Lessons Learned From the First-In-Human Compassionate Use of Connect-EA™ in Ten Patients With Esophageal Atresia.

INTRODUCTION: Delayed primary repair of esophageal atresia in patients with high-risk physiologic and anatomic comorbidities remains a daunting challenge with an increased risk for peri-operative morbidity and mortality via conventional repair. The Connect-EA device facilitates the endoscopic creation of a secure esophageal anastomosis. This follow-up study reports our long-term outcomes with the novel esophageal magnetic compression anastomosis (EMCA) Connect-EA device for EA repair, as well as lessons learned from the ten first-in-human cases. We propose an algorithm to maximize the advantages of the device for EA repair. METHODS: Under compassionate use approval, from June 2019 to December 2022, ten patients with prohibitive surgical or medical risk factors underwent attempted EMCA with this device. All patients underwent prior gastrostomy, tracheoesophageal fistula ligation (if necessary), and demonstrated pouch apposition prior to EMCA. RESULTS: Successful device deployment and EMCA formation were achieved in nine patients (90%). Mean time to anastomosis formation was 8 days (range 5-14) and the device was retrieved endoscopically in five (56%) cases. At median follow-up of 22 months (range 4-45), seven patients (78%) are tolerating oral nutrition. Balloon dilations (median 4, range 1-11) were performed either prophylactically for radiographic asymptomatic anastomotic narrowing (n = 7, 78%) or to treat clinically-significant anastomotic narrowing (n = 2, 22%) with no ongoing dilations at 3-month follow up post-repair. CONCLUSION: EMCA with the Connect-EA device is a safe and feasible minimally-invasive alterative for EA repair in high-risk surgical patients. Promising post-operative outcomes warrant further Phase I investigation. LEVEL OF EVIDENCE: IV, Case series of novel operative technique without comparison group.

Benchmarking Pediatric Trauma Care in Mixed Trauma Centers: Adult Risk-Adjusted Mortality Is Not a Reliable Indicator of Pediatric Outcomes.

BACKGROUND: Trauma center benchmarking has become standard practice for assessing quality. The American College of Surgeons adult trauma center verification standards do not specifically require participation in a pediatric-specific benchmarking program. Centers that treat adults and children may therefore rely solely on adult benchmarking metrics as a surrogate for pediatric quality. This study assessed discordance between adult and pediatric mortality within mixed trauma centers to determine the need to independently report pediatric-specific quality metrics. STUDY DESIGN: A cohort of trauma centers (n = 493, including 347 adult-only, 44 pediatric-only, and 102 mixed) that participated in the American College of Surgeons TQIP in 2017 to 2018 was analyzed. Center-specific observed-to-expected mortality estimates were calculated using TQIP adult inclusion criteria for 449 centers treating adults (16 to 65 years) and using TQIP pediatric inclusion criteria for 146 centers treating children (0 to 15 years). We then correlated risk-adjusted mortality estimates for pediatric and adult patients within mixed centers and evaluated concordance of their outlier status between adults and children. RESULTS: The cohort included 394,075 adults and 97,698 children. Unadjusted mortality was 6.1% in adults and 1.2% in children. Mortality estimates had only moderate correlation ( r = 0.41) between adult and pediatric cohorts within individual mixed centers. Mortality outlier status for adult and pediatric cohorts was discordant in 31% (32 of 102) of mixed centers (weighted Kappa statistic 0.06 [-0.11 to 0.22]), with 78% (23 of 32) of discordant centers having higher odds of mortality for children than for adults (6 centers with average adult mortality and high pediatric mortality and 17 centers with low adult mortality and average pediatric mortality, p < 0.01). CONCLUSIONS: Adult mortality is not a reliable surrogate for pediatric mortality in mixed trauma centers. Incorporation of pediatric-specific benchmarks should be required for centers that admit children.

Evaluation of a Magnetic Compression Anastomosis for Jejunoileal Partial Diversion in Rhesus Macaques.

PURPOSE: Metabolic surgery remains underutilized for treating type 2 diabetes, as less invasive alternative interventions with improved risk profiles are needed. We conducted a pilot study to evaluate the feasibility of a novel magnetic compression device to create a patent limited caliber side-to-side jejunoileal partial diversion in a nonhuman primate model. MATERIALS AND METHODS: Using an established nonhuman primate model of diet-induced insulin resistance, a magnetic compression device was used to create a side-to-side jejunoileal anastomosis. Primary outcomes evaluated feasibility (e.g., device mating and anastomosis patency) and safety (e.g., device-related complications). Secondary outcomes evaluated the device's ability to produce metabolic changes associated with jejunoileal partial diversion (e.g., homeostatic model assessment of insulin resistance [HOMA-IR] and body weight). RESULTS: Device mating, spontaneous detachment, and excretion occurred in all animals (n = 5). There were no device-related adverse events. Upon completion of the study, ex vivo anastomoses were widely patent with healthy mucosa and no evidence of stricture. At 6 weeks post-device placement, HOMA-IR improved to below baseline values (p < 0.05). Total weight also decreased in a linear fashion (R2 = 0.97) with total weight loss at 6 weeks post-device placement of 14.4% (p < 0.05). CONCLUSION: The use of this novel magnetic compression device to create a limited caliber side-to-side jejunoileal anastomosis is safe and likely feasible in a nonhuman primate model. The observed glucoregulatory and metabolic effects of a partial jejunoileal bypass with this device warrant further investigation to validate the long-term glucometabolic impact of this approach.

Beyond the gut: spectrum of magnetic surgery devices.

Since the 1970s, magnetic force has been used to augment modern surgical techniques with the aims of minimizing surgical trauma and optimizing minimally-invasive systems. The majority of current clinical applications for magnetic surgery are largely centered around gastrointestinal uses-such as gastrointestinal or bilioenteric anastomosis creation, stricturoplasty, sphincter augmentation, and the guidance of nasoenteric feeding tubes. However, as the field of magnetic surgery continues to advance, the development and clinical implementation of magnetic devices has expanded to treat a variety of non-gastrointestinal disorders including musculoskeletal (pectus excavatum, scoliosis), respiratory (obstructive sleep apnea), cardiovascular (coronary artery stenosis, end-stage renal disease), and genitourinary (stricture, nephrolithiasis) conditions. The purpose of this review is to discuss the current state of innovative magnetic surgical devices under clinical investigation or commercially available for the treatment of non-gastrointestinal disorders.

The Evolving Use of Magnets in Surgery: Biomedical Considerations and a Review of Their Current Applications.

The novel use of magnetic force to optimize modern surgical techniques originated in the 1970s. Since then, magnets have been utilized as an adjunct or alternative to a wide array of existing surgical procedures, ranging from gastrointestinal to vascular surgery. As the use of magnets in surgery continues to grow, the body of knowledge on magnetic surgical devices from preclinical development to clinical implementation has expanded significantly; however, the current magnetic surgical devices can be organized based on their core function: serving as a guidance system, creating a new connection, recreating a physiologic function, or utilization of an internal-external paired magnet system. The purpose of this article is to discuss the biomedical considerations during magnetic device development and review the current surgical applications of magnetic devices.

Standardized perioperative care reduces colorectal surgical site infection in children: A Western Pediatric Surgery Research Consortium multicenter analysis.

PURPOSE: Surgical site infection (SSI) remains a significant source of patient morbidity and resource utilization in children undergoing colorectal surgery. We examined the utility of a protocolized perioperative care bundle in reducing SSI in pediatric patients undergoing colorectal surgery. METHODS: We conducted a prospective cohort study of patients ≤18 years of age undergoing colorectal surgery at ten United States children's hospitals. Using a perioperative care protocol comprising eight elements, or "colon bundle", we divided patients into low (1-4 elements) or high (5-8 elements) compliance cohorts. Procedures involving colorectal repair or anastomosis with abdominal closure were included. Demographics and clinical outcomes were compared between low and high compliance cohorts. Compliance was compared with a retrospective cohort. The primary outcome was superficial SSI incidence at 30 days. RESULTS: Three hundred and thirty-six patients were included in our analysis: 138 from the low compliance cohort and 198 from the high compliance cohort. Age and gender were similar between groups. Preoperative diagnosis was similar except for more patients in the high compliance cohort having inflammatory bowel disease (18.2% versus 5.8%, p<0.01). The most common procedure performed was small bowel to colorectal anastomosis. Wound classification and procedure acuity were similar between groups. Superficial SSI at 30 days occurred less frequently among the high compliance compared to the low compliance cohort (4% versus 9.7%, p = 0.036). Median postoperative length of stay and 30-day rates of readmission, reoperation, intra-abdominal abscess and anastomotic leak requiring operation were not significantly different between groups. None of the individual colon bundle elements were independently protective against superficial SSI. CONCLUSION: Standardization of perioperative care is associated with a reduction in superficial SSI in pediatric colorectal surgery. Expansion of standardized protocols for children undergoing colorectal surgery may improve outcomes and decrease perioperative morbidity. TYPE OF STUDY: Clinical Research Paper LEVEL OF EVIDENCE: Level II.

The Rearing of Maternal-Fetal Surgery: The Maturation of a Field from Conception to Adulthood.

Maternal-fetal surgery is fraught with inherent controversy from within the medical community and general public. Despite these challenges, the field of maternal-fetal surgery evolved into an international enterprise. Carefully nurtured by pioneers with foresight and resilience, the field navigated ethical dilemmas with rigorous scientific methodology, collaboration, transparency, and accordance. These central pillars are consistent throughout the brief but momentous history of maternal-fetal surgery, serving as the catalyst for its success. The maturation of fetal intervention is an exemplar of technological innovation propelling clinical innovation, as well as a celebration of mastering the delicate balance between caution and optimism.

All body region injuries are not equal: Differences in pediatric discharge functional status based on Abbreviated Injury Scale (AIS) body regions and severity scores.

PURPOSE: Functional outcomes have been proposed for assessing quality of pediatric trauma care. Outcomes assessments often rely on Abbreviated Injury Scale (AIS) severity scores to adjust for injury characteristics, but the relationship between AIS severity and functional impairment is unknown. This study's primary aim was to quantify functional impairment associated with increasing AIS severity scores within body regions. The secondary aim was to assess differences in impairment between body regions based on AIS severity. METHODS: Children with serious (AIS≥ 3) isolated body region injuries enrolled in a multicenter prospective study were analyzed. The primary outcome was functional status at discharge measured using the Functional Status Scale (FSS). Discharge FSS was compared (1) within each body region across increasing AIS severity scores, and (2) between body regions for injuries with matching AIS scores. RESULTS: The study included 266 children, with 16% having abnormal FSS at discharge. Worse FSS was associated with increasing AIS severity only for spine injuries. Abnormal FSS was observed in a greater proportion of head injury patients with a severely impaired initial Glasgow Coma Scale (GCS) (GCS< 9) compared to those with a higher GCS score (43% versus 9%; p < 0.01). Patients with AIS 3 extremity and severe head injuries had a higher proportion of abnormal FSS at discharge than AIS 3 abdomen or non-severe head injuries. CONCLUSIONS: AIS severity does not account for variability in discharge functional impairment within or between body regions. Benchmarking based on functional status assessment requires clinical factors in addition to AIS severity for appropriate risk adjustment. LEVEL OF EVIDENCE: 1 (Prognostic and Epidemiological).

The novel application of an emerging device for salvage of primary repair in high-risk complex esophageal atresia.

INTRODUCTION: Preservation of native esophagus is a tenet of esophageal atresia (EA) repair. However, techniques for delayed primary anastomosis are severely limited for surgically and medically complex patients at high-risk for operative repair. We report our initial experience with the novel application of the Connect-EA, an esophageal magnetic compression anastomosis device, for salvage of primary repair in 2 high-risk complex EA patients. Compassionate use was approved by the FDA and treating institutions. OPERATIVE TECHNIQUE: Two approaches using the Connect-EA are described - a totally endoscopic approach and a novel hybrid operative approach. To our knowledge, this is the first successful use of a hybrid operative approach with an esophageal magnetic compression device. OUTCOMES: Salvage of delayed primary anastomosis was successful in both patients. The totally endoscopic approach significantly reduced operative time and avoided repeat high-risk operation. The hybrid operative approach salvaged delayed primary anastomosis and avoided cervical esophagostomy. CONCLUSION: The Connect-EA is a novel intervention to achieve delayed primary esophageal repair in complex EA patients with high-risk tissue characteristics and multi-system comorbidities that limit operative repair. We propose a clinical algorithm for use of the totally endoscopic approach and hybrid operative approach for use of the Connect-EA in high-risk complex EA patients.

Child physical abuse and COVID-19: Trends from nine pediatric trauma centers.

BACKGROUND: Economic, social, and psychologic stressors are associated with an increased risk for abusive injuries in children. Prolonged physical proximity between adults and children under conditions of severe external stress, such as witnessed during the COVID-19 pandemic with "shelter-in-place orders", may be associated with additional increased risk for child physical abuse. We hypothesized that child physical abuse rates and associated severity of injury would increase during the early months of the pandemic as compared to the prior benchmark period. METHODS: We conducted a nine-center retrospective review of suspected child physical abuse admissions across the Western Pediatric Surgery Research Consortium. Cases were identified for the period of April 1-June 30, 2020 (COVID-19) and compared to the identical period in 2019. We collected patient demographics, injury characteristics, and outcome data. RESULTS: There were no significant differences in child physical abuse cases between the time periods in the consortium as a whole or at individual hospitals. There were no differences between the study periods with regard to patient characteristics, injury types or severity, resource utilization, disposition, or mortality. CONCLUSIONS: Apparent rates of new injuries related to child physical abuse did not increase early in the COVID-19 pandemic. While this may suggest that pediatric physical abuse was not impacted by pandemic restrictions and stresses, it is possible that under-reporting, under-detection, or delays in presentation of abusive injuries increased during the pandemic. Long-term follow-up of subsequent rates and severity of child abuse is needed to assess for unrecognized injuries that may have occurred.

Modern fetal surgery-a historical review of the happenings that shaped modern fetal surgery and its practices.

The history of fetal surgery is one of constant evolution. Over the last 50 years, fetal surgery has progressed from a mere idea to an internationally respected innovative field of surgery. This article aims to provide a historical review of how the enterprise of maternal-fetal surgery came to be its modern version. This review is less focused on the history of specific therapies for a relatively small number of conditions, and more on how the whole field of maternal-fetal surgery evolved. The various internal and external influences that steered the field's evolution are discussed in chronologic order. Since the start of modern fetal surgery in the 1980s, large paradigm shifts have characterized the growth of the field as a whole. Innovative interventions are now based on physiologic manipulation as opposed to simple anatomic repair, fetoscopy has become the more frequently preferred surgical approach, and rigorous scientific evaluation with randomized controlled trials is now the standard expected by the community. In a very similar fashion to when the field first began in the early 1980s, recently community's leaders have risen to protect the integrity of maternal-fetal surgery by publishing ethical guidelines for innovation and clinical practice. This incredible history of innovation, rigorous science and ethical contemplation is the foundation on which modern maternal-fetal surgery rests.

Torso vascular trauma.

Vascular injury within the chest or abdomen represents a unique challenge to the pediatric general surgeon, as these life- or limb-threatening injuries are rare and may require emergent treatment. Vascular injury may present as life-threatening hemorrhage, or with critical ischemia from intimal injury, dissection, or thrombosis. Maintaining the skillset and requisite knowledge to address these injuries is of utmost importance for pediatric surgeons that care for injured children, particularly for surgeons practicing in freestanding children's hospitals that frequently do not have adult vascular surgery coverage. The purpose of this review is to provide an overview of torso vascular trauma, with a specific emphasis in rapid recognition of torso vascular injury as well as both open and endovascular management options. Specific injuries addressed include blunt and penetrating mediastinal vascular injury, subclavian injury, abdominal aortic and visceral segment injury, inferior vena cava injury, and pelvic vascular injury. Operative exposure, vascular repair techniques, and damage control options including preperitoneal packing for pelvic hemorrhage are discussed. The role and limitations of endovascular treatment of each of these injuries is discussed, including endovascular stent graft placement, angioembolization for pelvic hemorrhage, and resuscitative endovascular balloon occlusion of the aorta (REBOA) in children.

Novel Device for Endoluminal Esophageal Atresia Repair: First-in-Human Experience.

Thoracoscopic esophageal atresia (EA) repair affords many benefits to the patient; however, intracorporeal suturing of the anastomosis is technically challenging. Esophageal magnetic compression anastomosis (EMCA) is a compelling option for endoluminal EA repair, but available EMCA devices have prohibitive rates of recalcitrant stricture. Connect-EA is a new endoluminal EMCA device system that employs 2 magnetic anchors with a unique mating geometry designed to reliably create a robust anastomosis and decrease rates of leak and stricture. We describe our first-in-human experience with this novel endoluminal device for staged EA repair in 3 patients (Gross type A, B, and C) at high risk for conventional surgical repair. First, the esophageal pouches were approximated thoracoscopically. After acute tension subsided, the device anchors were endoscopically placed in the esophageal pouches and mated. Anchors were spontaneously excreted in 2 cases. Endoscopic repositioning and retrieval of the anchors were required in 1 patient because of narrowed esophageal anatomy. There were no perioperative complications. Patients were managed for 14 to 18 months. The strictures that developed in the patients were membranous and responded well to dilation alone, resolving after 4 to 5 outpatient dilations. Gastrostomies were closed between 6 and 11 months and all patients are tolerating full oral nutrition. Early experience with this new endoluminal EMCA device system is highly favorable. The device offers considerable benefit over conventional handsewn esophageal anastomosis and anastomotic outcomes are superior to available EMCA devices.

Hospital-based intervention is rarely needed for children with low-grade blunt abdominal solid organ injury: An analysis of the Trauma Quality Improvement Program registry.

BACKGROUND: Children with low-grade blunt solid organ injury (SOI) have historically been admitted to an inpatient setting for monitoring, but the evidence supporting the necessity of this practice is lacking. The purpose of this study was to quantify the frequency and timing of intervention for hemorrhage and to describe hospital-based resource utilization for low-grade SOI in the absence of other major injuries (OMIs). METHODS: A cohort of children (aged <16 years) with blunt American Association for the Surgery of Trauma grade 1 or 2 SOI from the American College of Surgeons Trauma Quality Improvement Program registry (2007-2017) was analyzed. Children were excluded if they had confounding factors associated with intervention for hemorrhage (comorbidities, OMIs, or extra-abdominal surgical procedures). Outcomes included frequency and timing of intervention (laparotomy, angiography, or transfusion) for hemorrhage, as well as hospital-based resource utilization. RESULTS: A total of 1,019 children were identified with low-grade blunt SOI and no OMIs. Nine hundred eighty-six (96.8%) of these children were admitted to an inpatient unit. Admitted children with low-grade SOI had a median length-of-stay of 2 days and a 23.9% intensive care unit admission rate. Only 1.7% (n = 17) of patients with low-grade SOI underwent an intervention, with the median time to intervention being the first hospital day. No child who underwent angiography was transfused or had an abnormal initial ED shock index. CONCLUSION: Children with low-grade SOI are routinely admitted to the hospital and often to the intensive care unit but rarely undergo hospital-based intervention. The most common intervention was angiography, with questionable indications in this cohort. These data question the need for inpatient admission for low-grade SOI and suggest that discharge from the emergency room may be safe. Prospective investigation into granular risk factors to identify the rare patient needing hospital-based intervention is needed, as is validation of the safety of ambulatory management. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Functional status impairment at six-month follow-up is independently associated with child physical abuse mechanism.

BACKGROUND: Children with abusive injuries have worse mortality, length-of-stay, complications, and healthcare costs compared to those sustaining an accidental injury. Long-term functional impairment is common in children with abusive head trauma but has not been examined in a cohort with heterogeneous body region injuries. OBJECTIVE: To assess for an independent association between child physical abuse and functional impairment at discharge and six-month follow-up. PARTICIPANTS AND SETTING: Seriously injured children (<15 years) treated at seven pediatric trauma centers. METHODS: Functional status was compared between child physical abuse and accidental injury groups at discharge and six-month follow-up. Functional impairment was defined at discharge ("new domain morbidity") as a change from pre-injury ≥2 points in any of the six domains of the Functional Status Scale (FSS), and impairment at six-month follow-up as an abnormal total FSS score. RESULTS: Children with abusive injuries accounted for 10.5% (n = 45) of the cohort. New domain morbidity was present in 17.8% (n = 8) of child physical abuse patients at discharge, with 10% (n = 3) of children having an abnormal FSS at six-months. There were no differences in new domain morbidity at hospital discharge between children injured by abuse and or accidental injury. However, children injured by physical abuse were 4.09 (2.15, 7.78) times more likely to have functional impairment at six months. CONCLUSIONS: Child physical abuse is an independent risk factor for functional impairment at six-month follow-up. Functional status measurement for this high-risk group of children should be routinely measured and incorporated into trauma center quality assessments.