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The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database was queried to document variation of patient characteristics, procedure types, and programmatic case-mix.All index cardiac operations in patients less than 18 years of age in the STS Congenital Heart Surgery Database (July 2016 to June 2020) were eligible for inclusion except patients weighing ≤2.5 kg undergoing isolated patent ductus arteriosus closure. At the hospital level, we describe variations in patient and procedural characteristics known from previous analyses to be associated with outcomes. We also report variations across hospitals of programmatic case-mix.Data were analyzed from 117 sites (90 322 total operations, 87 296 total index cardiac operations eligible for STAT [STS-European Association for Cardio-Thoracic Surgery] 2020 Mortality Score). The median annual total index cardiac operations eligible for STAT 2020 Mortality Score per hospital was 157 (interquartile range [IQR], 94-276). Wide variability was documented in total annual index cardiac operations eligible for STAT 2020 Mortality Score per hospital (ratio 90th/10th percentile = 9.01), operations in neonates weighing2.5 kg (ratio 90th/10th percentile = 4.09), operations in patients with noncardiac anatomic abnormalities (ratio 90th/10th percentile = 3.46), and operations in patients with preoperative mechanical ventilation (ratio 90th/10th percentile = 3.97). At the hospital level, the median percentage of all index cardiac operations in STAT 2020 Mortality Category 5 was 3.7% (IQR, 1.7%-4.9%), the median percentage of all index cardiac operations in STAT 2020 Mortality Category 4 or 5 was 24.4% (IQR, 19.0%-28.4%), the median hospital-specific mean STAT Mortality Category was 2.39 (IQR, 2.20-2.47), and the median hospital-specific mean STAT Mortality Score was 0.86 (IQR, 0.73-0.91).Substantial variation of patient characteristics, procedure types, and case-mix exists across pediatric and congenital cardiac surgical programs. Knowledge about programmatic case-mix augments data about indirectly standardized programmatic observed-to-expected (O/E) mortality. Indirectly standardized O/E ratios do not provide a complete description of a given pediatric and congenital cardiac surgical program. The indirectly standardized programmatic O/E ratios associated with a given program apply only to its specific case-mix of patients and may represent a quite different case-mix than that of another program.

For the more than 40,000 children in the United States undergoing congenital heart surgery annually, the relationship between hospital quality and costs remains unclear. Prior studies report conflicting results and clinical outcomes have continued to improve over time. We examined a large contemporary cohort, aiming to better inform ongoing initiatives seeking to optimize health care value in this population.Clinical information (The Society of Thoracic Surgeons Congenital Database) was merged with standardized cost data (Pediatric Health Information Systems) for children undergoing heart surgery from 2010 to 2015. In-hospital cost variability was analyzed using Bayesian hierarchical models adjusted for case-mix. Quality metrics examined included in-hospital mortality, postoperative complications, postoperative length of stay (PLOS), and a composite.Overall, 32 hospitals (n = 45,315 patients) were included. Median adjusted cost per case varied across hospitals from $67,700 to $51,200 in the high vs low cost tertile (ratio 1.32; 95% credible interval, 1.29 to 1.35), and all quality metrics also varied across hospitals. Across cost tertiles, there were no significant differences in the quality metrics examined, with the exception of PLOS. The PLOS findings were driven by high-risk The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery categories 4 and 5 cases (adjusted median length of stay 16.8 vs 14.9 days in high vs low cost tertile [ratio 1.13, 1.05 to 1.24]), and intensive care unit PLOS.Contemporary congenital heart surgery costs vary across hospitals but were not associated with most quality metrics examined, highlighting that performance in one area does not necessarily convey to others. Cost variability was associated with PLOS, particularly related to intensive care unit PLOS and high-risk cases. Care processes influencing PLOS may provide targets for value-based initiatives in this population.

BACKGROUND: Nearly every child undergoing congenital heart surgery has chest tubes (CT) placed intraoperatively. Center variation in removal practices and impact on outcomes has not been studied previously. We evaluated variation in CT management practices and outcomes across centers. METHODS: We included patients undergoing any of 10 benchmark operations from June 2017-May 2018 at participating Pediatric Acute Care Cardiology Collaborative (PAC(3))- Pediatric Cardiac Critical Care Consortium (PC(4)) centers. Clinical data from PC(4) were merged with CT data from PAC(3). Practices and outcomes were compared across centers in univariate and multivariable analysis. RESULTS: The cohort included 1029 patients (N=9 centers). Median CT duration varied significantly across centers for 9/10 benchmark operations (all p≤ 0.03) with a “model” center noted to have the shortest duration for 9/10 operations (range of 27.9–87.4% shorter duration vs. other centers across operations). This effect persisted in multivariable analysis (p

Background The purpose of this study was to evaluate the association between preoperative biomarker levels and 365-day readmission or mortality after pediatric congenital heart surgery. Methods Children aged 18 years or younger undergoing congenital heart surgery (n = 145) at Johns Hopkins Hospital from 2010 to 2014 were enrolled in the prospective cohort. Novel biomarkers suppression of tumorgenicity 2, galectin-3, N-terminal prohormone brain natriuretic peptide, and glial fibrillary acidic protein were measured. The composite study endpoint was unplanned readmission within 365 days after discharge or mortality either in hospital during the surgical admission or within 365 days after discharge. A clinical model based on covariates used in The Society of Thoracic Surgeons Congenital Heart Surgery Database mortality risk model and an augmented model using the clinical model in conjunction with a novel biomarker panel were evaluated. Results Readmission or mortality within 365 days of surgery occurred among 39 pediatric patients (27%). The clinical model alone resulted in a c-statistic of 0.719 (95% confidence interval, 0.63 to 0.81). The clinical model in conjunction with the log-transformed biomarkers improved the c-statistic to 0.805 (95% confidence interval, 0.73 to 0.88). The addition of biomarkers resulted in a significant improvement to the clinical model alone (P value = 0.035). Conclusions Novel biomarkers may add predictive value when assessing the likelihood of 365-day readmission or mortality after pediatric congenital heart surgery. After adjusting for clinical and novel biomarkers, preoperative and postoperative suppression of tumorgenicity 2 remained associated with 365-day readmission or mortality. Currently, The Society of Thoracic Surgeons clinical congenital mortality risk model can be applied to identify children with increased risk of repeat hospitalizations and postdischarge mortality and may inform preventative care interventions that aim to reduce these adverse events.

Although overall outcomes have improved for single-ventricle patients, substantial morbidity and mortality remain for certain high-risk groups. The hybrid stage I procedure is an alternative to the Norwood operation for stage I palliation, but it remains unclear whether it is associated with improved outcomes in high-risk patients.This single-center, nested, case-control study included high-risk patients with a systemic right ventricle who underwent hybrid stage I or Norwood palliation from January 2000 to December 2016. High-risk features included prematurity34 weeks, birth weight2.5 kg, restrictive/intact atrial septum, at least moderate atrioventricular valve regurgitation or right ventricular dysfunction, genetic or extracardiac anomalies, or left ventricular sinusoids. Patients were matched by presence of genetic anomaly, restrictive/intact atrial septum, and prematurity/weight2 kg. Early and midterm outcomes were compared in the matched hybrid vs Norwood groups.The study included 96 patients (35 hybrid, 61 Norwood). Despite improved 30-day survival in hybrid patients (91% vs 66%, P.01), 1-year survival was similar between the hybrid and Norwood groups (46% vs 48%, P = .9). No hybrid patients required dialysis or extracorporeal membrane oxygenation after stage I palliation as compared with 19% and 22% of Norwood patients, respectively (both P.01). Hybrid patients, however, required more unplanned reinterventions (43% vs 21%, P = .02).There remains significant morbidity and mortality among high-risk single-ventricle infants. Despite an early survival benefit, hybrid stage I palliation has not been associated with improved midterm outcomes at our center.

The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) provides observed-to-expected (O/E) operative mortality ratios to more than 100 congenital heart centers in North America. We compared the current approach for estimating O/E ratios to approaches incorporating information on diagnosis as moderators of procedures, other unused risk factors, and additional variation in confidence interval construction to characterize center performance.Bayesian additive regression trees (BART) and lasso models linked operative mortality to diagnosis-procedure categories, procedure-specific risk factors, and syndromes/abnormalities. Bootstrapping accounted for variation in the STS-CHSD (STS bootstrap) and lasso CIs. We compared O/E estimates, interquartile range of CI widths, and concordance of center performance categorizations (worse-than-, as-, or better-than-expected mortality) of the new approaches to the STS-CHSD.In 110 surgical centers including 98,822 surgical operative encounters, there were 2818 (2.85%) operative mortalities (center range, 0.37%-10%). Compared with the STS-CHSD, BART- and lasso-estimated O/E ratios varied more and had narrower confidence intervals (interquartile range of confidence interval: STS-CHSD = 1.11, STS bootstrap = 0.98; lasso = 0.80; BART = 0.96). Concordance of performance categorization with the STS-CHSD ranged from 84% (lasso) to 91% (STS Bootstrap); more than 70% of discordant centers improved categories. Discordant centers had smaller volumes, fewer operative mortalities, and treated more patients with congenital lung abnormalities.Relative to the STS-CHSD, up to 16% of hospitals changed performance categories, most improving performance. Given the significance of quality reports for congenital heart centers, inclusion of additional risk factors and unaddressed variation should be considered.

Background The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model adjusts not only for procedure and age group pairings but also for additional patient factors, including the binary presence or absence of a chromosomal abnormality (CA), syndrome (S), and/or a noncardiac congenital anatomic abnormality (NCAA). This analysis refines case-mix adjustment by adding more granular adjustment for individual conditions (CA, S, and NCAA), consistent with a hypothesis that associated risk of mortality differs between individual conditions. Methods CA/S corresponding to the same condition were merged to a single condition code. Odds ratios were estimated for all CA/S. For CA/S associated with at least 10 deaths in neonates and infants and at least 10 deaths in children and adults, odds ratios were estimated for the effect of the CA/S separately in neonates/infants and in children/adults. In addition to these condition/age interactions, condition/age/procedure interactions were explored (eg, effect of Down syndrome was estimated based on age and procedure subgroups, including atrioventricular canal repair and single-ventricle palliation). Bayesian modeling was used to create 5 maximally homogeneous groups of CA/S from 81 candidate CA/S variables. A standard logistic regression model then incorporated indicator variables for the 5 categories of CAs/Ss, 7 unique NCAAs, and all other covariates in the previously published Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Model. Results Analysis included 107,062 operations in 100 centers (2010 to 2015). Operative Mortality was 3,629 (3.4%). In the development sample, the C statistics of the original nonaugmented model and the augmented model were 0.872 and 0.875, respectively. Conclusions The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model has been augmented by addition of covariates representing individual CAs, Ss, and NCAAs.

Background Hospital readmission after pediatric cardiac surgery is incompletely understood. This study analyzed data from The Society of Thoracic Surgeons Congenital Heart Surgery Database to determine prevalence, to describe patient characteristics, and to evaluate risk factors for readmission. Methods Readmission was defined by the "readmission within 30 days after discharge" field. Routine variables were summarized. Regression analysis was used to identify factors associated with readmission. Results The study cohort included 56,429 patient records from 100 centers. Overall, 6,208 (11%) patients were readmitted. The most common reasons for readmission were respiratory or airway complications (14.2%), septic or infectious complications (11.4%), and reasons not related to the preceding surgical procedure (20.2%). Primary reason for readmission varied across benchmark operation groups. In multivariable analysis, factors associated with increased odds of readmission included the presence of noncardiac abnormalities (odds ratio [OR], 1.24), chromosomal abnormalities or genetic syndromes (OR, 1.24), preoperative mechanical circulatory support (OR, 1.36), other preoperative factors (OR, 1.21), prior cardiac surgery (OR, 1.31), Hispanic ethnicity (OR, 1.13), higher STAT procedural complexity (Society of Thoracic Surgeons/European Association for Cardio-Thoracic Surgery) (STAT level 3 vs 1, OR, 1.22; STAT 4 vs 1, OR, 1.48; STAT 5 vs 1, OR, 2.62), prolonged postoperative length of stay (OR, 1.07 per day from 0 to 14 days; OR, 1.01 per week >14 days), any major complication (OR, 1.27), any other postoperative complications (OR, 2.00), and discharge on a weekday (OR, 1.07). Conclusions Readmission is common after congenital heart surgery, mostly for noncardiovascular reasons. Process improvement initiatives targeted at high-risk patients could minimize its impact.

The Pediatric Heart Network Collaborative Learning Study (PHN CLS) successfully changed practice at four hospitals to increase the rate of early extubation within 6 hours after infant heart surgery. It is unknown whether this practice continued after study completion.We linked the PHN CLS dataset to the Pediatric Cardiac Critical Care Consortium registry to compare outcomes at four active hospitals between the study period (post-clinical practice guideline [CPG]) and the first year after study completion (follow-up) after a 3-month washout. Inclusion and exclusion criteria were the same across eras. Primary outcome was early extubation rate after tetralogy of Fallot or aortic coarctation repair. Secondary outcomes included time to first extubation and intensive care and hospital lengths of stay.There were 121 patients in the post-CPG era and 139 patients in the follow-up era with no difference in patient characteristics or operation subtypes. Post-CPG early extubation rate declined from 67% to 30% in follow-up (p0.0001); time to first extubation increased (4.5 versus 13.5 hours, p0.0001). One hospital maintained the rate of early extubation (72% versus 67%), whereas the other three hospitals had significantly lower rates in follow-up (p0.02 for each). Intensive care (2.8 versus 2.9 days) and postoperative hospital (6 versus 5 days) stays did not differ between eras (p0.05 for both). Findings were consistent across operation subtypes.Extubation practice in the first year of follow-up after the PHN CLS reverted toward prestudy levels. One of four hospitals maintained its early extubation strategy, suggesting that specific implementation and maintenance approaches may effectively sustain impact from quality initiatives.

Background The Pediatric Heart Network Collaborative Learning Study (PHN CLS) increased early extubation after infant tetralogy of Fallot (TOF) and coarctation repair overall at participating sites through implementing a clinical practice guideline (CPG). We evaluated variability across sites in CPG implementation and outcomes. Methods Patient characteristics and outcomes (time to extubation, length of stay [LOS]) were compared across sites, including pre-CPB to post-CPG changes. Semistructured interviews were analyzed to assess similarities and differences in implementation strategies across sites. Results A total of 322 patients were included (4 active sites, 1 model site). Patient characteristics were similar across active sites, whereas pre-CPG median time to extubation varied from 15.4 to 35.5 hours. All active sites had a significant post-CPG decline (p Conclusions All PHN CLS sites successfully reduced time to extubation. The magnitude of change varied and may be partly explained by different CPG implementation strategies. These data can guide CPG dissemination and design of future improvement projects.

Background Several countries have regionalized congenital heart surgery (CHS). Before considering regionalization in the US, the current landscape must be understood. This investigation characterized the network of US hospitals providing CHS, including hospital locations and patient travel patterns. Methods Patients ≤18 years undergoing CHS were identified in 2012 State Inpatient Databases from 39 states. Cases were stratified by the RACHS-1 method (high-risk defined as RACHS-1 categoris 4 to 6). Hospital and patient locations were identified. Patients were mapped to hospitals where they underwent surgery. Results A total of 153 hospitals across 36 states performed ≥1 RACHS-1 case (19,064 operations). Of these, 101 hospitals (66%) were located within 25 miles of another hospital. Median annual RACHS-1 case volume was 90 (range, 1 to 797), with 55 hospitals performing ≤50 cases. A total of 111 hospitals (73%) performed ≥1 high-risk case. Of these, 39 (35%) performed ≤10 high-risk cases/year. Overall mortality rate was 3.5% (n = 666), with risk-adjusted mortality being lowest at hospitals in the highest-volume quartile (≥150 cases/year). About 25% of patients (n = 4,012) traveled >100 miles, with most traveling to hospitals within the highest-volume quartile; 53% of patients (n = 8,376) bypassed the nearest CHS hospital. Mortality was not associated with travel distance. Conclusions We identified more US hospitals performing CHS than has been previously described. Many are small-volume and are in close proximity to one another. Patients are already traveling long distances to hospitals within the highest-volume quartile. These data help define the current landscape of CHS and associated considerations regarding regionalization.

Background We describe the statistical methods and results related to development of the first congenital heart surgery composite quality measure. Methods The composite measure was developed using The Society of Thoracic Surgeons Congenital Heart Surgery Database (2012 to 2015), Bayesian hierarchical modeling, and the current Society of Thoracic Surgeons risk model for case-mix adjustment. It consists of a mortality domain (operative mortality) and morbidity domain (major complications and postoperative length of stay). We evaluated several potential weighting schemes and properties of the final composite measure, including reliability (signal-to-noise ratio) and hospital classification in various performance categories. Results Overall, 100 hospitals (78,425 operations) were included. Each adjusted metric included in the composite varied across hospitals: operative mortality (median, 3.1%; 10th to 90th percentile, 2.1% to 4.4%) major complications (median 11.7%, 10th to 90th percentile, 6.4% to 17.4%), and length of stay (median, 7.0 days; 10th to 90th percentile, 5.9 to 8.2 days). In the final composite weighting scheme selected, mortality had the greatest influence, followed by major complications and length of stay (correlation with overall composite score of 0.87, 0.69, and 0.47, respectively). Reliability of the composite measure was 0.73 compared with 0.59 for mortality alone. The distribution of hospitals across composite measure performance categories (defined by whether the 95% credible interval overlapped The Society of Thoracic Surgeons average) was 75% (same as expected), 9% (worse than expected), and 16% (better than expected). Conclusions This congenital heart surgery composite measure incorporates aspects of both morbidity and mortality, has clinical face validity, and greater ability to discriminate hospital performance compared with mortality alone. Ongoing efforts will support the use of the composite measure in benchmarking and quality improvement activities.

The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) is the largest congenital and pediatric cardiac surgical clinical data registry in the world. The most recent biannual feedback report to participants includes analysis of data submitted from 125 hospitals, representing nearly all centers performing pediatric and congenital heart operations in the United States and Canada. In addition to serving as a platform for reporting of outcomes and for quality improvement, the database continues to be a primary data source for clinical research and for innovations related to quality measurement. Over the past year, several investigative teams reported analyses of data in the STS CHSD pertaining to various processes of care, including assessment of variation in specific practices and patient characteristics across centers participating in the STS CHSD, and their associations with outcomes. Additional ongoing projects involve the development of new or refined metrics for quality measurement and reporting of outcomes and center level performance. To meet the needs of investigators, the STS Research Center and Workforce on Research Development has created multiple pathways through which investigators may propose and, ultimately, perform outcomes research projects based on STS CHSD data. This article reviews published outcomes research and quality improvement projects from the past year and describes ongoing research related to quality measurement.

After pediatric heart operations, we sought to determine the incidence of unplanned cardiac reinterventions during the same hospitalization, assess risk factors for these reinterventions, and explore associations between reinterventions and outcomes. We hypothesized that younger patients undergoing more complex operations would be at greater risk for unplanned cardiac reinterventions and that operative mortality and postoperative length of stay (PLOS) would be greater in patients who undergo reintervention than in those who do not.Patients aged 18 years or younger in The Society of Thoracic Surgeons Congenital Heart Surgery Database (January 2010 to June 2015) were included. We used multivariable regression to evaluate risk factors for unplanned cardiac reintervention (operation or therapeutic catheterization) and associations of reintervention with operative mortality and PLOS.Of 84,404 patients (117 centers), 21% were neonates and 36% infants. An unplanned cardiac reintervention was performed in 5.4% of patients, including 11.8% of neonates, 5.2% of infants, and 2.8% of children. Independent risk factors for unplanned reintervention included presence of noncardiac anomalies/genetic syndromes, nonwhite race, younger age, lower weight among neonates and infants, prior cardiothoracic operations, preoperative mechanical ventilation, other Society of Thoracic Surgeons preoperative risk factors, and higher Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery Mortality Category (adjusted p0.001 for all). Unplanned reintervention was a risk factor for operative mortality (adjusted odds ratio, 5.3; 95% confidence interval, 4.8 to 5.8; p0.001) and longer PLOS (adjusted relative risk, 2.3; 95% confidence interval, 2.2 to 2.4; p0.001).Unplanned cardiac reinterventions are not rare, particularly in neonates, and are independently associated with operative mortality and increased PLOS. Patients at greater risk may be identified preoperatively, presenting opportunities for quality improvement.

BACKGROUND: The Norwood operation is associated with high healthcare utilization, and prior studies demonstrate 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 multi-center 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. Those undergoing transplant or Stage II 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—$230,851; p

Systemic-to-pulmonary shunt failure is a potentially catastrophic complication. We analyzed a large multicenter clinical registry to describe the prevalence and evaluate risk factors.Infants (aged ≤365 days) undergoing shunt operations (systemic artery-to-pulmonary artery or systemic ventricle-to-pulmonary artery) in The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) from 2010 to 2015 were included. Multivariable logistic regression was used to evaluate risk factors for in-hospital shunt failure. Model covariates included patient characteristics, preoperative factors, procedural factors including shunt type, and center effects. Centers with more than 15% missing data for key covariates were excluded.Shunt operations were performed in 9,172 infants (118 centers). In-hospital shunt failure occurred in 674 (7.3%). In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation (odds ratio [OR], 1.35; p = 0.001), preoperative hypercoagulable state (OR, 2.47; p = 0.031), and the presence of any other STS-CHSD preoperative risk factors (OR, 1.24; p = 0.038). Shunt failure was less likely with a systemic ventricle-to-pulmonary artery shunt than a systemic artery-to-pulmonary artery shunt (OR, 0.65; p = 0.020). Neither cardiopulmonary bypass nor single-ventricle diagnosis was a risk factor for shunt failure. Patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs 11.1%, p 0.001) and major morbidity (84.4% vs 29.4%, p0.001), and longer median postoperative length of stay among survivors (45 vs 22 days, p0.001).In-hospital shunt failure is common, and associated mortality risk is high. These data highlight at-risk patients and procedural cohorts that warrant expectant surveillance and may benefit from enhanced antithrombotic prophylaxis or other management strategies to reduce shunt failure. These findings may inform planning of future clinical trials.

BackgroundFew 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.MethodsThis 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 onobserved-to-expected (O/E) POMV to compare hospitals.ResultsOverall, 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). Weidentified 1 hospital with better-than-expected and3hospitals with worse-than-expected performance (p&nbsp