Background In 2007, the American Heart Association recommended cessation of antibiotic prophylaxis for infective endocarditis (IE) before dental procedures for all but those at highest risk for ...adverse outcomes from IE. The impact of these guidelines is unclear. We evaluated IE hospitalizations at US children's hospitals during this period. Methods Children <18 years old hospitalized from 2003 to 2010 with IE at 37 centers in the Pediatric Health Information Systems Database were included. Using Poisson regression, we evaluated the number IE hospitalizations over time (raw and indexed to total hospital admissions). Results A total of 1157 IE cases were identified; 68% had congenital heart disease (CHD). The raw number of IE cases did not change significantly over time (+1.6% difference post vs pre guidelines, 95% CI −6.4% to +10.3%, P = .7). When the number of IE cases was indexed per 1,000 hospital admissions, there was a significant decline during the time period before the guidelines (annual change: −5.9%, 95% CI −9.9 to −1.8, P = .005) and a similar decline in the post guidelines period such that the difference between the 2 periods was not significant ( P = .15). In subgroup analysis, no significant change over time in IE cases (raw or indexed) was found in the CHD subset, those 5 to 18 years old (subgroup most likely receiving dental care), or in cases coded as oral streptococci. Conclusions We found no evidence that release of new antibiotic prophylaxis guidelines was associated with a significant change in IE admissions across 37 US children's hospitals.
While there is an increasing emphasis on both optimizing quality of care and reducing health care costs, there are limited data regarding how to best achieve these goals for common and ...resource-intense conditions such as congenital heart disease. We evaluated excess costs associated with complications and prolonged length of stay (LOS) after congenital heart surgery in a large multicenter cohort.
Clinical data from The Society of Thoracic Surgeons Database were linked to estimated costs from the Pediatric Health Information Systems Database (2006 to 2010). Excess cost per case associated with complications and prolonged LOS was modeled for 9 operations of varying complexity adjusting for patient baseline characteristics.
Of 12,718 included operations (27 centers), average excess cost per case in those with any complication (versus none) was $56,584 (+$132,483 for major complications). The 5 highest cost complications were tracheostomy, mechanical circulatory support, respiratory complications, renal failure, and unplanned reoperation or reintervention (ranging from $57,137 to $179,350). Patients with an additional day of LOS above the median had an average excess cost per case of $19,273 (+$40,688 for LOS 4 to 7 days above median). Potential cost savings in the study cohort achievable through reducing major complications (by 10%) and LOS (by 1 to 3 days) were greatest for the Norwood operation ($7,944,128 and $3,929,351, respectively) and several other commonly performed operations of more moderate complexity.
Complications and prolonged LOS after congenital heart surgery are associated with significant costs. Initiatives able to achieve even modest reductions in these morbidities may lead to both improved outcomes and cost savings across both moderate and high complexity operations.
Administrative datasets are often used to assess outcomes and quality of pediatric cardiac programs; however their accuracy regarding case ascertainment is unclear. We linked patient data (2004-2010) ...from the Society of Thoracic Surgeons Congenital Heart Surgery (STS-CHS) Database (clinical registry) and the Pediatric Health Information Systems (PHIS) database (administrative database) from hospitals participating in both to evaluate differential coding/classification of operations between datasets and subsequent impact on outcomes assessment.
Eight individual benchmark operations and the Risk Adjustment in Congenital Heart Surgery, version 1 (RACHS-1) categories were evaluated. The primary outcome was in-hospital mortality.
The cohort included 59,820 patients from 33 centers. There was a greater than 10% difference in the number of cases identified between data sources for half of the benchmark operations. The negative predictive value (NPV) of the administrative (versus clinical) data was high (98.8%-99.9%); the positive predictive value (PPV) was lower (56.7%-88.0%). Overall agreement between data sources in RACHS-1 category assignment was 68.4%. These differences translated into significant differences in outcomes assessment, ranging from an underestimation of mortality associated with truncus arteriosus repair by 25.7% in the administrative versus clinical data (7.01% versus 9.43%; p = 0.001) to an overestimation of mortality associated with ventricular septal defect (VSD) repair by 31.0% (0.78% versus 0.60%; p = 0.1). For the RACHS-1 categories, these ranged from an underestimation of category 5 mortality by 40.5% to an overestimation of category 2 mortality by 12.1%; these differences were not statistically significant.
This study demonstrates differences in case ascertainment between administrative and clinical registry data for children undergoing cardiac operations, which translated into important differences in outcomes assessment.
Objectives Recent studies suggest adverse events associated with aprotinin in adults may not occur in children, and there is interest in further pediatric study of aprotinin. However, there are ...limited contemporary data comparing aprotinin with other available antifibrinolytics (aminocaproic acid ACA and tranexamic acid TXA) to guide current practice and aid in potential trial design. We performed a comparative analysis in a large multicenter cohort. Methods The Society of Thoracic Surgeons Congenital Heart Surgery Database (2004-2008) was linked to medication data from the Pediatric Health Information Systems Database. Efficacy and safety outcomes were evaluated in multivariable analysis adjusting for patient and center factors overall and in neonates and those undergoing redo sternotomy. Results A total of 22,258 patients (25 centers) were included: median age, 7.6 months (interquartile range, 2.6-43.4 months). Aprotinin (vs no drug) was associated with a significant reduction in combined hospital mortality/bleeding requiring surgical intervention overall (odds ratio OR, 0.81; 95% confidence intervals CI, 0.68-0.91) and in the redo sternotomy subgroup (OR, 0.57; 95% CI, 0.40-0.80). There was no benefit in neonates and no difference in renal failure requiring dialysis in any group. In comparative analysis, there was no difference in outcome in aprotinin versus ACA recipients. TXA (vs aprotinin) was associated with significantly reduced mortality/bleeding requiring surgical intervention overall (OR, 0.47; 95% CI, 0.30-0.74) and in neonates (OR, 0.30; 95% CI, 0.15-0.58). Conclusions These observational data suggest aprotinin is associated with reduced bleeding and mortality in children undergoing heart surgery with no increase in dialysis. Comparative analyses suggest similar efficacy of ACA and improved outcomes associated with TXA.
Previous studies suggest center volume is associated with outcome after the Norwood operation; however, the impact of surgeon volume is less clear. We evaluated the relative impact of surgeon and ...center volume on mortality in a large Norwood cohort.
Patients in the Society of Thoracic Surgeons Congenital Heart Surgery Database undergoing the Norwood operation (2000 to 2009) were included. Using multivariable logistic regression, we evaluated the relationship between in-hospital mortality and annual center and surgeon volume, adjusting for patient factors.
A total of 2,555 patients were operated on at 53 centers by 111 surgeons. Overall unadjusted mortality was 22.1%. When analyzed individually, both lower center and surgeon volume were associated with higher mortality (odds ratio for centers with 0 to 10 vs >20 cases per year 1.56 95% confidence interval 1.05 to 2.31; odds ratio for surgeons with 0 to 5 vs >10 cases per year 1.60 95% confidence interval 1.12 to 2.27). When analyzed together, the addition of surgeon volume to the center volume models attenuated but did not completely mitigate the association of center volume with outcome (relative attenuation of odds ratio=34%). Adjusted mortality rates in low, medium, and high volume centers were 25.6%, 22.3%, and 17.7%, respectively. Across all center volume strata, lower volume surgeons had higher adjusted mortality rates.
Both center and surgeon volumes appear to influence Norwood outcomes. These data suggest outcomes may potentially be improved through strategies that take advantage of the positive influence of both of these variables. This could include further investigation into the feasibility of regional collaborations, and the development of quality improvement initiatives within and across centers.
Norwood outcomes vary across centers, and a relationship between center volume and outcome has been previously described. It is unclear whether this volume-outcome relationship exists across all ...levels of patient risk or holds true for all centers. We evaluated the impact of patient risk status on the relationship between center volume and outcome, and the extent to which differences in center volume account for between-center variation in outcome.
Infants in The Society of Thoracic Surgeons Congenital Heart Surgery Database undergoing the Norwood operation (2000 to 2009) were included. Mortality associated with annual Norwood volume overall and across patient preoperative risk tertiles was evaluated in multivariable analysis. We also estimated the proportion of between-center variation in mortality explained by center volume.
The cohort included 2,557 infants from 53 centers: 34 centers with 0 to 10 Norwood cases per year; 13 centers with 11 to 20 cases per year; and 6 centers with more than 20 cases per year. Unadjusted in-hospital mortality was 22%. In multivariable analysis, lower center volume was associated with higher mortality (odds ratio in low-volume versus high-volume centers 1.54, 95% confidence interval: 1.02 to 2.32, p=0.04). The volume-outcome relationship did not differ across preoperative risk tertiles (p=0.7). Norwood volume explained an estimated 14% of the between-center variation in mortality observed, and significant between-center variation in mortality remained after adjusting for volume (p<0.001).
Center volume is modestly associated with outcome after the Norwood operation independent of patient risk status. However, this relationship explains only a portion of the between-center variation in mortality in this cohort.
Several initiatives aim to reduce postoperative infection across a variety of surgical patients as a means to improve overall quality of care and reduce variation across centers. However, the ...association of infection rates with hospital-level outcomes and resource utilization has not been well described. We evaluated this association across a multicenter cohort undergoing congenital heart surgery.
The Society of Thoracic Surgeons Congenital Heart Surgery Database was linked to resource utilization data from the Pediatric Health Information Systems Database for hospitals participating in both (2006 to 2010). Hospital-level infection rates (sepsis, wound infection, mediastinitis, endocarditis, pneumonia) adjusted for patient risk factors and case mix were calculated using Bayesian methodology, and association with hospital mortality rates, postoperative length of stay (LOS), and total costs evaluated.
The cohort included 32,856 patients (28 centers); 3.7% had a postoperative infection. Across hospitals, the adjusted infection rate varied from 0.9% to 9.8%. Hospitals with the highest infection rates had longer (LOS) (13.2 vs 11.7 days, p < 0.001) and increased hospital costs ($71,100 vs $65,100, p < 0.001), but similar mortality rates (odds ratio 0.99, 95% confidence interval 0.80 to 1.21, p = 0.9). The proportion of variation in costs and LOS explained by infection was 15% and 6%, respectively.
Infection after congenital heart surgery contributes to prolonged LOS and increased costs on a hospital level. However, given that infection rates alone explained relatively little of the variation in these outcomes across hospitals, further study is needed to identify additional factors that may be targeted in initiatives to reduce variation and improve outcomes across centers.
Objectives To assess the performance of 3 risk scores from Japan that were developed to predict, in children with Kawasaki disease, resistance to intravenous immunoglobulin (IVIG) treatment. Study ...design We used data from a randomized trial of pulsed steroids for primary treatment of Kawasaki disease to assess operating characteristics of the 3 risk scores, and we examined whether steroid therapy lowers the risk of coronary artery abnormalities in patients prospectively classified as IVIG resistant. Results For comparability with published cohorts, we analyzed the data of 99 patients who were not treated with steroids (16% IVIG-retreated) and identified male sex, lower albumin level, and higher aspartate aminotransferase level as independent risk factors for IVIG resistance. The Kobayashi score was similar in IVIG-resistant and -responsive patients, yielding a sensitivity of 33% and specificity of 87%. There was no interaction of high-risk versus low-risk status by treatment received (steroid versus placebo) with any of the 3 risk score algorithms. Conclusion Risk-scoring systems from Japan have good specificity but low sensitivity for predicting IVIG resistance in a North American cohort. Primary steroid therapy did not improve coronary outcomes in patients prospectively classified as being at high-risk for IVIG resistance.
Objective The study objective was to identify factors associated with death and cardiac transplantation in infants undergoing the Norwood procedure and to determine differences in associations that ...might favor the modified Blalock–Taussig shunt or a right ventricle-to-pulmonary artery shunt. Methods We used competing risks methodology to analyze death without transplantation, cardiac transplantation, and survival without transplantation. Parametric time-to-event modeling and bootstrapping were used to identify independent predictors. Results Data from 549 subjects (follow-up, 2.7 ± 0.9 years) were analyzed. Mortality risk was characterized by early and constant phases; transplant was characterized by only a constant phase. Early phase factors associated with death included lower socioeconomic status ( P = .01), obstructed pulmonary venous return ( P < .001), smaller ascending aorta ( P = .02), and anatomic subtype. Constant phase factors associated with death included genetic syndrome ( P < .001) and lower gestational age ( P < .001). The right ventricle-to-pulmonary artery shunt demonstrated better survival in the 51% of subjects who were full term with aortic atresia ( P < .001). The modified Blalock–Taussig shunt was better among the 4% of subjects who were preterm with a patent aortic valve ( P = .003). Lower pre-Norwood right ventricular fractional area change, pre-Norwood surgery, and anatomy other than hypoplastic left heart syndrome were independently associated with transplantation (all P < .03), but shunt type was not ( P = .43). Conclusions Independent risk factors for intermediate-term mortality include lower socioeconomic status, anatomy, genetic syndrome, and lower gestational age. Term infants with aortic atresia benefited from a right ventricle-to-pulmonary artery shunt, and preterm infants with a patent aortic valve benefited from a modified Blalock–Taussig shunt. Right ventricular function and anatomy, but not shunt type, were associated with transplantation.
Objective To determine the birth prevalence of congenital heart defects (CHDs) across the spectrum of common defects in very/extremely premature infants and to compare mortality rates between ...premature infants with and without CHDs. Study design The Kids' Inpatient Databases (2003-2012) were used to estimate the birth prevalence of CHDs (excluding patent ductus arteriosus) in very/extremely premature infants born between 25 and 32 weeks' gestational age. Birth prevalence was compared with term infants for a subset of “severe” defects expected to be near universally diagnosed in the neonatal period. Weighted multivariable logistic regression was used to calculate aORs of mortality comparing very and extremely premature infants with vs without CHDs. Results We identified 249 011 very/extremely premature infants, including 28 806 with CHDs. The overall birth prevalence of CHDs was 116 per 1000 very/extremely premature births. Severe CHDs had significantly higher birth prevalence in very/extremely premature infants when compared with term infants (7.4 per 1000 very/premature births vs 1.5 per 1000 term births; P < .001). Very/extremely premature infants with severe CHDs had an overall 26.3% in-hospital mortality and a 7.5-fold increased adjusted odds of death compared with those without CHDs. Mortality varied widely by defect in very/extremely premature infants, ranging from 12% for interrupted aortic arch to 67% for truncus arteriosus. Conclusions Given the increased birth prevalence of severe CHDs in very/extremely premature infants, and significantly higher mortality, there is justification for intensive interventions aimed at decreasing the likelihood of premature delivery for patients where CHD is diagnosed in utero.
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