Improved outcomes after implementation of a specialized pediatric cardiac rapid response team.

INTRODUCTION: The efficacy of a specialized pediatric cardiac rapid response team is unknown. We hypothesized that a specialized cardiac rapid response team would facilitate team-wide communication between the cardiac stepdown unit and cardiac intensive care unit (ICU) teams and improve patient care. MATERIALS AND METHODS: A specialized pediatric cardiac rapid response team was implemented in June 2015. All pediatric cardiac rapid response team activations and outcomes from implementation through December 2018 were reviewed. Cardiac arrests and unplanned transfers to the cardiac ICU were indexed to 1000 patient-days to account for inpatient volume trends and evaluated over time. RESULTS: There were 202 cardiac rapid response team activations in 108 unique patients during the study period. After implementation of the pediatric cardiac rapid response team, unplanned transfers from the cardiac stepdown unit to the cardiac ICU decreased from 16.8 to 7.1 transfers per 1000 patient days (p = 0.012). The stepdown unit cardiac arrest rate decreased from 1.2 to 0.0 arrests per 1000 patient-days (p = 0.015). There was one death on the cardiac stepdown unit in the 5 years since the implementation of the cardiac rapid response team, compared to four deaths in the previous 5 years. CONCLUSIONS: A reduction in unplanned cardiac ICU transfers, cardiac arrests, and mortality on the cardiac stepdown unit has been observed since the implementation of a specialized pediatric cardiac rapid response team. A specialized cardiac rapid response team may improve communication and empower the interdisciplinary care team to escalate care for patients experiencing clinical decline.

Human-centered design strategies in family and staff preparation for neonatal care.

OBJECTIVE: This paper describes human-centered design strategies used to develop solutions for neonatal intensive care unit (NICU) patients, families, and staff in preparation for transition from an open bay (OB) NICU to a single-family room (SFR) NICU. HUMAN-CENTERED DESIGN: Through a series of user group meetings, an interdisciplinary team of NICU families, administrators, providers, nurses, and other care team members (CTMs) collaborated with design professionals to create and carry out their vision for the new NICU. This process, which spanned the design, construction, and transition planning phases of the project, enabled stakeholders at the Medical University of South Carolina in Charleston, South Carolina (USA) to seek solutions for integrating patient and family-centered care into the fabric of its new facility and to redesign the care experience. RESULT: From this work, new opportunities for family and staff engagement emerged. CONCLUSIONS: Continuous end-user involvement led to targeted preparation for neonatal care.

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.

Improvement in Pediatric Cardiac Surgical Outcomes Through Interhospital Collaboration.

BACKGROUND: Patients undergoing complex pediatric cardiac surgery remain at considerable risk of mortality and morbidity, and variation in outcomes exists across hospitals. The Pediatric Cardiac Critical Care Consortium (PC4) was formed to improve the quality of care for these patients through transparent data sharing and collaborative learning between participants. OBJECTIVES: The purpose of this study was to determine whether outcomes improved over time within PC4. METHODS: The study analyzed 19,600 hospitalizations (18 hospitals) in the PC4 clinical registry that included cardiovascular surgery from August 2014 to June 2018. The primary exposure was 2 years of PC4 participation; this provided adequate time for hospitals to accrue data and engage in collaborative learning. Aggregate case mix-adjusted outcomes were compared between the first 2 years of participation (baseline) and all months post-exposure. We also evaluated outcomes from the same era in a cohort of similar, non-PC4 hospitals. RESULTS: During the baseline period, there was no evidence of improvement. We observed significant improvement in the post-exposure period versus baseline for post-operative intensive care unit mortality (2.1% vs. 2.7%; 22% relative reduction [RR]; p = 0.001), in-hospital mortality (2.5% vs. 3.3%; 24% RR; p = 0.001), major complications (10.1% vs. 11.5%; 12% RR; p < 0.001), intensive care unit length of stay (7.3 days vs. 7.7 days; 5% RR; p < 0.001), and duration of ventilation (61.3 h vs. 70.6 h; 13% RR; p = 0.01). Non-PC4 hospitals showed no significant improvement in mortality, complications, or hospital length of stay. CONCLUSIONS: This analysis demonstrates improving cardiac surgical outcomes at children's hospitals participating in PC4. This change appears unrelated to secular improvement trends, and likely reflects PC4's commitment to transparency and collaboration.

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.

Hospital Costs Related to Early Extubation After Infant Cardiac Surgery.

BACKGROUND: The Pediatric Heart Network Collaborative Learning Study (PHN CLS) increased early extubation rates after infant tetralogy of Fallot (TOF) and coarctation of the aorta (CoA) repair across participating sites by implementing a clinical practice guideline (CPG). The impact of the CPG on hospital costs has not been studied. METHODS: PHN CLS clinical data were linked to cost data from Children's Hospital Association by matching on indirect identifiers. Hospital costs were evaluated across active and control sites in the pre- and post-CPG periods using generalized linear mixed-effects models. A difference-in-difference approach was used to assess whether changes in cost observed in active sites were beyond secular trends in control sites. RESULTS: Data were successfully linked on 410 of 428 eligible patients (96%) from four active and four control sites. Mean adjusted cost per case for TOF repair was significantly reduced in the post-CPG period at active sites ($42,833 vs $56,304, p < 0.01) and unchanged at control sites ($47,007 vs $46,476, p = 0.91), with an overall cost reduction of 27% in active versus control sites (p = 0.03). Specific categories of cost reduced in the TOF cohort included clinical (-66%, p < 0.01), pharmacy (-46%, p = 0.04), lab (-44%, p < 0.01), and imaging (-32%, p < 0.01). There was no change in costs for CoA repair at active or control sites. CONCLUSIONS: The early extubation CPG was associated with a reduction in hospital costs for infants undergoing repair of TOF but not CoA. This CPG represents an opportunity to both optimize clinical outcome and reduce costs for certain infant cardiac surgeries.

Out-of-pocket medical expenses in severe CHD.

IntroductionFamilies of children born with CHD face added stress owing to uncertainty about the magnitude of the financial burden for medical costs they will face. This study seeks to assess the family responsibility for healthcare bills during the first 12 months of life for commercially insured children undergoing surgery for severe CHD. METHODS: The MarketScan ® database from Truven was used to identify commercially insured infants in 39 states from 2010 to 2012 with an ICD-9 diagnosis code for transposition of the great arteries, tetralogy of Fallot, or truncus arteriosus, as well as the corresponding procedure code for complete repair. Data extraction identified payment responsibilities of the patients' families in the form of co-payments, deductibles, and co-insurance during the 1st year of life. RESULTS: There were 481 infants identified who met the criteria. Average family responsibility for healthcare bills during the 1st year of life was $2928, with no difference between the three groups. The range of out-of-pocket costs was $50-$18,167. Initial hospitalisation and outpatient care accounted for the majority of these responsibilities. CONCLUSIONS: Families of commercially insured children with severe CHD requiring corrective surgery face an average of ~$3000 in out-of-pocket costs for healthcare bills during the first 12 months of their child's life, although the amount varied considerably. This information provides a framework to alleviate some of the uncertainty surrounding healthcare financial responsibilities, and further examination of the origination of these expenditures may be useful in informing future healthcare policy discussion.

Duration of Postoperative Mechanical Ventilation as a Quality Metric for Pediatric Cardiac Surgical Programs.

BACKGROUND: Few metrics exist to assess quality of care at pediatric cardiac surgical programs, limiting opportunities for benchmarking and quality improvement. Postoperative duration of mechanical ventilation (POMV) may be an important quality metric because of its association with complications and resource utilization. In this study we modelled case-mix-adjusted POMV duration and explored hospital performance across POMV metrics. METHODS: This study used the Pediatric Cardiac Critical Care Consortium clinical registry to analyze 4,739 hospitalizations from 15 hospitals (October 2013 to August 2015). All patients admitted to pediatric cardiac intensive care units after an index cardiac operation were included. We fitted a model to predict duration of POMV accounting for patient characteristics. Robust estimates of SEs were obtained using bootstrap resampling. We created performance metrics based on observed-to-expected (O/E) POMV to compare hospitals. RESULTS: Overall, 3,108 patients (65.6%) received POMV; the remainder were extubated intraoperatively. Our model was well calibrated across groups; neonatal age had the largest effect on predicted POMV. These comparisons suggested clinically and statistically important variation in POMV duration across centers with a threefold difference observed in O/E ratios (0.6 to 1.7). We identified 1 hospital with better-than-expected and 3 hospitals with worse-than-expected performance (p < 0.05) based on the O/E ratio. CONCLUSIONS: We developed a novel case-mix-adjusted model to predict POMV duration after congenital heart operations. We report variation across hospitals on metrics of O/E duration of POMV that may be suitable for benchmarking quality of care. Identifying high-performing centers and practices that safely limit the duration of POMV could stimulate quality improvement efforts.

Cost Variation Across Centers for the Norwood Operation.

BACKGROUND: The Norwood operation is associated with high health care utilization, and prior studies reported substantial variability in Norwood costs across centers. However, specific factors driving this cost variation are unclear. We assessed center variability in Norwood costs and underlying mechanisms in a multicenter cohort. METHODS: Clinical data from the Pediatric Heart Network Single Ventricle Reconstruction trial were linked with cost data from the Children's Hospital Association Inpatient Essentials database. Center variation was assessed by modeling Norwood costs adjusted for baseline patient characteristics, and the relationship with complications, length of stay (LOS), and specific cost categories was examined. Patients undergoing transplantation or stage 2 palliation during the Norwood admission were excluded. RESULTS: Nine centers (332 patients) were included. Adjusted mean cost/case varied 4.6-fold across centers (range: $50,559 to $230,851, p < 0.001). In addition, variation was found across centers in the adjusted mean number of complications/case (2.6-fold variation) and adjusted mean LOS/case (1.9-fold variation). Differences in complications explained 63% of the cost variation across centers. After accounting for complications, differences in LOS explained 66% of the remaining cost variation. Seven specific complications were found to occur more frequently at high-cost centers: pleural effusion, seizures, wound infection, thrombus, liver dysfunction, sepsis, necrotizing enterocolitis (all p < 0.001). With regard to types of cost, room and board/supplies and laboratory costs were the primary drivers of cost variation across centers. CONCLUSIONS: This study identified several factors associated with center variation in Norwood costs, which may be targeted in subsequent initiatives aimed at both improving quality of care and reducing costs.

Clinical epidemiology and centre variation in chylothorax rates after cardiac surgery in children: a report from the Pediatric Cardiac Critical Care Consortium.

Introduction Chylothorax after paediatric cardiac surgery incurs significant morbidity; however, a detailed understanding that does not rely on single-centre or administrative data is lacking. We described the present clinical epidemiology of postoperative chylothorax and evaluated variation in rates among centres with a multicentre cohort of patients treated in cardiac ICU. METHODS: This was a retrospective cohort study using prospectively collected clinical data from the Pediatric Cardiac Critical Care Consortium registry. All postoperative paediatric cardiac surgical patients admitted from October, 2013 to September, 2015 were included. Risk factors for chylothorax and association with outcomes were evaluated using multivariable logistic or linear regression models, as appropriate, accounting for within-centre clustering using generalised estimating equations. RESULTS: A total of 4864 surgical hospitalisations from 15 centres were included. Chylothorax occurred in 3.8% (n=185) of hospitalisations. Case-mix-adjusted chylothorax rates varied from 1.5 to 7.6% and were not associated with centre volume. Independent risk factors for chylothorax included age <1 year, non-Caucasian race, single-ventricle physiology, extracardiac anomalies, longer cardiopulmonary bypass time, and thrombosis associated with an upper-extremity central venous line (all p<0.05). Chylothorax was associated with significantly longer duration of postoperative mechanical ventilation, cardiac ICU and hospital length of stay, and higher in-hospital mortality (all p<0.001). CONCLUSIONS: Chylothorax after cardiac surgery in children is associated with significant morbidity and mortality. A five-fold variation in chylothorax rates was observed across centres. Future investigations should identify centres most adept at preventing and managing chylothorax and disseminate best practices.

Interpreting measurements of cardiac function using vendor-independent speckle tracking echocardiography in children: a prospective, blinded comparison with catheter-derived measurements.

BACKGROUND: Adult studies demonstrate that echocardiographic measurements of cardiac function using speckle tracking correlate with invasive measurements, but such data in the pediatric population are sparse. Our aim was to compare speckle-derived measures of cardiac function to measurements routinely obtained by cardiac catheterization in children. METHODS: Echocardiograms were performed on the day of cardiac catheterization. Using Tomtec 2D Cardiac Performance Analysis, longitudinal strain (LS), longitudinal strain rate (LSR), early diastolic LSR, and ejection fraction (EF) for the right and left ventricle (RV and LV) were calculated via speckle tracking. Global LS and LSR were calculated for the LV. These results were compared to cardiac index, maximum ventricular dp/dt (max dp/dt), ventricular end-diastolic pressure (EDP), and pulmonary capillary wedge pressure (PCWP) obtained by fluid-filled catheters. A blinded observer performed all echo measurements. RESULTS: Fifty studies were performed on 28 patients ages 4 months to 20 years old. Their diagnoses included cardiac transplant (48 studies), repaired AV septal defect (1), and dilated cardiomyopathy (1). RVEDP ranged from 2 to 22 mm Hg (median=6) and PCWP ranged from 6 to 32 mmHg (median 10). LV global LS and LV 2-chamber LSR by speckle-tracking negatively correlated with LV max dp/dt (LV global LS R=-.83, P=.001; LV 2-chamber LSR R=-.69, P=.009). RV LS weakly correlated with max dp/dt (R=.363, P=.002). Early diastolic strain rate did not correlate with EDP in either ventricle. CONCLUSION: Speckle-derived measurements of function in the LV have stronger correlation than the RV to catheter-derived measures. LV global LS has the strongest correlation with invasive function measures in children.

Utilizing a Collaborative Learning Model to Promote Early Extubation Following Infant Heart Surgery.

OBJECTIVE: To determine whether a collaborative learning strategy-derived clinical practice guideline can reduce the duration of endotracheal intubation following infant heart surgery. DESIGN: Prospective and retrospective data collected from the Pediatric Heart Network in the 12 months pre- and post-clinical practice guideline implementation at the four sites participating in the collaborative (active sites) compared with data from five Pediatric Heart Network centers not participating in collaborative learning (control sites). SETTING: Ten children's hospitals. PATIENTS: Data were collected for infants following two-index operations: 1) repair of isolated coarctation of the aorta (birth to 365 d) and 2) repair of tetralogy of Fallot (29-365 d). There were 240 subjects eligible for the clinical practice guideline at active sites and 259 subjects at control sites. INTERVENTIONS: Development and application of early extubation clinical practice guideline. MEASUREMENTS AND MAIN RESULTS: After clinical practice guideline implementation, the rate of early extubation at active sites increased significantly from 11.7% to 66.9% (p < 0.001) with no increase in reintubation rate. The median duration of postoperative intubation among active sites decreased from 21.2 to 4.5 hours (p < 0.001). No statistically significant change in early extubation rates was found in the control sites 11.7% to 13.7% (p = 0.63). At active sites, clinical practice guideline implementation had no statistically significant impact on median ICU length of stay (71.9 hr pre- vs 69.2 hr postimplementation; p = 0.29) for the entire cohort. There was a trend toward shorter ICU length of stay in the tetralogy of Fallot subgroup (71.6 hr pre- vs 54.2 hr postimplementation, p = 0.068). CONCLUSIONS: A collaborative learning strategy designed clinical practice guideline significantly increased the rate of early extubation with no change in the rate of reintubation. The early extubation clinical practice guideline did not significantly change postoperative ICU length of stay.

Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry.

BACKGROUND: Clinical databases in congenital and paediatric cardiac care provide a foundation for quality improvement, research, policy evaluations and public reporting. Structured audits verifying data integrity allow database users to be confident in these endeavours. We report on the initial audit of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry. Materials and methods Participants reviewed the entire registry to determine key fields for audit, and defined major and minor discrepancies for the audited variables. In-person audits at the eight initial participating centres were conducted during a 12-month period. The data coordinating centre randomly selected intensive care encounters for review at each site. The audit consisted of source data verification and blinded chart abstraction, comparing findings by the auditors with those entered in the database. We also assessed completeness and timeliness of case submission. Quantitative evaluation of completeness, accuracy, and timeliness of case submission is reported. RESULTS: We audited 434 encounters and 29,476 data fields. The aggregate overall accuracy was 99.1%, and the major discrepancy rate was 0.62%. Across hospitals, the overall accuracy ranged from 96.3 to 99.5%, and the major discrepancy rate ranged from 0.3 to 0.9%; seven of the eight hospitals submitted >90% of cases within 1 month of hospital discharge. There was no evidence for selective case omission. CONCLUSIONS: Based on a rigorous audit process, data submitted to the PC4 clinical registry appear complete, accurate, and timely. The collaborative will maintain ongoing efforts to verify the integrity of the data to promote science that advances quality improvement efforts.

Impact of postoperative complications on hospital costs following the Norwood operation.

UNLABELLED: Introduction Patients undergoing the Norwood operation consume considerable healthcare resources; however, detailed information regarding factors impacting hospitalisation costs is lacking. We evaluated the association of postoperative complications with hospital costs. METHODS: In the present study, we utilised a unique data set consisting of prospectively collected clinical data from the Pediatric Heart Network Single Ventricle Reconstruction trial linked at the patient level with cost data for 10 hospitals participating in the Children's Hospital Association Case Mix database during the trial period. The relationship between complications and cost was modelled using linear regression, accounting for the skewed distribution of cost, adjusting for within-centre clustering and baseline patient characteristics. RESULTS: A total of 334 eligible Norwood records (97.5%) were matched between data sets. Overall, 82% suffered from at least one complication (median 2; with a range from 0 to 33). Those with complications had longer postoperative length of stay (25 versus 12 days, p<0.001), more total ventilator days (7 versus 5 days, p<0.001), and higher in-hospital mortality (17.6 versus 3.4%, p<0.006). Mean adjusted hospital cost in those with a complication was $190,689 (95% CI $111,344-$326,577) versus $120,584 (95% CI $69,246-$209,983) in those without complications (p=0.002). Costs increased with the number of complications (1-2 complications=$132,800 versus 3-4 complications=$182,353 versus ⩾5 complications=$309,372 [p<0.001]). CONCLUSIONS: This merged data set of clinical trial and cost data demonstrated that postoperative complications are common following the Norwood operation and are associated with worse clinical outcomes and higher costs. Efforts to reduce complications in this population may lead to improved outcomes and cost savings.

Collaborative quality improvement in the cardiac intensive care unit: development of the Paediatric Cardiac Critical Care Consortium (PC4).

Despite many advances in recent years for patients with critical paediatric and congenital cardiac disease, significant variation in outcomes remains across hospitals. Collaborative quality improvement has enhanced the quality and value of health care across specialties, partly by determining the reasons for variation and targeting strategies to reduce it. Developing an infrastructure for collaborative quality improvement in paediatric cardiac critical care holds promise for developing benchmarks of quality, to reduce preventable mortality and morbidity, optimise the long-term health of patients with critical congenital cardiovascular disease, and reduce unnecessary resource utilisation in the cardiac intensive care unit environment. The Pediatric Cardiac Critical Care Consortium (PC4) has been modelled after successful collaborative quality improvement initiatives, and is positioned to provide the data platform necessary to realise these objectives. We describe the development of PC4 including the philosophical, organisational, and infrastructural components that will facilitate collaborative quality improvement in paediatric cardiac critical care.

Current Practice and Utility of Chromosome Microarray Analysis in Infants Undergoing Cardiac Surgery.

OBJECTIVE: Traditionally, karyotype and fluorescence in situ hybridization (FISH) were used for cytogenetic testing of infants with congenital heart disease (CHD) who underwent cardiac surgery at our institution. Recently, chromosome microarray analysis (CMA) has been performed in lieu of the traditional tests. A standardized approach to cytogenetic testing does not exist in this population. The purpose of this study was to assess the utility of CMA based on our current ordering practice. DESIGN: We reviewed the records of all infants (<1 year old) who underwent cardiac surgery at our institution from January 2010 to June 2013. Data included results of all cytogenetic testing performed. Diagnostic yield was calculated as the percentage of significant abnormal results obtained by each test modality. Patients were grouped by classification of CHD. RESULTS: Two hundred seventy-five (51%) of 535 infants who underwent cardiac surgery had cytogenetic testing. Of those tested, 154 (56%) had multiple tests performed and at least 18% were redundant or overlapping. The utilization of CMA has increased each year since its implementation. The diagnostic yield for karyotype, FISH and CMA was 10%, 12%, and 14%, respectively. CMA yield was significantly higher in patients with septal defects (33%, P = .01) compared with all other CHD classes. CMA detected abnormalities of unknown clinical significance in 13% of infants tested. CONCLUSIONS: In our center, redundant cytogenetic testing is frequently performed in infants undergoing cardiac surgery. The utilization of CMA has increased over time and abnormalities of unknown clinical significance are detected in an important subset of patients. A screening algorithm that risk-stratifies based on classification of CHD and clinical suspicion may provide a practical, data-driven approach to genetic testing in this population and limit unnecessary resource utilization.

Great need, scarce resources, and choice: reflections on ethical issues following a medical mission.

Medical missions to provide cardiac surgical procedures in developing and technologically less advanced countries is a great challenge. It is also immensely gratifying, personally and professionally. Such missions typically present significant ethical dilemmas, especially making difficult choices, given limited time and resources, and the inability to help all children in need of cardiac surgery. We describe some of these issues from our perspective as visiting cardiologists.

Association of human leukocyte antigen donor-recipient matching and pediatric heart transplant graft survival.

BACKGROUND: The effect of donor-recipient human leukocyte antigen (HLA) matching on outcomes remains relatively unexplored in pediatric patients. The objective of this study was to investigate the effects of donor-recipient HLA matching on graft survival in pediatric heart transplantation. METHODS AND RESULTS: The UNOS (United Network for Organ Sharing) database was queried for heart transplants occurring between October 31, 1987, and December 31, 2012, in a recipient aged ≤17 years with ≥1 postoperative follow-up visit. Retransplants were excluded. Transplants were divided into 3 donor-recipient matching groups: no HLA matches (HLA-no), 1 or 2 HLA matches (HLA-low), and 3 to 6 HLA matches (HLA-high). Primary outcome was graft loss. Four thousand four hundred seventy-one heart transplants met the study inclusion criteria. High degree of donor-recipient HLA matching occurred infrequently: HLA-high (n=269; 6%) versus HLA-low (n=2683; 60%) versus HLA-no (n=1495; 34%). There were no differences between HLA matching groups in the frequency of coronary vasculopathy (P=0.19) or rejection in the first post-transplant year (P=0.76). Improved graft survival was associated with a greater degree of HLA donor-recipient matching: HLA-high median survival, 17.1 (95% confidence interval, 14.0-20.2) years; HLA-low median survival, 14.2 (13.1-15.4) years; and HLA-no median survival, 12.1 (10.9-13.3 years) years; P<0.01, log-rank test. In Cox-regression analysis, HLA matching was independently associated with decreased graft loss: HLA-low versus HLA-no hazard ratio, 0.86 (95% confidence interval, 0.74-0.99), P=0.04; HLA-high versus HLA-no, 0.62 (95% confidence interval, 0.43-0.90), P<0.01. CONCLUSIONS: Decreased graft loss in pediatric heart transplantation was associated with a higher degree of donor-recipient HLA matching, although a difference in the frequency of early rejection or development of coronary artery vasculopathy was not seen.

A composite outcome for neonatal cardiac surgery research.

OBJECTIVE: The objective of this study was to determine whether a composite outcome, derived of objective signs of inadequate cardiac output, would be associated with other important measures of outcomes and therefore be an appropriate end point for clinical trials in neonatal cardiac surgery. METHODS: Neonates (n = 76) undergoing cardiac operations requiring cardiopulmonary bypass were prospectively enrolled. Patients were defined to have met the composite outcome if they had any of the following events before hospital discharge: death, the use of mechanical circulatory support, cardiac arrest requiring chest compressions, hepatic injury (2 times the upper limit of normal for aspartate aminotransferase or alanine aminotransferase), renal injury (creatinine >1.5 mg/dL), or lactic acidosis (an increasing lactate >5 mmol/L in the postoperative period). Associations between the composite outcome and the duration of mechanical ventilation, intensive care unit stay, hospital stay, and total hospital charges were determined. RESULTS: The median age at the time of surgery was 7 days, and the median weight was 3.2 kg. The composite outcome was met in 39% of patients (30/76). Patients who met the composite outcome compared with those who did not had a longer duration of mechanical ventilation (4.9 vs 2.9 days, P < .01), intensive care unit stay (8.8 vs 5.7 days, P < .01), hospital stay (23 vs 12 days, P < .01), and increased hospital charges ($258,000 vs $170,000, P < .01). In linear regression analysis, controlling for surgical complexity, these differences remained significant (R(2) = 0.29-0.42, P < .01). CONCLUSIONS: The composite outcome is highly associated with important early operative outcomes and may serve as a useful end point for future clinical research in neonates undergoing cardiac operations.