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ABSTRACT: Previous analyses have suggested center volume is associated with outcome in children undergoing heart surgery. However, data are limited regarding potential mediating factors, including the relationship of center volume with postoperative complications and mortality in those who suffer a complication. We examined this association in a large multicenter cohort.
Children 0 to 18 years undergoing heart surgery at centers participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2006-2009) were included. In multivariable analysis, we evaluated outcomes associated with annual center volume, adjusting for patient factors and surgical risk category.
A total of 35 776 patients (68 centers) were included. Overall, 40.6% of patients had ≥1 complication, and the in-hospital mortality rate was 3.9%. The mortality rate in those patients with a complication was 9.0%. In multivariable analysis, lower center volume was significantly associated with higher in-hospital mortality. There was no association of center volume with the rate of postoperative complications, but lower center volume was significantly associated with higher mortality in those with a complication (P = .03 when volume examined as a continuous variable; odds ratio in centers with <150 vs >350 cases per year = 1.59 [95% confidence interval: 1.16-2.18]). This association was most prominent in the higher surgical risk categories.
These data suggest that the higher mortality observed at lower volume centers in children undergoing heart surgery may be related to a higher rate of mortality in those with postoperative complications, rather than a higher rate of complications alone.
PEDIATRICS 02/2012; 129(2):e370-6. · 4.47 Impact Factor
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Danielle S Burstein,
Jeffrey P Jacobs,
Jennifer S Li,
Shubin Sheng,
Sean M O'Brien,
Anthony F Rossi,
Paul A Checchia,
Gil Wernovsky,
Karl F Welke,
Eric D Peterson,
Marshall L Jacobs,
Sara K Pasquali
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ABSTRACT: Recently, there has been a shift toward care of children undergoing heart surgery in dedicated pediatric cardiac intensive care units (CICU). The impact of this trend on patient outcomes is unclear. We evaluated postoperative outcomes associated with a CICU versus other ICU models.
Society of Thoracic Surgeons Congenital Heart Surgery Database participants (2007-2009) who completed an ICU survey were included. In multivariable analysis, we evaluated outcomes associated with a CICU versus other ICUs, adjusting for center volume, patient factors, and Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery surgical risk category.
A total of 20 922 patients (47 centers; 25 with a CICU) were included. Overall unadjusted mortality was 3.8%, median length of stay was 6 days (interquartile range: 4-13), and 21% had 1 or more complications. In multivariable analysis, there was no difference in mortality comparing CICUs versus other ICUs (odds ratio: 0.88 [95% confidence interval: 0.65-1.19]). In stratified analysis, CICUs were associated with lower mortality only among those in Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery category 3 (odds ratio: 0.47 [95% confidence interval: 0.25-0.86]), primarily related to atrioventricular canal repair and arterial switch operation. There was no difference in length of stay or complications overall or in stratified analysis.
We were not able to detect a difference in postoperative morbidity or mortality associated with the presence of a dedicated CICU for children undergoing heart surgery. There may be a survival benefit in certain subgroups .
PEDIATRICS 06/2011; 127(6):e1482-9. · 4.47 Impact Factor
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ABSTRACT: We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Provision, which provides economic incentives to pharmaceutical companies to conduct drug studies with children.
Published studies containing the main results of trials conducted in 1998-2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported.
Overall, 174 trials were included (sample size: 8-27 065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of trials that did report such information, 65% were conducted in >or=1 country outside the United States, and 11% did not include any sites in the United States. Fifty-four countries were represented, and 38% of trials enrolled patients in >or=1 site located in a developing/transition country, including more than one-third of infectious disease, cardiovascular, and allergy/immunology trials.
The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside the United States, and more than one-third of trials enrolled patients in developing/transition countries.
PEDIATRICS 09/2010; 126(3):e687-92. · 4.47 Impact Factor
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ABSTRACT: BACKGROUND: There are limited data regarding contemporary models of care delivery for patients undergoing congenital heart surgery. The purpose of this survey was to evaluate current US practice patterns in this patient population. METHODS: Cross-sectional evaluation of US centers caring for patients undergoing congenital heart surgery was performed using an internet-based survey. Data regarding post-operative care were collected and described overall, and compared in centers with a pediatric intensive care unit (PICU) vs. dedicated pediatric cardiac intensive care unit (CICU). RESULTS: A total of 94 (77%) of the estimated 122 US centers performing congenital heart surgery participated in the survey. The majority (79%) of centers were affiliated with a university. Approximately half were located in a free standing children's hospital, and half in a children's hospital in a hospital. Fifty-five percent provided care in a PICU vs. a CICU. A combination of cardiologists and/or critical care physicians made up the largest proportion of physicians primarily responsible for post-operative care. Trainee involvement most often included critical care fellows (53%), pediatric residents (53%), and cardiology fellows (47%). Many centers (76%) also utilized physician extenders. In centers with a CICU, there was greater involvement of cardiologists and physicians with dual training (cardiology and critical care), fellows vs. residents, and physician extenders. CONCLUSION: Results of this survey demonstrate variation in current models of care delivery utilized in patients undergoing congenital heart surgery in the US. Further study is necessary to evaluate the implications of this variability on quality of care and patient outcomes.
World journal for pediatric & congenital heart surgery. 04/2010; 1(1):8-14.
