Development and validation of a novel fetal vesico-amniotic shunt, the vortex shunt.

Fetal lower urinary tract obstruction (LUTO) is a severe malformation associated with an up to 80% mortality risk as well as significant renal and pulmonary morbidity in survivors. Fetal vesico-amniotic shunts (VAS) bypass the bladder obstruction, improve amniotic fluid volume and enhance in-utero pulmonary development. VAS has been shown to reduce respiratory morbidity and mortality in the neonatal period without proven benefit on long-term renal and bladder function. Clinically available shunts are associated with an up to 80% dislodgement rate, leading to repeat invasive procedures which increase fetal and maternal risks. We developed a novel "Vortex" shunt, which incorporates enhanced fixation to reduce dislodgement, a one-way valve to optimize in-utero bladder function, and enhanced sonographic echogenicity that optimizes the accurate deployment. Following the validation of these characteristics in initial benchtop experiments we have moved to feasibility studies in the fetal lamb model. We hope that the Vortex shunt may ultimately facilitate shunt deployment, reduce dislodgement risk, improve neonatal morbidity and mortality, and decrease the significant healthcare expenditures associated with long-term morbidity in LUTO survivors. In this manuscript, we review the natural history of LUTO, the risks and benefits of clinically available fetal shunts, and our development and early validation experiments.

A Novel Method for Administering Epinephrine during Neonatal Resuscitation.

OBJECTIVE: This study aimed to determine if prefilled epinephrine syringes will reduce time to epinephrine administration compared with conventional epinephrine during standardized simulated neonatal resuscitation. STUDY DESIGN: Timely and accurate epinephrine administration during neonatal resuscitation is lifesaving in bradycardic infants. Current epinephrine preparation is inefficient and error-prone. For other emergency use drugs, prefilled medication syringes have decreased error and administration time. Twenty-one neonatal intensive care unit nurses were enrolled. Each subject engaged in four simulated neonatal resuscitation scenarios involving term or preterm manikins using conventional epinephrine or novel prefilled epinephrine syringes specified for patient weight and administration route. All scenarios were video-recorded. Two investigators analyzed video recordings for time to epinephrine preparation and administration. Differences between conventional and novel techniques were evaluated using the Wilcoxon Signed Rank Tests. RESULTS: Twenty-one subjects completed 42 scenarios with conventional epinephrine and 42 scenarios with novel prefilled syringes. Epinephrine preparation was faster using novel prefilled epinephrine syringes (median = 17.0 s, interquartile range [IQR] = 13.3-22.8) compared with conventional epinephrine (median = 48.0 s, IQR = 40.5-54.9, n = 42, z = 5.64, p < 0.001). Epinephrine administration was also faster using novel prefilled epinephrine syringes (median = 26.9 s, IQR = 22.1-33.2) compared with conventional epinephrine (median = 57.6 s, IQR = 48.8-66.8, n = 42, z = 5.63, p < 0.001). In a poststudy survey, all subjects supported the clinical adoption of prefilled epinephrine syringes. CONCLUSION: During simulated neonatal resuscitation, epinephrine preparation and administration are faster using novel prefilled epinephrine syringes, which may hasten return of spontaneous circulation and be lifesaving for bradycardic neonates in clinical practice. KEY POINTS: · Currently, epinephrine administration in neonatal resuscitation is inefficient and error prone.. · Prefilled epinephrine syringes hasten medication administration in simulated neonatal resuscitation.. · Clinical use of prefilled epinephrine syringes may be lifesaving for bradycardic neonates..

The Value of Scientific Publications in Surgical Device Innovation.

BACKGROUND: Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature. PURPOSE: We set out to investigate the relationship between scientific publication by surgical device companies and the impact it has on company valuation. We hypothesize that publishing in the scientific literature correlates with success of the surgical device companies as measured by funding. RESEARCH DESIGN: We first obtained a list of surgical device startup companies and their financial deals using the Pitchbook database. Those companies were then cross referenced with the FDA database and the Dimensions database for product registrations and peer reviewed publications, respectively. Analysis was then performed using these query results. STUDY SAMPLE AND DATA COLLECTION: We obtained a list of US surgical device startups financing deals closed between 2010 and 2020 from the Pitchbook database. We queried the Pitchbook for deal dates from January 1, 2010 to January 1, 2020 for deal types spanning early stage investment to IPO. Deals were limited to those conducted in the United States and to the surgical device industry. We queried the FDA database for product registration information associated with each of the companies involved in the deals. We tabulated the number of journal articles associated with surgical device companies using the Dimensions Search API as well as a manual confirmation. RESULTS: Five hundred thirty five (535) deals from 222 companies were found in Pitchbook that met our criteria. Querying the FDA database resulted in 578 registrations associated with these companies. Publications per company ranged widely. CONCLUSIONS: Companies that are able to generate a more numerous publications had correspondingly higher valuations during funding rounds. A subset of outstanding companies were analyzed and at least four factors affect: direct value of publications, indirect valve of publications, survivorship bias, and adoption share; each of which will be discussed in this manuscript.

Development and in-vitro characterization of a novel fetal vesicoamniotic shunt - The Vortex shunt.

OBJECTIVES: To develop and test a novel vesicoamniotic shunt (VAS) to treat fetal lower urinary tract obstruction (LUTO), decrease dislodgement and optimize shunt deployment in-vitro. METHODS: Vesicoamniotic shunt design objectives included: (1) robust and atraumatic fixation elements, (2) kink resistant conduit to adjust to fetal movement and growth, (3) one-way pressure valve to facilitate bladder cycling, and (4) echogenic deployment visualization aids. The force to dislodge the novel Vortex shunt was compared with existing commercially available shunts in a bench-top porcine bladder model. Sonographic echogenicity was evaluated with ultrasound-guided deployment, and the shunt valve pressure measured. RESULTS: A prototype novel Vortex shunt was developed using braided nitinol "umbrella-type" ends with a kink-resistant stem incorporating an internal one-way valve. The peak force required to dislodge the Vortex shunt was significantly higher than commercially available shunts (p < 0.01). Shunt deployment in the bench-top model was easily confirmed with ultrasound guidance and the brisk decompression of the inflated porcine bladder thereafter. In-vitro valve gauge pressure testing mirrored bladder pressures in human LUTO cases. CONCLUSION: In-vitro testing shows that the Vortex shunt may improve deployment, sonographic visualization, kink resistance, and dynamic size adjustment. Validation in preclinical animal models are warranted and currently underway.

Novel Neonatal Umbilical Catheter Protection and Stabilization Device in In vitro Model of Catheterized Human Umbilical Cords: Effect of Material and Venting on Bacterial Colonization.

OBJECTIVE: Umbilical central lines deliver life-saving medications and nutrition for neonates; however, complications associated with umbilical catheters (UCs) occur more frequently than in adults with central lines (i.e., line migration, systemic infection). We have developed a device for neonatal UC protection and stabilization to reduce catheter exposure to bacteria compared with the standard of care: "goal post" tape configuration. This study analyzes the effect of device venting and material on bacterial load of human umbilical cords in vitro. STUDY DESIGN: Catheters were inserted into human umbilical cord segments in vitro, secured with plastic or silicone vented prototype versus tape, and levels of bacterial colonization were compared between groups after 7 days of incubation. RESULTS: Nonvented plastic prototype showed increased bacterial load compared with goal post (p = 0.04). Colonization was comparable between the goal post and all vented plastic prototypes (p ≥ 0.30) and when compared with the vented silicone device (p = 1). CONCLUSION: A novel silicone device does not increase external bacterial colonization compared with the current standard of care for line securement, and may provide a safe, convenient alternative to standard adhesive tape for UC stabilization. Future studies are anticipated to establish safety in vivo, alongside benefits such as migration and infection reduction.

Trends and surgical outcomes of laparoscopic versus open pyloromyotomy.

BACKGROUND: Hypertrophic pyloric stenosis (HPS) is one of the most common pediatric illnesses necessitating surgical intervention. Controversy remains over the optimal surgical approach between laparoscopic pyloromyotomy (LP) and open pyloromyotomy (OP). LP has gained acceptance for management of HPS in an era of expanding minimal access surgical approaches to pediatric conditions. Several studies suggest advantages of LP over OP; however, selection bias and small sample sizes remain a concern. This study compares the outcomes of LP versus OP using propensity score methods. METHODS: The 2013-2015 ACS NSQIP Pediatric PUF was queried for all infants undergoing pyloromyotomy. The trend in the proportion of infants undergoing LP was described and perioperative outcomes between the OP and LP cohorts were compared using propensity score weighted regression models. RESULTS: 4847 infants were identified to have undergone surgical pyloromyotomy. The proportion of LP performed increased significantly from 59% in 2013 to 65.5% in 2015 (p < 0.001). LP was associated with lower overall complications (1.4% vs 2.9%) (ORadj 0.52, 95% CI 0.34-0.80), surgical site-related complications (1.1% vs 2.1%) (ORadj 0.52, 95% CI 0.32-0.84), and post-operative length of stay (1.5 days vs 1.9 days) (ORadj 0.89, 95% CI 0.81-0.98) without significant differences in related re-operation (0.9% vs 0.9%) (ORadj 1.01, 95% CI 0.52-1.93) or readmissions (1.4% vs 2.1%) (ORadj 0.73, 95% CI 0.46-1.17). CONCLUSIONS: Our study demonstrates that LP is increasingly utilized for management of hypertrophic pyloric stenosis and is associated with shorter length of stay, and lower odds of surgical site-specific and overall complications without differences in related re-operations. This study supports LP as a safe and effective method for management of HPS.

Characterizing continuous positive airway pressure (CPAP) Belly Syndrome in preterm infants in the neonatal intensive care unit (NICU).

OBJECTIVE: Reproducibly define CPAP Belly Syndrome (CBS) in preterm infants and describe associated demographics, mechanical factors, and outcomes. STUDY DESIGN: A retrospective case-control study was conducted in infants <32 weeks gestation in the Stanford Children's NICU from January 1, 2020 to December 31, 2021. CBS was radiographically defined by a pediatric radiologist. Data analysis included descriptive statistics and comparator tests. RESULTS: Analysis included 41 infants with CBS and 69 infants without. CBS was associated with younger gestational age (median 27.7 vs 30 weeks, p < 0.001) and lower birthweight (median 1.00 vs 1.31 kg, p < 0.001). Infants with CBS were more likely to receive bilevel respiratory support and higher positive end expiratory pressure. Infants with CBS took longer to advance enteral feeds (median 10 vs 7 days, p = 0.003) and were exposed to more abdominal radiographs. CONCLUSIONS: Future CBS therapies should target small infants, prevent air entry from above, and aim to reduce time to full enteral feeds and radiographic exposure.

Innovation versus Experimentation: An Application of Ethical Frameworks to the Acceptance of Fluorescence-Guided Pediatric Surgery.

Innovation is essential to the advancement of the field of pediatric surgery. The natural skepticism toward new technologies in pediatrics leads to frequent confusion of surgical innovation and research. Using fluorescence-guided surgery as an archetype for this ethical discussion, we apply existing conceptual frameworks of surgical innovation to understand the distinction between innovation and experimentation, acknowledging the spectrum and "grey zone" in between. In this review, we discuss the role of Institutional Review Boards in evaluating surgical practice innovations, and the aspects of certain surgical innovations that are distinct from experimentation, including a thorough understanding of the risk profile, preexisting use in humans, and adaptation from related fields. Examining fluorescence-guided surgery through these existing frameworks as well as the concept of equipoise, we conclude that new applications of indocyanine green do not constitute human subjects research. Most importantly, this example gives practitioners a lens through which they may appraise potential surgical innovations to allow for a sensible and efficient improvement of the field of pediatric surgery. LEVEL OF EVIDENCE: V.

Optimizing Orthopaedic Trauma Implant Pricing Through a Data-Driven and Surgeon-Integrated Approach.

OBJECTIVE: To determine whether market-based pricing could be coupled with surgeon integration into negotiation strategies to achieve lower pricing levels for orthopaedic trauma implants. A secondary aim was to identify specific types of implants that may offer larger opportunities for cost savings. METHODS: Market pricing levels were reviewed from 2 industry implant databases. This information was used by surgeons and supply chain management at our institution to select appropriate target pricing levels (25th percentile) for commonly used orthopaedic trauma implants. Target price values were provided to the existing 12 vendors used by our institution with a clear expectation that vendors meet these thresholds. RESULTS: Benchmark modeling projected a potential savings of 20.0% over our prior annual spend on trauma implants. After 2 rounds of negotiation, savings amounted to 23.0% of prior annual spend. Total savings exceeded 1,000,000 USD with 11 of 12 vendors (91.7%) offering net savings. Total percent savings were highest for external fixators, drill bits, and K-wires. Plates and screws comprised the greatest proportion of our prior annual spend and achieved similar savings. CONCLUSION: A surgeon and supply chain coordinated effort led to major cost savings without a need for consolidation of vendors. LEVEL OF EVIDENCE: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

A Stepwise Replicable Approach to Negotiating Value-driven Supply Chain Contracts for Orthobiologics.

INTRODUCTION: Orthobiologics are increasingly used to augment healing of tissues. Despite growing demand for orthobiologic products, many health systems do not enjoy substantial savings expected with high-volume purchases. The primary goal of this study was to evaluate an institutional program designed to (1) prioritize high-value orthobiologics and (2) incentivize vendor participation in value-driven contractual programs. METHODS: A three-step approach was used to reduce costs through optimization of orthobiologics supply chain. First, surgeons with orthobiologics expertise were engaged in key supply chain purchasing decisions. Second, eight orthobiologics formulary categories were defined. Capitated pricing expectations were established for each product category. Capitated pricing expectations were established for each product using institutional invoice data and market pricing data. In comparison with similar institutions, products offered by multiple vendors were priced at a lower benchmark (10th percentile of market price) than more rare products priced at the 25th percentile of the market price. Pricing expectations were transparent to vendors. Third, a competitive bidding process required vendors to submit pricing proposals for products. Clinicians and supply chain leaders jointly awarded contracts to vendors that met pricing expectations. RESULTS: Compared with our projected estimate of $423,946 savings using capitated product prices, our actual annual savings was $542,216. Seventy-nine percent of savings came from allograft products. Although the number of total vendors decreased from 14 to 11, each of the nine returning vendors received a larger, three-year institutional contract. Average pricing decreased across seven of the eight formulary categories. DISCUSSION: This study demonstrates a three-step replicable approach to increase institutional savings for orthobiologic products, engaging clinician experts, and strengthening relationships with select vendors. Vendor consolidation permits a symbiotic win-win relationship: Health systems achieve increased value by reducing unnecessary complexity of multiple contracts, and vendors obtain larger contracts with increased market share. LEVEL OF EVIDENCE: Level IV study.

Video: two novel endoscopic esophageal lengthening and reconstruction techniques.

BACKGROUND: Esophageal reconstruction presents a significant clinical challenge in patients ranging from neonates with long-gap esophageal atresia to adults after esophageal resection. Both gastric and colonic replacement conduits carry significant morbidity. As emerging organ-sparring techniques become established for early stage esophageal tumors, less morbid reconstruction techniques are warranted. We present two novel endoscopic approaches for esophageal lengthening and reconstruction in a porcine model. METHODS: Two models of esophageal defects were created in pigs (30-35 kg) under general anesthesia and subsequently reconstructed with the novel techniques. The first model was a segmental defect of the esophagus created by thoracoscopically transecting the esophagus above the gastroesophageal (GE) junction. The first reconstruction technique involved bilateral submucosal endoscopic lengthening myotomies (BSELM) with a magnetic compression anastomosis (MAGNAMOSIS™). The second model was a wedge defect in the anterior esophagus created above the GE junction through a laparotomy. The second reconstruction technique involved an inverted mucosal-submucosal sleeve transposition graft (IMSTG) that crossed the esophageal gap and was secured in place with a self-expandable covered esophageal stent. RESULTS: Both techniques were feasible in the pig model. The BSELM approach lengthened the esophagus 1 cm for every 2 cm length of myotomy. The myotomy targeted only the inner circular fibers of the esophagus, with preservation of the longitudinal layer to protect against long-term dilation and pouching. The IMSTG approach generated a vascularized mucosal graft almost as long as the esophagus itself. CONCLUSIONS: Emerging endoscopic capabilities are enabling complex endoluminal esophageal procedures. BSELM and IMSTG are two novel and technically feasible approaches to esophageal lengthening and reconstruction. Further survival studies are needed to establish the safety and efficacy of these techniques.

Treating children with achalasia using per-oral endoscopic myotomy (POEM): Twenty-one cases in review.

BACKGROUND: Per-oral endoscopic myotomy (POEM), a modern treatment for achalasia, has only recently emerged as an option for pediatric patients. Here we describe and characterize the success of POEM in children with achalasia. METHODS: A single-institution prospective cohort study was performed of patients <18 years old who underwent POEM from 2014 to 2019. Main outcomes were success at one year (Eckardt ≤3), procedure duration, complications, reintervention. RESULTS: The median age of patients (n = 21) was 13 years (range 2-17). Median procedure duration was 92 min (range 52-259) with case duration plateau of 87.4 min and learning rate of 15.5 cases. Intraoperative complications included capnoperitoneum requiring needle decompression and mucosotomy requiring additional clips. One patient experienced chest pain with small capnoperitoneum seen on chest radiography, and three patients had extraluminal carbon dioxide found incidentally on routine radiography. All were managed with observation. Pre- versus 1-month postprocedure Eckardt scores were significantly improved (7 ±â€¯2 versus 1 ±â€¯2, p < 0.0001, and median ±â€¯SD) with 100% symptomatic relief at one year. To achieve this, 13 patients required further dilation(s), one required laparoscopic Heller myotomy, and two required repeat POEM. CONCLUSIONS: POEM is a viable and safe treatment for pediatric patients with achalasia. We demonstrate improvement in symptoms and procedure proficiency with minimal intra- and postoperative complications. TYPE OF STUDY: Prospective cohort study. LEVEL OF EVIDENCE: Level II.

Three-Dimensional Optical Imaging for Pectus Excavatum Assessment.

BACKGROUND: Corrective surgery for pectus excavatum often relies on the Haller index (HI), derived from chest roentgenograms or computed tomography; however, this exposes children to potentially unnecessary radiation. Our aim was to develop a novel three-dimensional (3D) optical imaging technique to accurately measure chest wall dimensions in a clinically relevant manner. METHODS: Patients with pectus excavatum were imaged using a 3D structured light scanner. Patient characteristics, including height, weight, body mass index, and radiographic HIs (rHI) were recorded. We defined the optical index (OI) as the ratio of the lateral to anterior-posterior measurements obtained from the 3D optical images and compared those to patients' rHIs. Two-thirds of the patients' images were used to develop a predictive model of the rHI, using their OI and biometric data in multilinear regression modeling. The predictive model was applied to the remaining images, and the predicted HIs (pHI) were compared to the rHIs. RESULTS: Optical imaging was performed in 42 patients (ages, 5-35 years) with pectus excavatum; of these, 31 had recent chest roentgenograms, with rHIs ranging from 2.00 to 7.20. The OIs derived from the images correlated closely with rHIs (r = 0.850). Our predictive model, using patients' OI, height, and weight, was able to accurately estimate their rHIs with a median error of 8.11% (interquartile range, 3.5%-17.4%). CONCLUSIONS: 3D optical imaging of patients with pectus excavatum is emerging as an alternative method to assess HIs without the use of ionizing radiation. Additional studies will focus on volumetric quantification of chest wall deformities, using the 3D capabilities of this technology.

Cutaneous Patches to Monitor Myoelectric Activity of the Gastrointestinal Tract in Postoperative Pediatric Patients.

PURPOSE: Limited means exist to assess gastrointestinal activity in pediatric patients postoperatively. Recently, myoelectric gastrointestinal activity recorded by cutaneous patches has been shown in adult patients to be predictive of clinical return of gastrointestinal function postoperatively. The aim of this case series is to demonstrate the feasibility of this system in pediatric patients and to correlate myoelectric signals with return of bowel function clinically. METHODS: Pediatric patients undergoing abdominal surgery were recruited to have wireless patches placed on the abdomen within two hours postoperatively. Myoelectric data were transmitted wirelessly to a mobile device with a user-interface and forwarded to a cloud server where processing algorithms identified episodes of motor activity, quantified their parameters and nominally assigned them to specific gastrointestinal organs based on their frequencies. RESULTS: Three patients (ages 5 months, 4 year, 16 year) were recruited for this study. Multiple patches were placed on the older subjects, while the youngest had a single patch due to space limitations. Rhythmic signals of the stomach, small intestine, and colon could be identified in all three subjects. Patients showed gradual increase in myoelectric intestinal and colonic activity leading up to the first recorded bowel movement. CONCLUSION: Measuring myoelectric intestinal activity continuously using a wireless patch system is feasible in a wide age range of pediatric patients. The increase in activity over time correlated well with the patients' return of bowel function. More studies are planned to determine if this technology can predict return of bowel function or differentiate between physiologic ileus and pathologic conditions.

Initial experience with peroral endoscopic myotomy for treatment of achalasia in children.

BACKGROUND: Achalasia is a primary esophageal motility disorder characterized by aperistalsis of the esophagus and failed relaxation of the lower esophageal sphincter that presents rarely in childhood. The peroral endoscopic myotomy (POEM) procedure is an emerging treatment for achalasia in adults that has recently been introduced into pediatric surgical practice. METHODS: This is a prospective case series of all children referred to Stanford University Lucile Packard Children's Hospital with manometry-confirmed achalasia who underwent a POEM procedure from 2014 to 2016. RESULTS: We enrolled 10 subjects ranging in age from 7 to 17years (M=13.4). The mean pre- and 1-month post-procedure Eckardt scores were 7 (SD=2.5) and 2.4 (SD=2) (p<0.001), respectively. The median procedure time for the entire cohort was 142min (range 60-259min) with ongoing improvement with increased experience (R2=0.6, p=0.008). There were no major adverse events. CONCLUSION: The POEM procedure can be successfully completed in children for the treatment of achalasia with demonstrated short-term post-operative improvement in symptoms. The adoption of advanced endoscopic techniques by pediatric surgeons may enable development of unique intraluminal approaches to congenital anomalies and other childhood diseases. LEVEL OF EVIDENCE: Treatment Study - Level IV.

Advanced minimal access surgery in infants weighing less than 3kg: A single center experience.

BACKGROUND: Minimal access surgery (MAS) has gained popularity in infants less than 5kg, however, significant challenges still arise in very low weight infants. STUDY DESIGN: A retrospective chart review was performed to identify all infants weighing less than 3kg who underwent an advanced MAS or equivalent open procedure from 2009 to 2016. Advanced case types included Nissen fundoplication, duodenal atresia repair, Ladd procedure, congenital diaphragmatic hernia repair, esophageal atresia/tracheoesophageal fistula repair, diaphragmatic plication, and pyloric atresia repair. A comparative analysis was performed between the MAS and open cohorts. RESULTS: A total of 45 advanced MAS cases and 17 open cases met the inclusion criteria. Gestational age and age at operation were similar between the cohorts, while infants who underwent open procedures had significantly lower weight at operation (p=0.003). There were no deaths within 30days related to surgery in either group. Only 3 MAS cases required unintended conversion to open. There were 2 (4.4%) postoperative complications related to surgery in the MAS cohort and 2 (11.8%) in the open cohort. CONCLUSION: Advanced MAS may be performed in infants weighing less than 3kg with low mortality, acceptable rates of conversion, and similar rates of complications as open procedures. TYPE OF STUDY: Prognosis study. LEVEL OF EVIDENCE: Level III.

Impact of multiple lymphatic channel drainage to a single nodal basin on outcomes in melanoma.

OBJECTIVE: To determine the impact of multiple lymphatic channels (MLCs) on outcome in melanoma. DESIGN: Retrospective cohort study. SETTING: Academic tertiary care center. PATIENTS: Of 1198 consecutive selective sentinel lymphadenectomies performed from 1995 to 2000 for primary invasive melanoma, 502 patients were identified with extremity or truncal melanoma that drained to a single nodal basin. Three cohorts were formed based on lymphatic channels (none, single, and multiple). Tumors with drainage to multiple nodal basins as well as all head and neck tumors were excluded. MAIN OUTCOME MEASURES: Multiple variables, including patterns of lymphatic drainage, were analyzed for impact on disease-free and overall survival. RESULTS: Demographics were similar among groups, with a median follow-up of 5.6 years. Univariate analysis revealed MLCs as an independent risk factor for both disease-free (P = .04) and overall survival (P = .003). Multivariate analysis confirmed that tumor depth, sentinel lymph node status, and MLCs were risk factors for both disease-free and overall survival. Kaplan-Meier analysis showed worse survival in the MLCs group. CONCLUSIONS: Our study reveals that MLCs are an independent risk factor for recurrence and mortality in melanoma. Multiple lymphatic channels may facilitate the process of metastasis.

A multidisciplinary approach to laparoscopic sleeve gastrectomy among multiethnic adolescents in the United States.

BACKGROUND: Childhood obesity has become a serious public health problem in our country with a prevalence that is disproportionately higher among minority groups. Laparoscopic sleeve gastrectomy (LSG) is gaining attention as a safe bariatric alternative for severely obese adolescents. STUDY DESIGN: A retrospective study on morbidly obese adolescents that underwent LSG at our institution from 2009 to 2017. Primary outcomes were weight loss as measured by change in BMI and percent excess weight loss (%EWL) at 1 year after surgery, resolution of comorbidities and occurrence of complications. RESULTS: Thirty-eight patients, of whom 71% were female and 74% were ethnic minorities, underwent LSG between 2009 and 2016. Mean age was 16.8years, mean weight was 132.0kg and mean BMI was 46.7. There were no surgical complications. Mean %EWL was 19.4%, 27.9%, 37.4%, 44.9%, and 47.7% at 1.5, 3, 6, 9, and 12month follow up visits, respectively. Comorbidity resolution rates were 100% for hypertension and nonalcoholic fatty liver disease, 91% for diabetes, 44% for prediabetes, 82% for dyslipidemia and 89% for OSA. CONCLUSIONS: LSG is an effective and safe method of treatment of morbid obesity in adolescents as it can significantly decrease excess body weight and resolve comorbid conditions. Further studies are needed to investigate the long-term effects of LSG in adolescents. CLINICAL RESEARCH STUDY: Descriptive case series with prospective database. LEVEL OF EVIDENCE: IV.