Associated With Coronary Artery Aneurysms After Kawasaki Disease: A Study From the International Kawasaki Disease Registry.

J Am Heart Assoc 2020 08 28;9(15):e016440. Epub 2020 Jul 28.

Division of Pediatric Cardiology Centre Hospitalier Universitaire Ste-Justine University of Montreal Quebec Canada.

Background Coronary artery aneurysms (CAAs) may occur after Kawasaki disease (KD) and lead to important morbidity and mortality. As CAA in patients with KD are rare and heterogeneous lesions, prognostication and risk stratification are difficult. We sought to derive the cumulative risk and associated factors for cardiovascular complications in patients with CAAs after KD. Methods and Results A 34-institution international registry of 1651 patients with KD who had CAAs (maximum CAA score ≥2.5) was used. Time-to-event analyses were performed using the Kaplan-Meier method and Cox proportional hazard models for risk factor analysis. In patients with CAA scores ≥10, the cumulative incidence of luminal narrowing (>50% of lumen diameter), coronary artery thrombosis, and composite major adverse cardiovascular complications at 10 years was 20±3%, 18±2%, and 14±2%, respectively. No complications were observed in patients with a CAA score <10. Higher CAA score and a greater number of coronary artery branches affected were associated with increased risk of all types of complications. At 10 years, normalization of luminal diameter was noted in 99±4% of patients with small (2.5≤<5.0), 92±1% with medium (5.0≤<10), and 57±3% with large CAAs (≥10). CAAs in the left anterior descending and circumflex coronary artery branches were more likely to normalize. Risk factor analysis of coronary artery branch level outcomes was performed with a total of 893 affected branches with score ≥10 in 440 patients. In multivariable regression models, hazards of luminal narrowing and thrombosis were higher for patients with CAAs of the right coronary artery and left anterior descending branches, those with CAAs that had complex architecture (other than isolated aneurysms), and those with CAAs with scores ≥20. Conclusions For patients with CAA after KD, medium-term risk of complications is confined to those with maximum CAA scores ≥10. Further risk stratification and close follow-up, including advanced imaging, in patients with large CAAs is warranted.
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http://dx.doi.org/10.1161/JAHA.119.016440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792232PMC
August 2020

Outlier detection methods to improve the quality of citizen science data.

Int J Biometeorol 2020 Nov 15;64(11):1825-1833. Epub 2020 Jul 15.

Department of Renewable Resources, Faculty of Agricultural, Life, and Environmental Sciences, University of Alberta, 751 General Services Building, Edmonton, AB, T6G 2H1, Canada.

Citizen science involves public participation in research, usually through volunteer observation and reporting. Data collected by citizen scientists are a valuable resource in many fields of research that require long-term observations at large geographic scales. However, such data may be perceived as less accurate than those collected by trained professionals. Here, we analyze the quality of data from a plant phenology network, which tracks biological response to climate change. We apply five algorithms designed to detect outlier observations or inconsistent observers. These methods rely on different quantitative approaches, including residuals of linear models, correlations among observers, deviations from multivariate clusters, and percentile-based outlier removal. We evaluated these methods by comparing the resulting cleaned datasets in terms of time series means, spatial data coverage, and spatial autocorrelations after outlier removal. Spatial autocorrelations were used to determine the efficacy of outlier removal, as they are expected to increase if outliers and inconsistent observations are successfully removed. All data cleaning methods resulted in better Moran's I autocorrelation statistics, with percentile-based outlier removal and the clustering method showing the greatest improvement. Methods based on residual analysis of linear models had the strongest impact on the final bloom time mean estimates, but were among the weakest based on autocorrelation analysis. Removing entire sets of observations from potentially unreliable observers proved least effective. In conclusion, percentile-based outlier removal emerges as a simple and effective method to improve reliability of citizen science phenology observations.
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http://dx.doi.org/10.1007/s00484-020-01968-zDOI Listing
November 2020

Causes of Death and Cardiovascular Comorbidities in Adults With Congenital Heart Disease.

J Am Heart Assoc 2020 07 11;9(14):e016400. Epub 2020 Jul 11.

Duke University Medical Center Durham NC.

Background Little is known about the contemporary mortality experience among adults with congenital heart disease (CHD). The objectives of this study were to assess the age at death, presence of cardiovascular comorbidities, and most common causes of death among adults with CHD in a contemporary cohort within the United States. Methods and Results Patients with CHD who had a healthcare encounter between 2008 and 2013 at 1 of 5 comprehensive CHD centers in North Carolina were identified by (), code. Only patients who could be linked to a North Carolina death certificate between 2008 and 2016 and with age at death ≥20 years were included. Median age at death and underlying cause of death based on death certificate data were analyzed. The prevalence of acquired cardiovascular risk factors was determined from electronic medical record data. Among the 629 included patients, the median age at death was 64.2 years. Those with severe CHD (n=157, 25%), shunts (n=202, 32%), and valvular lesions (n=174, 28%) had a median age at death of 46.0, 65.0, and 73.3 years, respectively. Cardiovascular death was most common in adults with severe CHD (60%), with 40% of those deaths caused by CHD. Malignancy and ischemic heart disease were the most common causes of death in adults with nonsevere CHD. Hypertension and hyperlipidemia were common comorbidities among all CHD severity groups. Conclusions The most common underlying causes of death differed by lesion severity. Those with severe lesions most commonly died from underlying CHD, whereas those with nonsevere disease more commonly died from non-CHD causes.
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http://dx.doi.org/10.1161/JAHA.119.016400DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660712PMC
July 2020

A Randomized, Controlled Pharmacokinetic and Pharmacodynamics Trial of Ambrisentan After Fontan Surgery.

Pediatr Crit Care Med 2020 09;21(9):e795-e803

Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.

Objectives: To determine the pharmacokinetics, pharmacodynamics, and safety of the hepatically metabolized endothelin receptor antagonist, ambrisentan in children after Fontan surgery.

Design: Prospective, randomized, double-blind, placebo-controlled pharmacokinetic/pharmacodynamics and safety trial.

Setting: Single-center, postoperative cardiac ICU.

Patients: Children undergoing elective Fontan surgery.

Interventions: Subjects randomized on postoperative day number 1 to short-term (3 d) treatment with oral ambrisentan (2.5 mg in suspension, daily) versus placebo (4:1 randomization).

Measurements And Main Results: Plasma drug concentrations were measured at 0.5, 1, 2, 4, and 18-36 hours after the first dose. We developed a population pharmacokinetic model in NONMEM 7.2 (Icon Solutions, Ellicott City, MD) and applied the model to dose-exposure simulations. Pharmacodynamics endpoints were assessed at baseline and 3 hours after study drug administration, using postoperative hemodynamic monitoring lines. The analysis included 16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males. There were no differences in baseline characteristics between ambrisentan and controls. A one-compartment model with first-order absorption and lag-time characterized the data well. Allometrically scaled weight was the only covariate retained in the final model. Typical values for clearance and volume of distribution were lower than previously reported in adults, 1 L/hr/70 kg and 13.7 L/70 kg, respectively. Simulated exposures with doses of 0.1-0.2 mg/kg approximated therapeutic exposures in adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses. Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.

Conclusions: Ambrisentan clearance is reduced following Fontan surgery, perhaps reflecting abnormal hepatic metabolism in this population. The observed safety profile appears favorable and hemodynamic effects of ambrisentan may be beneficial for Fontan patients.
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http://dx.doi.org/10.1097/PCC.0000000000002410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483887PMC
September 2020

Flattening the (BMI) Curve: Timing of Child Obesity Onset and Cardiovascular Risk.

Pediatrics 2020 08 6;146(2). Epub 2020 Jul 6.

Departments of Pediatrics and Population Health Sciences, School of Medicine, Duke University and Duke Clinical Research Institute, Duke Center for Childhood Obesity Research, Durham, North Carolina.

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http://dx.doi.org/10.1542/peds.2020-1353DOI Listing
August 2020

Clinical and socio-economic predictors of work participation in adult CHD patients.

Cardiol Young 2020 Aug 2;30(8):1081-1085. Epub 2020 Jul 2.

Department of Pediatrics, Pediatric Cardiology, Brody School of Medicine at East Carolina University, Greenville, NC, USA.

Background: Adults with CHD have reduced work participation rates compared to adults without CHD. We aimed to quantify employment rate among adult CHD patients in a population-based registry and to describe factors and barriers associated with work participation.

Methods: We retrospectively identified adults with employment information in the North Carolina Congenital Heart Defects Surveillance Network. Employment was defined as any paid work in a given year. Logistic regression was used to examine patients' employment status during each year.

Results: The registry included 1,208 adult CHD patients with a health care encounter between 2009 and 2013, of whom 1,078 had ≥1 year of data with known employment status. Overall, 401 patients (37%) were employed in their most recent registry year. On multivariable analysis, the odds of employment decreased with older age and were lower for Black as compared to White patients (odds ratio = 0.78; 95% confidence interval: 0.62, 0.98; p = 0.030), and single as compared to married patients (odds ratio = 0.50; 95% confidence interval: 0.39, 0.63; p < 0.001).

Conclusion: In a registry where employment status was routinely captured, only 37% of adult CHD patients aged 18-64 years were employed, with older patients, Black patients, and single patients being less likely to be employed. Further work is needed to consider how enhancing cardiology follow-up for adults with CHD can integrate support for employment.
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http://dx.doi.org/10.1017/S1047951120001572DOI Listing
August 2020

Overcoming underpowering: Trial simulations and a global rank end point to optimize clinical trials in children with heart disease.

Am Heart J 2020 08 20;226:188-197. Epub 2020 May 20.

Duke Clinical Research Institute, Durham, North Carolina.

Background: Randomized controlled trials (RCTs) in children with heart disease are challenging and therefore infrequently performed. We sought to improve feasibility of perioperative RCTs for this patient cohort using data from a large, multicenter clinical registry. We evaluated potential enrollment and end point frequencies for various inclusion cohorts and developed a novel global rank trial end point. We then performed trial simulations to evaluate power gains with the global rank end point and with use of planned covariate adjustment as an analytic strategy.

Methods: Data from the Society of Thoracic Surgery-Congenital Heart Surgery Database (STS-CHSD, 2011-2016) were used to support development of a consensus-based global rank end point and for trial simulations. For Monte Carlo trial simulations (n = 50,000/outcome), we varied the odds of outcomes for treatment versus placebo and evaluated power based on the proportion of trial data sets with a significant outcome (P < .05).

Results: The STS-CHSD study cohort included 35,967 infant index cardiopulmonary bypass operations from 103 STS-CHSD centers, including 11,411 (32%) neonatal cases and 12,243 (34%) high-complexity (Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery mortality category ≥4) cases. In trial simulations, study power was 21% for a mortality-only end point, 47% for a morbidity and mortality composite, and 78% for the global rank end point. With covariate adjustment, power increased to 94%. Planned covariate adjustment was preferable to restricting to higher-risk cohorts despite higher event rates in these cohorts.

Conclusions: Trial simulations can inform trial design. Our findings, including the newly developed global rank end point, may be informative for future perioperative trials in children with heart disease.
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http://dx.doi.org/10.1016/j.ahj.2020.05.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7442685PMC
August 2020

Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.

BMC Pediatr 2020 06 26;20(1):308. Epub 2020 Jun 26.

Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.

Background: The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems.

Methods: Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification.

Discussion: We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research-defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response.

Clinical Trial Registration: NCT03339440 .
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http://dx.doi.org/10.1186/s12887-020-02190-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318397PMC
June 2020

Variants in ADRB1 and CYP2C9: Association with Response to Atenolol and Losartan in Marfan Syndrome.

J Pediatr 2020 07;222:213-220.e5

Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Departments of Pharmacology and Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN.

Objective: To test whether variants in ADRB1 and CYP2C9 genes identify subgroups of individuals with differential response to treatment for Marfan syndrome through analysis of data from a large, randomized trial.

Study Design: In a subset of 250 white, non-Hispanic participants with Marfan syndrome in a prior randomized trial of atenolol vs losartan, the common variants rs1801252 and rs1801253 in ADRB1 and rs1799853 and rs1057910 in CYP2C9 were analyzed. The primary outcome was baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3 years, assessed using mixed effects models.

Results: Among 122 atenolol-assigned participants, the 70 with rs1801253 CC genotype had greater rate of improvement in aortic root z-score compared with 52 participants with CG or GG genotypes (Time × Genotype interaction P = .005, mean annual z-score change ± SE -0.20 ± 0.03 vs -0.09 ± 0.03). Among participants with the CC genotype in both treatment arms, those assigned to atenolol had greater rate of improvement compared with the 71 of the 121 assigned to losartan (interaction P = .002; -0.20 ± 0.02 vs -0.07 ± 0.02; P < .001). There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.

Conclusions: In this exploratory study, ADRB1-rs1801253 was associated with atenolol response in children and young adults with Marfan syndrome. If these findings are confirmed in future studies, ADRB1 genotyping has the potential to guide therapy by identifying those who are likely to have greater therapeutic response to atenolol than losartan.
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http://dx.doi.org/10.1016/j.jpeds.2020.03.064DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323908PMC
July 2020

Pulmonary Valve Endocarditis: The Potential Utility of Multimodal Imaging Prior to Surgery.

World J Pediatr Congenit Heart Surg 2020 03;11(2):192-197

Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.

Background: The presence of echocardiographic (echo) evidence is a major criterion for the diagnosis of infective endocarditis (IE) by modified Duke criteria. Pulmonary valve (PV) IE, however, can be challenging to identify by echo. We sought to evaluate the added utility of multimodal imaging in PV IE.

Methods: This is a single-center case series. We retrospectively analyzed demographic, laboratory, imaging, clinical, and surgical data from patients diagnosed with PV IE from 2008 to 2018.

Results: A total of 23 patients were identified with definite PV IE by Duke criteria (83% male and ages 2 months to 70 years). Twenty-two patients had congenital heart disease, with 21 involving the right ventricular outflow tract (including three with transcatheter PV implant). Overall, 20 (87%) of 23 had positive blood cultures. A total of 17 (74%) of 23 patients demonstrated echo evidence of PV IE. In three cases, echo was negative (did not show vegetations) but showed new PV obstruction. In four cases with negative transthoracic echocardiogram and transesophageal echocardiogram, evidence of PV IE was subsequently seen by positron emission tomography/computed tomography (n = 2) or cardiac magnetic resonance imaging (n = 2). Pulmonary valve IE was confirmed at surgery by evaluation of pathologic samples in 20 cases.

Conclusions: Multimodal imaging improves the ability to preoperatively identify endocardial involvement in PV IE in cases where echo is negative. Consideration should be given to revise Duke criteria to include new obstruction and endocardial involvement by multimodal imaging for PV IE.
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http://dx.doi.org/10.1177/2150135119896287DOI Listing
March 2020

Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.

Am Heart J 2020 02 9;220:192-202. Epub 2019 Dec 9.

Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.

For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double-blind, multicenter trial designed to evaluate safety and efficacy of perioperative steroids in infants (age < 1 year) undergoing heart surgery with CPB. Participants (planned enrollment = 1,200) are randomized 1:1 to methylprednisolone (30 mg/kg) administered into the CPB pump prime versus placebo. The trial is nested within the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. The primary outcome is a global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity. Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications. STRESS will be one of the largest trials ever conducted in children with heart disease and will answer a decades-old question related to safety and efficacy of perioperative steroids in infants undergoing heart surgery with CPB. The pragmatic "trial within a registry" design may provide a mechanism for conducting low-cost, high-efficiency trials in a heretofore-understudied patient population.
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http://dx.doi.org/10.1016/j.ahj.2019.11.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008076PMC
February 2020

Facilitating translational team science: The project leader model.

J Clin Transl Sci 2019 Aug 28;3(4):140-146. Epub 2019 Aug 28.

Duke Clinical and Translational Science Institute, Durham, NC, USA.

Project management expertise is employed across many professional sectors, including clinical research organizations, to ensure that efforts undertaken by the organization are completed on time and according to specifications and are capable of achieving the needed impact. Increasingly, project leaders (PLs) who possess this expertise are being employed in academic settings to support clinical and preclinical translational research team science. Duke University's clinical and translational science enterprise has been an early adopter of project management to support clinical and preclinical programs. We review the history and evolution of project management and the PL role at Duke, examine case studies that illustrate their growing value to our academic research environment, and address challenges and solutions to employing project management in academia. Furthermore, we describe the critical role project leadership plays in accelerating and increasing the success of translational team science and team approaches frequently required for systems biology and "big data" scientific studies. Finally, we discuss perspectives from Duke project leadership professionals regarding the training needs and requirements for PLs working in academic clinical and translational science research settings.
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http://dx.doi.org/10.1017/cts.2019.398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6798537PMC
August 2019

Behavior and Quality of Life at 6 Years for Children With Hypoplastic Left Heart Syndrome.

Pediatrics 2019 11 18;144(5). Epub 2019 Oct 18.

Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts; and.

Objectives: We measured behavioral, quality of life (QoL), and functional status outcomes for 6-year-old children with hypoplastic left heart syndrome enrolled in the Single Ventricle Reconstruction Trial. We sought to compare these outcomes with those in the normative population and to analyze risk factors for worse outcomes within the single-ventricle group.

Methods: Parent-response instruments included the Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) (primary outcome), Behavior Assessment System for Children 2, Pediatric Quality of Life Inventory 4.0, and other measures of QoL and functional status. We compared subjects with those in the normative sample using 1-sample Wilcoxon rank tests and assessed outcome predictors using multivariable regression.

Results: Of 325 eligible patients, 250 (77%) participated. Compared with population norms, participants had lower scores on the Vineland-II motor skills domain (90 ± 17 vs 100 ± 15; < .001), with 11% scoring >2 SDs below the normative mean. On nearly all major domains, more study subjects (3.3%-19.7%) scored outside the normal range than anticipated for the general population. Independent risk factors for lower Vineland-II scores included perioperative extracorporeal membrane oxygenation, male sex, use of regional cerebral perfusion, catheterization after stage 2 operation, visual problems, seizure history, and more complications after 2 years ( = 0.32). Independent predictors of worse Behavior Assessment System for Children 2 ( = 0.07-0.20) and Pediatric Quality of Life Inventory 4.0 ( = 0.17-0.25) domain scores also included sociodemographic factors and measures of morbidity and/or greater course complexity.

Conclusions: At 6 years, children with hypoplastic left heart syndrome had difficulty in areas of adaptive behavior, behavioral symptoms, QoL, and functional status. Principal risks for adverse outcomes include sociodemographic factors and measures of greater course complexity. However, models reveal less than one-third of outcome variance.
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http://dx.doi.org/10.1542/peds.2019-1010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6856798PMC
November 2019

Rivaroxaban, a direct Factor Xa inhibitor, versus acetylsalicylic acid as thromboprophylaxis in children post-Fontan procedure: Rationale and design of a prospective, randomized trial (the UNIVERSE study).

Am Heart J 2019 07 1;213:97-104. Epub 2019 May 1.

Duke University Medical Center, Durham, NC 27710. Electronic address:

Background: The Fontan procedure is the final step of the 3-stage palliative procedure commonly performed in children with single ventricle physiology. Thrombosis remains an important complication in children after this procedure. To date, guideline recommendations for the type and duration of thromboprophylaxis after Fontan surgery are mainly based on extrapolation of knowledge gained from adults at risk for thrombosis in other clinical settings. Warfarin is being used off-label, and because of its multiple interactions with other drugs and food, a new alternative is highly desirable. Rivaroxaban, a direct Factor Xa inhibitor with a predictable pharmacokinetic profile, is a candidate to address this medical need.

Study Design: The UNIVERSE study is a prospective, open-label, active-controlled, multicenter study in children 2 to 8 years of age who have single ventricle physiology and had the Fontan procedure within the 4 months preceding enrollment. This study consists of 2 parts. In Part A, rivaroxaban pharmacokinetics, pharmacodynamics, safety, and tolerability are assessed to validate the pediatric dosing selected. In Part B, safety and efficacy of rivaroxaban versus acetylsalicylic acid are evaluated for thromboprophylaxis in children post-Fontan procedure. Children in each part will receive study drug for 12 months. Part A has been completed with 12 children enrolled. Enrollment into Part B is currently ongoing.

Conclusions: The UNIVERSE study aims to provide dosing, pharmacokinetics/pharmacodynamics, safety, and efficacy information on the use of rivaroxaban, an oral anticoagulant, versus acetylsalicylic acid, an antiplatelet agent, in children with single ventricle physiology after the Fontan procedure.
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http://dx.doi.org/10.1016/j.ahj.2019.04.009DOI Listing
July 2019

Research Gaps in Primary Pediatric Hypertension.

Pediatrics 2019 05;143(5)

Office of Clinical Research Training and Medical Education, National Institutes of Health, Bethesda, Maryland.

Hypertension affects >40% of the US population and is a major contributor to cardiovascular-related morbidity and mortality. Although less common among children and adolescents, hypertension affects 1% to 5% of all youth. The 2017 Clinical Practice Guideline for the Diagnosis and Management of High Blood Pressure in Children and Adolescents provided updates and strategies regarding the diagnosis and management of hypertension in youth. Despite this important information, many gaps in knowledge remain, such as the etiology, prevalence, and trends of hypertension; the utility and practicality of ambulatory blood pressure monitoring; practical goals for lifestyle modification that are generalizable; the long-term end-organ impacts of hypertension in youth; and the long-term safety and efficacy of antihypertensive therapy in youth. The National Institute of Child Health and Human Development, in collaboration with the National Heart, Lung, and Blood Institute and the US Food and Drug Administration, sponsored a workshop of experts to discuss the current state of childhood primary hypertension. We highlight the results of that workshop and aim to (1) provide an overview of current practices related to the diagnosis, management, and treatment of primary pediatric hypertension; (2) identify related research gaps; and (3) propose ways to address existing research gaps.
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http://dx.doi.org/10.1542/peds.2018-3517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6564054PMC
May 2019

The Bayley-III scale may underestimate neurodevelopmental disability after cardiac surgery in infants.

Eur J Cardiothorac Surg 2020 01;57(1):63-71

Department of Cardiothoracic Surgery, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Objectives: Neurodevelopmental disability is the most common complication among congenital heart surgery survivors. The Bayley scales are standardized instruments to assess neurodevelopment. The most recent edition (Bayley Scales of Infant and Toddler Development 3rd Edition, Bayley-III) yields better-than-expected scores in typically developing and high-risk infants than the second edition (Bayley Scales of Infant Development 2nd Edition, BSID-II). We compared BSID-II and Bayley-III scores in infants undergoing cardiac surgery.

Methods: We evaluated 2198 infants who underwent operations with cardiopulmonary bypass between 1996 and 2009 at 26 institutions. We used propensity score matching to limit confounding by indication in a subset of patients (n = 705).

Results: Overall, unadjusted Bayley-III motor scores were higher than BSID-II Psychomotor Development Index scores (90.7 ± 17.2 vs 77.6 ± 18.8, P < 0.001), and unadjusted Bayley-III composite cognitive and language scores were higher than BSID-II Mental Development Index scores (92.0 ± 15.4 vs 88.2 ± 16.7, P < 0.001). In the propensity-matched analysis, Bayley-III motor scores were higher than BSID-II Psychomotor Development Index scores [absolute difference 14.1, 95% confidence interval (CI) 11.7-17.6; P < 0.001] and the Bayley-III classified fewer children as having severe [odds ratio (OR) 0.24; 95% CI 0.14-0.42] or mild-to-moderate impairment (OR 0.21; 95% CI 0.14-0.32). The composite of Bayley-III cognitive and language scores was higher than BSID-II Mental Development Index scores (absolute difference 4.0, 95% CI 1.4-6.7; P = 0.003), but there was no difference between Bayley editions in the proportion of children classified as having severe cognitive and language impairment.

Conclusions: The Bayley-III yielded higher scores than the BSID-II and classified fewer children as severely impaired. The systematic bias towards higher scores with the Bayley-III precludes valid comparisons between early and contemporary cardiac surgery cohorts.
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http://dx.doi.org/10.1093/ejcts/ezz123DOI Listing
January 2020

Agreement of an echocardiogram-based diagnosis of pulmonary hypertension in infants at risk for bronchopulmonary dysplasia among masked reviewers.

J Perinatol 2019 02 21;39(2):248-255. Epub 2018 Nov 21.

Division of Neonatal-Perinatal Medicine, Department of Pediatrics, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Objective: To evaluate the agreement of an echocardiogram-based pulmonary hypertension diagnosis in premature infants at risk for bronchopulmonary dysplasia (BPD).

Study Design: Echocardiograms from infants born ≤28 weeks post menstrual age were retrospectively reviewed with a standardized reading protocol by three pediatric cardiologists masked to patient's clinical history to determine the presence of pulmonary hypertension.

Results: A total of 483 echocardiograms from 49 unique patients were each reviewed by three pediatric cardiologists. Overall there was an 82.9% agreement on the presence of pulmonary hypertension among the three readers (95% CI: 78.4%, 85.4%) with a modified Fleiss' kappa of 0.759 (95% CI: 0.711, 0.801). Percent agreement between rereads was 92.4%, and modified Fleiss' kappa was 0.847 (95% CI: 0.750, 0.931).

Conclusions: Using a standardized reading protocol and echocardiogram-based definition of pulmonary hypertension, there is high inter- and intra-rater agreement for the diagnosis of pulmonary hypertension in at-risk premature infants, suggesting echocardiography can be successfully used for clinical and research monitoring of pulmonary hypertension in infants.
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http://dx.doi.org/10.1038/s41372-018-0277-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6724723PMC
February 2019

Severe Cardiac Involvement Is Rare in Patients with Late-Onset Pompe Disease and the Common c.-32-13T>G Variant: Implications for Newborn Screening.

J Pediatr 2018 07 4;198:308-312. Epub 2018 Apr 4.

Division of Medical Genetics, Department of Pediatrics, Duke University Medical Center, Durham, NC. Electronic address:

Based on a review of a large patient cohort, published literature, and 3 newborn screening cohorts, we concluded that children diagnosed through newborn screening with late-onset Pompe disease and the common heterozygous c.-32-13T>G variant require frequent cardiac follow-up with electrocardiography for arrhythmias. However, there is limited evidence for performing repeated echocardiography for cardiomyopathy.
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http://dx.doi.org/10.1016/j.jpeds.2018.02.007DOI Listing
July 2018

Transplant-Free Survival and Interventions at 6 Years in the SVR Trial.

Circulation 2018 05 1;137(21):2246-2253. Epub 2018 Feb 1.

University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.).

Background: In the SVR trial (Single Ventricle Reconstruction), 1-year transplant-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock-Taussig shunt in patients with hypoplastic left heart and related syndromes. At 6 years, we compared transplant-free survival and other outcomes between the groups.

Methods: Medical history was collected annually using medical record review, telephone interviews, and the death index. The cohort included 549 patients randomized and treated in the SVR trial.

Results: Transplant-free survival for the RVPAS versus modified Blalock-Taussig shunt groups did not differ at 6 years (64% versus 59%, =0.25) or with all available follow-up of 7.1±1.6 years (log-rank =0.13). The RVPAS versus modified Blalock-Taussig shunt treatment effect had nonproportional hazards (=0.009); the hazard ratio (HR) for death or transplant favored the RVPAS before stage II surgery (HR, 0.66; 95% confidence interval, 0.48-0.92). The effect of shunt type on death or transplant was not statistically significant between stage II to Fontan surgery (HR, 1.36; 95% confidence interval, 0.86-2.17; =0.17) or after the Fontan procedure (HR, 0.76; 95% confidence interval, 0.33-1.74; =0.52). By 6 years, patients with RVPAS had a higher incidence of catheter interventions (0.38 versus 0.23/patient-year, <0.001), primarily because of more interventions between the stage II and Fontan procedures (HR, 1.72; 95% confidence interval, 1.00-3.03). Complications did not differ by shunt type; by 6 years, 1 in 5 patients had had a thrombotic event, and 1 in 6 had had seizures.

Conclusions: By 6 years, the hazards of death or transplant and catheter interventions were not different between the RVPAS versus modified Blalock-Taussig shunt groups. Children assigned to the RVPAS group had 5% higher transplant-free survival, but the difference did not reach statistical significance, and they required more catheter interventions. Both treatment groups have accrued important complications.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00115934.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.117.029375DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5963989PMC
May 2018

Effect of renal function on antihypertensive drug safety and efficacy in children.

Pediatr Nephrol 2018 Jan 4;33(1):139-146. Epub 2017 Aug 4.

Department of Pediatrics, Duke University, Durham, NC, USA.

Background: Hypertension and chronic kidney disease (CKD) are common comorbidities. Guidelines recommend treating hypertension in children with CKD because it is a modifiable risk factor for subsequent cardiovascular disease. Children with CKD are frequently excluded from antihypertensive drug trials. Consequently, safety and efficacy data for antihypertensive drugs are lacking in children with CKD.

Methods: We determined the incidence of adverse events in 10 pediatric antihypertensive trials to determine the effect of renal function on antihypertensive safety and efficacy in children. These trials were submitted to the US Food and Drug Administration from 1998 to 2005. We determined the number and type of adverse events reported during the trials and compared these numbers in participants with normal renal function and those with decreased function (defined as an estimated glomerular filtration rate [eGFR] <90 mL/min/1.73 m calculated using the original Schwartz equation).

Results: Among the 1,703 children in the 10 studies, 315 had decreased renal function. We observed no difference between the two cohorts in the incidence of adverse events or adverse drug reactions related to study drug. Only 5 participants, all with decreased renal function, experienced a serious adverse event; none was recorded by investigators to be study drug-related. Among treated participants, children with decreased renal function who received a high dose of study drug had a significantly larger drop in diastolic blood pressure compared with children with normal renal function.

Conclusions: These data show that antihypertensive treatment in children with renal dysfunction can be safe and efficacious, and consideration should be given to their inclusion in selected drug development programs.
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http://dx.doi.org/10.1007/s00467-017-3763-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5700840PMC
January 2018

A survey of patients with bed bugs in the emergency department.

Am J Emerg Med 2017 May 3;35(5):697-698. Epub 2017 Jan 3.

University Hospitals Cleveland Medical Center, Case Western Reserve University, Department of Emergency Medicine, 11100 Euclid Ave., B-517, Cleveland, OH 44106, USA.

Bed bugs are one of the most important human ectoparasites in the United States, and a growing problem in the emergency department. We evaluated 40 emergency department (ED) patients found with a bed bug. The data show that ED patients with bed bugs are statistically more likely to be male, older, more likely to be admitted to the hospital, have higher triage emergency severity index (ESI) scores, and arrive by ambulance than the general ED patient population (p<0.05). On average bed bugs were found 108min after a patient arrived to the ED, after 35% of subjects had already received a blood draw, and after 23% had already received a radiology study; putting other ED patients and staff at risk for acquiring the infestation. We found that 13% and 18% of subjects had wheezing and a papular rash, respectively on physical exam. Of those patients found with a bed bug in the ED, 42% reported having bed bugs at home and 21% reporting having a possible home infestation.
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http://dx.doi.org/10.1016/j.ajem.2016.12.076DOI Listing
May 2017

Childhood Hypertension: An Underappreciated Epidemic?

Pediatrics 2016 12;138(6)

Duke Clinical Research Institute and Division of Pediatric Cardiology, Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1542/peds.2016-2857DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5127078PMC
December 2016

Congenital Heart Disease in Premature Infants 25-32 Weeks' Gestational Age.

J Pediatr 2017 02 3;181:37-41.e1. Epub 2016 Nov 3.

Duke Clinical Research Institute, Durham, NC; Department of Pediatrics, Division of Pediatric Cardiology, Duke University Medical Center, Durham, NC. Electronic address:

Objective: To determine the birth prevalence of congenital heart defects (CHDs) across the spectrum of common defects in very/extremely premature infants and to compare mortality rates between premature infants with and without CHDs.

Study Design: The Kids' Inpatient Databases (2003-2012) were used to estimate the birth prevalence of CHDs (excluding patent ductus arteriosus) in very/extremely premature infants born between 25 and 32 weeks' gestational age. Birth prevalence was compared with term infants for a subset of "severe" defects expected to be near universally diagnosed in the neonatal period. Weighted multivariable logistic regression was used to calculate aORs of mortality comparing very and extremely premature infants with vs without CHDs.

Results: We identified 249 011 very/extremely premature infants, including 28 806 with CHDs. The overall birth prevalence of CHDs was 116 per 1000 very/extremely premature births. Severe CHDs had significantly higher birth prevalence in very/extremely premature infants when compared with term infants (7.4 per 1000 very/premature births vs 1.5 per 1000 term births; P < .001). Very/extremely premature infants with severe CHDs had an overall 26.3% in-hospital mortality and a 7.5-fold increased adjusted odds of death compared with those without CHDs. Mortality varied widely by defect in very/extremely premature infants, ranging from 12% for interrupted aortic arch to 67% for truncus arteriosus.

Conclusions: Given the increased birth prevalence of severe CHDs in very/extremely premature infants, and significantly higher mortality, there is justification for intensive interventions aimed at decreasing the likelihood of premature delivery for patients where CHD is diagnosed in utero.
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http://dx.doi.org/10.1016/j.jpeds.2016.10.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5274591PMC
February 2017

Cardiopulmonary resuscitation in hospitalized infants.

Early Hum Dev 2016 10 9;101:17-22. Epub 2016 Jul 9.

Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA. Electronic address:

Background: Hospitalized infants requiring cardiopulmonary resuscitation (CPR) represent a high-risk group. Recent data on risk factors for mortality following CPR in this population are lacking.

Aims: We hypothesized that infant demographic characteristics, diagnoses, and levels of cardiopulmonary support at the time of CPR requirement would be associated with survival to hospital discharge following CPR.

Study Design: Retrospective cohort study.

Subjects: All infants receiving CPR on day of life 2 to 120 admitted to 348 Pediatrix Medical Group neonatal intensive care units from 1997 to 2012.

Outcomes Measures: We collected data on demographics, interventions, center volume, and death prior to NICU discharge. We evaluated predictors of death after CPR using multivariable logistic regression with generalized estimating equations to account for clustering of the data by center.

Results: Our cohort consisted of 2231 infants receiving CPR. Of these, 1127 (51%) survived to hospital discharge. Lower gestational age, postnatal age, 5-min APGAR, congenital anomaly, and markers of severity of illness were associated with higher mortality. Mortality after CPR did not change significantly over time (Cochran-Armitage test for trend p=0.35).

Conclusions: Mortality following CPR in infants is high, particularly for less mature, younger infants with congenital anomalies and those requiring cardiopulmonary support prior to CPR. Continued focus on at risk infants may identify targets for CPR prevention and improve outcomes.
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http://dx.doi.org/10.1016/j.earlhumdev.2016.03.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5035196PMC
October 2016

Clinicians' Adherence to Guidelines on Evaluation of Hypertension in Children and Adolescents.

World J Pediatr Congenit Heart Surg 2016 07;7(4):440-5

Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA

Background: Hypertension is increasingly prevalent among children. We sought to review provider adherence to the National High Blood Pressure Education Program (NHBPEP) recommendations at a single academic medical center.

Methods: We identified children 3-18 years of age with hypertension based on outpatient visit International Classification of Diseases, Ninth Edition, Clinical Modification codes from 2006 to 2012. We calculated the odds of individual tests administration for ten recommended tests, adjusting for demographic characteristics.

Results: We identified 3,588 (1.7%) of 216,855 children diagnosed with hypertension at a median age of 14 years (25th and 75th percentile 10 and 16, respectively). No child received all ten recommended tests. The median number of tests administered was 2 (1, 4) but varied significantly by race and age. Urine drug screen (<1%) and renin levels (1%) were the least common, whereas serum creatinine (49%) and echocardiogram (40%) were the most common tests. Male children were more likely to receive an echocardiogram (odds ratio 1.43; 95% confidence interval: 1.24-1.64), and black children and those ≥11 years old were less likely to have their serum creatinine checked. Adherence to the guidelines did not improve over time (P = .24).

Conclusion: Children evaluated for hypertension in the outpatient setting infrequently receive the diagnostic tests recommended in the NHBPEP's report. Test administration frequency varies by patient demographics but has not improved significantly over time.
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http://dx.doi.org/10.1177/2150135116641877DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5035390PMC
July 2016

Impact of imaging approach on radiation dose and associated cancer risk in children undergoing cardiac catheterization.

Catheter Cardiovasc Interv 2017 Apr 17;89(5):888-897. Epub 2016 Jun 17.

Division of Pediatric Cardiology, Department of Pediatrics (K.D.H., J.S.L, G.A.F.) and the Department of Radiology (C.W., T.Y., N.J., G.N.), Duke University Medical Center, Durham, North Carolina, and the Duke Clinical Research Institute (K.D.H., J.S.L.), Durham, North Carolina and the Department of Medicine, Division of Cardiology, and Department of Radiology, Columbia University Medical Center and New York-Presbyterian Hospital, New York NY (A.J.E.).

Objectives: To quantify the impact of image optimization on absorbed radiation dose and associated risk in children undergoing cardiac catheterization.

Background: Various imaging and fluoroscopy system technical parameters including camera magnification, source-to-image distance, collimation, antiscatter grids, beam quality, and pulse rates, all affect radiation dose but have not been well studied in younger children.

Methods: We used anthropomorphic phantoms (ages: newborn and 5 years old) to measure surface radiation exposure from various imaging approaches and estimated absorbed organ doses and effective doses (ED) using Monte Carlo simulations. Models developed in the National Academies' Biological Effects of Ionizing Radiation VII report were used to compare an imaging protocol optimized for dose reduction versus suboptimal imaging (+20 cm source-to-image-distance, +1 magnification setting, no collimation) on lifetime attributable risk (LAR) of cancer.

Results: For the newborn and 5-year-old phantoms, respectively ED changes were as follows: +157% and +232% for an increase from 6-inch to 10-inch camera magnification; +61% and +59% for a 20 cm increase in source-to-image-distance; -42% and -48% with addition of 1-inch periphery collimation; -31% and -46% with removal of the antiscatter grid. Compared with an optimized protocol, suboptimal imaging increased ED by 2.75-fold (newborn) and fourfold (5 years old). Estimated cancer LAR from 30-min of posteroanterior fluoroscopy using optimized versus suboptimal imaging, respectively was 0.42% versus 1.23% (newborn female), 0.20% versus 0.53% (newborn male), 0.47% versus 1.70% (5-year-old female) and 0.16% versus 0.69% (5-year-old male).

Conclusions: Radiation-related risks to children undergoing cardiac catheterization can be substantial but are markedly reduced with an optimized imaging approach. © 2016 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.26630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5164876PMC
April 2017