James Wall
Associate Professor of Surgery (Pediatric Surgery)
Surgery - Pediatric Surgery
Bio
Dr. James Wall is a pediatric surgeon who focuses on minimally-invasive approaches to children’s surgery. He is an alumnus of the Stanford Biodesign Innovation Fellowship. His research focuses on how to educate others to design and develop health technology, as well as on flexible endoscopic surgery in children. He has developed multiple health technologies including a novel epidural needle, a protection device for umbilical catheters, and a wearable leg compression system. James currently holds the roles of director of Program Development for the Stanford Biodesign Innovation and Policy Fellowships and PI of the UCSF-Stanford Pediatric Device Consortium. James graduated from Tulane University with an undergraduate degree in biomedical engineering and has a masters in bioengineering from Stanford. He attended the University of Pennsylvania School of Medicine and completed a general surgery residency training program at the University of California, San Francisco. He completed a fellowship in minimally invasive surgery at the IRCAD institute in France followed by a Pediatric Surgery fellowship at Stanford.
Clinical Focus
- Pediatric Surgery
- Neonatal Surgery
- Minimally Invasive Pediatric Surgery
- Endoscopic Gastrointestinal Surgery
- Achalasia
- Anorectal Malformations
- Congenital Diaphragmatic Hernia
- Hirschsprung's Disease
- Congenital Pulmonary Airway Malformations
- Pectus Excavatum
- Pectus Carinatum
Academic Appointments
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Associate Professor - University Medical Line, Surgery - Pediatric Surgery
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Member, Wu Tsai Neurosciences Institute
Administrative Appointments
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PI, UCSF-Stanford Pediatric Device Consortium (2018 - Present)
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Chairman Value Based Selection Committee, Lucile Packard Children's Hospital (2015 - 2021)
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Director, Program Development, Biodesign Innovation Fellowship, Stanford Byers Center for Biodesign (2019 - Present)
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Assistant Director, Biodesign Innovation Fellowship, Stanford Byers Center for Biodesign (2014 - 2019)
Honors & Awards
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Pediatric Surgery Fellowship Teaching Award, Division of Pediatric Surgery (2016)
Professional Education
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Fellowship: Stanford University Pediatric Surgery (2013) CA
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Residency: UCSF General Surgery Residency (2010) CA
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Internship: UCSF General Surgery Residency (2009) CA
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Board Certification: American Board of Surgery, Pediatric Surgery (2015)
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Board Certification: American Board of Surgery, General Surgery (2010)
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Medical Education: University of Pennsylvania (2003) PA
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Biodesign Fellowship, Stanford Byers Center for Biodesign (2007)
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Masters of Bioengineering, Stanford University (2008)
Current Research and Scholarly Interests
Health Technology Innovation
2024-25 Courses
- Biodesign Fundamentals
MED 175B, MED 275B (Spr) -
Independent Studies (6)
- Bioengineering Problems and Experimental Investigation
BIOE 191 (Aut, Win, Spr) - Directed Reading in Surgery
SURG 299 (Aut, Win, Spr, Sum) - Directed Study
BIOE 391 (Aut, Win, Spr) - Graduate Research
SURG 399 (Aut, Win, Spr, Sum) - Medical Scholars Research
SURG 370 (Aut, Win, Spr, Sum) - Undergraduate Research
SURG 199 (Aut, Win, Spr, Sum)
- Bioengineering Problems and Experimental Investigation
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Prior Year Courses
2023-24 Courses
- Biodesign Fundamentals
MED 175B, MED 275B (Spr) - Senior Capstone Design I
BIOE 141A (Aut) - Senior Capstone Design II
BIOE 141B (Win)
2022-23 Courses
- Biodesign Fundamentals
MED 175B, MED 275B (Spr) - Needs Finding in Healthcare
BIOE 10SC (Sum) - Senior Capstone Design I
BIOE 141A (Aut) - Senior Capstone Design II
BIOE 141B (Win)
2021-22 Courses
- Biodesign Fundamentals
MED 175B (Spr) - Biodesign Fundamentals
MED 275B (Spr) - Biodesign: Seminar in Need-Driven Medical Innovation
MED 260 (Spr) - Senior Capstone Design I
BIOE 141A (Aut)
- Biodesign Fundamentals
Stanford Advisees
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Med Scholar Project Advisor
Kathy Hu -
Postdoctoral Research Mentor
Marta Arenas Jal, Cyan Brown
Graduate and Fellowship Programs
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Pediatric Surgery (Fellowship Program)
All Publications
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Trends and surgical outcomes of laparoscopic versus open pyloromyotomy.
Surgical endoscopy
2018
Abstract
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.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.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).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.
View details for PubMedID 29340829
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Advanced minimal access surgery in infants weighing less than 3kg: A single center experience.
Journal of pediatric surgery
2017
Abstract
Minimal access surgery (MAS) has gained popularity in infants less than 5kg, however, significant challenges still arise in very low weight infants.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.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.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.Prognosis study.Level III.
View details for DOI 10.1016/j.jpedsurg.2017.05.006
View details for PubMedID 28549685
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Initial experience with peroral endoscopic myotomy for treatment of achalasia in children.
Journal of pediatric surgery
2017
Abstract
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.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.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.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.Treatment Study - Level IV.
View details for PubMedID 28827050
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Endoscopic Division of Duodenal Web Causing Near Obstruction in 2-Year-Old with Trisomy 21
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
2016; 26 (5): 413-417
Abstract
Surgical intervention for duodenal atresia most commonly entails duodenoduodenostomy in the neonatal period. Occasionally, type I duodenal atresia with incomplete obstruction may go undiagnosed until later in life. Endoscopic approach to dividing intestinal webs has been reported as successful in patients as young as 7 days of age, and can be a useful modality particularly in patients with comorbidities who may not tolerate open or laparoscopic surgery.A 2-year-old female with a history of trisomy 21 and tetralogy of Fallot underwent laparoscopic and endoscopic exploration of intestinal obstruction as seen on upper gastrointestinal series for symptoms of recurrent emesis and weight loss. After laparoscopy confirmed a duodenal web as the cause of intestinal obstruction, endoscopic division of the membrane was carried out with a triangle tip electrocautery knife and 15 mm radially dilating balloon.The patient tolerated the procedure well, and also tolerated full age-appropriate diet by time of discharge on postoperative day 2. She remains asymptomatic as of 6 months postoperatively.This report describes a successful endoscopic approach for definitive treatment of a duodenal web in a 2-year-old girl with trisomy 21, and laparoscopy confirmed no intraabdominal obstructive process or complication from endoscopy. Endoscopy enables minimal recovery time and suggests an improved method of duodenal web division over pure surgical intervention.
View details for DOI 10.1089/lap.2015.0462
View details for Web of Science ID 000376469600014
View details for PubMedID 26913816
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Endoscopic Submucosal Dissection of a Large Hamartoma in a Young Child.
Journal of pediatric gastroenterology and nutrition
2016; 62 (1): e5-7
View details for DOI 10.1097/MPG.0000000000000376
View details for PubMedID 26709909
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Biodesign process and culture to enable pediatric medical technology innovation
SEMINARS IN PEDIATRIC SURGERY
2015; 24 (3): 102-106
Abstract
Innovation is the process through which new scientific discoveries are developed and promoted from bench to bedside. In an effort to encourage young entrepreneurs in this area, Stanford Biodesign developed a medical device innovation training program focused on need-based innovation. The program focuses on teaching systematic evaluation of healthcare needs, invention, and concept development. This process can be applied to any field of medicine, including Pediatric Surgery. Similar training programs have gained traction throughout the United States and beyond. Equally important to process in the success of these programs is an institutional culture that supports transformative thinking. Key components of this culture include risk tolerance, patience, encouragement of creativity, management of conflict, and networking effects.
View details for DOI 10.1053/j.sempedsurg.2015.02.005
View details for Web of Science ID 000355070600002
View details for PubMedID 25976143
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Initial Results of Endoscopic Gastrocutaneous Fistula Closure in Children Using an Over-the-Scope Clip.
Journal of laparoendoscopic & advanced surgical techniques. Part A
2015; 25 (1): 69-72
Abstract
Gastrocutaneous fistula (GCF) occurs commonly in pediatric patients after removal of long-term gastrostomy tubes. Although open repair is generally successful, endoscopic approaches may offer benefits in terms of incisional complications, postoperative pain, and procedure time. In addition, endoscopic approaches may offer particular benefit in patients with varied degrees of skin irritation or erosion surrounding a GCF, making surgical repair difficult, or patients with significant comorbidities, making minimal intervention and anesthesia time preferable. Over-the-scope (OSC) clips are a new technology that enables endoscopic closure of intestinal fistulas up to 2 cm in diameter. Six pediatric patients underwent endoscopic GCF closure using OSC clips under Institutional Review Board approval. The procedure was technically successful in 5 of 6 cases with an average operating time of 29 minutes. The technical failure required an open revision, whereas all other patients reported full healing of the GCF site at 1 month. All successful cases were performed as outpatients without postoperative narcotics. In addition, all patients reported high satisfaction with the procedure and cosmetic results. Endoscopic GCF closure using an OSC clip is technically feasible in the pediatric population. Based on limited cases with a 1-month follow-up, the functional and cosmetic results of technically successful cases are excellent. Endoscopic GCF closure is a potential alternative to standard surgical closure in patients with skin irritation or erosion and/or significant comorbidities.
View details for DOI 10.1089/lap.2014.0379
View details for PubMedID 25531644
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Prenatal imaging and postnatal presentation, diagnosis and management of congenital lung malformations.
Current opinion in pediatrics
2014; 26 (3): 315-319
Abstract
Congenital lung malformations (CLMs) vary in their clinical presentation and severity. Increases in prenatal diagnosis, observed regression of certain lesions, and prognostic uncertainty are driving an evolution in management.There has been an increase in the early diagnosis of these malformations, a change that is attributable to the routine use of prenatal ultrasound. Although prenatal diagnosis of CLMs using ultrasound and MRI has increased, chest radiography and computed tomography still play important roles in diagnosis. The management of these lesions depends on the type of malformation and symptoms. The treatment of asymptomatic patients with lung malformations is controversial, because the prognosis of these lesions is largely unknown. Proponents of early intervention argue that the complications of CLM, which may include infection, pneumothorax, bleeding and malignant transformation, justify surgery. Advocates of conservative management note that some CLMs disappear postnatally, and that the long-term complication rate following surgery is unknown. There is a need to obtain natural history data regardless of the therapeutic recommendations.This article reviews the prenatal radiographic features and postnatal clinical findings of various CLMs and the dilemmas regarding treatment.
View details for DOI 10.1097/MOP.0000000000000091
View details for PubMedID 24739492
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Introduction of the per-oral endoscopic myotomy technique to pediatric surgical practice
Journal of Pediatric Surgery Case Reports
2014
View details for DOI 10.1016/j.epsc.2014.06.009
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A Prospective Randomized Trial of Ultrasound- vs Landmark-Guided Central Venous Access in the Pediatric Population.
Journal of the American College of Surgeons
2013; 216 (5): 939-943
Abstract
The purpose of this prospective randomized study was to compare landmark- to ultrasound-guided central venous access when performed by pediatric surgeons. The American College of Surgeons advocates for use of ultrasound in central venous catheter placement; however, this is not universally embraced by pediatric surgeons. Complication risk correlates positively with number of venous cannulation attempts.With IRB approval, a randomized prospective study of children under 18 years of age undergoing tunneled central venous catheter placement was performed. Patient accrual was based on power analysis. Exclusion criteria included known nonpatency of a central vein or coagulopathy. After randomization, the patients were assigned to either ultrasound-guided internal jugular vein access or landmark-guided subclavian/internal jugular vein access. The primary outcomes measure was number of attempts at venous cannulation. Secondary outcomes measures included: access times, number of arterial punctures, and other complications. Continuous variables were compared using 2-tailed Student's t-test. Discrete variables were analyzed with chi-square. Significance was defined as p < 0.05.There were 150 patients enrolled between April 2008 and September 2011. There was no difference when comparing demographic data. Success at first attempt was achieved in 65% of patients in the ultrasound group vs 45% in the landmark group (p = 0.021). Success within 3 attempts was achieved in 95% of ultrasound group vs 74% of landmark group (p = 0.0001).Ultrasound reduced the number of cannulation attempts necessary for venous access. This indicates a potential to reduce complications when ultrasound is used by pediatric surgeons.
View details for DOI 10.1016/j.jamcollsurg.2013.01.054
View details for PubMedID 23478546
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Virtual Neck Exploration for Parathyroid Adenomas A First Step Toward Minimally Invasive Image-Guided Surgery
JAMA SURGERY
2013; 148 (3): 232-238
Abstract
To evaluate the performance of 3-dimensional (3D) virtual neck exploration (VNE) as a modality for preoperative localization of parathyroid adenomas in primary hyperparathyroidism and assess the feasibility of using augmented reality to guide parathyroidectomy as a step toward minimally invasive imageguided surgery.Enhanced 3D rendering methods can be used to transform computed tomographic scan images into a model for 3D VNE. In addition to a standard imaging modality, 3D VNE was performed in all patients and used to preoperatively plan minimally invasive parathyroidectomy. All preoperative localization studies were analyzed for their sensitivity, specificity, positive predictive value, and negative predictive value for the correct side of the adenoma(s) (lateralization) and the correct quadrant of the neck (localization). The 3D VNE model was used to generate intraoperative augmented reality in 3 cases.Tertiary care center.A total of 114 consecutive patients with primary hyperparathyroidism were included from January 8, 2008, through July 26, 2011.The accuracy of 3D VNE in lateralization and localization was 77.2% and 64.9%, respectively. Virtual neck exploration had superior sensitivity to ultrasonography (P.001), sestamibi scanning (P=.07), and standard computed tomography (P.001). Use of the 3D model for intraoperative augmented reality was feasible.3-Dimensional VNE is an excellent tool in preoperative localization of parathyroid adenomas with sensitivity, specificity, and diagnostic accuracy commensurate with accepted first-line imaging modalities. The added value of 3D VNE includes enhanced preoperative planning and intraoperative augmented reality to enable less-invasive image-guided surgery.
View details for DOI 10.1001/jamasurg.2013.739
View details for Web of Science ID 000316682000005
View details for PubMedID 23682370
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Optimizing Orthopaedic Trauma Implant Pricing Through a Data-Driven and Surgeon-Integrated Approach.
Journal of orthopaedic trauma
2022
Abstract
To determine if 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.Market pricing levels were reviewed from two industry implant databases. This information was used by surgeons and supply chain management (SCM) 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 utilized by our institution with a clear expectation that vendors meet these thresholds.Benchmark modeling projected a potential savings of 20.0% over our prior annual spend on trauma implants. Following two 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.A surgeon and supply chain coordinated effort led to major cost savings without a need for consolidation of vendors.
View details for DOI 10.1097/BOT.0000000000002560
View details for PubMedID 36728607
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The utility of endoscopic functional luminal imaging (EndoFLIP) in the diagnosis and management of children with achalasia.
Journal of pediatric surgery
2022
Abstract
BACKGROUND: Per-oral endoscopic myotomy (POEM) has is an alternative treatment to laparoscopic Heller myotomy for children with achalasia. The EndoFLIP functional luminal imaging system is used to measure esophagogastric junction (EGJ) distensibility pre- and post-POEM. Previous adult studies have established a correlation between obstructive symptoms and Distensibility Index (DI). Here we analyze the utility of EndoFLIP in diagnosis and management of achalasia in the largest study on pediatric POEM patients and hypothesize that DI may aid diagnosis and treatment of pediatric achalasia.METHODS: Demographics, preoperative basal and residual pressures measured on manometry, and EndoFLIP measurements pre- and post-POEM were recorded for children that underwent POEM. Pearson correlation coefficient and T-scores were used to assess for correlation between manometry measurements and pre-POEM DI. Linear regression was conducted to analyze the relationship between pre-POEM DI, Eckardt scores, and manometry pressures.RESULTS: Of 33 patients that underwent POEM and EndoFLIP since 2014 (21 male, 12 female), the median pre-POEM Eckardt score decreased from 7 to 1 post-POEM. The median basal pressure was 50±25mmHg, pre-POEM DI was 0.9 (0.8-1.6) mm2/mmHg and the post-POEM DI was 3.8 (3.2-4.4) mm2/mmHg. There was no correlation between DI and basal pressure or residual pressure, though there was a strong negative correlation between Eckardt scores and DI.CONCLUSION: The EndoFLIP system is a valuable tool in adult patients in diagnosing achalasia and defining the endpoint of the POEM procedure. We find that there is a role for EndoFLIP in the pediatric population in diagnosis and management of the disease.TYPE OF STUDY & LEVEL OF EVIDENCE: Study of diagnostic test; Level IV.
View details for DOI 10.1016/j.jpedsurg.2022.12.019
View details for PubMedID 36683001
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The Value of Scientific Publications in Surgical Device Innovation.
Surgical innovation
2022: 15533506221143267
Abstract
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.
View details for DOI 10.1177/15533506221143267
View details for PubMedID 36511818
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Does healthcare system device volume correlate with price paid for spinal implants: a cross-sectional analysis of a national purchasing database.
BMJ open
2022; 12 (4): e057547
Abstract
OBJECTIVES: Amid continuously rising US healthcare costs, particularly for inpatient and surgical services, strategies to more effectively manage supply chain expenses are urgently necessary. Across industries, the 'economy of scale' principle indicates that larger purchasing volumes should correspond to lower prices due to 'bulk discounts'. Even as such advantages of scale have driven health system mergers in the USA, it is not clear whether they are being achieved, including for specialised products like surgical implants which may be more vulnerable to cost inefficiency. The objective of this observational cross-sectional study was to investigate whether purchasing volumes for spinal implants was correlated with price paid.SETTING: USA.PARTICIPANTS: Market data based on pricing levels for spine implants were reviewed from industry implant price databases. Filters were applied to narrow the sample to include comparable institutions based on procedural volume, patient characteristics and geographical considerations. Information on the attributes of 619 health systems representing 12471 provider locations was derived from national databases and analytics platforms.PRIMARY OUTCOME MEASURE: Institution-specific price index paid for spinal implants, normalised to the national average price point achieved.RESULTS: A Spearman's correlation test indicated a weak relationship between purchasing volume and price index paid (rho=-0.35, p<0.001). Multivariable linear regression adjusting for institutional characteristics including type of hospital, accountable care organisation status, payer-mix, geography, number of staffed beds, number of affiliated physicians and volume of patient throughput also did not exhibit a statistically significant relationship between purchasing volume and price index performance (p=0.085).CONCLUSIONS: National supply chain data revealed that there was no significant relationship between purchasing volume and price paid by health systems for spinal implants. These findings suggest that factors other than purchasing or patient volume are responsible for setting prices paid by health systems to surgical vendors and/or larger healthcare systems are not negotiating in a way to consistently achieve optimal pricing.
View details for DOI 10.1136/bmjopen-2021-057547
View details for PubMedID 35473724
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Development and in-vitro characterization of a novel fetal vesicoamniotic shunt - the Vortex Shunt.
Prenatal diagnosis
1800
Abstract
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: VAS 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. This article is protected by copyright. All rights reserved.
View details for DOI 10.1002/pd.6096
View details for PubMedID 35048376
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Hospital Value Committees: The Role of the Surgeon in New Technology Adoption.
Surgical innovation
2021: 15533506211031094
View details for DOI 10.1177/15533506211031094
View details for PubMedID 34281433
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Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.
JAMA network open
2021; 4 (6): e2112562
Abstract
Importance: Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed.Objective: To identify and characterize high-risk devices with pediatric age indications derived from PMA statements.Design, Setting, and Participants: In this cross-sectional study of PMA statements, those statements containing the words indicated or intended for medical devices listed in the FDA PMA database as of February 2020 were retrieved. Age indications were manually annotated in these approval statements via PubAnnotation. Based on the PMA identification from the PMA statements, device metadata including product codes, regulation numbers, advisory panels, and approval dates were queried.Main Outcomes and Measures: The main outcome was discernment of the distribution of devices indicated for the pediatric population (neonate, infant, child, and adolescent). Secondary measures included outlining the clinical specialties, device types, and lag time between the initial approval date and the first date of an approval statement with a pediatric indication for generic device categories.Results: A total of 297 documents for 149 unique devices were analyzed. Based on the manual age annotations, 102 devices with a pediatric indication, 10 with a neonate age indication, 32 with an infant age indication, 60 with a child age indication, and 94 with an adolescent age indication were identified. For indications for patients from age 17 to 18 years, the number of devices available nearly doubled from 42 devices to 81 devices. Although more than half of the surveyed devices had a pediatric age indication, many were available only for a limited range of the pediatric population (age 18-21 years). For indications for patients from age 0 to 17 years, the mean (SD) number of clinical specialties at each age was 7.27 (1.4), and 12 clinical specialties were represented from ages 18 to 21 years.Conclusions and Relevance: In this cross-sectional study on device PMA statements, a gap was identified in both quantity and diversity of high-risk devices indicated for the pediatric population. Because the current scarcity of pediatric devices may limit therapeutic possibilities for children, this study represents a step toward quantifying this scarcity and identifying clinical specialties with the greatest need for pediatric device innovation and may help inform future device development efforts.
View details for DOI 10.1001/jamanetworkopen.2021.12562
View details for PubMedID 34156454
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The design and evaluation of a novel algorithm for automated preference card optimization.
Journal of the American Medical Informatics Association : JAMIA
2021
Abstract
BACKGROUND: Inaccurate surgical preference cards (supply lists) are associated with higher direct costs, waste, and delays. Numerous preference card improvement projects have relied on institution-specific, manual approaches of limited reproducibility. We developed and tested an algorithm to facilitate the first automated, informatics-based, fully reproducible approach.METHODS: The algorithm cross-references the supplies used in each procedure and listed on each preference card and uses a time-series regression to estimate the likelihood that each quantity listed on the preference card is inaccurate. Algorithm performance was evaluated by measuring changes in direct costs between preference cards revised with the algorithm and preference cards that were not revised or revised without use of the algorithm. Results were evaluated with a difference-in-differences (DID) multivariate fixed-effects model of costs during an 8-month pre-intervention and a 15-month post-intervention period.RESULTS: The accuracies of the quantities of 469155 surgeon-procedure-specific items were estimated. Nurses used these estimates to revise 309 preference cards across eight surgical services corresponding to, respectively, 1777 and 3106 procedures in the pre- and post-intervention periods. The average direct cost of supplies per case decreased by 8.38% ($352, SD $6622) for the intervention group and increased by 13.21% ($405, SD $14706) for the control group (P<.001). The DID analysis showed significant cost reductions only in the intervention group during the intervention period (P<.001).CONCLUSION: The optimization of preference cards with a variety of institution-specific, manually intensive approaches has led to cost savings. The automated algorithm presented here produced similar results that may be more readily reproducible.
View details for DOI 10.1093/jamia/ocaa275
View details for PubMedID 33497439
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The Value of Surgical Data-Impact on the Future of the Surgical Field.
Surgical innovation
2021: 15533506211003538
Abstract
The combination of computing power, connectivity, and big data has been touted as the future of innovation in many fields, including medicine. There has been a groundswell of companies developing tools for improving patient care utilizing healthcare data, but procedural specialties, like surgery, have lagged behind in benefitting from data-based innovations, given the lack of data that is well structured. While many companies are attempting to innovate in the surgical field, some have encountered difficulties around collecting surgical data, given its complex nature. As there is no standardized way in which to interact with healthcare systems to purchase these data, the authors attempt to characterize the various ways in which surgical data are collected and shared. By surveying and conducting interviews with various surgical technology companies, at least 3 different methods to collect surgical data were identified. From this information, the authors conclude that an attempt to outline best practices should be undertaken that benefits all stakeholders.
View details for DOI 10.1177/15533506211003538
View details for PubMedID 33830831
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Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables.
IEEE journal of translational engineering in health and medicine
2021; 9: 4800105
Abstract
OBJECTIVE: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices.METHODS: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting.RESULTS: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices.DISCUSSION/CONCLUSION: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.
View details for DOI 10.1109/JTEHM.2021.3092559
View details for PubMedID 34327067
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Treating children with achalasia using per -oral endoscopic myotomy (POEM): Twenty-one cases in review
W B SAUNDERS CO-ELSEVIER INC. 2020: 1006–12
View details for Web of Science ID 000541166300005
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Mechanical Compression Augments Venous Flow Equal to Intermittent Pneumatic Compression.
Journal of orthopaedic research : official publication of the Orthopaedic Research Society
2020
Abstract
Intermittent pneumatic compression is part of the current standard of care model for preventing venous thromboembolic events (VTE) after total joint arthroplasty. Pneumatic motors limit the rate of inflation resulting in bulky devices with uncomfortable sleeves that inhibited patient compliance and mobility. Non-pneumatic mechanical; devices are an alternative for providing mobile, graded, intermittent, sequential, rapid, and monitorable compression post-hospitalization. Fifteen healthy volunteers underwent mechanical compression using the Cirvo (Radial Medical, Mountain View, CA) as well as pneumatic compression with four commercially available systems (VenaFlow Elite, Kendall SCD Compression System, ActiveCare DVT, Vasculaire Compression System,) and manual calf compression. Peak flow velocity (PFV) was measured by ultrasound of the femoral vein during compression and at baseline. Mechanical compression for 1 second resulted in a significant increase in femoral venous PFV to 107.8 ± 38.2 cm/s from 17.1 ± 4.7 cm/s at baseline (p < 0.001, Figure 2). The change in femoral venous PFV with mechanical compression for 1 second (90.7 ± 34.9 cm/s) was not statistically different from pneumatic compression from VenaFlow system (106.0 ± 35.6 cm/s, p = 0.124) and statistically lower than manual calf compression (115.5 ± 26.8 cm/s, p = 0.015). Pneumatic compression from VenaFlow system produced the largest change in femoral venous PFV of all commercial pneumatic systems tested. Mechanical compression replicates or exceeds femoral venous PFV available from currently available intermittent pneumatic compression. This article is protected by copyright. All rights reserved.
View details for DOI 10.1002/jor.24664
View details for PubMedID 32175638
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Treating children with achalasia using per-oral endoscopic myotomy (POEM): Twenty-one cases in review.
Journal of pediatric surgery
2020
Abstract
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 ± 2 versus 1 ± 2, p < 0.0001, and median ± 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.
View details for DOI 10.1016/j.jpedsurg.2020.02.028
View details for PubMedID 32197825
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Stanford's Biodesign Innovation program: Teaching opportunities for value-driven innovation in surgery.
Surgery
2019
Abstract
The Stanford Biodesign Innovation process, which identifies meaningful clinical needs, develops solutions to meet those needs, and plans for subsequent implementation in clinical practice, is an effective training approach for new generations of healthcare innovators. Continued success of this process hinges on its evolution in response to changes in healthcare delivery and an ever-increasing demand for economically viable solutions. In this article, we provide perspective on opportunities for value-driven innovation in surgery and relate these to value-related teaching elements currently integrated in the Stanford Biodesign process.
View details for DOI 10.1016/j.surg.2019.10.012
View details for PubMedID 31862172
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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.
American journal of perinatology
2019
Abstract
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.
View details for DOI 10.1055/s-0039-1700542
View details for PubMedID 31739365
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The Digital Surgeon: How Big Data, Automation, and Artificial Intelligence Will Change Surgical Practice.
Journal of pediatric surgery
2019
Abstract
Exponential growth in computing power, data storage, and sensing technology has led to a world in which we can both capture and analyze incredible amounts of data. The evolution of machine learning has further advanced the ability of computers to develop insights from massive data sets that are beyond the capacity of human analysis. The convergence of computational power, data storage, connectivity, and Artificial Intelligence (AI) has led to health technologies that, to date, have focused on diagnostic areas such as radiology and pathology. The question remains how the digital revolution will translate in the realm of surgery. There are three main areas where the authors believe that AI could impact surgery in the near future: enhancement of training modalities, cognitive enhancement of the surgeon, and procedural automation. While the promise of Big Data, AI, and Automation is high, there have been unanticipated missteps in the use of such technologies that are worth considering as we evaluate how such technologies could/should be adopted in surgical practice. Surgeons must be prepared to adopt smarter training modalities, supervise the learning of machines that can enhance cognitive function, and ultimately oversee autonomous surgery without allowing for a decay in the surgeon's operating skills.
View details for DOI 10.1016/j.jpedsurg.2019.09.008
View details for PubMedID 31767194
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Cutaneous Patches to Monitor Myoelectric Activity of the Gastrointestinal Tract in Postoperative Pediatric Patients.
Pediatric gastroenterology, hepatology & nutrition
2019; 22 (6): 518-526
Abstract
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.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.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.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.
View details for DOI 10.5223/pghn.2019.22.6.518
View details for PubMedID 31777717
View details for PubMedCentralID PMC6856497
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Prolonged esophageal foreign body: Management strategies in the setting of complicated tracheoesophageal fistula
JOURNAL OF PEDIATRIC SURGERY CASE REPORTS
2019; 48
View details for DOI 10.1016/j.epsc.2019.101266
View details for Web of Science ID 000484864800013
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3D Optical Imaging for Pectus Excavatum Assessment.
The Annals of thoracic surgery
2019
Abstract
Corrective surgery for pectus excavatum often relies on the Haller index (HI), derived from chest radiographs or computed tomography; however, this exposes children to potentially unnecessary radiation. Our aim was to develop a novel 3D optical imaging technique to accurately measure chest wall dimensions in a clinically relevant manner.Patients with pectus excavatum were imaged using a 3D structured light scanner. Patient characteristics, including height, weight, BMI, 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, utilizing 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.Forty-two patients (ages 5-35) with pectus excavatum underwent optical imaging; 31 had recent chest radiographs, with rHIs ranging from 2.00-7.20. The OIs derived from the images correlated closely with rHIs (R=0.850). Our predictive model, utilizing patients' OI, height, and weight was able to accurately estimate their rHIs with a median error of 8.11% (IQR 3.5-17.4%).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, utilizing the 3D capabilities of this technology.
View details for DOI 10.1016/j.athoracsur.2019.04.074
View details for PubMedID 31201783
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Algorithm for Calculating Haller Index for Pectus Excavatum Using 3-Dimensional Optical Scanning
ELSEVIER SCIENCE INC. 2018: S192
View details for DOI 10.1016/j.jamcollsurg.2018.07.422
View details for Web of Science ID 000447760600376
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A Simplified Method for Three-Dimensional Optical Imaging and Measurement of Patients with Chest Wall Deformities.
Journal of laparoendoscopic & advanced surgical techniques. Part A
2018
Abstract
BACKGROUND: Pectus excavatum and carinatum are two of the most commonly observed chest wall deformities in pediatrics. The standard diagnostic evaluation for these conditions includes either chest radiograph (CXR) or computed tomography (CT). Our research aims to develop a novel and reliable way of quantifying chest wall deformities in the clinic setting without radiation exposure.METHODS: Using a handheld structured light scanner, we created three-dimensional (3D) models of patients with chest wall deformities through an IRB-approved protocol. Raters from a variety of backgrounds were then asked to take measurements based on the 3D model utilizing commercially available 3D graphical software. The standard deviation of the measurements and intraclass correlation coefficient (ICC) were then calculated to quantify inter-rater reliability.RESULTS: Sixty patients with pectus excavatum (Haller index range 2.0-6.38) and pectus carinatum were enrolled and imaged in our outpatient clinic using a structured light scanner. Five patients were used to verify interuser reliability. The standard deviation of all the measurements was 2.2mm. The ICC for absolute agreement was 0.99139, with 1.0 being perfect correlation.CONCLUSION: Structured light scanners provide an alternative approach to quantifying chest wall deformities in pediatric patients without radiation exposure. Our method is highly reliable, even among users with minimal image processing or 3D modeling experience. Our protocol can potentially be used to track treatment progress in children with chest wall deformities.
View details for PubMedID 30207836
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A Simplified Method for Three-Dimensional Optical Imaging and Measurement of Patients with Chest Wall Deformities
MARY ANN LIEBERT, INC. 2019: 267–71
View details for DOI 10.1089/lap.2018.0191
View details for Web of Science ID 000444377300001
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Initial experience with peroral endoscopic myotomy for treatment of achalasia in children
JOURNAL OF PEDIATRIC SURGERY
2018; 53 (8): 1532–36
View details for DOI 10.1016/j.jpedsurg.2017.07.023
View details for Web of Science ID 000439577000014
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Trends and surgical outcomes of laparoscopic versus open pyloromyotomy
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
2018; 32 (7): 3380–85
View details for DOI 10.1007/s00464-018-6060-0
View details for Web of Science ID 000434361600045
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How Good Ideas Die: Understanding Common Pitfalls of Medtech Innovation
MEDICAL INNOVATION: CONCEPT TO COMMERCIALIZATION
2018: 117–27
View details for DOI 10.1016/B978-0-12-814926-3.00012-7
View details for Web of Science ID 000488302600013
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Dilation of Esophageal Stricture in a Pediatric Patient Using Functional Lumen Imaging Probe Technology Without the Use of Fluoroscopy.
Journal of pediatric gastroenterology and nutrition
2018
View details for DOI 10.1097/MPG.0000000000001936
View details for PubMedID 29470294
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Trends and Surgical Outcomes of Laparoscopic vs Open Pyloromyotomy in the United States
ELSEVIER SCIENCE INC. 2017: E141
View details for DOI 10.1016/j.jamcollsurg.2017.07.907
View details for Web of Science ID 000413319300344
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Advanced minimal access surgery in infants weighing less than 3kg: A single center experience.
Journal of pediatric surgery
2017
Abstract
Minimal access surgery (MAS) has gained popularity in infants less than 5kg, however, significant challenges still arise in very low weight infants.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.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.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.Prognosis study.Level III.
View details for DOI 10.1016/j.jpedsurg.2017.05.006
View details for PubMedID 28549685
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The Impact of Postgraduate Health Technology Innovation Training: Outcomes of the Stanford Biodesign Fellowship
ANNALS OF BIOMEDICAL ENGINEERING
2017; 45 (5): 1163-1171
Abstract
Stanford Biodesign launched its Innovation Fellowship in 2001 as a first-of-its kind postgraduate training experience for teaching biomedical technology innovators a need-driven process for developing medical technologies and delivering them to patients. Since then, many design-oriented educational programs have been initiated, yet the impact of this type of training remains poorly understood. This study measures the career focus, leadership trajectory, and productivity of 114 Biodesign Innovation Fellowship alumni based on survey data and public career information. It also compares alumni on certain publicly available metrics to finalists interviewed but not selected. Overall, 60% of alumni are employed in health technology in contrast to 35% of finalists interviewed but not selected. On leadership, 72% of alumni hold managerial or higher positions compared to 48% of the finalist group. A total of 67% of alumni reported that the fellowship had been "extremely beneficial" on their careers. As a measure of technology translation, more than 440,000 patients have been reached with technologies developed directly out of the Biodesign Innovation Fellowship, with another 1,000,000+ aided by solutions initiated by alumni after their training. This study suggests a positive impact of the fellowship program on the career focus, leadership, and productivity of its alumni.
View details for DOI 10.1007/s10439-016-1777-1
View details for Web of Science ID 000399805600001
View details for PubMedCentralID PMC5397448
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A multidisciplinary approach to laparoscopic sleeve gastrectomy among multiethnic adolescents in the United States.
Journal of pediatric surgery
2017
Abstract
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.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.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.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.Descriptive case series with prospective database.IV.
View details for PubMedID 28697852
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The Impact of Postgraduate Health Technology Innovation Training: Outcomes of the Stanford Biodesign Fellowship.
Annals of biomedical engineering
2016
Abstract
Stanford Biodesign launched its Innovation Fellowship in 2001 as a first-of-its kind postgraduate training experience for teaching biomedical technology innovators a need-driven process for developing medical technologies and delivering them to patients. Since then, many design-oriented educational programs have been initiated, yet the impact of this type of training remains poorly understood. This study measures the career focus, leadership trajectory, and productivity of 114 Biodesign Innovation Fellowship alumni based on survey data and public career information. It also compares alumni on certain publicly available metrics to finalists interviewed but not selected. Overall, 60% of alumni are employed in health technology in contrast to 35% of finalists interviewed but not selected. On leadership, 72% of alumni hold managerial or higher positions compared to 48% of the finalist group. A total of 67% of alumni reported that the fellowship had been "extremely beneficial" on their careers. As a measure of technology translation, more than 440,000 patients have been reached with technologies developed directly out of the Biodesign Innovation Fellowship, with another 1,000,000+ aided by solutions initiated by alumni after their training. This study suggests a positive impact of the fellowship program on the career focus, leadership, and productivity of its alumni.
View details for DOI 10.1007/s10439-016-1777-1
View details for PubMedID 28004213
View details for PubMedCentralID PMC5397448
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Advanced Minimal Access Surgery in Infants Weighing Less Than 3 Kilograms: A Single Center Experience
ELSEVIER SCIENCE INC. 2016: E153
View details for DOI 10.1016/j.jamcollsurg.2016.08.391
View details for Web of Science ID 000395825100336
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A Multidisciplinary Approach to Laparoscopic Sleeve Gastrectomy Among Multiethnic Adolescents in the United States
ELSEVIER SCIENCE INC. 2016: E153
View details for DOI 10.1016/j.jamcollsurg.2016.08.390
View details for Web of Science ID 000395825100335
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Case Report: Rapid staged abdominal closure using Gore-Tex (R) mesh as a bridge to primary omphalocele sac closure
JOURNAL OF PEDIATRIC SURGERY CASE REPORTS
2016; 9: 37–39
View details for DOI 10.1016/j.epsc.2016.04.013
View details for Web of Science ID 000376386500012
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Salvage of a failed open gastrocutaneous fistula repair with an endoscopic over-the-scope clip
JOURNAL OF PEDIATRIC SURGERY CASE REPORTS
2016; 8: 40–41
View details for DOI 10.1016/j.epsc.2016.03.015
View details for Web of Science ID 000376096600013
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Large intra-thoracic desmoid tumor with airway compression: A case report and review of the literature
JOURNAL OF PEDIATRIC SURGERY CASE REPORTS
2016; 5: 15–18
View details for DOI 10.1016/j.epsc.2015.12.005
View details for Web of Science ID 000370155600005
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Ultrasound-Guided Percutaneous Vein Access for Placement of Broviac Catheters in Extremely Low Birth Weight Neonates: A Series of 3 Successful Cases
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
2015; 25 (11): 958-960
Abstract
As medical and surgical interventions to support premature infants have evolved, the need for long-term vascular access in extremely low birth weight infants has increased. The classic approach to Broviac(®) (C.R. Bard, Covington, GA) catheter placement in very small neonates has been through an open surgical cutdown technique. Ultrasound guidance has emerged as a potentially beneficial method for obtaining central venous access in children and is being applied to smaller and smaller infants. This case series reports the feasibility of using ultrasound-guided percutaneous vein access to obtain a long-term central venous line in three extremely low birth weight infants who all weighed less than 850 g at the time of line placement.
View details for DOI 10.1089/lap.2015.0315
View details for Web of Science ID 000364766300017
View details for PubMedID 26288340
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Long-term follow-up of laparoscopic transcutaneous inguinal herniorraphy with high transfixation suture ligature of the hernia sac.
Journal of pediatric surgery
2015; 50 (10): 1767-1771
Abstract
Laparoscopic transcutaneous inguinal hernia repair in children may reduce postoperative pain, improve cosmesis, allow for less manipulation of the cord structures, and offer easy access to the contralateral groin. However, there is concern for unacceptably high recurrence rates when the procedure is generalized. To address this increase in recurrence, in 2011 we described in this journal a modification of the laparoscopic transcutaneous technique that replicates high transfixation ligature of the hernia sac with the aim of inducing more secure healing, preventing suture slippage, and distributing tension across two suture passes. We now describe our long-term follow-up of this novel repair.After obtaining IRB approval, a retrospective chart review and phone follow-up were performed on all patients who underwent laparoscopic transfixation ligature hernia repair between October 2009 and August 2014 (including further follow-up of the 21 patients reviewed in the 2011 report of this technique). Data collection included demographics, laterality of hernia, evidence of recurrence, complications, and time to follow-up.Median follow-up was 24months (range 2-52months). Three pediatric surgeons performed 216 laparoscopic transfixation ligature repairs on 166 patients. Demographics: mean age 29.5months (range 1-192months); male 67.2% and female 32.8%; 4.2% of patients were premature at operation. Repairs were bilateral in 42% of patients, right sided in 34%, and left sided in 24%. Three patients together experienced 4 recurrences, for an overall recurrence rate of 1.8%. Two of the recurrences occurred in a 2-month old syndromic patient with severe congenital heart disease who recurred twice after laparoscopic transfixation ligature repair then subsequently failed an attempt at open repair. Excluding this one outlier patient, the recurrence rate was 0.9%. The complication rate was 1.7% (3 hydroceles and 1 inguinal hematoma; all resolved spontaneously).Laparoscopic high transfixation ligature hernia repair can be adopted by surgeons with basic laparoscopic skills, and result in excellent outcomes with acceptable recurrence rates.
View details for DOI 10.1016/j.jpedsurg.2015.06.006
View details for PubMedID 26201542
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Challenges and climate of business environment and resources to support pediatric device development
SEMINARS IN PEDIATRIC SURGERY
2015; 24 (3): 107-111
Abstract
The incidence of pediatric disease conditions pales in comparison to adult disease. Consequently, many pediatric disorders are considered orphan diseases. Resources for the development of devices targeting orphan diseases are scarce and this poses a unique challenge to the development of pediatric devices. This article outlines these challenges and offers solutions.
View details for DOI 10.1053/j.sempedsurg.2015.02.006
View details for Web of Science ID 000355070600003
View details for PubMedID 25976144
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Congenital peribronchial myofibroblastic tumor: case report of an asymptomatic infant with a rapidly enlarging pulmonary mass and review of the literature.
Annals of clinical and laboratory science
2015; 45 (1): 83-89
Abstract
Congenital peribronchial myofibroblastic tumor (CPMT) is a rare, benign lung tumor of infants, with only 19 reported cases worldwide. It is often diagnosed by prenatal imaging or in the immediate postnatal period due to co-morbidities like polyhydramnios, fetal hydrops, respiratory distress, and heart failure.We report the oldest known infant (8 weeks old) diagnosed with CPMT, and present his clinical course including the relevant radiographic and histopathologic findings.CPMT is a rare tumor that should be considered among other primary lung tumors of infancy (developmental, benign, and malignant) even if not detected prenatally or in the immediate postnatal period.
View details for PubMedID 25696016
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Long-term follow-up of laparoscopic transcutaneous inguinal herniorraphy with high transfixation suture ligature of the hernia sac
Journal Pediatric Surgery
2015
Abstract
Laparoscopic transcutaneous inguinal hernia repair in children may reduce postoperative pain, improve cosmesis, allow for less manipulation of the cord structures, and offer easy access to the contralateral groin. However, there is concern for unacceptably high recurrence rates when the procedure is generalized. To address this increase in recurrence, in 2011 we described in this journal a modification of the laparoscopic transcutaneous technique that replicates high transfixation ligature of the hernia sac with the aim of inducing more secure healing, preventing suture slippage, and distributing tension across two suture passes. We now describe our long-term follow-up of this novel repair.After obtaining IRB approval, a retrospective chart review and phone follow-up were performed on all patients who underwent laparoscopic transfixation ligature hernia repair between October 2009 and August 2014 (including further follow-up of the 21 patients reviewed in the 2011 report of this technique). Data collection included demographics, laterality of hernia, evidence of recurrence, complications, and time to follow-up.Median follow-up was 24months (range 2-52months). Three pediatric surgeons performed 216 laparoscopic transfixation ligature repairs on 166 patients. Demographics: mean age 29.5months (range 1-192months); male 67.2% and female 32.8%; 4.2% of patients were premature at operation. Repairs were bilateral in 42% of patients, right sided in 34%, and left sided in 24%. Three patients together experienced 4 recurrences, for an overall recurrence rate of 1.8%. Two of the recurrences occurred in a 2-month old syndromic patient with severe congenital heart disease who recurred twice after laparoscopic transfixation ligature repair then subsequently failed an attempt at open repair. Excluding this one outlier patient, the recurrence rate was 0.9%. The complication rate was 1.7% (3 hydroceles and 1 inguinal hematoma; all resolved spontaneously).Laparoscopic high transfixation ligature hernia repair can be adopted by surgeons with basic laparoscopic skills, and result in excellent outcomes with acceptable recurrence rates.
View details for DOI 10.1016/j.jpedsurg.2015.06.006
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Thoracoscopic repair of esophageal atresia with distal tracheoesophageal fistula and a proximal type-H tracheoesophageal fistula
Journal of Pediatric Surgery Case Reports
2014; 2 (5): 232-235
View details for DOI 10.1016/j.epsc.2014.04.004
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Complete resection of a rare intrahepatic variant of a choledochal cyst
JOURNAL OF PEDIATRIC SURGERY
2013; 48 (3): 652-654
Abstract
The vast majority of choledochal cysts occur as either saccular or diffuse fusiform dilatation of the extrahepatic bile duct. We describe the complete resection of a rare single intrahepatic choledochal cyst communicating with the extrahepatic biliary tree. While previous reports describe partial resection with enteral drainage, we performed a complete resection of this rare choledochal cyst.
View details for DOI 10.1016/j.jpedsurg.2012.12.016
View details for Web of Science ID 000316470100037
View details for PubMedID 23480926
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Successful extracorporeal membrane oxygenation treatment for pheochromocytoma-induced acute cardiac failure
AMERICAN JOURNAL OF EMERGENCY MEDICINE
2012; 30 (6)
Abstract
The aim of this study is to report the case of a catecholamine-induced cardiogenic shock bridged to curative adrenalectomy using extracorporeal membrane oxygenation (ECMO) and medical management. A 37-year-old woman presented an acute cardiogenic shock due to a left-sided pheochromocytoma. Echocardiography revealed a severe global hypokinesia with a left ventricular ejection fraction of 15%. Despite maximal ionotropic support, adequate perfusion could not be achieved; and ECMO was used to bridge the patient during medical management with calcium-channel blockers. The left ventricular ejection fraction improved to 65%, and ECMO was discontinued after 11 days. An open left adrenalectomy was performed 10 days after ECMO. At 1-year follow-up, the patient is in good health with normal cardiac function. Pheochromocytomas can present with dramatic cardiovascular collapse. With timely diagnosis and medical therapy, followed by surgical resection, the cardiovascular effects can be reversed; and the condition, cured. Young patients with catecholamine-induced cardiac failure refractory to medical therapy are ideal candidates for short-term ECMO support, as the underlying cause is imminently reversible.
View details for DOI 10.1016/j.ajem.2011.05.006
View details for Web of Science ID 000305811600046
View details for PubMedID 21741786
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Submucosal Endoscopic Myotomies for Esophageal Lengthening: A Novel Minimally Invasive Technique with Feasibility Study
EUROPEAN JOURNAL OF PEDIATRIC SURGERY
2012; 22 (3): 217-221
Abstract
Replacement conduits carry significant morbidity in long gap esophageal atresia. Surgical myotomies can lengthen the esophagus, but have not gained widespread adoption due to long-term dilatation. The aim of this study is to assess the feasibility of an emerging minimally invasive technique of submucosal endoscopic myotomy for esophageal lengthening.Bilateral submucosal lengthening endoscopic myotomies (BSLEM) were performed in three swine. Circular esophageal muscle fibers were selectively divided in a bilateral 3 cm longitudinal pattern. Ex-vivo tensile testing was performed on the BSLEM and compared with three circular myotomies, three spiral myotomies, and three controls.BSLEM was completed in all cases with one esophageal microperforation. The mean operating time was 38 minutes. Over physiologic force ranges of 0 to 100 g, the percentage esophageal elongation was significantly different among the four groups (p<0.05). Spiral myotomy enabled the maximal lengthening among the techniques. BSLEM enabled lengthening significantly greater than controls, but less than both types of surgical myotomy.BSELM is feasible and allows significant esophageal lengthening. Unlike surgical myotomies, BSELM enables selective division of circular fibers to potentially preserve perfusion near the anastomosis and prevent long-term dilatation. Studies are ongoing to characterize the ideal pattern of selective endoscopic myotomy and long-term effects.
View details for DOI 10.1055/s-0032-1308711
View details for Web of Science ID 000306110600008
View details for PubMedID 22576306
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Prospective evaluation of peritoneal fluid contamination following transabdominal vs. transanal specimen extraction in laparoscopic left-sided colorectal resections
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
2012; 26 (6): 1495-1500
Abstract
Natural orifice specimen extraction (NOSE) in colorectal surgery prevents the need for an enlarged port site or minilaparotomy to extract the surgical specimen. The downside of this technique may be an increased risk of bacterial contamination of the peritoneal cavity from the external milieu. The aim of this study was to prospectively analyze the peritoneal bacterial contamination in NOSE and non-NOSE laparoscopic colorectal procedures.Consecutive patients operated for sigmoid diverticulitis with laparoscopic approach and transanal extraction of the specimen from January to December 2010 at our university hospital were enrolled. Patients who underwent a laparoscopic sigmoidectomy in the same study period with conventional specimen extraction were used as reference. Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.Twenty-nine patients underwent laparoscopic sigmoidectomy for diverticulitis with transanal NOSE, while 9 patients underwent laparoscopic sigmoidectomy with conventional specimen extraction during the same period. The two groups were successfully matched 1:2 (17 NOSE and 9 non-NOSE) according age, sex, ASA, and Charlson comorbidity score. The contamination rate of peritoneal fluid was 100% vs. 88.9% in NOSE and non-NOSE procedures, respectively (P = 0.23). Overall and major complications rates were 27.6% vs. 11.10% (P = 0.41) and 5.08% vs. 11.1% (P = 1) in NOSE vs. non-NOSE procedures, respectively. In the NOSE group there was a statistically significant lower consumption of oral paracetamol (P = 0.007) and of oral tramadol (P = 0.02).Although a higher peritoneal contamination was found in the NOSE procedures, there were no significant differences in clinical outcomes relative to standard approach. Avoiding a minilaparotomy to extract the specimen resulted in a significantly lower postoperative analgesic requirement in the NOSE group.
View details for DOI 10.1007/s00464-011-2066-6
View details for Web of Science ID 000304161500001
View details for PubMedID 22179455
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An Original Endoluminal Magnetic Anastomotic Device Allowing Pure NOTES Transgastric and Transrectal Sigmoidectomy in a Porcine Model: Proof of Concept
SURGICAL INNOVATION
2012; 19 (2): 109-116
Abstract
While experimental natural orifice transluminal endoscopic surgery (NOTES) sigmoid colectomies have been reported, pure NOTES anastomoses are restricted by the limited reach of commercially available circular staplers. MAGNAMOSIS is a set of self-orienting magnetic rings that can be delivered endoluminally throughout the colon to generate a compression anastomosis. Aim. To assess the feasibility of a pure NOTES transrectal (TR) and transgastric (TG) approach to perform any segmental colectomy.One pig (50 kg) underwent the experimental procedure as follows: (a) creation of the TG access to the peritoneal cavity, (b) precise transluminal placement of the proximal MAGNAMOSIS ring, (c) creation of the TR access with the TEO and transrectal dissection of the sigmoid mesentery, (d) resection of the surgical specimen, (e) transrectal extraction of the specimen, (f) delivery and mating of the distal MAGNAMOSIS ring, and (g) closure of the TG and TR viscerotomies. The animal survived for 14 days at which time burst pressure and histology were performed.A pure NOTES TR and TG segmental colectomy was performed in 139 minutes. The postoperative course was uneventful. The animal had a formed bowel movement including the magnetic rings on postoperative day 5. Endoscopic examination at postoperative day 14 revealed a patent anastomosis. Necropsy revealed no abscess or signs of peritonitis. Burst pressure was >198 mm Hg. The histology showed a sealed anastomosis with mild inflammation.MAGNAMOSIS enabled a totally NOTES partial colectomy with combined TG and TR access. The flexible delivery options and low cost of manufacturing could make MAGNAMOSIS an attractive alternative to circular staplers.
View details for DOI 10.1177/1553350611429029
View details for Web of Science ID 000304822100001
View details for PubMedID 22143749
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Totally Endoscopic Magnetic Enteral Bypass by External Guided Rendez-Vous Technique
SURGICAL INNOVATION
2011; 18 (4): 317-320
Abstract
This study aimed to assess the feasibility of a totally endoscopic enteral bypass using a self-orienting, dual ring, magnetic anastomosis system (MAGNAMOSIS) guided by a magnetic tracking system (3D METRIS).In an anesthetized pig, 2 endoscopes were advanced, one each into the stomach and the colon. Both endoscopes were equipped with a MAGNAMOSIS ring secured with an endoscopic snare and a 3D METRIS within one working channel. The whole procedure was followed laparoscopically. The tracking system guided tips of endoscopes to a "rendez-vous" location between the colon and stomach.MAGNAMOSIS magnets automatically joined in the correct configuration when guided to within 2 cm of each other. At necropsy, magnetic rings were secure without entrapment of excess bowel or mesentery.An endoscopic enteral bypass with magnetic anastomosis and magnetic tracking device was feasible. More accurate tracking and advanced techniques could enable endoscopic bypasses at multiple sites in the gastrointestinal tract.
View details for DOI 10.1177/1553350611409761
View details for Web of Science ID 000299896100004
View details for PubMedID 21742664
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Two novel endoscopic esophageal lengthening and reconstruction techniques
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
2011; 25 (10): 3440-3440
Abstract
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.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.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.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.
View details for DOI 10.1007/s00464-011-1711-4
View details for Web of Science ID 000294964600048
View details for PubMedID 21556998
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Original Technique to Close the Transrectal Viscerotomy Access in a NOTES Transrectal and Transgastric Segmental Colectomy
SURGICAL INNOVATION
2011; 18 (3): 193-200
Abstract
Segmental colectomy is an ideal procedure for natural orifice transluminal endoscopic surgery (NOTES). Transanal endoscopic approaches have enabled rectosigmoid colectomy through a viscerotomy that is resected with the specimen. To extend NOTES segmental colectomy to the entire colon and beyond, a rectal viscerotomy will have to be safely and effectively closed at the end of the procedure. A new technique for rectal viscerotomy closure using a circular EEA hemorrhoid and prolapse stapler with DST series technology (Covidien) is described.
View details for DOI 10.1177/1553350611411490
View details for Web of Science ID 000297596400004
View details for PubMedID 21727099
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Robotic Gastrectomy Is Safe and Feasible, but Real Benefits Remain Elusive
ARCHIVES OF SURGERY
2011; 146 (9): 1092-1092
View details for Web of Science ID 000295002900027
View details for PubMedID 22029074
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Laparo-Endoscopic Single-Site (LESS) with Transanal Natural Orifice Specimen Extraction (NOSE) Sigmoidectomy: A New Step before Pure Colorectal Natural Orifices Transluminal Endoscopic Surgery (NOTES (R))
JOURNAL OF GASTROINTESTINAL SURGERY
2011; 15 (8): 1488-1492
Abstract
We present the first human case of laparo-endoscopic single-site sigmoidectomy with transanal natural orifice specimen extraction.This technical achievement is a new step toward pure colorectal Natural Orifices Transluminal Endoscopic Surgery. It is the product of a gradual development with critical steps being conceived and standardised in years of experimental and clinical procedures.
View details for DOI 10.1007/s11605-011-1557-z
View details for Web of Science ID 000293243200035
View details for PubMedID 21584823
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From Idea to Bedside: The Process of Surgical Invention and Innovation
KEY TOPICS IN SURGICAL RESEARCH AND METHODOLOGY
2010: 647–56
View details for DOI 10.1007/978-3-540-71915-1_52
View details for Web of Science ID 000274802900052
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Intellectual property and royalty streams in academic departments: Myths and realities
SURGERY
2008; 143 (2): 183-191
View details for DOI 10.1016/j.surg.2007.11.011
View details for Web of Science ID 000253172300009
View details for PubMedID 18242333
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Impact of multiple lymphatic channel drainage to a single nodal basin on outcomes in melanoma
78th Annual Meeting of the Pacific-Coast-Surgical-Association
AMER MEDICAL ASSOC. 2007: 753–56
Abstract
To determine the impact of multiple lymphatic channels (MLCs) on outcome in melanoma.Retrospective cohort study.Academic tertiary care center.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.Multiple variables, including patterns of lymphatic drainage, were analyzed for impact on disease-free and overall survival.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.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.
View details for Web of Science ID 000248721200013
View details for PubMedID 17709729