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Objective: To assess the association between primary (PR) and staged repair (SR) of neonatal symptomatic tetralogy of Fallot (sTOF) and neurodevelopmental outcomes in preschool through school-age children., Study Design: Multi-center cohort (n=9 sites) study of sTOF patients who underwent neonatal intervention between 2005 and 2017. The neurodevelopmental outcomes measures included caregivers' ratings of executive function with the Behavior Rating Inventory of Executive Function (BRIEF), and psychosocial functioning with the Behavior Assessment System for Children - 3 rd Edition (BASC-3). Results were compared with normative data and by treatment strategy (PR versus SR). A parent survey assessed history of disabilities and access to services related to neurodevelopment., Results: Although the majority of patients (median age 8.3 years, interquartile range 5.7-11.2) had median BRIEF and BASC-3 scores within the normal range, a proportion had clinically elevated (abnormal) scores, especially in the school-age patient subgroup (BRIEF 24-30% and BASC 20-37%). There were no statistically significant differences based on treatment strategy for either the BRIEF or BASC-3. However, lower birth weight, genetic syndrome, and medical complexity were significantly associated with worse executive function, and lower maternal education was associated in school age children with lower executive and psychosocial functioning. Ongoing disabilities were relatively common (learning disability 35%, speech delay 33%, developmental delay 31%), although up to 50% of children were not receiving educational or developmental services., Conclusion: Elevated executive and psychosocial concerns are present in the sTOF patient population. Although initial treatment strategy appears unrelated to neurodevelopmental outcomes, lower birth weight, genetic syndrome, and medical complexity, and lower maternal education are risk factors. Early recognition of neurodevelopmental concerns can facilitate access to appropriate neuro-developmental services in this high-risk group., Competing Interests: Conflicts of Interest Dr. Jeffrey Zampi is a consultant for Medtronic, Inc and WL Gore and Associates. He also serves on the Data Safety Monitoring Board for Encore Medical. Dr. Athar Qureshi is a consultant for Medtronic, Inc, B Braun, and WL Gore and Associates. Dr. Bryan Goldstein is a consultant for Medtronic, Inc, WL Gore and Associates, PECA labs, and Mezzion Pharma, (Copyright © 2024. Published by Elsevier Inc.)

Neonates with congenital heart disease (CHD) and ductal-dependent pulmonary blood flow (DD-PBF) require early intervention. Historically, this intervention was most often a surgical systemic-to-pulmonary shunt (SPS; e.g., Blalock-Thomas-Taussig shunt). However, over the past two decades an alternative to SPS has emerged in the form of transcatheter ductal artery stenting (DAS). While many reports have indicated safety and durability of the DAS approach, few studies compare outcomes between DAS and SPS. The reports that do exist are comprised primarily of small-cohort single-center reviews. Two multicenter retrospective studies suggest that DAS is associated with similar or superior survival compared to SPS. These studies offer the best evidence to-date, and yet both have important limitations. The authors describe herein the rationale and design of the COMPASS (COmparison of Methods for Pulmonary blood flow Augmentation: Shunt vs. Stent) Trial (NCT05268094, IDE G210212). The COMPASS Trial aims to randomize 236 neonates with DD-PBF to either DAS or SPS across approximately 27 pediatric centers in North America. The goal of this trial is to compare important clinical outcomes between DAS and SPS over the first year of life in a cohort of neonates balanced by randomization to assess whether one method of palliation demonstrates therapeutic superiority., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

To evaluate the association between initial management strategy of neonatal symptomatic Tetralogy of Fallot (sTOF) and later health-related quality of life (HRQOL) outcomes. We performed a multicenter, cross-sectional evaluation of a previously assembled cohort of infants with sTOF who underwent initial intervention at ≤ 30 days of age, between 2005 and 2017. Eligible patients' parents/guardians completed an age-appropriate Pediatric Quality of Life Inventory, a Pediatric Quality of Life Inventory Cardiac Module Heart Disease Symptoms Scale, and a parental survey. The association between treatment strategy and HRQOL was evaluated, and the entire sTOF cohort was compared to published values for the healthy pediatric population and to children with complex congenital heart disease and other chronic illness. The study cohort included 143 sTOF subjects, of which 59 underwent a primary repair, and 84 had a staged repair approach. There was no association between initial management strategy and lower HRQOL. For the entire cohort, in general, individual domain scores decreased as age sequentially increased. Across domain measurements, mean scores for the sTOF cohort were significantly lower than the healthy pediatric population and comparable to those with other forms of complex CHD and other chronic health conditions. The presence of a genetic syndrome was significantly associated with a poor HRQOL (p = 0.003). Initial treatment strategy for sTOF was not associated with differences in late HRQOL outcomes, though the overall HRQOL in this sTOF cohort was significantly lower than the general population, and comparable to others with chronic illness., (© 2024. The Author(s).)

Objective: To test the hypothesis that neonates with symptomatic tetralogy of Fallot (TOF) and absent ductus arteriosus (ADA) have worse clinical outcomes compared with those with a ductus arteriosus (DA), and that this difference is driven by those born with ADA and with critically deficient pulmonary blood flow (CDPBF)., Study Design: We performed a retrospective, multicenter cohort study of neonates who underwent intervention for symptomatic TOF comparing death and reintervention between subjects with and without a DA identified on fetal echocardiogram or on echocardiogram performed in the first postnatal day. Exclusion criteria were as follows: inability to define DA status, collaterals supplying pulmonary blood flow, atrioventricular septal defect, and absent pulmonary valve. We defined CDPBF as undergoing a procedure to augment pulmonary blood flow on the date of birth or extracorporeal membrane oxygenation prior to such a procedure., Results: The study cohort included 519 patients, among whom 11% had ADA. Patients with ADA were more likely to have a genetic syndrome and had smaller branch pulmonary artery size. In analyses adjusting for center, interventional treatment strategy, genetic syndrome, and minimum branch pulmonary artery size, ADA was associated with higher mortality risk (adjusted hazard ratio of 2.37 (95% CI: 1.07,5.27; P = .034). Seven patients had CDPBF (1.3% of the entire cohort and 12% of patients with ADA)., Conclusions: A minority of symptomatic TOF neonates have ADA, which is associated with higher adjusted mortality risk compared with those with a DA. CDPBF appears to be a rare but important entity in this population., Competing Interests: Declaration of Competing Interest This research is supported, in part, by donations to the Congenital Cardiac Research Collaborative from the Kennedy Hammill Pediatric Cardiac Research Fund, Liam Sexton Foundation, and A Heart Like Ava. The authors declare no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

In research assessing the effect of an intervention or exposure, a key secondary objective often involves assessing differential effects of this intervention or exposure in subgroups of interest; this is often referred to as assessing effect modification or heterogeneity of treatment effects (HTE). Observed HTE can have important implications for policy, including intervention strategies (e.g., will some patients benefit more from intervention than others?) and prioritizing resources (e.g., to reduce observed health disparities). Analysis of HTE is well understood in studies where the independent unit is an individual. In contrast, in studies where the independent unit is a cluster (e.g., a hospital or school) and a cluster-level outcome is used in the analysis, it is less well understood how to proceed if the HTE analysis of interest involves an individual-level characteristic (e.g., self-reported race) that must be aggregated at the cluster level. Through simulations, we show that only individual-level models have power to detect HTE by individual-level variables; if outcomes must be defined at the cluster level, then there is often low power to detect HTE by the corresponding aggregated variables. We illustrate the challenges inherent to this type of analysis in a study assessing the effect of an intervention on increasing COVID-19 booster vaccination rates at long-term care centers., (© 2023. The Author(s).)

Context: The long-term effect of gender-affirming hormone therapy (GAHT) on glucose metabolism is an area of priority in transgender health research., Objectives: To evaluate the relation between GAHT and changes in fasting blood glucose (FG) and glycosylated hemoglobin (HbA1c) in transmasculine (TM) and transfeminine (TF) persons relative to the corresponding temporal changes in presumably cisgender persons (i.e. without any evidence of TGD status)., Design: Retrospective cohort study., Setting: Three large integrated health systems., Participants: 2,425 TF and 2,127 TM persons compared with 33,995 cisgender males (CM) and 38,913 cisgender females (CF) enrolled in the same health plans., Outcomes/measures: Temporal changes in FG and HbA1c levels examined using linear mixed models with main results expressed as ratios-of-ratios., Results: The pre- versus post-GAHT ratios-of-ratio (95% confidence interval) estimates adjusted for age, race/ethnicity, study site, and body mass index in the model comparing TF and CM groups were 1.05 (1.01, 1.09) for FG and 1.03 (0.99, 1.06) for HbA1c. By contrast, the corresponding results in the models contrasting TM and cisgender cohort members were in the 0.99-1.00 range. The ratio-of-ratios comparing post-GAHT changes among transgender and cisgender persons were close to the null and without a discernable pattern., Conclusion: Though the within-transgender cohort data suggest an increase in the levels of FG and HbA1c following feminizing GAHT initiation, these changes were no longer evident when compared with the corresponding changes in cisgender referents. Based on these results, clinically important effects of GAHT on routine laboratory markers of glucose metabolism appear unlikely., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. See the journal About page for additional terms.)

Lay Abstract: Currently, the prevalence of autism spectrum disorder (henceforth "autism") is 1 in 36, an increasing trend from previous estimates. In 2015, the United States adopted a new version (International Classification of Diseases, 10th Revision) of the World Health Organization coding system, a standard for classifying medical conditions. Our goal was to examine how the transition to this new coding system impacted autism diagnoses in 10 healthcare systems. We obtained information from electronic medical records and insurance claims data from July 2014 through December 2016 for each healthcare system. We used member enrollment data for 30 consecutive months to observe changes 15 months before and after adoption of the new coding system. Overall, the rates of autism per 1000 enrolled members was increasing for 0- to 5-year-olds before transition to International Classification of Diseases, 10th Revision and did not substantively change after the new coding was in place. There was variation observed in autism diagnoses before and after transition to International Classification of Diseases, 10th Revision for other age groups. The change to the new coding system did not meaningfully affect autism rates at the participating healthcare systems. The increase observed among 0- to 5-year-olds is likely indicative of an ongoing trend related to increases in screening for autism rather than a shift associated with the new coding.

Effective respiratory syncytial virus (RSV) vaccines have been developed and licensed for elderly adults and pregnant women but not yet for infants and young children. The RSV immune state of the young child, i.e., previously RSV infected or not, is important to the conduct and interpretation of epidemiology studies and vaccine clinical trials. To address the need for sensitive assays to detect immunologic evidence of past infection, we developed, characterized, and evaluated 7 assays including 4 IgG antibody enzyme immunoassays (EIAs), two neutralizing antibody assays, and an IFN-γ EliSpot (EliSpot) assay. The four IgG EIAs used a subgroup A plus subgroup B RSV-infected Hep-2 cell lysate antigen (Lysate), an expressed RSV F protein antigen (F), an expressed subgroup A G protein antigen (Ga), or an expressed subgroup B G protein (Gb) antigen. The two neutralizing antibody assays used either a subgroup A or a subgroup B RSV strain. The EliSpot assay used a sucrose cushion purified combination of subgroup A and subgroup B infected cell lysate. All seven assays had acceptable repeatability, signal against control antigen, lower limit of detection, and, for the antibody assays, effect of red cell lysis, lipemia and anticoagulation of sample on results. In 44 sera collected from children >6 months after an RSV positive illness, the lysate, F, Ga and Gb IgG EIAs, and the subgroup A and B neutralizing antibody assays, and the EliSpot assays were positive in 100%, 100%, 86%, 95%, 43%, and 57%, respectively. The Lysate and F EIAs were most sensitive for detecting RSV antibody in young children with a documented RSV infection. Unexpectedly, the EliSpot assay was positive in 9/15 (60%) of PBMC specimens from infants not exposed to an RSV season, possibly from maternal microchimerism. The Lysate and F EIAs provide good options to reliably detect RSV antibodies in young children for epidemiologic studies and vaccine trials., Competing Interests: LA has done paid consultancies on RSV vaccines for AstraZeneca, Bavarian Nordic, GSK, and Janssen and on influenza virus vaccines for Pfizer. His laboratory is currently receiving funding through Emory University from Pfizer for RSV surveillance and maternal infant studies and from Advac, Sciogen and Vernagen for RSV vaccine-related studies. LA is co-inventor on several CDC or Emory patents or patent filings on the RSV G protein and its CX3C chemokine motif relative to immune therapy and vaccine development and a patent filing for use of RSV platform VLPs with the F and G proteins for vaccines. EA has consulted for Pfizer, Sanofi Pasteur, GSK, Janssen, Moderna, and Medscape, and his institution receives funds to conduct clinical research unrelated to this manuscript from MedImmune, Regeneron, PaxVax, Pfizer, GSK, Merck, Sanofi-Pasteur, Janssen, and Micron. He serves on a safety monitoring board for Kentucky BioProcessing, Inc. and Sanofi Pasteur. He serves on a data adjudication board for WCG and ACI Clinical. His institution has also received funding from NIH to conduct clinical trials of COVID-19 vaccines. EA is currently an employee of Moderna, Boston, MA. CR has received institutional research support from Pfizer Inc., BioFire Inc., GSK plc, Janssen Pharmaceuticals, MedImmune, Micron Technology Inc., ModernaTX, Inc., Merck & Co., Inc., Novavax, PaxVax, Regeneron, Sanofi Pasteur, and from the Centers for Disease Control and Prevention and the National Institutes of Health. She is coinventor of patented RSV vaccine technology which has been licensed to Meissa Vaccines, Inc. CM is currently employed by Kaiser Permanente, Atlanta, GA, United States. JY is currently employed by Merck & Co., Inc., Rahway, NJ, United States. AJ is employed by The Emmes Company, Rockville, MD, United States. EA is currently employed by Moderna, Boston, MA. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Anderson, Jadhao, Hussaini, Ha, McCracken, Gibson, Yildirim, Yi, Stephens, Korski, Kao, Sun, Lee, Jaunarajs, Rostad and Anderson.)

Objective: Neonates with tetralogy of Fallot and pulmonary atresia (TOF/PA) but no major aorta-pulmonary collaterals are dependent on the arterial duct for pulmonary blood flow and require early intervention, either by primary (PR) or staged repair (SR) with initial palliation (IP) followed by complete repair (CR). The optimal approach has not been established., Methods: Neonates with TOF/PA who underwent PR or SR were retrospectively reviewed from the Congenital Cardiac Research Collaborative. Outcomes were compared between PR and SR (IP + CR) strategies. Propensity scoring was used to adjust for baseline differences. The primary outcome was mortality. Secondary outcomes included complications, length of stay, cardiopulmonary bypass and anesthesia times, reintervention (RI), and pulmonary artery (PA) growth., Results: Of 282 neonates, 106 underwent PR and 176 underwent SR (IP: 144 surgical, 32 transcatheter). Patients who underwent SR were more likely to have DiGeorge syndrome and greater rates of mechanical ventilation before the initial intervention. Mortality was not significantly different. Duration of mechanical ventilation, inotrope use, and complication rates were similar. Cumulative length of stay, cardiopulmonary bypass, and anesthesia times favored PR (P ≤ .001). Early RI was more common in patients who underwent SR (rate ratio, 1.42; P = .003) but was similar after CR (P = .837). Conduit size at the time of CR was larger with SR. Right PA growth was greater with PR., Conclusions: In neonates with TOF/PA, SR is more common in greater-risk patients. Accounting for this, SR and PR strategies have similar mortality. Perioperative morbidities, RI, and right PA growth generally favor PR, whereas SR allows for larger initial conduit implantation., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Neonates with symptomatic tetralogy of Fallot (sTOF) with hypoplastic pulmonary arteries (hPA) are considered high risk. Data are needed to inform the impact of hPA on outcomes, and the ideal management strategy., Objectives: The objectives of this study were to quantify the impact of hPA on outcomes in neonates with sTOF and measure the impact of strategy on pulmonary artery (PA) growth in this population., Methods: Neonates with sTOF from 2005 to 2017 were reviewed from the Congenital Cardiac Research Collaborative. Criteria for hPA included a unilateral PA z score <-2.0 and contralateral PA z score <0. Primary outcome was mortality. Secondary outcomes included reintervention and PA growth., Results: We included 542 neonates with sTOF, including 188 (35%) with hPA and 354 (65%) with normal PA, with median follow-up of 4.1 years. Median right and left hPA z scores were -2.19 (25th-75th percentile: -2.55 to -1.94) and -2.23 (25th-75th percentile: -2.64 to -1.91), respectively. Staged repair (vs primary TOF repair) was less common in the hPA cohort (36 vs 44%; P = 0.07). Survival was similar between groups (unadjusted P = 0.16; adjusted P = 0.25). Reintervention was more common in the hPA group (HR: 1.28; 95% CI: 1.01-1.63; P = 0.044); there was no difference after definitive repair (HR: 1.21; 95% CI: 0.93-1.58; P = 0.16). PA growth at 1 year was greater in the hPA cohort, particularly for the right PA (P < 0.001)., Conclusions: Despite perception, the presence of hPA in neonates with sTOF conferred no increase in overall hazard of mortality or reintervention after definitive repair. PA growth was superior in the hPA cohort. These findings suggest that the presence of hPA does not adversely impact outcomes in sTOF., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Complete repair (CR) can be delayed in neonates with symptomatic tetralogy of Fallot (sTOF) using surgical or transcatheter palliation to relieve cyanosis. Balloon pulmonary valvuloplasty (BPV) is an established treatment for pulmonary valve stenosis; however, its effectiveness in palliating neonates with sTOF has not been well investigated., Methods: A retrospective chart review between 2005 and 2017 on neonates with sTOF who underwent initial BPV from 9 participating centers of the Congenital Cardiac Research Collaborative was performed. Primary outcome was CR at >30 days after BPV without interval reintervention (RI)., Results: In total, 47 neonates with sTOF underwent BPV, of whom 27 (57%) underwent CR at >30 days after BPV without RI. The median time to CR was 151 days (106-210). RI before CR occurred in 17 patients (36%): surgical shunt (n = 7), outflow tract stenting (n = 6), patent ductus arteriosus stenting (n = 2), and surgical outflow patch (n = 2). Valve-sparing repair at CR was performed in 6 patients (13%) after initial BPV. RI or CR ≤30 days from BPV was associated with smaller infundibular diastolic diameter ( P = .004). An infundibular diastolic diameter of <3.4 mm demonstrated 75% sensitivity and 67% specificity to predict early CR or RI., Conclusions: BPV can be an effective palliative therapy in select neonates with sTOF to delay CR. A smaller diastolic infundibulum diameter is a predictor of RI or early CR, and valve-sparing repair is uncommon, making patient selection and alternative palliative methods key when considering BPV palliation in neonates with sTOF., (© 2023 The Author(s).)

Background: The COVID-19 pandemic forced many US health care organizations to shift from mostly in-person care to a hybrid of virtual visits (VV) and in-person visits (IPV). While there was an expected and immediate shift to virtual care (VC) early in the pandemic, little is known about trends in VC use after restrictions eased., Methods: This is a retrospective study using data from 3 health care systems. All completed visits from adult primary care (APC) and behavioral health (BH) were extracted from the electronic health record of adults aged 19 years and older from January 1, 2019 to June 30, 2021. Standardized weekly visit rates were calculated by department and site and analyzed using time series analysis., Results: There was an immediate decrease in APC visits following the onset of the pandemic. IPV were quickly replaced by VV such that VV accounted for most APC visits early in the pandemic. By 2021, VV rates declined, and VC visits accounted for <50% of all APC visits. By Spring 2021, all 3 health care systems saw a resumption of APC visits as rates neared or returned to prepandemic levels. In contrast, BH visit rates remained constant or slightly increased. By April 2020, almost all BH visits were being delivered virtually at each of the 3 sites and continue to do so without changes to utilization., Conclusions: VC use peaked during the early pandemic period. While rates of VC are higher than prepandemic levels, IPV are the predominant visit type in APC. In contrast, VC use has sustained in BH, even after restrictions eased., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The purpose of this study was to examine the extent to which the presence of chronic noncancer pain (CNCP) impacts the likelihood that patients with diagnoses of depression will initiate depression treatment compared with those without CNCP., Methods: We performed a retrospective cohort study of Kaiser Permanente of Georgia members older than 18 years who received a diagnosis of depression. Demographics and medical history were extracted from the electronic health record database. Members were further classified by the presence or absence of a CNCP diagnosis. Outcomes of interest were treated as time dependent and included ( 1 ) time to fulfillment of a new antidepressant medication and ( 2 ) time to a follow-up mental health encounter. Outcomes were compared between members with and without a CNCP diagnosis using Kaplan-Meier survival curves and Cox proportional hazard regression models., Results: During the study period, 22,996 members met the inclusion criteria and 27.4% had a diagnosis of CNCP. In the matched sample, there was no difference in the time to a new antidepressant fill among members with and without CNCP (hazard ratio = 0.96; 95% confidence interval = 0.90-1.02; p = .18). In contrast, members with CNCP were significantly less likely to have a new mental health encounter after diagnosis (hazard ratio = 0.87; 95% confidence interval = 0.81-0.94; p < .001)., Conclusions: Patients with CNCP were significantly less likely to have a new mental health encounter after a depression diagnosis compared with patients without CNCP. Additional outreach and consideration may be needed to improve initiation of depression treatment for newly diagnosed patients with comorbid depression and CNCP., (Copyright © 2023 by the American Psychosomatic Society.)

Background/objective: In recent years, 2 circumstances have changed provider-patient interactions in ambulatory care: (1) the replacement of virtual for in-person visits and (2) the COVID-19 pandemic. We studied the potential impact of each event on provider practice and patient adherence by comparing the frequency of the association of provider orders, and patient fulfillment of those orders, by visit mode and pandemic period, for incident neck or back pain (NBP) visits in ambulatory care., Methods: Data were extracted from the electronic health records of 3 Kaiser Permanente regions (Colorado, Georgia, and Mid-Atlantic States) from January 2017 to June 2021. Incident NBP visits were defined from ICD-10 coded as primary or first listed diagnoses on adult, family medicine, or urgent care visits separated by at least 180 days. Visit modes were classified as virtual or in-person. Periods were classified as prepandemic (before April 2020 or the beginning of the national emergency) or recovery (after June 2020). Percentages of provider orders for, and patient fulfillment of orders, were measured for 5 service classes and compared on: virtual versus in-person visits, and prepandemic versus recovery periods. Comparisons were balanced on patient case-mix using inverse probability of treatment weighting., Results: Ancillary services in all 5 categories at each of the 3 Kaiser Permanente regions were substantially ordered less frequently on virtual compared with in-person visits in both the prepandemic and recovery periods (both P ≤ 0.001). Conditional on an order, patient fulfillment within 30 days was high (typically ≥70%) and not likely meaningfully different between visit modes or pandemic periods., Conclusions: Ancillary services for incident NBP visits were ordered less frequently during virtual than in-person visits in both prepandemic and recovery periods. Patient fulfillment of orders was high, and not significantly different by mode or period., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background/objective: In recent years, 2 circumstances changed provider-patient interactions in primary care: the substitution of virtual (eg, video) for in-person visits and the COVID-19 pandemic. We studied whether access to care might affect patient fulfillment of ancillary services orders for ambulatory diagnosis and management of incident neck or back pain (NBP) and incident urinary tract infection (UTI) for virtual versus in-person visits., Methods: Data were extracted from the electronic health records of 3 Kaiser Permanente Regions to identify incident NBP and UTI visits from January 2016 through June 2021. Visit modes were classified as virtual (Internet-mediated synchronous chats, telephone visits, or video visits) or in-person. Periods were classified as prepandemic [before the beginning of the national emergency (April 2020)] or recovery (after June 2020). Percentages of patient fulfillment of ancillary services orders were measured for 5 service classes each for NBP and UTI. Differences in percentages of fulfillments were compared between modes within periods and between periods within the mode to assess the possible impact of 3 moderators: distance from residence to primary care clinic, high deductible health plan (HDHP) enrollment, and prior use of a mail-order pharmacy program., Results: For diagnostic radiology, laboratory, and pharmacy services, percentages of fulfilled orders were generally >70-80%. Given an incident NBP or UTI visit, longer distance to the clinic and higher cost-sharing due to HDHP enrollment did not significantly suppress patients' fulfillment of ancillary services orders. Prior use of mail-order prescriptions significantly promoted medication order fulfillments on virtual NBP visits compared with in-person NBP visits in the prepandemic period (5.9% vs. 2.0%, P=0.01) and in the recovery period (5.2% vs. 1.6%, P=0.02)., Conclusions: Distance to the clinic or HDHP enrollment had minimal impact on the fulfillment of diagnostic or prescribed medication services associated with incident NBP or UTI visits delivered virtually or in-person; however, prior use of mail-order pharmacy option promoted fulfillment of prescribed medication orders associated with NBP visits., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The delivery of adult primary care (APC) shifted from predominately in-person to modes of virtual care during the COVID-19 pandemic. It is unclear how these shifts impacted the likelihood of APC use during the pandemic, or how patient characteristics may be associated with the use of virtual care., Methods: A retrospective cohort study using person-month level datasets from 3 geographically disparate integrated health care systems was conducted for the observation period of January 1, 2020, through June 30, 2021. We estimated a 2-stage model, first adjusting for patient-level sociodemographic, clinical, and cost-sharing factors, using generalized estimating equations with a logit distribution, along with a second-stage multinomial generalized estimating equations model that included an inverse propensity score treatment weight to adjust for the likelihood of APC use. Factors associated with APC use and virtual care use were separately assessed for the 3 sites., Results: Included in the first-stage models were datasets with total person-months of 7,055,549, 11,014,430, and 4,176,934, respectively. Older age, female sex, greater comorbidity, and Black race and Hispanic ethnicity were associated with higher likelihood of any APC use in any month; measures of greater patient cost-sharing were associated with a lower likelihood. Conditional on APC use, older age, and adults identifying as Black, Asian, or Hispanic were less likely to use virtual care., Conclusions: As the transition in health care continues to evolve, our findings suggest that to ensure vulnerable patient groups receive high quality health care, outreach interventions to reduce barriers to virtual care use may be warranted., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background/objective: In multisite studies, a common data model (CDM) standardizes dataset organization, variable definitions, and variable code structures and can support distributed data processing. We describe the development of a CDM for a study of virtual visit implementation in 3 Kaiser Permanente (KP) regions., Methods: We conducted several scoping reviews to inform our study's CDM design: (1) virtual visit mode, implementation timing, and scope (targeted clinical conditions and departments); and (2) extant sources of electronic health record data to specify study measures. Our study covered the period from 2017 through June 2021. Integrity of the CDM was assessed by a chart review of random samples of virtual and in-person visits, overall and by specific conditions of interest (neck or back pain, urinary tract infection, major depression)., Results: The scoping reviews identified a need to address differences in virtual visit programs across the 3 KP regionsto harmonize measurement specifications for our research analyses. The final CDM contained patient-level, provider-level, and system-level measures on 7,476,604 person-years for KP members aged 19 years and above. Utilization included 2,966,112 virtual visits (synchronous chats, telephone visits, video visits) and 10,004,195 in-person visits. Chart review indicated the CDM correctly identified visit mode on>96% (n=444) of visits, and presenting diagnosis on >91% (n=482) of visits., Conclusions: Upfront design and implementation of CDMs may be resource intensive. Once implemented, CDMs, like the one we developed for our study, provide downstream programming and analytic efficiencies by harmonizing, in a consistent framework, otherwise idiosyncratic temporal and study site differences in source data., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: During the COVID-19 pandemic, more health care issues were being managed remotely. Urinary tract infections (UTIs) are being managed more often using telehealth although few reports compare the rate of UTI ancillary service orders placed and fulfilled during these visits., Objectives: We aimed to evaluate and compare the rate of ancillary service orders and order fulfillments in incident UTI diagnoses between virtual and in-person encounters., Research Design: The retrospective cohort study involved 3 integrated health care systems: Kaiser Permanente (KP) Colorado, KP Georgia, and KP Mid-Atlantic States., Subjects: We included incident UTI encounters from adult primary care data from January 2019 to June 2021., Measures: Data were categorized as: prepandemic (January 2019-March 2020), COVID-19 Era 1 (April 2020-June 2020), and COVID-19 Era 2 (July 2020-June 2021). UTI-specific ancillary services included medication, laboratory, and imaging. Orders and order fulfillments were dichotomized for analyses. Weighted percentages for orders and fulfillments were calculated using inverse probability treatment weighting from logistic regression and compared between virtual and in-person encounters using χ2 tests., Results: We identified 123,907 incident encounters. Virtual encounters increased from 13.4% prepandemic to 39.1% in COVID-19 Era 2. Ancillary service orders from virtual encounters were not placed as often as in-person encounters. However, the weighted percentage for ancillary service order fulfillment across all services remained above 65.3% across sites and eras, with many fulfillment percentages above 90%., Conclusions: Our study reported a high rate of order fulfillment for both virtual and in-person encounters. Health care systems should encourage providers to place ancillary service orders for uncomplicated diagnoses, such as UTI, to provide enhanced access to patient-centered care., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The abrupt shift to virtual care at the onset of the COVID-19 pandemic had the potential to disrupt care practices in virtual behavioral health encounters. We examined changes over time in virtual behavioral health-care-related practices for patient encounters with diagnoses of major depression., Methods: This retrospective cohort study utilized electronic health record data from 3 integrated health care systems. Inverse probability of treatment weighting was used to adjust for covariates across 3 time periods, prepandemic (January 2019-March 2020), peak-pandemic shift to virtual care (April 2020-June 2020), and recovery of health care operations (July 2020-June 2021). First virtual follow-up behavioral health department encounters after an incident diagnostic encounter were examined for differences across the time periods in rates of antidepressant medication orders and fulfillments, and completion of patient-reported symptoms screeners in service of measurement-based care., Results: Antidepressant medication orders declined modestly but significantly in 2 of the 3 systems during the peak-pandemic period but rebounded during the recovery period. There were no significant changes in patient fulfillment of ordered antidepressant medications. Completion of symptom screeners increased significantly in all 3 systems during the peak-pandemic period and continued to increase significantly in the subsequent period., Conclusions: A rapid shift to virtual behavioral health care was possible without compromising health-care-related practices. The transition and subsequent adjustment period have instead been marked by improved adherence to measurement-based care practices in virtual visits, signaling a potential new capacity for virtual health care delivery., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

One of the common complications of non-traumatic subarachnoid hemorrhage (SAH) is delayed cerebral ischemia (DCI). Intrathecal (IT) administration of nicardipine, a calcium channel blocker (CCB), upon detection of large-artery cerebral vasospasm holds promise as a treatment that reduces the incidence of DCI. In this observational study, we prospectively employed a non-invasive optical modality called diffuse correlation spectroscopy (DCS) to quantify the acute microvascular cerebral blood flow (CBF) response to IT nicardipine (up to 90 min) in 20 patients with medium-high grade non-traumatic SAH. On average, CBF increased significantly with time post-administration. However, the CBF response was heterogeneous across subjects. A latent class mixture model was able to classify 19 out of 20 patients into two distinct classes of CBF response: patients in Class 1 ( n = 6) showed no significant change in CBF, while patients in Class 2 ( n = 13) showed a pronounced increase in CBF in response to nicardipine. The incidence of DCI was 5 out of 6 in Class 1 and 1 out of 13 in Class 2 ( p < 0.001). These results suggest that the acute (<90 min) DCS-measured CBF response to IT nicardipine is associated with intermediate-term (up to 3 weeks) development of DCI., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Sathialingam, Cowdrick, Liew, Fang, Lee, McCracken, Akbik, Samuels, Kandiah, Sadan and Buckley.)

Background: Viral respiratory infections trigger pulmonary exacerbations (PEs) in children with cystic fibrosis (CF), but their clinical impact is not well understood., Methods: A retrospective review of pediatric patients with CF who underwent nasopharyngeal respiratory viral panel testing during hospitalization for a PE between 2011 and 2018 was conducted. Patients were dichotomized into viral-positive and viral-negative groups. The results of spirometry, respiratory cultures, duration of hospitalization, and risk for subsequent PEs were analyzed., Results: Ninety-five patients had 210 hospitalizations for PE (viral-positive = 71/210, 34%) during the study period. Rhinovirus/enterovirus was the most common virus (52/71, 73%) identified. Viral-positive patients were younger (p < 0.001), had higher baseline forced expiratory volume in 1 s (FEV1) (p = 0.037), continued to maintain higher FEV1 at 3 and 6 months following PE (p = 0.003 and 0.002, respectively), and had a shorter duration of hospitalization (p = 0.006) compared to the viral-negative group. There was no difference between the two groups in the rate of recovery of FEV1 at 3 and 6 months following PE (p = 0.71 and 0.405, respectively), time to the next PE (hazard ratio = 1.34, p = 0.157), number of subsequent PEs in 6 months (p = 0.99), or Pseudomonas aeruginosa (PA) acquisition (p = 0.707)., Conclusions: In this single pediatric CF center cohort, one-third of PEs requiring hospitalization were associated with a viral infection, with rhinovirus/enterovirus being the most common. Viral-positive PEs were not associated with a greater decline or delayed recovery of lung function, increased risk for PA acquisition, shortened duration to next PE, longer hospital stay, or an increase in the frequency of subsequent PEs in 6 months compared to viral-negative PEs., (© 2022 Wiley Periodicals LLC.)

Objective: To evaluate early growth following primary or staged repair of neonatal symptomatic tetralogy of Fallot (sTOF)., Study Design: We performed a retrospective, multicenter cohort study of consecutive infants with sTOF who underwent initial intervention at age ≤30 days, from 2005 to 2017. Management strategies were either primary repair or staged repair (ie, initial palliation followed by complete repair). The primary outcome was change in weight-for-age z-score (ΔWAZ) from the initial intervention to age 6 ± 2 months. Secondary outcomes included method and mode of feeding, feeding-related medications, and feeding-related readmissions. Propensity score adjustment was used to account for baseline differences between groups. A secondary analysis was performed comparing patients stratified by the presence of adequate growth (6-month ΔWAZ > -0.5) or inadequate growth (6-month ΔWAZ ≤ -0.5), independent of treatment strategy., Results: The study cohort included 143 primary repair subjects and 240 staged repair subjects. Prematurity was more common in the staged repair group. After adjustment, median ΔWAZ did not differ between treatment groups over the first 6 months of life (primary: -0.43 [IQR, -1.17 to 0.50]; staged: -0.31 [IQR, -1.31 to 0.71]; P = .55). For the entire cohort, ΔWAZ was negative (-0.36; IQR, -1.21 to 0.63). There were no between-group differences in the secondary outcomes. Secondary analysis revealed that the subjects with adequate growth were more likely to be orally fed at initial hospital discharge (P = .04)., Conclusions: In neonates with sTOF, growth trajectory over the first 6 months of life was substandard, irrespective of treatment strategy. Those patients with adequate growth were more likely to be discharged from the index procedure on oral feeds., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Neonates with symptomatic tetralogy of Fallot (sTOF) may undergo palliations with varying physiology, namely systemic to pulmonary artery connections (SPC) or right ventricular outflow tract interventions (RVOTI). A comparison of palliative strategies based on the physiology created is lacking. Consecutive sTOF neonates undergoing SPC or RVOTI from 2005-2017 were reviewed from the Congenital Cardiac Research Collaborative. The primary outcome was survival with successful complete repair (CR) by 18 months. A variety of secondary outcomes were assessed including overall survival, hospitalization-related comorbidities, and interstage reinterventions. Propensity score adjustment was utilized to compare treatment strategies. The cohort included 252 SPC (surgical shunt = 226, ductus arteriosus stent = 26) and 68 RVOTI (balloon pulmonary valvuloplasty = 48, RVOT stent = 11, RVOT patch = 9) patients. Genetic syndrome (29 [42.6%] v 75 [29.8%], p = 0.04), weight < 2.5 kg (28 [41.2%] v 68 [27.0%], p = 0.023), bilateral pulmonary artery Z-score < - 2 (19 [28.0%] v 36 [14.3%], p = 0.008), and pre-intervention antegrade flow (48 [70.6%] v 104 [41.3%], p < 0.001) were more common in RVOTI. Significant center differences were noted (p < 0.001). Adjusted survival to CR by 18 months (HR = 0.87, 95% CI = 0.63-1.21, p = 0.41) and overall survival (HR = 2.08, 95% CI = 0.93-4.65, p = 0.074) were similar. RVOTI had increased interstage reintervention (HR = 2.15, 95% CI = 1.36-3.99, p = 0.001). Total anesthesia (243 [213, 277] v 328 [308, 351] minutes, p < 0.001) and cardiopulmonary bypass times (117 [103, 132] v 151 [143, 160] minutes, p < 0.001) favored RVOTI. In this multicenter comparison of physiologic palliation strategies for sTOF, survival to successful CR and overall survival were similar; however, reintervention burden was significantly higher in RVOTI., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: The 'DSD Pathways' study was initiated to assess health status and patterns of care among people enrolled in large integrated healthcare systems and diagnosed with conditions comprising the broad category of disorders (differences) of sex development (DSD). The objectives of this communication are to describe methods of cohort ascertainment for two specific DSD conditions-classic congenital adrenal hyperplasia with 46,XX karyotype (46,XX CAH) and complete androgen insensitivity syndrome (CAIS)., Participants: Using electronic health records we developed an algorithm that combined diagnostic codes, clinical notes, laboratory data and pharmacy records to assign each cohort candidate a 'strength-of-evidence' score supporting the diagnosis of interest. A sample of cohort candidates underwent a review of the full medical record to determine the score cutoffs for final cohort validation., Findings to Date: Among 5404 classic 46,XX CAH cohort candidates the strength-of-evidence scores ranged between 0 and 10. Based on sample validation, the eligibility cut-off for full review was set at the strength-of-evidence score of ≥7 among children under the age of 8 years and ≥8 among older cohort candidates. The final validation of all cohort candidates who met the cut-off criteria identified 115 persons with classic 46,XX CAH. The strength-of-evidence scores among 648 CAIS cohort candidates ranged from 2 to 10. There were no confirmed CAIS cases among cohort candidates with scores <6. The in-depth medical record review for candidates with scores ≥6 identified 61 confirmed cases of CAIS., Future Plans: As the first cohort of this type, the DSD Pathways study is well-positioned to fill existing knowledge gaps related to management and outcomes in this heterogeneous population. Analyses will examine diagnostic and referral patterns, adherence to care recommendations and physical and mental health morbidities examined through comparisons of DSD and reference populations and analyses of health status across DSD categories., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Pulmonary vein stenosis is a progressive disease associated with a high rate of mortality in children. If left untreated, myofibroblastic proliferation can lead to pulmonary vein atresia (PVA). In our experience, transcatheter recanalization has emerged as a favorable interventional option. We sought to determine the acute success rate of recanalization of atretic pulmonary veins and mid-term outcomes of individual veins after recanalization., Methods: We reviewed all patients with PVA at our institution between 2008 and 2020 diagnosed by either catheterization or cardiac computed tomography. All veins with successful recanalization were reviewed and procedural success rate and patency rate were noted. Competing risk analysis was performed to demonstrate outcomes of individual atretic veins longitudinally., Results: Between 2008 and 2020, our institution diagnosed and treated 131 patients with pulmonary vein stenosis. Of these, 61 patients developed atresia of at least one pulmonary vein. In total, there were 97 atretic pulmonary veins within this group. Successful recanalization was accomplished in 47/97 (48.5%) atretic veins. No atretic pulmonary veins were successfully recanalized before 2012. The majority of veins were recanalized between 2017 and 2020-39/56 (70%). The most common intervention after recanalization was drug-eluting stent placement. At 2-year follow-up 42.6% of recanalized veins (20.6% of all atretic veins) remained patent with a median of 4 reinterventions per person., Conclusions: Transcatheter recanalization of PVA can result in successful reestablishment of flow to affected pulmonary veins in many cases. Drug-eluting stent implantation was the most common intervention performed immediately post-recanalization. Vein patency was maintained in 42.6% of patients at 2-year follow-up from recanalization with appropriate surveillance and reintervention. Overall, only a small portion of atretic pulmonary veins underwent successful recanalization with maintained vessel patency at follow-up. Irrespective of successful recanalization, there was no detectable survival difference between the more recently treated PVA cohort and non-PVA cohort.

Objective: The ideal valve substitute for surgical intervention of congenital aortic valve disease in children remains unclear. Data on outcomes beyond 10-15 years after valve replacement are limited but important for evaluating substitute longevity. We aimed to describe up to 25-year death/cardiac transplant by type of valve substitute and assess the potential impact of treatment centre. Our hypothesis was that patients with pulmonic valve autograft would have better survival than mechanical prosthetic., Methods: This is a retrospective cohort study from the Pediatric Cardiac Care Consortium, a multi-institutional US-based registry of paediatric cardiac interventions, linked with the National Death Index and United Network for Organ Sharing through 2019. Children (0-20 years old) receiving aortic valve replacement (AVR) from 1982 to 2003 were identified. Kaplan-Meier transplant-free survival was calculated, and Cox proportional hazard models estimated hazard ratios for mechanical AVR (M-AVR) versus pulmonic valve autograft., Results: Among 911 children, the median age at AVR was 13.4 years (IQR=8.4-16.5) and 73% were male. There were 10 cardiac transplants and 153 deaths, 5 after transplant. The 25-year transplant-free survival post AVR was 87.1% for autograft vs 76.2% for M-AVR and 72.0% for tissue (bioprosthetic or homograft). After adjustment, M-AVR remained related to increased mortality/transplant versus autograft (HR=1.9, 95% CI=1.1 to 3.4). Surprisingly, survival for patients with M-AVR, but not autograft, was lower for those treated in centres with higher in-hospital mortality., Conclusion: Pulmonic valve autograft provides the best long-term outcomes for children with aortic valve disease, but AVR results may depend on a centre's experience or patient selection., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Recent data have demonstrated that overall mortality and adverse events are not significantly different for primary repair (PR) and staged repair (SR) approaches to management of neonates with symptomatic tetralogy of Fallot (sTOF). Cost data can be used to compare the relative value (cost for similar outcomes) of these approaches and are a potentially more sensitive measure of morbidity., Objectives: This study sought to compare the economic costs associated with PR and SR in neonates with sTOF., Methods: Data from a multicenter retrospective cohort study of neonates with sTOF were merged with administrative data to compare total costs and cost per day alive over the first 18 months of life in a propensity score-adjusted analysis. A secondary analysis evaluated differences in department-level costs., Results: In total, 324 subjects from 6 centers from January 2011 to November 2017 were studied (40% PR). The 18-month cumulative mortality (P = 0.18), procedural complications (P = 0.10), hospital complications (P = 0.94), and reinterventions (P = 0.22) did not differ between PR and SR. Total 18-month costs for PR (median $179,494 [IQR: $121,760-$310,721]) were less than for SR (median: $222,799 [IQR: $167,581-$327,113]) (P < 0.001). Cost per day alive (P = 0.005) and department-level costs were also all lower for PR. In propensity score-adjusted analyses, PR was associated with lower total cost (cost ratio: 0.73; P < 0.001) and lower department-level costs., Conclusions: In this multicenter study of neonates with sTOF, PR was associated with lower costs. Given similar overall mortality between treatment strategies, this finding suggests that PR provides superior value., Competing Interests: Funding Support and Author Disclosures Financial support for this research was derived in part from the Kennedy Hamill Pediatric Cardiac Research Fund, the Liam Sexton Foundation, and a Heart Like Ava. Dr O’Byrne received research support from the National Institute of Health/National Heart, Lung, and Blood Institute (K23 HL130420-01). The funding agencies had no role in the planning or execution of the study, nor did they edit the manuscript as presented. The study also used resources from The Children's Hospital of Philadelphia Cardiac Center Clinical Research Core. The manuscript represents the opinions of the authors alone. Dr Glatz has served as a consultant for Ampio Pharmaceuticals. Dr Goldstein has served as a consultant for Medtronic, W.L. Gore & Associates, and Mezzion Pharma; and has served as a consultant and on the advisory board for PECA Labs. Dr Qureshi has served as a consultant for Medtronic, W.L. Gore & Associates, Edwards Lifesciences, and Abiomed. Dr Shahanavaz has served as a consultant for Medtronic, Edwards Lifesciences, W.L Gore & Associates, and Abbott Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Epidemiological data on childhood idiopathic nephrotic syndrome (INS) are limited. We estimated childhood INS incidence in a racially and ethnically diverse U.S. population and performed a meta-analysis of published reports to examine differences by race, ethnicity, and time., Methods: One hundred seventy-five children aged 1-17 years living in the Atlanta Metropolitan Statistical Area (MSA) between 2013 and 2018 were identified by retrospective chart review. Annual INS incidence was estimated by dividing cases by population data from the Georgia Department of Public Health. We calculated pooled incidence estimates using random-effects regression models in a meta-analysis of the current and prior studies. Subgroup incidence estimates by race, ethnicity, and time were compared and tested for heterogeneity., Results: One hundred seventy-five children aged 1-17 were diagnosed with INS between 2013 and 2018 in the Atlanta MSA. Average annual incidence was 2.13/100,000 (95% CI, 1.83-2.47). Twenty-four studies were included in meta-analysis. Our study was the only one to report incidence for Hispanic children, 2.13/100,000/y (95% CI, 1.40-3.10). In meta-analysis, incidence was highest in Asian children (7.14/ 100,000/y; 95% CI, 4.73-9.54), followed by Black (3.53/100,000/y; 95% CI, 2.93-4.12), and Caucasian (1.83/100,000/y; 95% CI, 1.52-2.14). Annual incidence in the U.S. was stable comparing studies performed before and after 1984, 2.05 vs. 2.26/100,000 (p 0.08)., Conclusions: Risk of INS may be higher among Asian and Black children compared to White children. Incidence appears stable over time in the U.S. Future studies should use standardized methodology and assess the contribution of demographic and genetic factors to INS incidence and long-term outcomes., (© 2021. Italian Society of Nephrology.)

Patent ductus arteriosus (PDA) stenting is an accepted method for securing pulmonary blood flow in cyanotic neonates. In neonates with pulmonary atresia and single source ductal-dependent pulmonary blood flow (SSPBF), PDA stenting remains controversial. We sought to evaluate outcomes in neonates with SSPBF, comparing PDA stenting and surgical Blalock-Taussig shunt (BTS). Neonates with SSPBF who underwent PDA stenting or BTS at the four centers of the Congenital Catheterization Research Collaborative from January 2008 to December 2015 were retrospectively reviewed. Reintervention on the BTS or PDA stent prior to planned surgical repair served as the primary endpoint. Additional analyses of peri-procedural complications, interventions, and pulmonary artery growth were performed. A propensity score was utilized to adjust for differences in factors. Thirty-five patients with PDA stents and 156 patients with BTS were included. The cohorts had similar baseline characteristics, procedural complications, and mortality. Interstage reintervention rates were higher in the PDA stent cohort (48.6% vs. 15.4%, p < 0.001)., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To compare management strategies for neonates <2.5 kg with tetralogy of Fallot and symptomatic cyanosis who either undergo staged repair (SR) (initial palliation followed by later complete repair) or primary repair (PR)., Methods: Consecutive neonates with tetralogy of Fallot and symptomatic cyanosis weighing <2.5 kg at initial intervention and between 2005 and 2017 were retrospectively reviewed from the Congenital Cardiac Research Collaborative. Primary outcome was mortality and secondary outcomes included component (eg, initial palliation, complete repair, or primary repair) and cumulative (SR: initial palliation followed by later complete repair) hospital and intensive care unit lengths of stay, durations of ventilation, inotrope use, cardiopulmonary bypass time, procedural complications, and reintervention. Outcomes were compared with propensity score adjustments with PR as the reference group., Results: The cohort included 76 SR (initial palliation: 53 surgical and 23 transcatheter) and 44 PR patients. The observed risk of overall mortality was similar between SR and PR groups (15.8% vs 18.2%: P = .735). The adjusted hazard of mortality remained similar between groups overall (hazard ratio, 0.59; 95% confidence interval, 0.26-1.36; P = .214), as well as during short-term (<4 months: hazard ratio, 0.37; 95% confidence interval, 0.13-1.09; P = .071) and midterm (>4 months: hazard ratio, 1.32; 95% confidence interval, 0.30-5.79; P = .717) follow-up. Reintervention in the first 18 months was common in both groups (53.2% vs 48.4%; hazard ratio, 1.69; 95% confidence interval, 0.96-2.28; P = .072). Adjusted procedural complications and neonatal morbidity burden were overall lower in the SR group. Cumulative secondary outcome burdens largely favored the PR group., Conclusions: In this study comparing SR and PR treatment strategies for neonates with tetralogy of Fallot and symptomatic cyanosis and weight <2.5 kg, mortality and reintervention burden was high and independent of treatment strategy. Other potential advantages were observed with each approach., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Stenting of the patent ductus arteriosus (PDA) is an established palliative option for infants with ductal-dependent pulmonary blood flow. Following initial palliation, reintervention on the PDA stent is common, but risk factors have not been characterized., Methods: Infants with ductal-dependent pulmonary blood flow palliated with PDA stent between 2008 and 2015 were reviewed within the Congenital Cardiac Research Collaborative. Rates and risk factors for reintervention were analyzed., Results: Among 105 infants who underwent successful PDA stenting, 41 patients (39%) underwent a total of 53 reinterventions on the PDA stent, with all but one occurring within 6 months of the initial intervention. Stent redilation constituted the majority of reintervention (n=35; 66%) followed by additional stent placement (n=11; 21%) and surgical shunt placement (n=7; 13%). The majority of reintervention was nonurgent, and there were no deaths during the reintervention procedure. All but one reintervention occurred within 6 months of the initial procedure. On univariate analysis, risk factors for reintervention included anticipated single-ventricle physiology, lack of prior balloon pulmonary valvuloplasty, use of drug-eluting stent, and increased ductal tortuosity., Conclusions: In infants with ductal-dependent pulmonary blood flow palliated with PDA stent implantation, reintervention is common, can be performed safely, and is associated with both anatomic/procedural factors and anticipated final physiology.

Elopement is a common and dangerous concern in autism spectrum disorder (ASD). There is evidence that behavior analytic treatments can successfully treat elopement, but the research is limited due to small samples and treatment components varying across studies. The current study evaluated the feasibility of studying a manualized intervention for elopement, based on strategies from single-subject research, in a randomized clinical trial with 24 individuals with ASD. Results demonstrated that recruitment was feasible; the manual was acceptable to parents; and therapists followed the manual with high-integrity. Initial efficacy results measured by the Aberrant Behavior Checklist, Clinical Global Impression Scale, and a Home Elopement Safety Checklist suggested improvement in the treatment group that should be studied in future research.

Objective: To describe clinical factors associated with mortality and causes of death in tracheostomy-dependent (TD) children. Methods: A retrospective study of patients with a new or established tracheostomy requiring hospitalization at a large tertiary children's hospital between 2009 and 2015 was conducted. Patient groups were developed based on indication for tracheostomy: pulmonary, anatomic/airway obstruction, and neurologic causes. The outcome measures were overall mortality rate, mortality risk factors, and causes of death. Results: A total of 187 patients were identified as TD with complete data available for 164 patients. Primary indications for tracheostomy included pulmonary (40%), anatomic/airway obstruction (36%), and neurologic (24%). The median age at tracheostomy and duration of follow up were 6.6 months (IQR 3.5-19.5 months) and 23.8 months (IQR 9.9-46.7 months), respectively. Overall, 45 (27%) patients died during the study period and the median time to death following tracheostomy was 9.8 months (IQR 6.1-29.7 months). Overall survival at 1- and 5-years following tracheostomy was 83% (95% CI: 76-88%) and 68% (95% CI: 57-76%), respectively. There was no significant difference in mortality based on indication for tracheostomy ( p = 0.35), however pulmonary indication for tracheostomy was associated with a shorter time to death (HR: 1.9; 95% CI: 1.04-3.4; p = 0.04). Among the co-morbid medical conditions, children with seizure disorder had higher mortality ( p = 0.04). Conclusion: In this study, TD children had a high mortality rate with no significant difference in mortality based on indication for tracheostomy. Pulmonary indication for tracheostomy was associated with a shorter time to death and neurologic indication was associated with lower decannulation rates., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Hebbar, Kasi, Vielkind, McCracken, Ivie, Prickett and Simon.)

Background: Neonates with tetralogy of Fallot and symptomatic cyanosis (sTOF) require early intervention., Objectives: This study sought to perform a balanced multicenter comparison of staged repair (SR) (initial palliation [IP] and subsequent complete repair [CR]) versus primary repair (PR) treatment strategies., Methods: Consecutive neonates with sTOF who underwent IP or PR at ≤30 days of age from 2005 to 2017 were retrospectively reviewed from the Congenital Cardiac Research Collaborative. The primary outcome was death. Secondary outcomes included component (IP, CR, PR) and cumulative (SR): hospital and intensive care unit lengths of stay; durations of cardiopulmonary bypass, anesthesia, ventilation, and inotrope use; and complication and reintervention rates. Outcomes were compared using propensity score adjustment., Results: The cohort consisted of 342 patients who underwent SR (IP: surgical, n = 256; transcatheter, n = 86) and 230 patients who underwent PR. Pre-procedural ventilation, prematurity, DiGeorge syndrome, and pulmonary atresia were more common in the SR group (p ≤0.01). The observed risk of death was not different between the groups (10.2% vs 7.4%; p = 0.25) at median 4.3 years. After adjustment, the hazard of death remained similar between groups (hazard ratio: 0.82; 95% confidence interval: 0.49 to 1.38; p = 0.456), but it favored SR during early follow-up (<4 months; p = 0.041). Secondary outcomes favored the SR group in component analysis, whereas they largely favored PR in cumulative analysis. Reintervention risk was higher in the SR group (p = 0.002)., Conclusions: In this multicenter comparison of SR or PR for management of neonates with sTOF, adjusted for patient-related factors, early mortality and neonatal morbidity were lower in the SR group, but cumulative morbidity and reinterventions favored the PR group, findings suggesting potential benefits to each strategy., Competing Interests: Funding Support and Author Disclosures Financial support for this research was derived, in part, from the Kennedy Hammill Pediatric Cardiac Research Fund, the Liam Sexton Foundation, and A Heart Like Ava. Dr. Goldstein has reported consulting relationships with Medtronic, W.L. Gore & Associates, and Edwards Lifesciences; and is an advisory board member for PECA Labs. Dr. Qureshi has reported consulting relationships with W.L Gore & Associates, Edwards Lifesciences, and Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Isolated pulmonary artery (PA) of ductal origin (IPADO) is a rare cardiac defect which requires surgical repair, with or without preceding palliation. We sought to determine the impact of treatment strategy on outcomes. Retrospective study of consecutive patients with IPADO that underwent staged or primary repair from 1/05 to 9/16 at 6 Congenital Cardiac Research Collaborative centers. Patients with single ventricle physiology, major aortopulmonary collaterals, or bilateral IPADO were excluded. Primary outcome was isolated PA z-score at late follow-up. Secondary outcomes included PA symmetry index (isolated:confluent PA diameter) and reintervention burden. Propensity score adjustment was used to account for baseline differences. Of 60 patients in the study cohort, 26 (43%) underwent staged and 34 (57%) primary repair. The staged and primary repair groups differed in weight at diagnosis and presence of other heart disease but not in baseline PA dimensions. Staged patients underwent ductal stent (n = 16) or surgical shunt (n = 10) placement followed by repair at 210 vs. 21 days in the primary repair group (p < 0.001). At median follow-up of 4.5 years post-repair, after adjustment, isolated PA z-score (- 0.74 [- 1.75, - 0.26] vs. - 1.95 [- 2.91, - 1.59], p = 0.012) and PA symmetry index (0.81 [0.49, 1.0] vs. 0.55 [0.48, 0.69], p = 0.042) significantly favored the staged repair group. Freedom from PA reintervention was not different between groups (adjusted HR 0.78 [0.41, 1.48]; p = 0.445). A staged approach to repair of IPADO is associated with superior isolated PA size and symmetry at late follow-up. Consideration should be given to initial palliation in IPADO patients, when feasible.

Background: Concern exists over exponential growth in cardiac imaging in adults, but there is paucity of such data for cardiac imaging trends in pediatric patients. The aims of this study were to determine temporal trends in the use of noninvasive cardiac imaging and compare these with trends in the use of noncardiac imaging and to identify factors influencing those trends using the Pediatric Health Information Service database., Methods: Pediatric inpatient encounter data from January 2004 to December 2017 at 35 pediatric hospitals were extracted from the Pediatric Health Information Service database. Temporal imaging utilization trends in cardiac and noncardiac ultrasound or echocardiography, magnetic resonance imaging (MRI), and computed tomography (CT) were assessed using linear mixed-effects models. Models were adjusted for case-mix index, complex chronic conditions, patient age, length of stay, payer source, and cardiac surgical volume., Results: A total of 5,869,335 encounters over 14 years were analyzed (median encounters per center per year, 11,411; median patient age, 4 years; median length of stay, 3 days). From 2004 to 2017, the rates of pediatric inpatient cardiac and noncardiac ultrasound and MRI increased, whereas the rate of noncardiac CT decreased. Cardiac CT use increased beginning in 2014 (+0.264 cardiac CT encounters per 1,000 encounters per year), surpassing the rate of rise of cardiac MRI. Case-mix index, cardiac surgical volume, and payer source affected the largest number of imaging trends., Conclusions: Among pediatric inpatients, utilization of cardiac and noncardiac ultrasound and MRI has steadily increased. Noncardiac CT use declined and cardiac CT use increased after 2014. Factors influencing imaging trends include case-mix index, cardiac surgical volume, and payer source. This study lays a foundation for investigations of imaging-related resource utilization and outcomes among pediatric inpatients., (Copyright © 2020 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Study Objective: Acute chest syndrome is a leading cause of mortality in patients with sickle cell disease (SCD). Because early detection of acute chest syndrome is directly tied to prognosis, young patients with SCD undergo countless chest radiography screenings throughout their lifetime for commonly occurring acute chest syndrome risk factors such as fever, chest pain, or cough. Chest radiography is not an ideal screening method because it is associated with radiation exposure, which accumulates with repeated imaging. Point-of-care lung ultrasonography is a nonradiating imaging modality that has been used to identify other lung pathology and may have a role in SCD. The goal of this study was to determine the accuracy of point-of-care lung ultrasound to identify an infiltrate suggestive of acute chest syndrome in patients with SCD compared to chest radiography as the gold standard., Methods: This was a prospective observational study in 2 urban pediatric emergency departments to evaluate the accuracy of point-of-care lung ultrasonography in identifying patients with SCD who were aged 0 to 21 years and had an infiltrate suggestive of acute chest syndrome compared with chest radiography. Clinicians and trainees with point-of-care lung ultrasonographic training obtained informed consent and performed investigational point-of-care lung ultrasonography to evaluate for lung consolidation. A blinded point-of-care lung ultrasonographic expert reviewed results for quality assurance and agreement. Accuracy, sensitivity, specificity, likelihood ratios, and positive and negative predictive value were calculated for point-of-care lung ultrasonography test performance characteristics, with chest radiography as a reference standard., Results: Point-of-care lung ultrasonography was performed on 191 SCD patients with a mean age of 8 years; 41% were female patients, and there was a 17% prevalence of acute chest syndrome. Accuracy of point-of-care lung ultrasonography to detected acute chest syndrome was 92%, sensitivity was 88%, and specificity was 93% compared with that for chest radiography., Conclusion: Point-of-care lung ultrasonography is a feasible alternative to chest radiography for screening for acute chest syndrome in young patients with SCD. Further studies are needed to determine how this test performs within clinical practice., (Copyright © 2020 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to determine correlation and temporal association between automated pupillary measurements and intracranial pressure in pediatric patients with brain injury or encephalopathy requiring intracranial pressure monitoring. We hypothesized that abnormal pupillary measurements would precede increases in intracranial pressure., Design: A prospective cohort study was performed. Automated pupillometry measurements were obtained at the same frequency as the patients' neurologic assessments with concurrent measurement of intracranial pressure, for up to 72 hours. Pupillary measurements and the Neurologic Pupil index, an algorithmic score that combines measures of pupillary reactivity, were assessed for correlation with concurrent and future intracranial pressure measurements., Setting: Single-center pediatric quaternary ICU, from July 2017 to October 2018., Patients: Pediatric patients 18 years or younger with a diagnosis of acute brain injury or encephalopathy requiring an intracranial pressure monitor., Interventions: None., Measurements and Main Results: Twenty-eight patients were analyzed with a total of 1,171 intracranial pressure measurements. When intracranial pressure was elevated, the Neurologic Pupil index, percent change in pupillary size, constriction velocity, and dilation velocity were significantly lower than when intracranial pressure was within normal range (p < 0.001 for all). There were mild to moderate negative correlations between concurrent intracranial pressure and pupillary measurements. However, there was an inconsistent pattern of abnormal pupillary measurements preceding increases in intracranial pressure; some patients had a negative association, while others had a positive relationship or no relationship between Neurologic Pupil index and intracranial pressure., Conclusions: Our data indicate automated assessments of pupillary reactivity inversely correlate with intracranial pressure, demonstrating that pupillary reactivity decreases as intracranial pressure increases. However, a temporal association in which abnormal pupillary measurements precede increases in intracranial pressure was not consistently observed. This work contributes to limited data available regarding automated pupillometry in neurocritically ill patients, and the even more restricted subset available in pediatrics.

Objective: To assess characteristics and outcomes of young children receiving intensive multidisciplinary intervention for chronic food refusal and feeding tube dependence., Study Design: We conducted a retrospective study of consecutive patients (birth to age 21 years) admitted to an intensive multidisciplinary intervention program over a 5-year period (June 2014-June 2019). Inclusion criteria required dependence on enteral feeding, inadequate oral intake, and medical stability to permit tube weaning. Treatment combined behavioral intervention and parent training with nutrition therapy, oral-motor therapy, and medical oversight. Data extraction followed a systematic protocol; outcomes included anthropometric measures, changes in oral intake, and percentage of patients fully weaned from tube feeding., Results: Of 229 patients admitted during the 5-year period, 83 met the entry criteria; 81 completed intervention (98%) and provided outcome data (46 males, 35 females; age range, 10-230 months). All patients had complex medical, behavioral, and/or developmental histories with longstanding feeding problems (median duration, 33 months). At discharge, oral intake improved by 70.5%, and 27 patients (33%) completely weaned from tube feeding. Weight gain (mean, 0.39 ± 1 kg) was observed. Treatment gains continued following discharge, with 58 patients (72%) weaned from tube feeding at follow-up., Conclusions: Our findings support the effectiveness of our intensive multidisciplinary intervention model in promoting oral intake and reducing dependence on tube feeding in young children with chronic food refusal. Further research on the generalizability of this intensive multidisciplinary intervention approach to other specialized treatment settings and/or feeding/eating disorder subtypes is warranted., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Various measures and definitions for undernutrition are used in pediatrics. Younger children treated for cancer are at high risk, but lack well-defined risk-based screening and intervention., Methods: A retrospective study collected weight longitudinally for patients less than three years-old over two years after initiating cancer treatment. We included those diagnosed 2007-2015 at a large pediatric cancer center. Exclusion criteria included treatment starting outside our system, secondary or relapsed malignancy, or incomplete information. A decrease ≥1 in weight-for-age or weight-for-height z-score signified clinically significant weight loss. Univariate and multivariate models assessed hazards for developing first episode of clinically significant weight loss., Results: Of 372 patients, only 24.6% of patients lost 10% of weight, but 58.6% lost weight-for-age z-score ≥1 and 64.8% lost ≥1 weight-for-height z-score within two years of treatment initiation. Patients who lost weight were younger (median age 15 vs. 24 months, p < 0.001). Compared to patients diagnosed in the first year of life, those diagnosed 24-35 months were less likely to lose weight (HR 0.62, p < 0.001) and lost weight later (median time to weight loss 144 vs. 35 days). Higher treatment intensity increased weight loss risk (HR 2.30, p < 0.001) and decreased time to weight loss (35 vs. 154 days). No differences were found based on sex, diagnosis, enteral or parenteral nutrition, gastroenterology consults, or intensive care admissions., Conclusions: Using normalized z-scores is more sensitive for identifying weight loss. Younger children are more likely to lose weight with higher intensity cancer therapy. Patient and treatment specific information should be used in risk stratifying weight loss screening and nutritional interventions., Competing Interests: Declaration of Competing Interest The authors do not have a financial relationship with the organizations sponsoring this research that would create a real or perceived conflict of interest. The corresponding author has full control and ownership of the data presented here and can be produced for review by the journal if requested., (Copyright © 2020 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)

Diffuse correlation spectroscopy (DCS) is an optical modality used to measure an index of blood flow in biological tissue. This blood flow index depends on both the red blood cell flow rate and density (i.e., hematocrit), although the functional form of hematocrit dependence is not well delineated. Herein, we develop and validate a novel tissue-simulating phantom containing hundreds of microchannels to investigate the influence of hematocrit on blood flow index. For a fixed flow rate, we demonstrate a significant inverse relationship between hematocrit and blood flow index that must be accounted for to accurately estimate blood flow under anemic conditions., Competing Interests: The authors declare no conflicts of interest., (© 2020 Optical Society of America under the terms of the OSA Open Access Publishing Agreement.)

Background: The pediatric Appropriate Use Criteria (AUC) for outpatient transthoracic echocardiography (TTE) aim to reduce practice variation. Little is known on variation in TTE use between physicians. Understanding this variation will help identify areas for improvement in standardization of TTE use., Methods and Results: This is a retrospective review of initial outpatient visits at 6 pediatric cardiology centers in the United States prior to AUC release. Variation in TTE use was examined using multilevel generalized mixed effects models. Forward selection identified combinations of variables that explained the most variance in TTE use between physicians. Due to collinearity, physician compensation model and center were analyzed separately. Of 2883 encounters, the most common indication was murmur (36%), followed by chest pain (15.2%). Overall TTE use was 41.9%, and varied widely between centers (22.9%-52.6%), and between physicians within centers. Center alone explained 29% of this physician variance. Adding physician characteristics increased the variance explained to 57%, which only minimally improved by adding patient characteristics. The variance explained was driven by subspecialty. The center-based multivariable model explained more variance over compensation model., Conclusions: Center was the single largest determinant of physician variance in TTE use, followed by physician subspecialty. Efforts to reduce practice variation, such as the AUC, should be employed across centers and all pediatric cardiac providers. Center appears to have a stronger impact on variance than compensation model, though in this dataset the effect of center and compensation are hard to separate from each other and deserve further evaluation., (© 2020 Wiley Periodicals, LLC.)

Background: Pediatric subspecialists routinely provide procedural sedation outside the operating room. No large study has reported trends in outpatient pediatric procedural sedation. Our purpose in this study was to identify significant trends in outpatient procedural sedation using the Pediatric Sedation Research Consortium., Methods: Prospectively collected data from 2007 to 2018 were used for trending procedural sedation. Patient characteristics, medications, type of providers, serious adverse events, and interventions were reported. The Cochran-Armitage test for trend was used to explore the association between the year and a given characteristic., Results: A total of 432 842 sedation encounters were identified and divided into 3 4-year epochs (2007-2011, 2011-2014, and 2014-2018). There was a significant decrease in infants <3 months of age receiving procedural sedation (odds ratio = 0.97; 95% confidence interval, 0.96-0.98). A large increase was noticed in pediatric hospitalists providing procedural sedation (0.6%-9.5%; P < .001); there was a decreasing trend in sedation by other providers who were not in emergency medicine, critical care, or anesthesiology (13.9%-3.9%; P < .001). There was an increasing trend in the use of dexmedetomidine (6.3%-9.3%; P < .001) and a decreasing trend in the use of chloral hydrate (6.3%-0.01%; P < .001) and pentobarbital (7.3%-0.5%; P < .001). Serious adverse events showed a nonsignificant increase overall (1.35%-1.75%)., Conclusions: We report an increase in pediatric hospitalists providing sedation and a significant decrease in the use of chloral hydrate and pentobarbital by providers. Further studies are required to see if sedation services decrease costs and optimize resource use., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2020 by the American Academy of Pediatrics.)

Background: Adults with traumatic brain injury (TBI) who present hypertensive suffer worse outcomes and increased mortality compared to normotensive patients. The purpose of this study is to determine if age-adjusted hypertension on presentation is associated with worsened outcomes in pediatric TBI., Methods: A retrospective chart review was conducted on pediatric patients with severe TBI admitted to a single system pediatric tertiary care center. The primary outcome was mortality. Secondary outcomes included length of stay, need for neurosurgical intervention, duration of mechanical ventilation, and the need for inpatient rehabilitation., Results: Of 150 patients, 70% were hypertensive and 30% were normotensive on presentation. Comparing both groups, no statistically significant differences were noted in mortality (13.3% for both groups), need for neurosurgical intervention (51.4% vs 48.8%, p = 0.776), length of stay (6 vs 8 days, p = 0.732), duration of mechanical ventilation (2 vs 3 days, p = 0.912), or inpatient rehabilitation rates (48.6% vs 48.9%, p = 0.972). In comparing just the hypertensive patients, there was a trend toward increased mortality in the 95th and 99th percentile groups at 15.8% and 14.1%, versus the 90th percentile group at 6.7% but the difference was not statistically significant (p = 0.701)., Conclusions: Contrary to the adult literature, pediatric patients with severe TBI and hypertension on presentation do not appear to have worsened outcomes compared to those who are normotensive. However, a trend toward increased mortality did exist at extremes of age adjusted hypertension. Larger scale studies are needed to validate these findings., Study Type: Retrospective cohort study LEVEL OF EVIDENCE: III., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Carotid artery (CA) and axillary artery (AA) access are increasingly used for transcatheter stenting of the patent ductus arteriosus (PDA), although reports are limited., Methods: The Congenital Catheterization Research Collaborative (CCRC) reviewed multicenter data from infants who underwent PDA stenting via the CA or AA approach from 2008 to 2017, and compared outcomes to those of infants undergoing PDA stenting via the femoral artery (FA) approach. Post-procedure ultrasound (US) imaging was reviewed., Results: Forty-nine infants underwent PDA stenting from the CA (n = 43) or AA (n = 6) approach, compared with 55 infants who underwent PDA stenting from the FA approach. The PDA was the sole pulmonary blood flow (PBF) source in 61% of infants in the CA/AA cohort, compared with 33% of the FA cohort (p < .01). Ductal tortuosity for CA/AA cohort was Type I (straight) in 10 (20%), Type II (one turn) in 17 (35%), and Type III (multiple turns) in 22 (45%) infants and reflected a greater degree of tortuosity when compared to the FA cohort (p < .01). In 17 infants with CA/AA approach, the "flip technique" was used, and was associated with shorter procedure times for highly tortuous PDA (Type III) patients. Rates of procedural complications were similar across access sites. Most common complications were access site injury (thrombus or bleeding) and stent malposition. No complications were specifically related to the "flip technique.", Conclusions: Use of CA and AA approach for PDA stenting was found to be more commonly employed in sole source PBF and highly tortuous PDAs. Procedural modifications such as the "flip technique" may lead to shorter procedure times. CA and AA approaches are associated with a similar burden of procedural or late complications. Post-procedural surveillance of the CA and AA is suggested, given the incidence of vascular findings on US., (© 2019 Wiley Periodicals, Inc.)

Aim: To prospectively validate a pediatric clinical prediction model to identify children at low risk of clinically significant ingestions to prevent unnecessary pediatric intensive care unit (PICU) admissions. Methods: Calls received by the Georgia Poison Center about children for acute ingestions between May 25, 2017 and May 17, 2018 were scored in real time using the full, age-stratified, and simplified clinical scoring tool to r educe c hildhood a dmissions to P ICUs for p oisoning (RECAP 2 ). Clinically significant ingestions with a poison center recommendation of PICU admission are defined in the simple RECAP 2 model as ingestion of clonidine, ethanol, an oral anti-hyperglycemic agent, or exposure to carbon monoxide, as well as the presence of symptoms occurring within 2 h for an immediate release, or 4 h for an extended release, medication exposure. Model statistics and percent reduction in PICU admissions were computed. Results: There were 886 children admitted after ingestions, of which 454 (51.2%) children were admitted to intensive care. At the time of the initial poison center call to report the ingestion, 44 cases (5%) were incomplete using the full, age-stratified model compared to the complete scoring using the simple scoring model. Seventy-two children (8.1%) required monitoring or interventions performed only in a PICU. Real-time application of the full model compared with the simple model would have reduced PICU admissions by 33.3 and 31.7%, respectively. Conclusions: The simple RECAP 2 clinical scoring model is a sensitive prediction tool to identify children at very low risk for clinically significant ingestions for whom PICU admission can be avoided. Clinical implementation of the simple RECAP 2 model and recommendation for admission to an inpatient unit versus PICU should be further evaluated, to reduce unnecessary PICU admissions following acute ingestions.