Central Venous Catheter Consideration in Pediatric Oncology: A Systematic Review and Meta-analysis From the American Pediatric Surgical Association Cancer Committee.

BACKGROUND: Tunneled central venous catheters (CVCs) are the cornerstone of modern oncologic practice. Establishing best practices for catheter management in children with cancer is essential to optimize care, but few guidelines exist to guide placement and management. OBJECTIVES: To address four questions: 1) Does catheter composition influence the incidence of complications; 2) Is there a platelet count below which catheter placement poses an increased risk of complications; 3) Is there an absolute neutrophil count (ANC) below which catheter placement poses an increased risk of complications; and 4) Are there best practices for the management of a central line associated bloodstream infection (CLABSI)? METHODS: Data Sources: English language articles in Ovid Medline, PubMed, Embase, Web of Science, and Cochrane Databases. STUDY SELECTION: Independently performed by 2 reviewers, disagreements resolved by a third reviewer. DATA EXTRACTION: Performed by 4 reviewers on forms designed by consensus, quality assessed by GRADE methodology. RESULTS: Data were extracted from 110 manuscripts. There was no significant difference in fracture rate, venous thrombosis, catheter occlusion or infection by catheter composition. Thrombocytopenia with minimum thresholds of 30,000-50,000 platelets/mcl was not associated with major hematoma. Limited evidence suggests a platelet count <30,000/mcL was associated with small increased risk of hematoma. While few studies found a significant increase in CLABSI in CVCs placed in neutropenic patients with ANC<500Kcells/dl, meta-analysis suggests a small increase in this population. Catheter removal remains recommended in complicated or persistent infections. Limited evidence supports antibiotic, ethanol, or hydrochloric lock therapy in definitive catheter salvage. No high-quality data were available to answer any of the proposed questions. CONCLUSIONS: Although over 15,000 tunneled catheters are placed annually in North America into children with cancer, there is a paucity of evidence to guide practice, suggesting multiple opportunities to improve care. LEVEL OF EVIDENCE: III. This study was registered as PROSPERO 2019 CRD42019124077.

Critical elements in the operative management of pediatric malignant ovarian germ cell tumors.

Performance of the appropriate operation is highly important to ensure that any patient with a suspected ovarian germ cell tumor receives optimal therapy that prioritizes cure while simultaneoulsy minimizing risk of short and long-term toxicities of treatment. The following critical elements of any operative procedure performed for a suspected pediatric or adolescent ovarian germ cell tumor are reviewed: 1. Complete resection of the tumor via ipsilateral oophorectomy while avoiding tumor rupture and spillage, and 2. Performance of complete intraperitoneal staging at the time of initial tumor resection.

Extended Lymph Node Sampling During Surgery for Pediatric Renal Tumors Concerning for Malignancy Does Not Increase Postoperative Complication Rates.

PURPOSE: Although Children's Oncology Group renal tumor protocols mandate lymph node sampling during extirpative surgery for pediatric renal tumors, lymph node sampling is often omitted or low yield. Concerns over morbidity associated with extended lymph node sampling have led to hesitancy in adopting a formal lymph node sampling template. We hypothesized that complications in children undergoing lymph node sampling for renal tumors would be rare, and not associated with the number of lymph nodes sampled. MATERIALS AND METHODS: A single-institution, retrospective review of patients aged 0-18 years undergoing extirpative renal surgery with lymph node sampling for a suspected malignancy between 2005 and 2019 was performed. Patients with 0 or an unknown number of lymph nodes sampled or <150 days of follow-up were excluded. A "clinically significant" complication was defined as any Clavien complication ≥III, small-bowel obstruction, chylous ascites, organ injury, or wound infection. The number of lymph nodes sampled and its influence on the odds of experiencing a clinically significant complication was examined. RESULTS: A total of 144 patients met inclusion criteria. Median patient age was 38 months. Twenty-one patients (15%) had a clinically significant complication, the most common of which was ileus/small-bowel obstruction (n=16). In a multivariable analysis, increased lymph node yield was not found to influence the odds of experiencing a clinically significant complication (P = .6). CONCLUSIONS: In this cohort, there was no statistically significant difference in clinically significant complications in patients who underwent more extensive lymph node sampling during surgery for a suspected malignant pediatric renal tumor. Future studies on protocol adherence, staging accuracy, and survival trends using a lymph node sampling template in these patients should be performed.

Diagnostic Accuracy of Suspected Appendicitis: A Comparative Analysis of Misdiagnosed Appendicitis in Children.

OBJECTIVE: When evaluating suspected appendicitis, limited data support quality benchmarks for negative appendectomy (NA); none exist for delayed diagnosis of appendicitis (DDA). The objectives of this study are the following: (1) to provide preliminary evidence supporting a quality benchmark for DDA and 2) to compare presenting features and diagnostic evaluations of children with NA and DDA with those with pathology-confirmed appendicitis (PCA) diagnosed during initial emergency department (ED) encounter. METHODS: Secondary analysis of data from a QI project designed to reduce the use computed tomography when evaluating suspected appendicitis using a case-control design. Patients undergoing appendectomy in an academic tertiary care children's hospital system between January 1, 2015, and December 31, 2016 (n = 1,189) were eligible for inclusion in this case-control study. Negative appendectomy was defined as no pathologic change or findings consistent with a different diagnosis. Delayed diagnosis of appendicitis was defined as patients undergoing appendectomy within 7 days of a prior ED visit for a related complaint. Controls of PCA (n = 150) were randomly selected from all cases undergoing appendectomy. RESULTS: There were 42 NA (3.5%) and 31 DDA (2.6%). Cases of PCA and NA exhibited similar histories, examination findings, and underwent comparable diagnostic evaluations. Cases of PCA more frequently demonstrated a white blood cell count greater than 10 × 103/µL (85% vs 67%; P = 0.01), a left-shift (77% vs 45%; P < 0.001), and an ultrasound interpretation with high probability for appendicitis (73% vs 54%; P = 0.03). Numerous significant differences in history, examination findings, and diagnostic tests performed existed between cases of PCA and DDA. CONCLUSIONS: Children with PCA and NA present similarly and undergo comparable evaluations resulting in appendectomy. A 3% to 4% NA rate may be unavoidable given these similarities. Presenting features in DDA significantly differ from those of PCA. An irreducible proportion of appendicitis diagnoses may be delayed.

A surgeon's predicament: Clinical predictors of surgery and mortality in neutropenic enterocolitis.

BACKGROUND: Neutropenic enterocolitis is uncommon but potentially life-threatening, with the cornerstone of treatment being medical management (MM), and surgical intervention reserved for clinical deterioration or bowel perforation. We hypothesized that the Shock Index Pediatric Age-Adjusted (SIPA) is elevated in patients who are at greatest risk for surgical intervention and mortality. We also sought to identify computed tomography (CT) findings associated with surgical intervention and mortality. METHODS: A single-center cancer registry was reviewed for neutropenic enterocolitis patients from 2006 -2018. Survival models compared patients with normal versus elevated SIPA throughout their hospitalizations for the time to surgical management (SM), as well as in-hospital mortality. RESULTS: Seventy-four patients with neutropenic enterocolitis were identified; 7 underwent surgery. In-hospital mortality was 12% in MM and 29% in SM; mortality among patients with elevated SIPA was 4.7 times higher compared to those with normal SIPA (95% CI: 1.1, 19.83, p = 0.04). CT findings of bowel obstruction, pneumatosis, and a greater percentage of large bowel involvement were associated with surgical intervention (all ps < 0.05). CONCLUSION: Select pre-operative CT findings were associated with need for operative management. Elevated SIPA was associated with increased mortality. Elevated SIPA in pediatric cancer patients with neutropenic enterocolitis may help to identify those with more severe disease and expedite beneficial interventions.

In-utero gastric perforation from combined duodenal and esophageal atresia without consistent polyhydramnios.

We present a case in which prenatal imaging at 21-weeks' gestation suggested duodenal atresia with a double-bubble sign and enlarged stomach. Fetal magnetic resonance imaging findings demonstrated dilation of the stomach and proximal duodenum favoring duodenal atresia but no indications of esophageal atresia. Subsequent prenatal imaging demonstrated interval spontaneous decompression of the stomach without the development of polyhydramnios, obscuring the diagnosis. Postnatally, initial abdominal radiography showed a gasless abdomen, and an oral gastric tube could not pass the mid-esophagus, raising concern for pure esophageal atresia. Intraoperative findings were consistent with duodenal atresia, pure esophageal atresia and a gastric perforation due to a closed obstruction. In this case report, we review the prenatal diagnostic challenges and the limited literature pertaining to this unique pathology.

Transforming surgical morbidity and mortality into a systematic case review.

BACKGROUND/PURPOSE: The surgical morbidity and mortality (M&M) conferences at a regional children's hospital achieved the goals of case by case peer review and education for trainees but provided limited data for trending and analysis. In 2019, an institution-wide effort was initiated to create an electronic case review system with the goals of improving event capture and real-time practice performance feedback. Surgical M&M was migrated to this structured case review format to provide a platform for surgical performance improvement. METHODS: An online secure database was created with a 3-step classification system based on Clavien-Dindo severity score, peer review, and causality fishbone analysis. The data entered were available in an interactive dashboard. Retrospective tabulation of the 2018 M&M data was performed using the archived paper system used prior to 2019. RESULTS: For the calendar year of 2019, the division of pediatric surgery captured and categorized 193 complications in the case review system. The capture rate was 50 per 1000 surgical procedures. For a similar time frame in 2018, the capture rate was 35 per 1000 surgical procedures. The dashboard provided run charts of the incidence and types of complications by procedure and by surgeon. Similar trend data were not available in 2018. The dashboard output has made possible the creation of (non- risk adjusted) individual surgeon performance reports. The output has been used to direct process improvement projects and educational content. CONCLUSION: Creation of an online database with interactive dashboard has allowed surgical M&M to evolve into a systematic case review that greatly facilitates quality improvement efforts. This system increased the event capture rate and provided novel practice performance feedback, resulting in process improvement projects and educational objectives predicated on the trending data. These electronic reporting tools are now available to all surgical divisions and represent a transformative approach to surgical case review. TYPE OF STUDY: Retrospective Historical control; Quality improvement. LEVEL OF EVIDENCE: Level III.

Minimally invasive surgery for abdominal and thoracic neuroblastic tumors: A systematic review by the APSA Cancer committee.

BACKGROUND: Minimally invasive surgery has broad applicability to pediatric diseases, including pediatric cancer resection. Neuroblastic tumors of childhood are highly variable in presentation, and so careful selection of appropriate candidates for minimally invasive resection is paramount to achieving safe and durable surgical and oncological outcomes. METHODS: The American Pediatric Surgical Association Cancer Committee developed questions seeking to better define the role of minimally invasive surgery for neuroblastic tumors. A search using PubMed, Medline, Embase, Web of Science, ProQuest Dissertations, and Clinical Trials was performed for articles published from 1998 to 2018 in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. RESULTS: The evidence identified is all retrospective in nature. Minimally invasive surgical resection of neuroblastic tumors is safe for carefully selected smaller (4-6 cm) image defined risk factor (IDRF)-negative abdominal tumors when oncologic principles are followed. Size is a less-well defined criterion for thoracic neuroblastic tumors. Open approaches for both abdominal and thoracic tumors may be preferable in the presence of IDRF's. CONCLUSION: Small tumors without IDRF's are reasonable candidates for minimally invasive resection. Surgical oncologic guidelines should be closely followed. The quality of data supporting this systematic review is poor and highlights the need for refinement in the study of such surgical techniques to improve knowledge and outcomes for patients with neuroblastic tumors. TYPE OF STUDY: Systematic Review. LEVEL OF EVIDENCE: Level III and Level IV.

Pediatric empyemas - Has the pendulum swung too far?

BACKGROUND: The management of childhood empyemas has transformed over the past decade, with current trends favoring chest tube placement and intrapleural fibrinolytic therapy. Although this strategy often avoids the need for video-assisted thoracoscopic surgery (VATS), hospital length of stay can be long. METHODS: To characterize national trends and outcomes associated with empyema management, the Pediatric Health Information System (PHIS) database was queried to identify children (2 months-18 years) treated for an empyema between January 2010 and December 2017. The cohort was divided into those treated with primary VATS and those treated with chest tube and intrapleural fibrinolysis. Number of chest radiographic studies obtained, frequency of pediatric intensive care unit (PICU) admission, mechanical ventilation requirements, and length of hospitalization were compared between groups. RESULTS: A total of 3,365 otherwise healthy children met inclusion criteria. Among them, 523 (16%) were managed with primary VATS and 2,842 (84%) were managed with chest tube and fibrinolytic therapy. Of those who were treated with chest tube and fibrinolysis, 193 (6.8%) subsequently underwent VATS. The percentage of children treated with chest tube and fibrinolysis increased from 65% in 2010 to 95% in 2017 (p<0.001). After adjusting for age, race, ethnicity, payer, and region, children who underwent primary VATS received fewer chest radiographic studies, were less likely to be admitted to the PICU or require mechanical ventilation and had a shorter PICU and hospital length of stay compared to those who were treated with chest tube and fibrinolytic therapy (p<0.001 for all analyses). DISCUSSION: Although national trends favor chest tube and fibrinolysis, primary VATS are associated with a shorter hospital and PICU length of stay and a lower requirement for mechanical ventilation. Future studies should aim to risk stratify children who may suffer from a protracted course with the goal to offer primary VATS to this subset of children and return them to normal life more expeditiously. LEVEL OF EVIDENCE: III.

What's new in pediatric melanoma: An update from the APSA cancer committee.

BACKGROUND/PURPOSE: Melanoma is the most common skin cancer in children and often presents in an atypical fashion when compared to adults. The purpose of this review is to present an update on the epidemiology, surgical and medical management and prevention strategies in pediatric melanoma. METHODS: A comprehensive review of the current literature on the epidemiology, surgical and medical management and prevention of adult and pediatric melanoma was performed by the authors and the results of this review are summarized in the manuscript. RESULTS: Most recently, the incidence of melanoma in children has been declining, possibly owing to increased awareness and sun exposure prevention. The mainstay of therapy is surgical resection, often with sentinel lymph node biopsy. A positive sentinel node has prognostic value; however, completion node dissection is no longer recommended in the absence of clinically or radiographically positive nodes. Those with advanced disease also receive adjuvant systemic therapy using increasingly targeted immunologic therapies. CONCLUSIONS: Sentinel lymph node positive patients no longer require completion lymph node dissection and instead may be followed by ultrasound. However, it is important to note that children have been excluded from most melanoma clinical trials to date, and therefore, recommendations for management are based on existing pediatric retrospective data and extrapolation from adult studies. LEVEL OF EVIDENCE: IV.

A decision tree to guide long term venous access placement in children and adolescents undergoing surgery for renal tumors.

BACKGROUND/PURPOSE: While many children with renal tumors require long term venous access (VA) for adjuvant chemotherapy, certainly not all do. This study develops and tests a VA decision tree (DT) to direct the placement of VA in patients with renal tumors. METHODS: Utilizing data readily available at surgery a VADT was developed. The VADT was tested retrospectively by 2 independent reviewers on a historic cohort. The ability of the VADT to appropriately select which patients would benefit from VA placement was tested. RESULTS: 160 patients underwent renal tumor surgery between 2005 and 2018. 70 (43.8%) patients met study criteria with median age of 45.1 months (range 1.1-224); 73% required VA. Using the VADT, VA placement was "needed" in 67.1% of patients and "deferred" in 32.9%. Interrater reliability was very high (kappa = 0.97, 95% CI 0.91-1, p < 0.001). The sensitivity and specificity of the VADT to correctly decide on VA placement were 0.92 (0.8-0.98) and 1 (0.79-1). Using the VADT, no patient would have undergone unnecessary VA placement. In reality, 4.3% of patients had an unnecessary VA placed which required a subsequent removal. CONCLUSIONS: These preliminary data support the continued study of this VADT to guide intraoperative decisions regarding VA placement in patients with renal tumors. LEVEL OF EVIDENCE: III - Study of diagnostic test.

Pediatric ulcerative colitis: three- versus two-stage colectomy with ileal pouch-anal anastomosis.

BACKGROUND: Despite advancements in medical therapy for ulcerative colitis (UC), a significant proportion of children progress to colectomy with ileal pouch-anal anastomosis (IPAA). Procedural related complications between two- and three-stage operations in children have not been well described. METHODS: We performed a retrospective review of patients who underwent a colectomy for UC or inflammatory bowel disease unclassified between 2008 and 2018. RESULTS: Forty-nine children underwent an IPAA at the time of colectomy (two stage) or during a subsequent operation (three stage). Preoperative hemoglobin and albumin concentrations were lower among those undergoing three-stage procedures. The rate of early complications (≤30 days) was similar between the two groups (p = 0.46); however, late complications (>30 days) were more commonly associated with three-stage procedures (p = 0.03). Time with a stoma was 3.2 months longer among those who underwent a three-stage procedure. While three-stage procedures were more often performed during the first half of the study period (2008-2012), two-stage procedures became more common during the second half (2013-2018). During this transition to favor two-stage procedures, complication rates did not significantly change. CONCLUSION: Although three-stage procedures were thought to be associated with fewer complications, we found comparable complication rates as we transition to two-stage procedures.

Update on neuroblastoma.

Neuroblastoma is an embryonic cancer arising from neural crest stem cells. This cancer is the most common malignancy in infants and the most common extracranial solid tumor in children. The clinical course may be highly variable with the possibility of spontaneous regression in the youngest patients and increased risk of aggressive disease in older children. Clinical heterogeneity is a consequence of the diverse biologic characteristics that determine patient risk and survival. This review will focus on current progress in neuroblastoma staging, risk stratification, and treatment strategies based on advancing knowledge in tumor biology and genetic characterization. TYPE OF STUDY: Review article. LEVEL OF EVIDENCE: Level II.

Timing of Radiation Therapy in Pediatric Wilms Tumor: A Report From the National Cancer Database.

PURPOSE: To determine, using the National Cancer Database (NCDB), the impact of the surgery to radiation therapy interval (SRI) on survival in contemporary patients with Wilms tumor (WT). METHODS AND MATERIALS: The NCDB was queried for patients aged ≤25 years diagnosed from 2004 to 2013 with unilateral WT who underwent definitive surgery and radiation therapy. The SRI was calculated for each patient. A stratified analysis was performed based on presence of metastasis using logistic regression to calculate risk factors for prolonged SRI, with a focus on the recommended SRI according to recent Children's Oncology Group trials (by day 14) and National Wilms Tumor Study-5 (by day 9). Cox regression was performed to assess the association of SRI with overall survival. RESULTS: A total of 1488 patients were included; 32.1% had metastasis at diagnosis. Among both metastatic and nonmetastatic groups, older patients were more likely to have prolonged SRI. For those without metastasis, SRI > 14 days was associated with increased risk of mortality (hazard ratio 2.13, P = .013). Analyzing SRI as a continuous variable also demonstrated an increased risk of death with longer SRI (hazard ratio 1.04 per day, P = .006) in this group. In contrast, among patients with metastasis, no significant association between SRI and mortality was found. CONCLUSION: Early initiation of radiation therapy remains a critical component of multimodal treatment for patients with nonmetastatic WT. For nonmetastatic patients, SRI ≤ 14 days correlates with improved overall survival. However, no such association was noted for patients with metastases. These results may inform the development of future WT trials.

Metastatic Pheochromocytoma in an Asymptomatic 12-Year-Old With von Hippel-Lindau Disease.

Pheochromocytoma is a rare chromaffin cell tumor that may be associated with a genetic predisposition, such as von Hippel-Lindau (VHL) disease. VHL is an autosomal dominant disorder that is characterized by a predisposition to multiple tumors, including retinal and central nervous system hemangioblastomas, renal cell carcinoma, and pheochromocytomas. The classic presentation of pheochromocytoma is episodic hypertension, headaches, palpitations, and diaphoresis. In the pediatric population, 40% of pheochromocytomas have a hereditary basis. We present a case of metastatic pheochromocytoma in a child with VHL and discuss the relevant current medical literature.

Diagnostic utility of core needle biopsy versus open wedge biopsy for pediatric intraabdominal solid tumors: Results of a prospective clinical study.

PURPOSE: The best method for diagnosing pediatric nonnephroblastoma solid intraabdominal tumors is unknown. We hypothesized that core needle biopsy (CNB) is noninferior to open wedge biopsy (OWB) for pathologic diagnosis. METHODS: We prospectively enrolled children aged 1day to 17years with radiographic evidence of nonnephroblastoma solid intraabdominal tumors scheduled for OWB from 5/2013 to 12/2015 at a single institution. Four 16-gauge CNBs were obtained, followed by OWB. Two pathologists independently reviewed all specimens to determine adequacy for diagnosis. RESULTS: Fourteen patients enrolled, 57% male, with an average age of 4years (range 7days to 16years). Both pathologists agreed OWB was completely sufficient for diagnosis in 13 patients (93%), compared to 4 patients for CNB (29%: Burkitt lymphoma, adrenocortical tumor, inflammatory myofibroblastic tumor, p=0.001, δ=-0.64±0.27, 95% CI). In 6 patients (43%), CNB was incompletely diagnostic according to at least one pathologist (neuroblastoma, hepatoblastoma). In 4 patients (29%), both pathologists determined that CNB was nondiagnostic (ganglioneuroblastoma, teratoma, hepatoblastoma, and recurrent neuroblastoma). CONCLUSIONS: In a prospective clinical study, CNB is inferior to OWB for the pathologic diagnosis of pediatric nonnephroblastoma solid intraabdominal tumors. These data suggest that OWB should generally be performed in these patients. LEVEL OF EVIDENCE: Study of Diagnostic Test, Level I.

Reliability of intraoperative frozen section for the diagnosis of renal tumors suspicious for malignancy in children and adolescents.

BACKGROUND: The ability of intraoperative frozen section (IFS) to reliably diagnose renal tumors in children and adolescents is largely unknown. The objective of our study is to evaluate the ability of IFS to establish a histologic diagnosis for renal tumors in this population. METHODS: We reviewed our experience with patients who underwent IFS at the time of surgery for a renal tumor suspicious for malignancy from 2005 to 2015. The IFS was compared to the final pathology (FP). Data on concordance and reliability were analyzed. RESULTS: One hundred thirty patients underwent surgical interventions for a renal tumor suspicious for malignancy, and 32 (25%) patients underwent IFS. Median turnaround time for IFS was 20 min (range 13-44). The histologic IFS diagnosis correlated with FP in 26 (81.2%) cases was discrepant in three (9.4%) cases, and IFS was deferred to FP in three (9.4%) cases (kappa 0.71, 95% confidence interval [CI]: 0.52-0.899, P < 0.001). The IFS correctly distinguished between Wilms tumor and non-Wilms tumor in 30 (94%) cases (kappa 0.874, 95% CI: 0.705-1, P < 0.001). A total of 17 of 19 (89.5%) Wilms tumors were correctly diagnosed by IFS, yielding a sensitivity of 0.89 (95% CI: 0.67-0.99) and a specificity of 1 (95% CI: 0.75-1). CONCLUSION: IFS is a reliable tool to establish a histologic diagnosis and to differentiate between Wilms and non-Wilms tumors in children and adolescents with renal tumors. The use of IFS should be encouraged in cases in which obtaining a diagnosis will provide guidance for important "real-time" medical decision making, specifically additional adjunctive surgical procedures.

Factors associated with peritoneal dialysis catheter complications in children.

BACKGROUND/PURPOSE: Peritoneal dialysis (PD) is a common method of renal replacement therapy for children. However, placement of PD catheters has risk, and some are never used. METHODS: We conducted a retrospective chart review of children with a PD catheter placed between 2000 and 2014. Logistic regression analyses were used to identify covariates associated with complications. RESULTS: We identified 175 children with PD catheters. 110 complications developed in 80 children (45.7%). Complications including unexpected return to the operating room and peritonitis increased as the length of time a catheter was in place increased. Children who weighed <12.4 kg had 3.2 times greater odds of developing a leak (95% CI 1.21-8.63, p=0.02). Twelve children never used their PD catheters, 9 with acute kidney injury (AKI) who recovered from their disease more quickly than expected. No covariate was associated with nonuse. CONCLUSIONS: Complications with PD catheters are common and increase the longer catheters are in place. Lower weight children are at greater risk of PD catheter leak. Decreased initial volumes of dialysate in smaller children may mitigate this risk. Nonuse may be reduced if dialysis is permitted the day of placement for children with AKI.

Short-term mortality following surgical procedures for the diagnosis of pediatric brain tumors: outcome analysis in 5533 children from SEER, 2004-2011.

OBJECT Thirty-day mortality is increasingly a reference metric regarding surgical outcomes. Recent data estimate a 30-day mortality rate of 1.4-2.7% after craniotomy for tumors in children. No detailed analysis of short-term mortality following a diagnostic neurosurgical procedure (e.g., resection or tissue biopsy) for tumor in the US pediatric population has been conducted. METHODS The Surveillance, Epidemiology and End Results (SEER) data sets identified patients ≤ 21 years who underwent a diagnostic neurosurgical procedure for primary intracranial tumor from 2004 to 2011. One- and two-month mortality was estimated. Standard statistical methods estimated associations between independent variables and mortality. RESULTS A total of 5533 patients met criteria for inclusion. Death occurred within the calendar month of surgery in 64 patients (1.16%) and by the conclusion of the calendar month following surgery in 95 patients (1.72%). Within the first calendar month, patients < 1 year of age (n = 318) had a risk of death of 5.66%, while those from 1 to 21 years (n = 5215) had a risk of 0.88% (p < 0.0001). By the end of the calendar month following surgery, patients < 1 year (n = 318) had a risk of death of 7.23%, while those from 1 to 21 years (n = 5215) had a risk of 1.38% (p < 0.0001). Children < 1 year at diagnosis were more likely to harbor a high-grade lesion than older children (OR 1.9, 95% CI 1.5-2.4). CONCLUSIONS In the SEER data sets, the risk of death within 30 days of a diagnostic neurosurgical procedure for a primary pediatric brain tumor is between 1.16% and 1.72%, consistent with contemporary data from European populations. The risk of mortality in infants is considerably higher, between 5.66% and 7.23%, and they harbor more aggressive lesions.

Surgical innovation-enhanced quality and the processes that assure patient/provider safety: A surgical conundrum.

Innovation is a crucial part of surgical history that has led to enhancements in the quality of surgical care. This comprises both changes which are incremental and those which are frankly disruptive in nature. There are situations where innovation is absolutely required in order to achieve quality improvement or process improvement. Alternatively, there are innovations that do not necessarily arise from some need, but simply are a new idea that might be better. All change must assure a significant commitment to patient safety and beneficence. Innovation would ideally enhance patient care quality and disease outcomes, as well stimulate and facilitate further innovation. The tensions between innovative advancement and patient safety, risk and reward, and demonstrated effectiveness versus speculative added value have created a contemporary "surgical conundrum" that must be resolved by a delicate balance assuring optimal patient/provider outcomes. This article will explore this delicate balance and the rules that govern it. Recommendations are made to facilitate surgical innovation through clinical research. In addition, we propose options that investigators and institutions may use to address competing priorities.