Developing the WE BEAT Well-Being Education Programme to foster resilience and build connection in paediatric heart disease.

BACKGROUND: The study of psychological well-being and related resilient outcomes is of increasing focus in cardiovascular research. Despite the critical importance of psychological well-being and related resilient outcomes in promoting optimal cardiac health, there have been very few psychological interventions directed towards children with heart disease. This paper describes the development and theoretical framework of the WE BEAT Wellbeing Education Program, a group-based psychoeducation and coping skills training intervention designed to improve psychological well-being and resilience in adolescents with paediatric heart disease. METHODS: Program development was informed by patient and family needs and input gathered via large, international survey methods as well as qualitative investigation, a theoretical framework, and related resilience intervention research. RESULTS: An overview of the WE BEAT intervention components and structure of the programme is provided. CONCLUSIONS: The WE BEAT Wellbeing Education Program was developed as one of the first resiliency-focused interventions in paediatric heart disease with an overall objective to foster positive psychological well-being and resilient outcomes through a health promotion and prevention lens in an accessible format while providing access to safe, peer-to-peer community building. Feasibility pilot results are forthcoming. Future directions include mobile app-based delivery and larger-scale efficacy and implementation trials.

Assessing enrollment of eligible infants in the national pediatric cardiology quality improvement collaborative (NPC-QIC) through linkage to the pediatric cardiac critical care consortium (PC4) registry.

BACKGROUND: The National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) lacks a rigorous enrollment audit process, unlike other collaborative networks. Most centers require individual families to consent to participate. It is unknown whether there is variation across centers or biases in enrollment. METHODS: We used the Pediatric Cardiac Critical Care Consortium (PC4) registry to assess enrollment rates in NPC-QIC for those centers participating in both registries using indirect identifiers (date of birth, date of admission, gender, and center) to match patient records. All infants born 1/1/2018-12/31/2020 and admitted 30 days of life were eligible. In PC4, all infants with a fundamental diagnosis of hypoplastic left heart or variant or who underwent a surgical or hybrid Norwood or variant were eligible. Standard descriptive statistics were used to describe the cohort and center match rates were plotted on a funnel chart. RESULTS: Of 898 eligible NPC-QIC patients, 841 were linked to 1,114 eligible PC4 patients (match rate 75.5%) in 32 centers. Match rates were lower in patients of Hispanic/Latino ethnicity (66.1%, p = 0.005), and those with any specified chromosomal abnormality (57.4%, p = 0.002), noncardiac abnormality (67.8%, p = 0.005), or any specified syndrome (66.5%, p = 0.001). Match rates were lower for patients who transferred to another hospital or died prior to discharge. Match rates varied from 0 to 100% across centers. CONCLUSIONS: It is feasible to match patients between the NPC-QIC and PC4 registries. Variation in match rates suggests opportunities for improvement in NPC-QIC patient enrollment.

Prediction of extubation failure in the paediatric cardiac ICU using machine learning and high-frequency physiologic data.

BACKGROUND: Cardiac intensivists frequently assess patient readiness to wean off mechanical ventilation with an extubation readiness trial despite it being no more effective than clinician judgement alone. We evaluated the utility of high-frequency physiologic data and machine learning for improving the prediction of extubation failure in children with cardiovascular disease. METHODS: This was a retrospective analysis of clinical registry data and streamed physiologic extubation readiness trial data from one paediatric cardiac ICU (12/2016-3/2018). We analysed patients' final extubation readiness trial. Machine learning methods (classification and regression tree, Boosting, Random Forest) were performed using clinical/demographic data, physiologic data, and both datasets. Extubation failure was defined as reintubation within 48 hrs. Classifier performance was assessed on prediction accuracy and area under the receiver operating characteristic curve. RESULTS: Of 178 episodes, 11.2% (N = 20) failed extubation. Using clinical/demographic data, our machine learning methods identified variables such as age, weight, height, and ventilation duration as being important in predicting extubation failure. Best classifier performance with this data was Boosting (prediction accuracy: 0.88; area under the receiver operating characteristic curve: 0.74). Using physiologic data, our machine learning methods found oxygen saturation extremes and descriptors of dynamic compliance, central venous pressure, and heart/respiratory rate to be of importance. The best classifier in this setting was Random Forest (prediction accuracy: 0.89; area under the receiver operating characteristic curve: 0.75). Combining both datasets produced classifiers highlighting the importance of physiologic variables in determining extubation failure, though predictive performance was not improved. CONCLUSION: Physiologic variables not routinely scrutinised during extubation readiness trials were identified as potential extubation failure predictors. Larger analyses are necessary to investigate whether these markers can improve clinical decision-making.

National Variation in Congenital Heart Surgery Outcomes.

BACKGROUND: Optimal strategies to improve national congenital heart surgery outcomes and reduce variability across hospitals remain unclear. Many policy and quality improvement efforts have focused primarily on higher-risk patients and mortality alone. Improving our understanding of both morbidity and mortality and current variation across the spectrum of complexity would better inform future efforts. METHODS: Hospitals participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2014-2017) were included. Case mix-adjusted operative mortality, major complications, and postoperative length of stay were evaluated using Bayesian models. Hospital variation was quantified by the interdecile ratio (IDR, upper versus lower 10%) and 95% credible intervals (CrIs). Stratified analyses were performed by risk group (Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery [STAT] category) and simulations evaluated the potential impact of reductions in variation. RESULTS: A total of 102 hospitals (n=84 407) were included, representing ≈85% of US congenital heart programs. STAT category 1 to 3 (lower risk) operations comprised 74% of cases. All outcomes varied significantly across hospitals: adjusted mortality by 3-fold (upper versus lower decile 5.0% versus 1.6%, IDR 3.1 [95% CrI 2.5-3.7]), mean length of stay by 1.8-fold (19.2 versus 10.5 days, IDR 1.8 [95% CrI 1.8-1.9]), and major complications by >3-fold (23.5% versus 7.0%, IDR 3.4 [95% CrI 3.0-3.8]). The degree of variation was similar or greater for low- versus high-risk cases across outcomes, eg, ≈3-fold mortality variation across hospitals for STAT 1 to 3 (IDR 3.0 [95% CrI 2.1-4.2]) and STAT 4 or 5 (IDR 3.1 [95% CrI 2.4-3.9]) cases. High-volume hospitals had less variability across outcomes and risk categories. Simulations suggested potential reductions in deaths (n=282), major complications (n=1539), and length of stay (101 183 days) over the 4-year study period if all hospitals were to perform at the current median or better, with 37% to 60% of the improvement related to the STAT 1 to 3 (lower risk) group across outcomes. CONCLUSIONS: We demonstrate significant hospital variation in morbidity and mortality after congenital heart surgery. Contrary to traditional thinking, a substantial portion of potential improvements that could be realized on a national scale were related to variability among lower-risk cases. These findings suggest modifications to our current approaches to optimize care and outcomes in this population are needed.

Trajectories in Neurodevelopmental, Health-Related Quality of Life, and Functional Status Outcomes by Socioeconomic Status and Maternal Education in Children with Single Ventricle Heart Disease.

Trajectories of neurodevelopment and quality of life were analyzed in children with hypoplastic left heart syndrome according to socioeconomic status (SES) and maternal education. Lower SES and less maternal education were associated with greater early delays in communication and problem-solving and progressive delays in problem-solving and fine motor skills over time.

Spillover of Early Extubation Practices From the Pediatric Heart Network Collaborative Learning Study.

OBJECTIVES: The Pediatric Heart Network Collaborative Learning Study used collaborative learning strategies to implement a clinical practice guideline that increased rates of early extubation after infant repair of tetralogy of Fallot and coarctation of the aorta. We assessed early extubation rates for infants undergoing cardiac surgeries not targeted by the clinical practice guideline to determine whether changes in extubation practices spilled over to care of other infants. DESIGN: Observational analyses of site's local Society of Thoracic Surgeons Congenital Heart Surgery Database and Pediatric Cardiac Critical Care Consortium Registry. SETTING: Four Pediatric Heart Network Collaborative Learning Study active-site hospitals. PATIENTS: Infants undergoing ventricular septal defect repair, atrioventricular septal defect repair, or superior cavopulmonary anastomosis (lower complexity), and arterial switch operation or isolated aortopulmonary shunt (higher complexity). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Aggregate outcomes were compared between the 12 month pre-clinical practice guideline and 12 months after study completion (Follow Up). In infants undergoing lower complexity surgeries, early extubation increased during Follow Up compared with Pre-Clinical Practice Guideline (30.2% vs 18.8%, p = 0.006), and hours to initial postoperative extubation decreased. We observed variation in these outcomes by surgery type, with only ventricular septal defect repair associated with a significant increase in early extubation during Follow Up compared with Pre-Clinical Practice Guideline (47% vs 26%, p = 0.006). Variation by study site was also seen, with only one hospital showing an increase in early extubation. In patients undergoing higher complexity surgeries, there was no difference in early extubation or hours to initial extubation between the study eras. CONCLUSIONS: We observed spillover of extubation practices promoted by the Collaborative Learning Study clinical practice guideline to lower complexity operations not included in the original study that was sustainable 1 year after study completion, though this effect differed across sites and operation subtypes. No changes in postoperative extubation outcomes following higher complexity surgeries were seen. The significant variation in outcomes by site suggests that center-specific factors may have influenced spillover of clinical practice guideline practices.

Impact of the COVID-19 pandemic on CHD care and emotional wellbeing.

BACKGROUND: Understanding the impact of the COVID-19 pandemic on paediatric non-COVID-19-related care, as well as patient and caregiver concerns and stressors, is critical for informing healthcare delivery. It was hypothesised that high care disruptions and psychological stress would be observed among paediatric and adult CHD patients in the early phase of the pandemic. METHODS: A cross-sectional, international, electronic survey study was completed. Eligible participants included parents of children with acquired or CHD, adults with CHD, or caregivers of adults with CHD. RESULTS: A total of 1220 participants from 25 countries completed the survey from 16 April to 4 May, 2020. Cardiac care disruption was significant with 38% reporting delays in pre-pandemic scheduled cardiac surgeries and 46% experiencing postponed cardiac clinic visits. The majority of respondents (75%) endorsed moderate to high concern about the patient with heart disease becoming ill from COVID-19. Worry about returning for in-person care was significantly greater than worry of harm to patient due to postponed care. Clinically significant psychological stress was high across the sample including children (50%), adults with CHD (42%), and caregivers (42%). CONCLUSIONS: The early phase of the COVID-19 pandemic contributed to considerable disruptions in cardiac care for patients with paediatric and adult CHD. COVID-19-related fears are notable with potential to impact willingness to return to in-person care. Psychological stress is also very high necessitating intervention. Further study of the impact of delays in care on clinical outcomes is warranted.

Registry-based trials: a potential model for cost savings?

BACKGROUND/AIMS: Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials. METHODS: We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design. RESULTS: Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field. CONCLUSIONS: Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.

Extubation Failure Rates After Pediatric Cardiac Surgery Vary Across Hospitals.

OBJECTIVES: Many hospitals aim to extubate children early after cardiac surgery, yet it remains unclear how this practice associates with extubation failure. We evaluated adjusted extubation failure rates and duration of postoperative mechanical ventilation across hospitals and assessed cardiac ICU organizational factors associated with extubation failure. DESIGN: Secondary analysis of the Pediatric Cardiac Critical Care Consortium clinical registry. SETTING: Pediatric Cardiac Critical Care Consortium cardiac ICUs. PATIENTS: Patients with qualifying index surgical procedures from August 2014 to June 2017. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We modeled hospital-level adjusted extubation failure rates using multivariable logistic regression. A previously validated Pediatric Cardiac Critical Care Consortium model was used to calculate adjusted postoperative mechanical ventilation. Observed-to-expected ratios for both metrics were derived for each hospital to assess performance. Hierarchical logistic regression was used to assess the association between cardiac ICU factors and extubation failure. Overall, 16,052 surgical hospitalizations were analyzed. Predictors of extubation failure (p < 0.05 in final case-mix adjustment model) included younger age, underweight, greater surgical complexity, airway anomaly, chromosomal anomaly/syndrome, longer cardiopulmonary bypass time, and other preoperative comorbidities. Three hospitals were better-than-expected outliers for extubation failure (95% CI around observed-to-expected < 1), and three hospitals were worse-than-expected (95% CI around observed-to-expected > 1). Two hospitals were better-than-expected outliers for both extubation failure and postoperative mechanical ventilation, and three were worse-than-expected for both. No hospital was an outlier in opposite directions. Greater nursing hours per patient day and percent nursing staff with critical care certification were associated with lower odds of extubation failure. Cardiac ICU factors such as fewer inexperienced nurses, greater percent critical care trained attendings, cardiac ICU-dedicated respiratory therapists, and fewer patients per cardiac ICU attending were not associated with lower odds of extubation failure. CONCLUSIONS: We saw no evidence that hospitals trade higher extubation failure rates for shorter duration of postoperative mechanical ventilation after pediatric cardiac surgery. Increasing specialized cardiac ICU nursing hours per patient day may achieve better extubation outcomes and mitigate the impact of inexperienced nurses.

A Novel Model Demonstrates Variation in Risk-Adjusted Mortality Across Pediatric Cardiac ICUs After Surgery.

OBJECTIVE: To develop a postoperative mortality case-mix adjustment model to facilitate assessment of cardiac ICU quality of care, and to describe variation in adjusted cardiac ICU mortality across hospitals within the Pediatric Cardiac Critical Care Consortium. DESIGN: Observational analysis. SETTING: Multicenter Pediatric Cardiac Critical Care Consortium clinical registry. PARTICIPANTS: All surgical cardiac ICU admissions between August 2014 and May 2016. The analysis included 8,543 admissions from 23 dedicated cardiac ICUs. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We developed a novel case-mix adjustment model to measure postoperative cardiac ICU mortality after congenital heart surgery. Multivariable logistic regression was performed to assess preoperative, intraoperative, and immediate postoperative severity of illness variables as candidate predictors. We used generalized estimating equations to account for clustering of patients within hospital and obtain robust SEs. Bootstrap resampling (1,000 samples) was used to derive bias-corrected 95% CIs around each predictor and validate the model. The final model was used to calculate expected mortality at each hospital. We calculated a standardized mortality ratio (observed-to-expected mortality) for each hospital and derived 95% CIs around the standardized mortality ratio estimate. Hospital standardized mortality ratio was considered a statistically significant outlier if the 95% CI did not include 1. Significant preoperative predictors of mortality in the final model included age, chromosomal abnormality/syndrome, previous cardiac surgeries, preoperative mechanical ventilation, and surgical complexity. Significant early postoperative risk factors included open sternum, mechanical ventilation, maximum vasoactive inotropic score, and extracorporeal membrane oxygenation. The model demonstrated excellent discrimination (C statistic, 0.92) and adequate calibration. Comparison across Pediatric Cardiac Critical Care Consortium hospitals revealed five-fold difference in standardized mortality ratio (0.4-1.9). Two hospitals had significantly better-than-expected and two had significantly worse-than-expected mortality. CONCLUSIONS: For the first time, we have demonstrated that variation in mortality as a quality metric exists across dedicated cardiac ICUs. These findings can guide efforts to reduce mortality after cardiac surgery.

Variation in Adjusted Mortality for Medical Admissions to Pediatric Cardiac ICUs.

OBJECTIVES: Pediatric cardiac ICUs should be adept at treating both critical medical and surgical conditions for patients with cardiac disease. There are no case-mix adjusted quality metrics specific to medical cardiac ICU admissions. We aimed to measure case-mix adjusted cardiac ICU medical mortality rates and assess variation across cardiac ICUs in the Pediatric Cardiac Critical Care Consortium. DESIGN: Observational analysis. SETTING: Pediatric Cardiac Critical Care Consortium clinical registry. PATIENTS: All cardiac ICU admissions that did not include cardiac surgery. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary endpoint was cardiac ICU mortality. Based on multivariable logistic regression accounting for clustering, we created a case-mix adjusted model using variables present at cardiac ICU admission. Bootstrap resampling (1,000 samples) was used for model validation. We calculated a standardized mortality ratio for each cardiac ICU based on observed-to-expected mortality from the fitted model. A cardiac ICU was considered a statistically significant outlier if the 95% CI around the standardized mortality ratio did not cross 1. Of 11,042 consecutive medical admissions from 25 cardiac ICUs (August 2014 to May 2017), the observed mortality rate was 4.3% (n = 479). Final model covariates included age, underweight, prior surgery, time of and reason for cardiac ICU admission, high-risk medical diagnosis or comorbidity, mechanical ventilation or extracorporeal membrane oxygenation at admission, and pupillary reflex. The C-statistic for the validated model was 0.87, and it was well calibrated. Expected mortality ranged from 2.6% to 8.3%, reflecting important case-mix variation. Standardized mortality ratios ranged from 0.5 to 1.7 across cardiac ICUs. Three cardiac ICUs were outliers; two had lower-than-expected (standardized mortality ratio <1) and one had higher-than-expected (standardized mortality ratio >1) mortality. CONCLUSIONS: We measured case-mix adjusted mortality for cardiac ICU patients with critical medical conditions, and provide the first report of variation in this quality metric within this patient population across Pediatric Cardiac Critical Care Consortium cardiac ICUs. This metric will be used by Pediatric Cardiac Critical Care Consortium cardiac ICUs to assess and improve outcomes by identifying high-performing (low-mortality) centers and engaging in collaborative learning.

Relationship Between Time to Left Atrial Decompression and Outcomes in Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation Support: A Multicenter Pediatric Interventional Cardiology Early-Career Society Study.

OBJECTIVES: To assess the variation in timing of left atrial decompression and its association with clinical outcomes in pediatric patients supported with venoarterial extracorporeal membrane oxygenation across a multicenter cohort. DESIGN: Multicenter retrospective study. SETTING: Eleven pediatric hospitals within the United States. PATIENTS: Patients less than 18 years on venoarterial extracorporeal membrane oxygenation who underwent left atrial decompression from 2004 to 2016. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 137 patients (median age, 4.7 yr) were included. Cardiomyopathy was the most common diagnosis (47%). Cardiac arrest (39%) and low cardiac output (50%) were the most common extracorporeal membrane oxygenation indications. Median time to left atrial decompression was 6.2 hours (interquartile range, 3.8-17.2 hr) with the optimal cut-point of greater than or equal to 18 hours for late decompression determined by receiver operating characteristic curve. In univariate analysis, late decompression was associated with longer extracorporeal membrane oxygenation duration (median 8.5 vs 5 d; p = 0.02). In multivariable analysis taking into account clinical confounder and center effects, late decompression remained significantly associated with prolonged extracorporeal membrane oxygenation duration (adjusted odds ratio, 4.4; p = 0.002). Late decompression was also associated with longer duration of mechanical ventilation (adjusted odds ratio, 4.8; p = 0.002). Timing of decompression was not associated with in-hospital survival (p = 0.36) or overall survival (p = 0.42) with median follow-up of 3.2 years. CONCLUSIONS: In this multicenter study of pediatric patients receiving venoarterial extracorporeal membrane oxygenation, late left atrial decompression (≥ 18 hr) was associated with longer duration of extracorporeal membrane oxygenation support and mechanical ventilation. Although no survival benefit was demonstrated, the known morbidities associated with prolonged extracorporeal membrane oxygenation use may justify a recommendation for early left atrial decompression.

Prenatal Diagnosis Influences Preoperative Status in Neonates with Congenital Heart Disease: An Analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

The early postnatal course for a newborn with critical congenital heart disease (CHD) can be negatively impacted if diagnosis is delayed. Despite this, there continues to be inconsistent evidence regarding potential benefits associated with prenatal diagnosis (PND) in neonates who undergo cardiac surgery. The objective of this study was to better define the impact of a PND on pre-operative morbidity by utilizing a large clinical database. Neonates (< 30 days) undergoing heart surgery from 2010 to 2014 and entered in the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) were included. Multivariable logistic regression was used to evaluate the association between PND and a composite measure including nine major pre-operative risk factors. Co-variates were included to adjust for important patient characteristics (e.g., weight-for-age z-score, genetic syndromes, prematurity), case complexity, and center effects. Centers and patients with excess missing data for relevant co-variates were excluded. Included were 12,899 neonates undergoing surgery at 112 centers. Major pre-operative risk factors were present in 34% overall. By univariate analysis, PND was associated with a lower overall prevalence of major pre-operative risk factors. After adjusting for potential confounders, major pre-operative risk factors were less prevalent among neonates with PND compared to neonates without PND (adjusted OR 0.62, 95% CI 0.57-0.68, p < 0.001). A sensitivity analysis excluding neonates with genetic syndromes, non-cardiac anatomic abnormalities, and prematurity demonstrated similar findings (adjusted OR 0.55, 95% CI 0.49-0.61, p < 0.0001). Among neonates with CHD, prenatal diagnosis is associated with significantly lower rates of pre-operative risk factors for cardiac surgery. Further studies are needed to define association of these pre-operative benefits of a PND with longer term clinical outcomes.

Enhancing efficiency and scientific impact of a clinical trials network: the Pediatric Heart Network Integrated CARdiac Data and Outcomes (iCARD) Collaborative.

Recent years have seen an exponential increase in the variety of healthcare data captured across numerous sources. However, mechanisms to leverage these data sources to support scientific investigation have remained limited. In 2013 the Pediatric Heart Network (PHN), funded by the National Heart, Lung, and Blood Institute, developed the Integrated CARdiac Data and Outcomes (iCARD) Collaborative with the goals of leveraging available data sources to aid in efficiently planning and conducting PHN studies; supporting integration of PHN data with other sources to foster novel research otherwise not possible; and mentoring young investigators in these areas. This review describes lessons learned through the development of iCARD, initial efforts and scientific output, challenges, and future directions. This information can aid in the use and optimisation of data integration methodologies across other research networks and organisations.

Cardiac Networks United: an integrated paediatric and congenital cardiovascular research and improvement network.

Optimising short- and long-term outcomes for children and patients with CHD depends on continued scientific discovery and translation to clinical improvements in a coordinated effort by multiple stakeholders. Several challenges remain for clinicians, researchers, administrators, patients, and families seeking continuous scientific and clinical advancements in the field. We describe a new integrated research and improvement network - Cardiac Networks United - that seeks to build upon the experience and success achieved to-date to create a new infrastructure for research and quality improvement that will serve the needs of the paediatric and congenital heart community in the future. Existing gaps in data integration and barriers to improvement are described, along with the mission and vision, organisational structure, and early objectives of Cardiac Networks United. Finally, representatives of key stakeholder groups - heart centre executives, research leaders, learning health system experts, and parent advocates - offer their perspectives on the need for this new collaborative effort.

Lessons learned in the use of clinical registry data in a multi-centre prospective study: the Pediatric Heart Network Residual Lesion Score Study.

BACKGROUND: Using existing data from clinical registries to support clinical trials and other prospective studies has the potential to improve research efficiency. However, little has been reported about staff experiences and lessons learned from implementation of this method in pediatric cardiology. OBJECTIVES: We describe the process of using existing registry data in the Pediatric Heart Network Residual Lesion Score Study, report stakeholders' perspectives, and provide recommendations to guide future studies using this methodology. METHODS: The Residual Lesion Score Study, a 17-site prospective, observational study, piloted the use of existing local surgical registry data (collected for submission to the Society of Thoracic Surgeons-Congenital Heart Surgery Database) to supplement manual data collection. A survey regarding processes and perceptions was administered to study site and data coordinating center staff. RESULTS: Survey response rate was 98% (54/55). Overall, 57% perceived that using registry data saved research staff time in the current study, and 74% perceived that it would save time in future studies; 55% noted significant upfront time in developing a methodology for extracting registry data. Survey recommendations included simplifying data extraction processes and tailoring to the needs of the study, understanding registry characteristics to maximise data quality and security, and involving all stakeholders in design and implementation processes. CONCLUSIONS: Use of existing registry data was perceived to save time and promote efficiency. Consideration must be given to the upfront investment of time and resources needed. Ongoing efforts focussed on automating and centralising data management may aid in further optimising this methodology for future studies.

Variation in Case-Mix Adjusted Unplanned Pediatric Cardiac ICU Readmission Rates.

OBJECTIVES: To identify modifiable factors leading to unplanned readmission and characterize differences in adjusted unplanned readmission rates across hospitals. DESIGN: Retrospective cohort study using prospectively collected clinical registry data SETTING:: Pediatric Cardiac Critical Care Consortium clinical registry. PATIENTS: Patients admitted to a pediatric cardiac ICU at Pediatric Cardiac Critical Care Consortium hospitals. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We examined pediatric cardiac ICU encounters in the Pediatric Cardiac Critical Care Consortium registry from October 2013 to March 2016. The primary outcomes were early (< 48 hr from pediatric cardiac ICU transfer) and late (2-7 d) unplanned readmission. Generalized logit models identified independent predictors of unplanned readmission. We then calculated observed-to-expected ratios of unplanned readmission and identified higher-than or lower-than-expected unplanned readmission rates for those with an observed-to-expected ratios greater than or less than 1, respectively, and a 95% CI that did not cross 1. Of 11,301 pediatric cardiac ICU encounters (16 hospitals), 62% were surgical, and 18% were neonates. There were 175 (1.6%) early unplanned readmission, and 300 (2.7%) late unplanned readmission, most commonly for respiratory (31%), or cardiac (28%) indications. In multivariable analysis, unique modifiable factors were associated with unplanned readmission. Although shorter time between discontinuation of vasoactive infusions and pediatric cardiac ICU transfer was associated with early unplanned readmission, nighttime discharge was independently associated with a greater likelihood of late unplanned readmission. Two hospitals had lower-than-expected unplanned readmission in both the early and late categories, whereas two other hospitals were higher-than-expected in both. CONCLUSIONS: This analysis demonstrated time from discontinuation of critical care therapies to pediatric cardiac ICU transfer as a significant, modifiable predictor of unplanned readmission. We identified two hospitals with lower-than-expected adjusted rates of both early and late unplanned readmission, suggesting that their systems are well designed to prevent unplanned readmission. This offers the possibility of disseminating best practices to other hospitals through collaborative learning.

Characteristics, Risk Factors, and Outcomes of Extracorporeal Membrane Oxygenation Use in Pediatric Cardiac ICUs: A Report From the Pediatric Cardiac Critical Care Consortium Registry.

OBJECTIVES: Cardiopulmonary failure in children with cardiac disease differs from the general pediatric critical care population, yet the epidemiology of extracorporeal membrane oxygenation support in cardiac ICUs has not been described. We aimed to characterize extracorporeal membrane oxygenation utilization and outcomes across surgical and medical patients in pediatric cardiac ICUs. DESIGN: Retrospective analysis of the Pediatric Cardiac Critical Care Consortium registry to describe extracorporeal membrane oxygenation frequency and outcomes. Within strata of medical and surgical hospitalizations, we identified risk factors associated with extracorporeal membrane oxygenation use through multivariate logistic regression. SETTING: Tertiary-care children's hospitals. PATIENTS: Neonates through adults with cardiac disease. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 14,526 eligible hospitalizations from August 1, 2014, to June 30, 2016; 449 (3.1%) included at least one extracorporeal membrane oxygenation run. Extracorporeal membrane oxygenation was used in 329 surgical (3.5%) and 120 medical (2.4%) hospitalizations. Systemic circulatory failure and extracorporeal cardiopulmonary resuscitation were the most common extracorporeal membrane oxygenation indications. In the surgical group, risk factors associated with postoperative extracorporeal membrane oxygenation use included younger age, extracardiac anomalies, preoperative comorbidity, higher Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery category, bypass time, postoperative mechanical ventilation, and arrhythmias (all p < 0.05). Bleeding requiring reoperation (25%) was the most common extracorporeal membrane oxygenation complication in the surgical group. In the medical group, risk factors associated with extracorporeal membrane oxygenation use included acute heart failure and higher Vasoactive Inotropic Score at cardiac ICU admission (both p < 0.0001). Stroke (15%) and renal failure (15%) were the most common extracorporeal membrane oxygenation complications in the medical group. Hospital mortality was 49% in the surgical group and 63% in the medical group; mortality rates for hospitalizations including extracorporeal cardiopulmonary resuscitation were 50% and 83%, respectively. CONCLUSIONS: This is the first multicenter study describing extracorporeal membrane oxygenation use and outcomes specific to the cardiac ICU and inclusive of surgical and medical cardiac disease. Mortality remains high, highlighting the importance of identifying levers to improve care. These data provide benchmarks for hospitals to assess their outcomes in extracorporeal membrane oxygenation patients and identify unique high-risk subgroups to target for quality initiatives.

Prevalence and risk factors associated with non-attendance in neurodevelopmental follow-up clinic among infants with CHD.

BACKGROUND: Neurodevelopmental impairment is increasingly recognised as a potentially disabling outcome of CHD and formal evaluation is recommended for high-risk patients. However, data are lacking regarding the proportion of eligible children who actually receive neurodevelopmental evaluation, and barriers to follow-up are unclear. We examined the prevalence and risk factors associated with failure to attend neurodevelopmental follow-up clinic after infant cardiac surgery. METHODS: Survivors of infant (<1 year) cardiac surgery at our institution (4/2011-3/2014) were included. Socio-demographic and clinical characteristics were evaluated in neurodevelopmental clinic attendees and non-attendees in univariate and multivariable analyses. RESULTS: A total of 552 patients were included; median age at surgery was 2.4 months, 15% were premature, and 80% had moderate-severe CHD. Only 17% returned for neurodevelopmental evaluation, with a median age of 12.4 months. In univariate analysis, non-attendees were older at surgery, had lower surgical complexity, fewer non-cardiac anomalies, shorter hospital stay, and lived farther from the surgical center. Non-attendee families had lower income, and fewer were college graduates or had private insurance. In multivariable analysis, lack of private insurance remained independently associated with non-attendance (adjusted odds ratio 1.85, p=0.01), with a trend towards significance for distance from surgical center (adjusted odds ratio 2.86, p=0.054 for ⩾200 miles). CONCLUSIONS: The majority of infants with CHD at high risk for neurodevelopmental dysfunction evaluated in this study are not receiving important neurodevelopmental evaluation. Efforts to remove financial/insurance barriers, increase access to neurodevelopmental clinics, and better delineate other barriers to receipt of neurodevelopmental evaluation are needed.

Examining variation in interstage mortality rates across the National Pediatric Cardiology Quality Improvement Collaborative: do lower-mortality centres have lower-risk patients?

BACKGROUND: Although interstage mortality for infants with hypoplastic left heart syndrome has declined within the National Pediatric Cardiology Quality Improvement Collaborative, variation across centres persists. It remains unclear whether centres with lower interstage mortality have lower-risk patients or whether differences in care may explain this variation. We examined previously established risk factors across National Pediatric Cardiology Quality Improvement Collaborative centres with lower and higher interstage mortality rates. METHODS: Lower-mortality centres were defined as those with >25 consecutive interstage survivors. Higher-mortality centres were defined as those with cumulative interstage mortality rates >10%, which is a collaborative historic baseline rate. Baseline risk factors and perioperative characteristics were compared. RESULTS: Seven lower-mortality centres were identified (n=331 patients) and had an interstage mortality rate of 2.7%, as compared with 13.3% in the four higher-mortality centres (n=173 patients, p<0.0001). Of all baseline risk factors examined, the only factor that differed between the lower- and higher-mortality centres was postnatal diagnosis (18.4 versus 31.8%, p=0.001). In multivariable analysis, there remained a significant mortality difference between the two groups of centres after adjusting for this variable: adjusted mortality rate was 2.8% in lower-mortality centres compared with 12.6% in higher-mortality centres, p=0.003. Secondary analyses identified multiple differences between groups in perioperative practices and other variables. CONCLUSIONS: Variation in interstage mortality rates between these two groups of centres does not appear to be explained by differences in baseline risk factors. Further study is necessary to evaluate variation in care practices to identify targets for improvement efforts.