Neonatal surgery in low- vs. high-volume institutions: a KID inpatient database outcomes and cost study after repair of congenital diaphragmatic hernia, esophageal atresia, and gastroschisis.

BACKGROUND/PURPOSE: The volume-outcome relationship and optimal surgical volumes for repair of congenital anomalies in neonates is unknown. METHODS: A retrospective study of infants who underwent diaphragmatic hernia (CDH), gastroschisis (GS), and esophageal atresia/tracheoesophageal fistula (EA/TEF) repair at US hospitals using the Kids' Inpatient Database 2009-2012. Distribution of institutional volumes was calculated. Multi-level logistic/linear regressions were used to determine the association between volume and mortality, length of stay, and costs. RESULTS: Total surgical volumes were 1186 for CDH, 1280 for EA/TEF, and 3372 for GS. Median case volume per institution was three for CDH and EA/TEF, and four for GS. Hospitals with annual case volumes ≥ 75th percentile were considered high volume. Approximately, half of all surgeries were performed at low-volume hospitals. No clinically meaningful association between volume and outcomes was found for any procedure. Median cost was greater at high- vs. low-volume hospitals [CDH: $165,964 (p < 0.0001) vs. $104,107, EA/TEF: $85,791 vs. $67,487 (p < 0.006), GS: $83,156 vs. $72,710 (p < 0.0009)]. CONCLUSIONS: An association between volume and outcome was not identified in this study using robust outcome measures. The cost of care was higher in high-volume institutions compared to low-volume institutions. LEVEL OF EVIDENCE: III.

American College of Surgeons National Surgical Quality Improvement Program Pediatric: a beta phase report.

PURPOSE: The American College of Surgeons (ACS) National Surgical Quality Improvement Program Pediatric (NSQIP-P) expanded to beta phase testing with the enrollment of 29 institutions. Data collection and analysis were aimed at program refinement and development of risk-adjusted models for inter-institutional comparisons. METHODS: Data from the first full year of beta-phase NSQIP-P were analyzed. Patient accrual used ACS-NSQIP methodology tailored to pediatric specialties. Preliminary risk adjusted modeling for all pediatric and neonatal operations and pediatric (excluding neonatal) abdominal operations was performed for all cause morbidity (other than death) and surgical site infections (SSI) using hierarchical logistic regression methodology and eight predictor variables. Results were expressed as odds ratios with 95% confidence intervals. RESULTS: During calendar year 2010, 29 institutions enrolled 37,141 patients. 1644 total CPT codes were entered, of which 456 accounted for 90% of the cases. 450 codes were entered only once (1.2% of cases). For all cases, overall mortality was 0.25%, overall morbidity 7.9%, and the SSI rate 1.8%. For neonatal cases, mortality was 2.39%, morbidity 18.7%, and the SSI rate 3%. For the all operations model, risk-adjusted morbidity institutional odds ratios ranged 0.48-2.63, with 9/29 hospitals categorized as low outliers and 9/29 high outliers, while risk-adjusted SSI institutional odds ratios ranged 0.36-2.04, with 2/29 hospitals low outliers and 7/29 high outliers. CONCLUSION: This report represents the first risk-adjusted hospital-level comparison of surgical outcomes in infants and children using NSQIP-P data. Programmatic and analytic modifications will improve the impact of this program as it moves into full implementation. These results indicate that NSQIP-P has the potential to serve as a model for determining risk-adjusted outcomes in the neonatal and pediatric population with the goal of developing quality improvement initiatives for the surgical care of children.

Contemporary pediatric splenectomy: continuing controversies.

PURPOSE: We undertook the current study to update the literature on pediatric splenectomy in the age of minimally invasive proficiency among pediatric surgeons. The study is designed to address specific concerns among surgeons about the suitability of the laparoscopic approach in specific situations and among hematologists about the relative benefits and risks of splenectomy in children. METHODS: Retrospective analysis of clinicopathologic data for 118 children who underwent open (OS) or laparoscopic (LS) splenectomy at an urban tertiary children's hospital from January 2000 to July 2008. RESULTS: One hundred and three cases (87%) were started as LS. Operative times were equivalent for LS and OS (P = 0.8). In the LS group, there were four conversions (3.9%) from LS to OS and five early post-operative complications (4.9%). Median length of stay was 2 days for LS and 4 days for both OS and LS converted to OS (P < 0.0001). The ten largest spleens removed by LS had greater mass (P = 0.02) and tended to have greater volume (P = 0.1) than those removed by OS. Children with hereditary spherocytosis, ITP, and hemoglobinopathy had favorable clinical outcomes, regardless of operative approach. There were no cases of overwhelming post-splenectomy sepsis in this series. CONCLUSIONS: Laparoscopic splenectomy is the preferred approach for splenectomy in children with hematological diseases, with or without splenomegaly. Compared to open splenectomy, laparoscopic splenectomy has equivalent operative time and improved length of stay. Both approaches have excellent therapeutic outcomes for appropriate indications.

Pediatric American College of Surgeons National Surgical Quality Improvement Program: feasibility of a novel, prospective assessment of surgical outcomes.

PURPOSE: The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) provides validated assessment of surgical outcomes. This study reports initiation of an ACS NSQIP Pediatric at 4 children's hospitals. METHODS: From October 2008 to June 2009, 121 data variables were prospectively collected for 3315 patients, including 30-day outcomes and tailoring the ACS NSQIP methodology to children's surgical specialties. RESULTS: Three hundred seven postoperative complications/occurrences were detected in 231 patients representing 7.0% of the study population. Of the patients with complications, 175 (75.7%) had 1, 39 (16.9%) had 2, and 17 (7.4%) had 3 or more complications. There were 13 deaths (0.39%) and 14 intraoperative occurrences (0.42%) detected. The most common complications were infection, 105 (34%) (SSI, 54; sepsis, 31; pneumonia, 13; urinary tract infection, 7); airway/respiratory events, 27 (9%); wound disruption, 18 (6%); neurologic events, 8 (3%) (nerve injury, 4; stroke/vascular event, 2; hemorrhage, 2); deep vein thrombosis, 3 (<1%); renal failure, 3 (<1%); and cardiac events, 3 (<1%). Current sampling captures 17.5% of cases across institutions with unadjusted complication rates ranging from 6.8% to 10.2%. Completeness of data collection for all variables exceeded 95% with 98% interrater reliability and 87% of patients having full 30-day follow-up. CONCLUSION: These data represent the first multiinstitutional prospective assessment of specialty-specific surgical outcomes in children. The ACS NSQIP Pediatric is poised for institutional expansion and future development of risk-adjusted models.

American College of Surgeons National Surgical Quality Improvement Program Pediatric: a phase 1 report.

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.

Predicting response to splenectomy in children with immune thrombocytopenic purpura.

PURPOSE: Predicting the response to splenectomy in children with immune thrombocytopenic purpura (ITP) continues to be a clinical challenge. The purpose of this study is to identify preoperative predictors of outcome for splenectomy in children with ITP. METHODS: The charts of 19 children who underwent splenectomy for ITP were retrospectively reviewed. Platelet responses to treatment are categorized as complete response (CR, > or =150,000/microL), partial response (PR, > or =50,000 but <150,000/microL), or nonresponse (NR, <50,000/microL). RESULTS: After splenectomy, 13 patients (68%) had CR, 3 (16%) had PR, and 3 (16%) had NR. No correlation existed between CR to splenectomy and any of the following: age, platelet count at diagnosis, last platelet count before splenectomy, platelet count on postoperative day 1, or responses to preoperative intravenous immunoglobulin, WinRho, or Rituximab. However, all 7 patients who had NR to a full course of steroids subsequently had CR to splenectomy. Nonresponse to steroid therapy was directly correlated with CR to splenectomy (P = .01, Fisher's Exact test). Furthermore, postsplenectomy platelet counts were inversely related to peak platelet response to steroids (correlation coefficient = -0.68, P = .01). CONCLUSIONS: Preoperative responsiveness to steroid therapy, as measured by peak platelet count, predicts NR to splenectomy for ITP in children, whereas NR to steroid therapy is highly correlated with CR to splenectomy. These findings challenge the widely held notion that steroid responsiveness portends a favorable outcome after splenectomy.

Complicated appendicitis in children: a clear role for drainage and delayed appendectomy.

INTRODUCTION: Children presenting with complicated appendicitis represent a common and challenging problem. Conflicting data exist concerning optimal treatment of these patients with primary versus delayed appendectomy. METHODS: A retrospective review of all children undergoing appendectomy over a 5-year period was performed. RESULTS: We identified 1,106 children: 360 had evidence of perforation and 92 had an intra-abdominal abscess or right lower quadrant phlegmon. Of these 92, 60 underwent primary appendectomy and 32 underwent drainage and/or antibiotic therapy with delayed appendectomy. Children undergoing delayed appendectomy had a longer prodrome of symptoms (6.9 vs 4.6 days, P = .002), slightly higher presenting white blood cell count (19.3 vs 16.6, P = .08), and had the same hospital length of stay, yet had a lower complication rate requiring readmission to the hospital (0% vs 10%) compared to those undergoing immediate appendectomy. CONCLUSION: In children presenting with prolonged symptoms and a discrete appendiceal abscess or phlegmon, drainage and delayed appendectomy should be the treatment of choice.

Surgical management of pulmonary and gastrointestinal complications in children with cystic fibrosis.

PURPOSE OF REVIEW: Cystic fibrosis is a common disorder, affecting as many as 1:2500 Caucasian live births. Despite improved medical management, disease-specific complications are common and are responsible for substantial morbidity and ultimately mortality. Both pulmonary and gastrointestinal complications of cystic fibrosis are well known; however, the complications requiring surgical intervention in the pediatric population are infrequent. We provide a detailed review of the cystic fibrosis-associated pulmonary and gastrointestinal complications and potential surgical options for management in children with cystic fibrosis. RECENT FINDINGS: Recent operative approaches are described that include application of minimally invasive surgical techniques primarily for intrathoracic disease. Novel medical therapies are also presented. Finally an attempt is made to put in perspective those surgical care advances that have had a benefit on disease outcomes. SUMMARY: This report will provide the physician caring for the child with cystic fibrosis an understanding of those disease complications that will require surgical consultation and potential operative intervention.

Operative strategies for necrotizing enterocolitis: The prevention and treatment of short-bowel syndrome.

Necrotizing enterocolitis (NEC) is the leading cause of short-bowel syndrome (SBS) in infancy. Studies on the acute medical and surgical management of NEC have traditionally focused on short-term morbidity and mortality, with less emphasis on long-term outcomes. Acute surgical management of NEC involves the often competing priorities of controlling sepsis and preserving bowel length. Bowel-preserving strategies for NEC, designed to limit SBS, are based on peritoneal drainage, limited resection, or a combination of both. Drainage-based strategies are generally favored in smaller neonates, while laparotomy-based strategies are favored in larger patients, especially those with a more limited extent of intestinal injury. Comparisons of drainage-based approaches and resection-based approaches are limited by confounding variables, and neither approach is clearly superior with regard to subsequent SBS. These traditional as well as more creative approaches to bowel preservation have application in NEC, yet they depend on a series of patient and treatment characteristics that include the ability of diseased but viable bowel to recover both absorptive and motility function after acute NEC, the ability of the infant to tolerate appropriately drained intraperitoneal contamination, and the ability of the injured intestine to subsequently undergo intestinal adaptive change. In addition, there are a series of operative options that have been designed to mitigate the impact of SBS once it is established. These procedures are not uniquely applied exclusively for NEC-induced SBS. However, strategies that slow intestinal transit, improve peristaltic function, or enhance mucosal absorptive function each have application in the management of SBS.

Pediatric surgical training: an historic perspective, a formula for change.

BACKGROUND/PURPOSE: American pediatric surgical education has more than a 65-year history of formalizing the organization and the curriculum of the training process. However, never before have so many simultaneous internal and external forces appeared on the horizon that have the collective potential of influencing the quality of future pediatric surgeons. It is the purpose of this study to identify and detail these opportunities, compare them with the historical past, and propose the beginnings of a strategy to control the destiny. The ultimate goal should be to continue to assure that pediatric surgeons are of the highest attainable quality that will optimize the surgical health of America's children. METHODS AND RESULTS: Using a current literature review, 7 specific influencing forces have been identified: a declining applicant pool, the generation-X factor, medical economics, early specialization of training, restricted residency work hours, pediatric surgical manpower, and competency-based surgical education. An effective response to these forces is multifactorial, but a first need might be consideration of a new educational oversight organizational structure for pediatric surgery. Thereafter, specific curricular reform is needed to match the strengths of the candidates as well as the training programs. Finally, as a specialty field we must assert the leadership needed to define optimal educational outcomes. CONCLUSIONS: This report defines the educational history and the contemporary influencing forces, and it proposes a strategy to assure that pediatric surgical education exceeds the needs of America's children into the future.

Fetal tissue engineering from amniotic fluid.

BACKGROUND: We have recently shown, in an animal model, that amniotic fluid can be a source of cells for fetal tissue engineering. This study was aimed at determining whether fetal tissue constructs could also be engineered from cells normally found in human amniotic fluid. STUDY DESIGN: Cells obtained from the amniotic fluid of pregnant women at 15 to 19 weeks of gestation (n=6) were cultured in Dulbecco's Modified Eagle's medium (Sigma Chemical, St Louis, MO) containing 20% fetal bovine serum and 5 ng/mL basic fibroblast growth factor in a 95% humidified, 5% CO(2) chamber at 37 degrees C. A subpopulation of morphologically distinct cells was then mechanically isolated from the rest and selectively expanded. The lineage of this subpopulation of amniocytes was determined by immunofluorescent staining with antibodies against standard intermediate filaments and surface antigens. Cell proliferation rates were determined by oxidation assay. After cell expansion, colonies of amniocytes were statically and dynamically seeded onto both unwoven, 1-mm-thick polyglycolic acid polymer scaffold and acellular human dermis for 72 hours. The resulting constructs were analyzed by scanning electron microscopy. RESULTS: Amniocytes stained positively for smooth muscle actin, vimentin, cytokeratin 18, and fibroblast surface protein, and negatively for desmin, cluster of differentiation 31, and von Willebrand's factor (Dako, Carpenteria, CA). These findings are consistent with a mesenchymal, fibroblast-myofibroblast cell lineage. Mesenchymal amniocytes could be rapidly expanded in culture, based on results of the proliferation assay. Scanning electron microscopy of amniocyte constructs revealed dense, confluent layers of cells surrounding the polymer matrices and firm cell adhesion to both PGA and Alloderm (Lifecell Corp, Branchburg, NJ) scaffolds. No evidence of cell death was observed. CONCLUSIONS: Subpopulations of fetal mesenchymal cells can be consistently isolated from human amniotic fluid and rapidly expanded in vitro. Human mesenchymal amniocytes attach firmly to both polyglycolic acid polymer and acellular human dermis. The amniotic fluid can be a valuable and practical cell source for fetal tissue engineering.

The placenta as a cell source in fetal tissue engineering.

PURPOSE: This study was aimed at determining whether fetal tissue constructs can be engineered from cells derived from the placenta. METHODS: A subpopulation of morphologically distinct cells was isolated mechanically from specimens of human placenta (n = 6) and selectively expanded. The lineage of these cells was determined by immunofluorescent staining against multiple intermediate filaments and surface antigens. Cell proliferation rates were determined by oxidation assays and compared with those of immunocytochemically identical cells derived from human amniotic fluid samples (n = 6). Statistical analysis was by analysis of variance (ANOVA). After expansion, the cells were seeded onto a polyglycolic acid polymer/poly-4-hydroxybutyrate scaffold. The resulting construct was analyzed by both optical and scanning electron microscopy. RESULTS: The immunocytochemical profile of expanded placental cells was consistent with a nontrophoblastic, mesenchymal origin. Their proliferation rate in culture was not significantly different when compared with mesenchymal fetal cells isolated from human amniotic fluid; however, it was greater than previously reported rates for similar cells obtained from postnatal or adult tissues. Construct analysis showed dense layers of cells firmly attached to the scaffold without evidence of cell death. CONCLUSIONS: Subpopulations of nontrophoblastic, mesenchymal cells can be isolated consistently from the human placenta. These cells proliferate as rapidly as fetal mesenchymal amniocytes in vitro and attach firmly to polyglycolic acid scaffolds. The placenta can be a valuable and practical source of cells for the engineering of select fetal tissue constructs.