Jennifer C. Hirsch-Romano

Hemorrhagic complications in pediatric cardiac patients on extracorporeal membrane oxygenation: an analysis of the Extracorporeal Life Support Organization Registry.

Objectives: To determine the prevalence of and risk factors for hemorrhagic complications in children with cardiac disease requiring extracorporeal membrane oxygenation. Design: Retrospective review of the Extracorporeal Life Support Organization Registry (2002–2013). Setting: Participating Extracorporeal Life Support Organization centers. Patients: Patients less than 18 years old on extracorporeal membrane oxygenation. Interventions: None. Measurements and Main Results: Of 21,845 patients requiring extracorporeal membrane oxygenation during the study period, 8,905 (41%) had cardiac disease, and 79% of whom (6,995) had cardiac surgery. Hemorrhagic complications occurred in 8,480 patients (39% of overall cohort), with higher rates in cardiac versus noncardiac patients (49% vs 32%; p < 0.0001) related to cannulation and surgical site bleeding. Cardiac surgical patients had higher rates of hemorrhage compared with cardiac medical patients (57% vs 38%; p < 0.0001), and cardiac patients with hemorrhage had higher extracorporeal membrane oxygenation mortality compared with those without (42% vs 22% in medical patients and 34% vs 20% in surgical patients; both p < 0.0001). In multivariable analysis in both the cardiac medical and surgical groups, hemorrhage risk was higher in children greater than 1 year old and in patients with longer extracorporeal membrane oxygenation duration. Additional independent risk factors for hemorrhage in cardiac surgical patients included pre-extracorporeal membrane oxygenation mediastinal exploration (odds ratio, 3.6; 95% CI, 2.1–6.3), Society of Thoracic Surgeons morbidity category 4–5 (odds ratio, 1.2; 95% CI, 1.03–1.5), cannulation less than 24 hours after surgery (odds ratio, 1.6; 95% CI, 1.3–1.9), and longer cardiopulmonary bypass time (≥ 282 min [upper quartile]; odds ratio, 1.5; 95% CI, 1.3–1.9). Conclusions: In this large, multicenter analysis, hemorrhagic complications occurred in nearly half of children with heart disease on extracorporeal membrane oxygenation and were associated with a significant mortality risk. Several factors were associated with hemorrhagic complications in cardiac surgical patients including pre-extracorporeal membrane oxygenation mediastinal exploration, greater surgical complexity, early postoperative cannulation, and longer bypass times. Whether these risks can be mitigated by modifying or delaying systemic anticoagulation requires further investigation.

Association of Complications With Blood Transfusions in Pediatric Cardiac Surgery Patients

BACKGROUND Blood product transfusion during cardiopulmonary bypass has been demonstrated to be associated with increased morbidity and mortality in adult cardiac surgery populations. The aim of this study was to characterize the risk-adjusted occurrence of postoperative complications and mortality in relation to intraoperative blood product transfusion in our pediatric cardiac surgery population. METHODS A retrospective review was performed on 1,631 consecutive cardiopulmonary bypass cases to determine the effects of intraoperative blood product transfusion on selected outcomes. After adjusting for patient and operative risk factors, multivariate analysis was performed to determine the association between blood product transfusion and postoperative complications. Cox proportional hazards model was used to examine the relationship of packed red blood cell transfusion to hospital length of stay. RESULTS Red blood cell and fresh frozen plasma transfusion was associated with pulmonary complications (adjusted odds ratio, 1.55; 95% confidence interval, 1.05 to 2.28; p=0.03). Red blood cell transfusion also correlated with prolonged hospital stay (p<0.01). Cryoprecipate transfusion was associated with postoperative pulmonary complications (adjusted odds ratio, 1.79; 95% confidence interval, 1.13 to 2.55; p=0.01), but decreased incidence of 30-day mortality (adjusted odds ratio, 0.44; 95% confidence interval, 0.23 to 0.85; p=0.02). Platelet transfusion was associated with decreased 30-day mortality (adjusted odds ratio, 0.51; 95% confidence interval, 0.28 to 0.93; p=0.04), but not overall mortality. CONCLUSIONS Blood product transfusion was associated with an increased incidence of postoperative pulmonary complications and prolonged hospital length of stay, but not overall mortality. These findings suggest that minimizing blood product transfusion would be beneficial in the pediatric cardiopulmonary bypass surgery patient population.

Technical performance score is associated with outcomes after the Norwood procedure

OBJECTIVES The technical performance score (TPS) has been reported in a single center study to predict the outcomes after congenital cardiac surgery. We sought to determine the association of the TPS with outcomes in patients undergoing the Norwood procedure in the Single Ventricle Reconstruction trial. METHODS We calculated the TPS (class 1, optimal; class 2, adequate; class 3, inadequate) according to the predischarge echocardiograms analyzed in a core laboratory and unplanned reinterventions that occurred before discharge from the Norwood hospitalization. Multivariable regression examined the association of the TPS with interval to first extubation, Norwood length of stay, death or transplantation, unplanned postdischarge reinterventions, and neurodevelopment at 14 months old. RESULTS Of 549 patients undergoing a Norwood procedure, 356 (65%) had an echocardiogram adequate to assess atrial septal restriction or arch obstruction or an unplanned reintervention, enabling calculation of the TPS. On multivariable regression, adjusting for preoperative variables, a better TPS was an independent predictor of a shorter interval to first extubation (P=.019), better transplant-free survival before Norwood discharge (P<.001; odds ratio, 9.1 for inadequate vs optimal), shorter hospital length of stay (P<.001), fewer unplanned reinterventions between Norwood discharge and stage II (P=.004), and a higher Bayley II psychomotor development index at 14 months (P=.031). The TPS was not associated with transplant-free survival after Norwood discharge, unplanned reinterventions after stage II, or the Bayley II mental development index at 14 months. CONCLUSIONS TPS is an independent predictor of important outcomes after Norwood and could serve as a tool for quality improvement.

Quality-Cost Relationship in Congenital Heart Surgery.

BACKGROUND There is an increasing focus on optimizing health care quality and reducing costs. The care of children undergoing heart surgery requires significant investment of resources, and it remains unclear how costs of care relate to quality. We evaluated this relationship across a multicenter cohort. METHODS Clinical data from The Society of Thoracic Surgeons Database were merged with cost data from the Pediatric Health Information Systems Database for children undergoing heart surgery (2006 to 2010). Hospital-level costs were modeled using Bayesian hierarchical methods adjusting for case-mix, and hospitals were categorized into cost tertiles. The primary quality metric evaluated was in-hospital mortality. RESULTS Overall, 27 hospitals (30,670 patients) were included. Median adjusted cost per case was

The Impact of Differential Case Ascertainment in Clinical Registry Versus Administrative Data on Assessment of Resource Utilization in Pediatric Heart Surgery

82,360 and varied fivefold across hospitals, while median adjusted mortality was 3.4% and ranged from 2.4% to 5.0% across hospitals. Overall, hospitals in the lowest cost tertile had significantly lower adjusted mortality rates compared with the middle and high cost tertiles (2.5% vs 3.8% and 3.5%, respectively, both p < 0.001). When assessed at the individual hospital level, most (75%) but not all hospitals in the lowest cost tertile were also in the lowest mortality tertile. Similar relationships were seen across the spectrum of surgical complexity. Lower cost hospitals also had shorter length of stay and trends toward fewer major complications. CONCLUSIONS Lowest cost hospitals generally deliver the highest quality care for children undergoing heart surgery, although there is some variation in this relationship. This information is important in the design of initiatives aiming to optimize health care value in this population.

Survival Through Staged Palliation: Fate of Infants Supported by Extracorporeal Membrane Oxygenation After the Norwood Operation

Background: Resource utilization in congenital heart surgery is typically assessed using administrative data sets. Recent analyses have called into question the accuracy of coding of cases in administrative data; however, it is unclear whether miscoding impacts assessment of associated resource use. Methods: We merged data coded within both an administrative data set and clinical registry on children undergoing heart surgery (2004-2010) at 33 hospitals. The impact of differences in coding of operations between data sets on reporting of postoperative length of stay (PLOS) and total hospital costs associated with these operations was assessed. Results: For each of the eight operations of varying complexity evaluated (total n = 57,797), there were differences in coding between data sets, which translated into differences in the reporting of associated resource utilization for the cases coded in either data set. There were statistically significant differences in PLOS and cost for seven of the eight operations, although most PLOS differences were relatively small with the exception of the Norwood operation and truncus repair (differences of two days, P < .001). For cost, there was a >5% difference for three of the eight operations and >10% difference for truncus repair (US

Linking the Congenital Heart Surgery Databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons' Society: Part 1—Rationale and Methodology

10,570; P < .01). Grouping of operations into categories of similar risk appeared to mitigate many of these differences. Conclusion: Differences in coding of cases in administrative versus clinical registry data can translate into differences in assessment of associated PLOS and cost for certain operations. This may be minimized through evaluating larger groups of operations when using administrative data or using clinical registry data to accurately identify operations of interest.

Linking the congenital heart surgery databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons' Society: part 2--lessons learned and implications.

BACKGROUND Infants supported by extracorporeal membrane oxygenation (ECMO) after a Norwood operation face in-hospital mortality rates of 60% to 70%. There are limited data on completion of staged palliation for the subset of patients who survive to hospital discharge. METHODS We performed a retrospective case-control study of 64 sequential patients at a single institution supported by ECMO after a Norwood operation. Primary endpoints were survival to hospital discharge, stage II palliation, and stage III palliation. Predictors of non-survival to each endpoint were identified with logistic regression. Survival was compared with a 3:1 era-matched group of control patients who underwent a Norwood operation but did not require ECMO. RESULTS Survival to hospital discharge, stage II palliation, and stage III palliation was 43.8%, 35.9%, and 25.4%, respectively for ECMO cases. Factors independently associated with non-survival to hospital discharge included female gender, ECMO 7 days or greater, and need for renal replacement therapy on ECMO. Non-Caucasian race and ECMO 7 days or greater were independently associated with non-survival to stage II, while non-Caucasian race, lower birth weight, and ECMO 7 days or greater were independently associated with non-survival to stage III. Extracorporeal membrane oxygenation was associated with decreased survival at each endpoint. Patients who survived ECMO had increased interstage mortality between hospital discharge and stage II palliation. CONCLUSIONS Extracorporeal membrane oxygenation after a Norwood operation can be life-saving but ultimate survival through staged palliation remains suboptimal. The elevated mortality risk for patients supported by ECMO persists after hospital discharge. Both socioeconomic factors and ECMO-related morbidity may contribute to midterm mortality.

Risk factors for requiring extracorporeal membrane oxygenation support after a Norwood operation.

Purpose: The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) is the largest Registry in the world of patients who have undergone congenital and pediatric cardiac surgical operations. The Congenital Heart Surgeons’ Society Database (CHSS-D) is an Academic Database designed for specialized detailed analyses of specific congenital cardiac malformations and related treatment strategies. The goal of this project was to create a link between the STS-CHSD and the CHSS-D in order to facilitate studies not possible using either individual database alone and to help identify patients who are potentially eligible for enrollment in CHSS studies. Methods: Centers were classified on the basis of participation in the STS-CHSD, the CHSS-D, or both. Five matrices, based on CHSS inclusionary criteria and STS-CHSD codes, were created to facilitate the automated identification of patients in the STS-CHSD who meet eligibility criteria for the five active CHSS studies. The matrices were evaluated with a manual adjudication process and were iteratively refined. The sensitivity and specificity of the original matrices and the refined matrices were assessed. Results: In January 2012, a total of 100 centers participated in the STS-CHSD and 74 centers participated in the CHSS. A total of 70 centers participate in both and 40 of these 70 agreed to participate in this linkage project. The manual adjudication process and the refinement of the matrices resulted in an increase in the sensitivity of the matrices from 93% to 100% and an increase in the specificity of the matrices from 94% to 98%. Conclusion: Matrices were created to facilitate the automated identification of patients potentially eligible for the five active CHSS studies using the STS-CHSD. These matrices have a sensitivity of 100% and a specificity of 98%. In addition to facilitating identification of patients potentially eligible for enrollment in CHSS studies, these matrices will allow (1) estimation of the denominator of patients potentially eligible for CHSS studies and (2) comparison of eligible and enrolled patients to potentially eligible and not enrolled patients to assess the generalizability of CHSS studies.

Hybrid approach for pulmonary atresia with intact ventricular septum: Early single center results and comparison to the standard surgical approach

Purpose: A link has been created between the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) and the Congenital Heart Surgeons’ Society Database (CHSS-D). Five matrices have been created that facilitate the automated identification of patients who are potentially eligible for the five active CHSS studies using the STS-CHSD. These matrices are now used to (1) estimate the denominator of patients eligible for CHSS studies and (2) compare “eligible and enrolled patients” to “potentially eligible and not enrolled patients” to assess the generalizability of CHSS studies. Methods: The matrices were applied to 40 consenting institutions that participate in both the STS-CHSD and the CHSS to (1) estimate the denominator of patients that are potentially eligible for CHSS studies, (2) estimate the completeness of enrollment of patients eligible for CHSS studies among all CHSS sites, (3) estimate the completeness of enrollment of patients eligible for CHSS studies among those CHSS institutions participating in each CHSS cohort study, and (4) compare “eligible and enrolled patients” to “potentially eligible and not enrolled patients” to assess the generalizability of CHSS studies. The matrices were applied to all participants in the STS-CHSD to identify patients who underwent frequently performed operations and compare “eligible and enrolled patients” to “potentially eligible and not enrolled patients” in following five domains: (1) age at surgery, (2) gender, (3) race, (4) discharge mortality, and (5) postoperative length of stay. Completeness of enrollment was defined as the number of actually enrolled patients divided by the number of patients identified as being potentially eligible for enrollment. Results: For the CHSS Critical Left Ventricular Outflow Tract Study (LVOTO) study, for the Norwood procedure, completeness of enrollment at centers actively participating in the LVOTO study was 34%. For the Norwood operation, discharge mortality was 15% among 227 enrolled patients and 16% among 1768 nonenrolled potentially eligible patients from the 40 consenting institutions. Median postoperative length of stay was 31 days and 26 days for these enrolled and nonenrolled patients. For the CHSS anomalous aortic origin of a coronary artery (AAOCA) study, for AAOCA repair, completeness of enrollment at centers actively participating in the AAOCA study was 40%. Conclusion: Determination of the denominator of patients eligible for CHSS studies and comparison of “eligible and enrolled patients” to “potentially eligible and not enrolled patients” provides an estimate of the extent to which patients in CHSS studies are representative of the overall population of eligible patients; however, opportunities exist to improve enrollment.