Objectives To determine the incidence of surgical site infections (SSIs) in congenital heart surgery (CHS) patients undergoing delayed sternal closure (DSC) and to evaluate risk factors for SSI. ...Methods A nested case–control study was performed within a cohort of CHS patients undergoing DSC at our institution between 2005 and 2009. Cases met 2008 Centers for Disease Control and Prevention criteria for SSI; control subjects were matched based on year of surgery. Uni- and multivariate logistic regressions were performed to identify SSI risk factors. Results Of 375 patients who underwent DSC, 43 (11%) developed an SSI. The analysis included 172 patients (43 cases, 129 controls); 118 (69%) were neonates, 80 (47%) had undergone Norwood procedure, and 150 (87%) had DSC initiated in the operating room. Case and control subjects were similar based on pre- and intraoperative characteristics. Duration of mechanical ventilation, intensive care unit and hospital length of stay, and mortality were significantly greater in patients with an SSI. Multiple periods of DSC, longer duration of DSC, greater dependence on parenteral nutrition, and extracorporeal membrane oxygenation were significantly associated with SSI in univariate analyses. Multivariate analysis demonstrated that multiple periods of DSC (adjusted odds ratio, 5.9; 95% confidence interval, 1.7-20.1) and extracorporeal membrane oxygenation (adjusted odds ratio, 2.9; 95% confidence interval, 1.1-7.6) remained independent risk factors for SSI. Conclusions For CHS patients undergoing DSC, extracorporeal membrane oxygenation and multiple periods of DSC are independent risk factors for SSI. New strategies for prevention and prophylaxis of SSI may be indicated for these high-risk patients who have worse outcomes and greater health care resource utilization.
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.
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.
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.
Overall, 27 hospitals (30,670 patients) were included. Median adjusted cost per case was $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.
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.
Objectives Heart transplantation in patients with adult congenital heart disease is increasing, yet no large studies have defined how this subgroup differs from other adult recipients. We ...investigated outcomes and risk factors for mortality and retransplantation among patients with adult congenital heart disease compared with adult recipients. Methods A review was performed of 18- to 45-year-old patients undergoing heart transplantation from 1990–2008 reported to the United Network for Organ Sharing database. Trends were compared between 2 eras: era 1 (1990–1998) and era 2 (1999–2008). Multivariable semiparametric hazard models identified factors associated with time-related death and retransplantation. Results Of 8496 patients identified, 575 had adult congenital heart disease. The prevalence of heart transplantation among adult recipients decreased by 28% over time ( P < .001) and increased among patients with adult congenital heart disease by 41% ( P < .001). Induction therapy use was less in patients with adult congenital heart disease (66%) compared with that seen in adult recipients (71%, P = .02). Steroid maintenance was less in patients with adult congenital heart disease (92%) compared with that seen in adult recipients (97%, P < .001). Post–heart transplantation survival among adult recipients improved over time ( P = .02) but not among patients with adult congenital heart disease ( P = .81). Overall post–heart transplantation mortality ( P = .006) and retransplantation ( P = .03) were significantly higher for patients with adult congenital heart disease than for adult recipients, mainly because of an early hazard phase. Adult congenital heart disease was a risk factor for both death ( P < .001) and retransplantation ( P = .04). Any induction therapy and steroid maintenance was associated with improved survival for all recipients ( P = .001). Conclusions Adult congenital heart disease represent an increasing proportion of heart transplant recipients. Compared with adult recipients, patients with adult congenital heart disease experience higher post–heart transplantation mortality and retransplantation. Immunosuppression differs among patients with adult congenital heart disease and adult recipients. Further studies should investigate whether post–heart transplantation outcomes would be improved by more aggressive induction therapy or judicious steroid tapers.
Background There has been a long-standing desire to implement a multi-institutional, multispecialty program to address surgical quality improvement for children. This report documents results of the ...initial phase of the American College of Surgeons National Surgical Quality Improvement Program Pediatric. Study Design From October 2008 to December 2009, patients from 4 pediatric referral centers were sampled using American College of Surgeons National Surgical Quality Improvement Program methodology tailored to children. Results A total of 7,287 patients were sampled, representing general/thoracic surgery (n = 2,237; 30.7%), otolaryngology (n = 1,687; 23.2%), orthopaedic surgery (n = 1,367; 18.8%), urology (n = 893; 12.3%), neurosurgery (n = 697; 9.6%), and plastic surgery (n = 406; 5.6%). Overall mortality rate detected was 0.3% and 287 (3.9%) patients had postoperative occurrences. After accounting for demographic, preoperative, and operative factors, occurrences were 4 times more likely in those undergoing inpatient versus outpatient procedures (odds ratio OR = 4.71; 95% CI, 3.01−7.35). Other factors associated with higher likelihood of postoperative occurrences included nutritional/immune history, such as preoperative weight loss/chronic steroid use (OR = 1.49; 95% CI, 1.03−2.15), as well as physiologic compromise, such as sepsis/inotrope use before surgery (OR = 1.68; 95% CI, 1.10−1.95). Operative factors associated with occurrences included multiple procedures under the same anesthetic (OR = 1.58; 95% CI, 1.21−2.06) and American Society of Anesthesiologists classification category 4/5 versus 1 (OR = 5.74; 95% CI, 2.94−11.24). Specialty complication rates varied from 1.5% for otolaryngology to 9.0% for neurosurgery (p < 0.001), with specific procedural groupings within each specialty accounting for the majority of complications. Although infectious complications were the predominant outcomes identified across all specialties, distribution of complications varied by specialty. Conclusions Based on this initial phase of development, the highly anticipated American College of Surgeons National Surgical Quality Improvement Program Pediatric has the potential to identify outcomes of children's surgical care that can be targeted for quality improvement efforts.
There are limited data regarding long-term outcomes after the Ross procedure in children. We evaluated mortality and reintervention in a large pediatric cohort.
A retrospective analysis of all ...patients aged younger than 18 years who underwent the Ross procedure at our institution (1991 to 2013) was conducted. Kaplan-Meier curves and Cox proportion hazard models were used to evaluate long-term outcomes and associated risk factors.
Included were 240 consecutive patients undergoing a Ross/Ross-Konno procedure: 18% infants, 48% children, and 33% adolescents. Infants were more likely to have complex left heart disease (p = 0.005). Overall survival to hospital discharge was 96%; infants had the highest mortality (18%). Long-term survival status was known for 99.6% (median follow-up, 10.7 years). Overall 15-year survival was 87% (lowest in infants, 72%; p = 0.003). Reintervention status was known in 87%. Overall 15-year freedom from any left ventricular outflow tract reintervention was 59%; 85% still had their autograft valve at the latest follow-up. Left ventricular outflow tract reintervention was uncommon in infants (n = 2). Overall 15-year freedom from right ventricular outflow tract reintervention was 53%, and was lower in infants (19%) than in children (51%) and adolescents (76%; p < 0.0001).
Outcomes after the Ross procedure in children vary by age. Infants more commonly have complex left heart disease and experience higher mortality but have excellent long-term autograft durability. Children and adolescents have higher rates of left ventricular outflow tract reintervention, whereas infants are at highest risk of right ventricular outflow tract reintervention.
Extracorporeal membrane oxygenation (ECMO) is the most common form of cardiac support for postcardiotomy cardiac failure in children. While its benefits have been thoroughly explored in infants ...weighing more than 3 kg, similar analyses are lacking in lower weight neonates. This single-center study investigated outcomes and risks for poor survival among infants weighing 3 kg or less.
A retrospective review of infants 3 kg or less who required postcardiotomy ECMO support was performed (January 1, 1999 to December 31, 2010). Primary outcome was 30-day survival after decannulation. Factors analyzed for association with poor outcome included demographics, cardiac anatomy, bypass and circulatory arrest times, total ECMO support time, postoperative lactate, inotrope use, and need for renal replacement therapy.
During the study period, 64 patients weighing 3 kg or less required postcardiotomy ECMO. Median gestational age and age at ECMO initiation were 38 weeks (interquartile range, 36 to 39) and 7 days (interquartile range, 4 to 9), respectively, with median ECMO support time of 164 hours (interquartile range, 95 to 231). Overall 30-day survival after decannulation was 33%. Factors associated with poor outcome were longer duration of support (231 hours or more, 12% survival, versus less than 231 hours, 40% survival; p = 0.05) and renal replacement therapy (n = 36, survival 17% versus 54%; p = 0.002). Multivariable regression analysis identified renal replacement therapy as the only independent factor associated with poor survival (odds ratio 4.3, 95% confidence interval: 1.3 to 14.9, p = 0.02).
For infants weighing 3 kg or less, 30-day survival after decannulation after cardiac ECMO is poor. Factors associated with poor prognosis were need for renal replacement therapy and longer duration of ECMO support. These findings may provide a useful guide for medical decision making among this unique, high-risk patient group.
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.
Abstract Objectives Aortic arch reconstruction in children with single ventricle lesions may predispose to circulatory inefficiency and maladaptive physiology leading to increased myocardial ...workload. We sought to describe neoaortic anatomy and physiology, risk factors for abnormalities, and impact on right ventricular function in patients with single right ventricle lesions after arch reconstruction. Methods Prestage II aortic angiograms from the Pediatric Heart Network Single Ventricle Reconstruction trial were analyzed to define arch geometry (Romanesque normal, crenel elongated, or gothic angular), indexed neoaortic dimensions, and distensibility. Comparisons were made with 50 single-ventricle controls without prior arch reconstruction. Factors associated with ascending neoaortic dilation, reduced distensibility, and decreased ventricular function on the 14-month echocardiogram were evaluated using univariate and multivariable logistic regression. Results Interpretable angiograms were available for 326 of 389 subjects (84%). Compared with controls, study subjects more often demonstrated abnormal arch geometry (67% vs 22%, P < .01) and had increased ascending neoaortic dilation ( Z score 3.8 ± 2.2 vs 2.6 ± 2.0, P < .01) and reduced distensibility index (2.2 ± 1.9 vs 8.0 ± 3.8, P < .01). Adjusted odds of neoaortic dilation were increased in subjects with gothic arch geometry (odds ratio OR, 3.2 vs crenel geometry, P < .01) and a right ventricle-pulmonary artery shunt (OR, 3.4 vs Blalock–Taussig shunt, P < .01) but were decreased in subjects with aortic atresia (OR, 0.7 vs stenosis, P < .01) and those with recoarctation (OR, 0.3 vs no recoarctation, P = .04). No demographic, anatomic, or surgical factors predicted reduced distensibility. Neither dilation nor distensibility predicted reduced right ventricular function. Conclusions After Norwood surgery, the reconstructed neoaorta demonstrates abnormal anatomy and physiology. Further study is needed to evaluate the longer-term impact of these features.
Prevention of brain injury during congenital heart surgery has focused on intraoperative and perioperative neuroprotection and neuromonitoring. Many strategies have been adopted as "standard of ...care." However, the strength of evidence for these practices and the relationship to long-term outcomes are unknown. We performed a systematic review (January 1, 1990 to July 30, 2010) of neuromonitoring and neuroprotection strategies during cardiopulmonary bypass (CPB) in infants of age 1 year or less. Papers were graded individually and as thematic groups, assigning evidence-based medicine and American College of Cardiology/American Heart Association (ACC/AHA) level of evidence grades. Consensus scores were determined by adjudication. Literature search identified 527 manuscripts; 162 met inclusion criteria. Study designs were prospective observational cohort (53.7%), case-control (21.6%), randomized clinical trial (13%), and retrospective observational cohort (9.9%). Median sample size was 43 (range 3 to 2,481). Primary outcome was evidence of structural brain injury or functional disability (neuroimaging, electroencephalogram, formal neurologic examination, or neurodevelopmental testing) in 43%. Follow-up information was reported in only 29%. The most frequent level of evidence was evidence-based medicine level 4 (33.3%) or ACC/AHA class IIB: level B (42%). The only intervention with sufficient evidence to recommend "the procedure or treatment should be performed" was avoidance of extreme hemodilution during CPB. Data supporting use of current neuromonitoring and neuroprotective techniques are limited. The level of evidence is insufficient to support effectiveness of most of these strategies. Well-designed studies with correlation to clinical outcomes and long-term follow-up are needed to develop guidelines for neuromonitoring and neuroprotection during CPB in infants.
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