Critical design and validation considerations for the development of neonatal minimally invasive surgery simulators

Background/PurposePediatric surgical trainees have limited exposure to advanced minimally invasive surgery (MIS) during their clinical training, particularly for cases such as esophageal atresia/tracheoesophageal fistula (EA/TEF). Simulation on validated neonatal models offers an alternative means of training that may augment traditional forms of training; but to be useful, they must fulfill certain criteria.MethodologyReview of the currently available MIS, thoracoscopic and laparoscopic, simulators for pediatric surgery, and identification of those factors that contribute to their fidelity and validity as a training tool that must be incorporated in the design of future simulation models.ResultsThere are few neonatal laparoscopic and thoracoscopic models currently available, or in the research stage. To our knowledge, there is no commercially available, synthetic, high fidelity and low cost thoracoscopic model in existence. Use of animal tissue has disadvantages of ethical dilemmas, cost, and logistic and procurement issues. Newer synthetic models need to be validated for fidelity, to replicate those components of the operation that pose the greatest technical challenge, and incorporate means of measuring acquisition of technical expertise.ConclusionThis review describes the principles that need to be considered to develop low cost, validated high-fidelity MIS simulator that can be used for training, and that is capable of measuring the acquisition of the technical skills that can be applied to the repair of complex procedures such as esophageal atresia.Level of evidence III     

One-year outcomes of congenital diaphragmatic hernia repair: Factors associated with recurrence and complications

PurposeCongenital diaphragmatic hernia (CDH) is a congenital anomaly associated with lifelong multisystem morbidity. This study sought to identify factors contributing to hospital readmission after CDH repair.MethodsThe Nationwide Readmissions Database from 2010 to 2014 was used to identify patients with CDH who underwent surgical repair. Primary outcomes included all cause readmission at 30-days and 1 year and readmission for hernia recurrence. Patient and hospital factors were compared using chi-squared analysis.ResultsFive hundred eleven patients were identified with neonatal CDH. All repairs were performed at teaching hospitals via laparotomy in 59% (n = 303), thoracotomy in 36% (n = 183), and minimally invasive (MIS) repair in 5% (n = 25). The readmission rate within 30-days was 32% (n = 163), and 97% (n = 495) within 1 year. The most common conditions surrounding readmission were for gastroesophageal reflux (20%), CDH recurrence (17%), and surgery for gastrostomy tube and/or fundoplication (16%). Recurrence was significantly higher after MIS repair (48%) compared to those with open repair via either approach (16%), p < 0.001.ConclusionsThis is the first study to evaluate nationwide readmissions in newborns with CDH. Readmission is commonly due to CDH recurrence and reflux-associated complications. The recurrence rate is higher than previously reported and is more common after MIS and repair via thoracotomy.Level of evidenceLevel III treatment study.     

SuSiPed: An initial step towards a universal,low-cost, 3D-printable platform for pediatric minimal-invasive surgery training

BackgroundTraining platforms such as the Fundamentals of Laparoscopic Surgery have become an integral part of postgraduate adult general surgical education. So far, however, there is no such universal tool for pediatric minimal-invasive surgery (MIS). We therefore designed and validated a novel 3D printable pediatric MIS simulation program.MethodsThe SuSiPed (Surgical Simulation in Pediatrics) curriculum consists of 6 MIS training modules: camera guidance, shell transfer, figure cutting, cyst resection, single interrupted suturing, and slipknot suturing. All modules can be 3D printed, and thus manufactured in a low-cost, sustainable and reproducible fashion. Instructional videos for the participants for each module were created. For validation, a group of medical students and surgical residents were compared to a group of pediatric surgical specialists with experience in MIS. All participants performed the entire SuSiPed curriculum 3 times, measuring time to task completion and technical mistakes. The results of the last attempt were compared using Welch's T-test.ResultsThere were 25 participants in the novice group and 5 in expert group. Times to task completion were lower in the expert group for all modules except camera guidance. Errors were significantly more frequent during slipknot suturing in the novice group, while there were no difference in the other modules.ConclusionOur novel training platform showed good construct validity for 5 out of 6 modules, while scores of camera navigation was not associated with prior experience. The SuSiPed platform is useful for pediatric minimal-invasive surgery training and evaluation, even in low-resource countries where expensive simulators are not affordable.Level of evidenceLevel III, Validation Study.     

Construct validation of a 3D printed neonatal thoracoscopic simulator: Can it measure expertise?

Backgroundacquiring technical expertise for neonatal thoracoscopy is challenging. To address this, we designed a fully synthetic thoracoscopic simulator for which we established its construct validity.Methodsthree thoracoscopic tasks were assessed: ring transfer, needle pass and incision of a blind upper esophageal pouch (EA cut). Participants watched instructional videos with accompanying written instructions for each task before having their attempt video recorded. All tasks were marked by three blinded pediatric surgeons using a modified Objective Structured Assessment of Technical Skills (OSATS). Scores were assessed using appropriate statistical analysis and inter-rater reliability was analyzed by interclass correlation coefficient (ICC).Results23 participants completed the ring transfer and needle pass and 21 the EA cut: 5 experts (consultant surgeons), 5 intermediate (registrars on a training program) and 13 novices (medical students, house surgeons or non-training registrars). All three tasks distinguished between novice and intermediate/expert (ring transfer p = 0.00001, needle pass p = 0.0004 and EA cut p = 0.0014, respectively). Interrater reliability was good for ring transfer and needle pass but poor for EA cut.Conclusionthe tasks distinguished between novice and intermediate/expert but not between expert and intermediate. In needle pass and EA cut, there was a trend for the experts to score higher than intermediate participants. Ring transfer and needle pass tasks achieved construct validity, had good interrater reliability and were found to be useful in assessing a novice surgeon's progression towards the intermediate level. Distinguishing between intermediate and expert may require assessment of more complex tasks such as intracorporeal suturing and tying.Level of evidenceII     

Congenital heart disease associated with congenital diaphragmatic hernia: A systematic review on incidence,prenatal diagnosis,management, and outcome

PurposeThe purpose of this study was to evaluate the impact of congenital heart disease (CHD) on infants with congenital diaphragmatic hernia (CDH).MethodsUsing a defined search strategy (PubMed, Cochrane, Embase, Web of Science MeSH headings), we searched studies reporting the incidence, management, and outcome of CDH infants born with associated CHD.ResultsOf 6410 abstracts, 117 met criteria. Overall, out of 28,974 babies with CDH, 4427 (15%) had CHD, of which 42% were critical. CDH repair was performed in a lower proportion of infants with CHD (72%) than in those without (85%; p < 0.0001). Compared to CDH babies without CHD, those born with a cardiac lesion were more likely to have a patch repair (45% vs. 30%; p < 0.01) and less likely to undergo minimally invasive surgery (5% vs. 17%; p < 0.0001). CDH babies with CHD had a lower survival rate than those without CHD (52 vs. 73%; p < 0.001). Survival was even lower (32%) in babies with critical CHD.ConclusionCHD has a strong impact on the management and outcome of infants with CDH. The combination of CDH and CHD results in lower survival than those without CHD or an isolated cardiac defect. Further studies are needed to address some specific aspects of the management of this fragile CDH cohort.Type of studySystematic review and meta-analysis.Level of evidenceLevel III.     

Validated simulation models in pediatric surgery: A review

Introduction: This review evaluates the validation and availability of simulation models in the field of pediatric surgery that can be used for training purposes.MethodsMEDLINE and EMBASE were searched for studies describing a simulation models in pediatric surgery. Articles were included if face, content and/or construct validity was described. Additionally, the costs and availability were assessed. Validation scores for each model were depicted as percentage (0–100), based on the reported data, to compare the outcomes. A score of >70% was considered adequate.ResultsForty-three studies were identified, describing the validation process of 38 simulation models. Face validity was evaluated in 33 articles, content in 36 and construct in 19. Twenty-two models received adequate validation scores (>70%). The majority (27/38, 70%) was strictly inanimate. Five models were available for purchase and eleven models were replicable based on the article.ConclusionThe number of validated inanimate simulation models for pediatric surgery procedures is growing, however, few are replicable or available for widespread training purposes.Level of evidence: Level II.     

The effects of tracheal occlusion on Wnt signaling in a rabbit model of congenital diaphragmatic hernia

PurposeTracheal occlusion (TO) reverses pulmonary hypoplasia (PH) in congenital diaphragmatic hernia (CDH), but its mechanism of action remains poorly understood. Wnt signaling plays a critical role in lung development, but few studies exist. The purpose of our study was to a) confirm that our CDH rabbit model produced PH which was reversed by TO and b) determine the effects of CDH +/− TO on Wnt signaling.MethodsCDH was created in fetal rabbits at 23 days, TO at 28 days, and lung collection at 31 days. Lung body weight ratio (LBWR) and mean terminal bronchiole density (MTBD) were determined. mRNA and miRNA expression was determined in the left lower lobe using RT-qPCR.ResultsFifteen CDH, 15 CDH + TO, 6 sham CDH, and 15 controls survived and were included in the study. LBWR was low in CDH, while CDH + TO was similar to controls (p = 0.003). MTBD was higher in CDH fetuses and restored to control levels in CDH + TO (p < 0.001). Reference genes TOP1, SDHA, and ACTB were consistently expressed within and between treatment groups. miR-33 and MKI67 were increased, and Lgl1 was decreased in CDH + TO.ConclusionTO reversed pulmonary hypoplasia and stimulated early Wnt signaling in CDH fetal rabbits.Type of studyBasic science, prospective.Level of evidenceII.     

Management of Congenital and Postoperative Chylothorax: Use of Thoracoscopic Lymphatic Leak Ligations with Intraoperative ICG Lymphangiography

BackgroundCongenital chylothorax (CCT) and postoperative chylothorax (POCT) are rare and difficult to treat. We report our treatment strategy and outcomes for chylothorax, including thoracoscopic surgery with indocyanine-green (ICG) near-infrared fluorescence lymphangiography.MethodsA retrospective review of patients with CCT and POCT from 2014 to 2021 was performed. After definitive diagnosis, conservative treatments with octreotide, followed by intravenous steroids as needed, were performed. Patients who were refractory to conservative treatment were transferred to surgical treatment, consisting of thoracoscopic lymphatic leak ligations using ICG intraoperative lymphangiography. The effectiveness of conservative and surgical treatment was then examined.ResultsWe included 19 cases of CCT and 31 cases of POCT. The 31 POCT patients included 23 of 84 postoperative patients with congenital diaphragmatic hernia (CDH), 7 of 54 postoperative patients with esophageal atresia (EA), and 1 of 3 postoperative patients with lymphatic malformation. The efficacy of conservative treatment was 12/19 for CCT, 22/23 for CDH, and 4/7 for EA. Surgical intervention was performed in 10 patients, and the rate of resolution of chylothorax within 3 weeks after surgery was 90%.ConclusionThoracoscopic lymphatic leak ligations with intraoperative ICG lymphangiography are feasible and useful in patients with chylothorax refractory to conservative treatment.Level of evidenceLevel IV     

Current status of simulation-based training in pediatric surgery: A systematic review

BackgroundSimulation based training enables pediatric surgical trainees to attain proficiency in surgical skills. This study aims to identify the currently available simulators for pediatric surgery, assess their validation and strength of evidence supporting each model.MethodsBoth Medline and EMBASE were searched for English language articles either describing or validating simulation models for pediatric surgery. A level of evidence (LoE) followed by a level of recommendation (LoR) was assigned to each validation study and simulator, based on a modified Oxford Centre for Evidence-Based Medicine classification for educational studies.ResultsForty-nine articles were identified describing 44 training models and courses. Of these articles, 44 were validation studies. Face validity was evaluated by 20 studies, 28 for content, 24 demonstrated construct validity and 1 showed predictive validity. Of the validated models, 3 were given an LoR of 2, 21 an LoR of 3 and 12 an LoR of 4. None reached the highest LoR.ConclusionsThere are a growing number of simulators specific to pediatric surgery. However, these simulators have limited LoE and LoR in current studies. The lack of NoTSS training is also apparent. We advocate more randomized trials to validate these models, and attempts to determine predictive validity.Type of studyOriginal / systematic review.Level of evidence1.     

The prevalence of hearing loss in children with congenital diaphragmatic hernia: A longitudinal population-based study

BackgroundThe true prevalence of hearing loss among children with congenital diaphragmatic hernia (CDH) is unknown, with some studies reporting rates up to 60%.PurposeThe purpose of this study was to determine the prevalence of hearing loss among children with CDH and compare it to age-matched controls.MethodsWe used population-based datasets to compare the number of hearing loss diagnoses in children younger than 10 years-of-age born between 1992 and 2009 with CDH to date-of-birth matched controls without CDH. Factors associated with CDH disease severity were analyzed to determine their effect on the prevalence of hearing loss. A sensitivity analysis was performed to determine if selection bias of improved care over the course of the study affected hearing loss in CDH patients. The prevalences of hearing loss were compared using Fisher's exact tests and statistical significance was defined as p < 0.05.ResultsA total of 529 children, 38 CDH cases and their 491 date-of-birth matched controls, met the inclusion criteria. Hearing loss was found in 7 children with CDH (18.4%) compared to 26 (5.3%) controls; the risk ratio (RR) of hearing loss was 3.48 (95%CI = 1.61–7.49, p = 0.006). There was no association between CDH disease severity and hearing loss.ConclusionsCDH is associated with hearing loss compared to the general population. Our results suggest that congenital factors may contribute to hearing loss in CDH more than perinatal exposures.Level of evidence3.     

Evaluation of Lung Injury in Infants with Congenital Diaphragmatic Hernia

Background/PurposeThe presence of lung injury and the factors that contribute to it in infants with congenital diaphragmatic hernia (CDH) have not been objectively measured during their clinical course. In adults with acute respiratory distress syndrome, higher serum levels of surfactant protein D (SP-D) are linked to lung injury and worse outcomes. We hypothesized that serum SP-D levels would be elevated in CDH infants and that the levels would correlate to the amount of lung injury present.MethodsIn this retrospective cohort study, serum SP-D levels were analyzed in 37 CDH infants and 5 control infants using a commercially available enzyme-linked immunosorbent assay kit.ResultsInfants with more severe CDH had a statistically significant increase (p < 0.001) in serum SP-D over their first month of life. SP-D levels in CDH infants were similar to control infants while on extracorporeal membrane oxygenation (ECMO) but were 2.5-fold higher (p = 0.03) than controls following ECMO termination. SP-D levels increased 1.6-fold following surgical repair of the diaphragm and were significantly higher in the second week following surgery when compared to pre-operative levels (p < 0.03).ConclusionsThese results demonstrate that CDH infants experience lung injury during the first week of life, around the time of surgery, and at the time of ECMO termination.Level II prognosis study.     

Development and validation of a low-cost laparoscopic simulation box

IntroductionThe acquisition of laparoscopic technique skills in an operating room is conditioned by the expertise of the tutor and the number of training interventions by the trainee. For students and surgeons to use a laparoscopic simulator to train their skills, it must be validated beforehand.MethodsA laparoscopic simulator box was designed, along with 6 interchangeable training games. The simulator was validated by a group of 19 experts, physicians with an experience from at least 100 laparoscopic surgeries, and 20 students of 4^th to 6^th grades of medical school (non-experts). To evaluate its construct validity, time-to-completion and the number of successfully completed games were assessed. We used 11 and 9-item questionnaires to gather information on content and face validity respectively. In both questionnaires, answers were collected through Likert-type scales, scored from 1 to 5.ResultsThe group of experts required less time and successfully completed more games than the group of non-experts (p < 0.01). The group of non-experts gave a score ≥ 4 points on each of the questions regarding the content validity of the tool, however, the experts rated with a significant lower mean score the need for the simulator to learn the surgical technique (3.68 points; p < 0.01). Regarding the face validity, all items were graded with a score ≥ 4 points except for the question relating to the spatial realism (3.82 points).ConclusionThe laparoscopy simulation box and the games were valid means for training surgeons and medical students to develop the skills required for the laparoscopic technique.     

Potential survival benefit with repair of congenital diaphragmatic hernia (CDH) after extracorporeal membrane oxygenation (ECMO) in select patients: Study by ELSO CDH Interest Group

PurposeStudying the timing of repair in CDH is prone to confounding factors, including variability in disease severity and management. We hypothesized that delaying repair until post-ECMO would confer a survival benefit.MethodsNeonates who underwent CDH repair were identified within the ELSO Registry. Patients were then divided into on-ECMO versus post-ECMO repair. Patients were 1:1 matched for severity based on pre-ECMO covariates using the propensity score (PS) for the timing of repair. Outcomes examined included mortality and severe neurologic injury (SNI).ResultsAfter matching, 2,224 infants were included. On-ECMO repair was associated with greater than 3-fold higher odds of mortality (OR 3.41, 95% CI: 2.84–4.09, p < 0.01). The odds of SNI was also higher for on-ECMO repair (OR 1.49, 95% CI: 1.13–1.96, p < 0.01). A sensitivity analysis was performed by including the length of ECMO as an additional matching variable. On-ECMO repair was still associated with higher odds of mortality (OR 2.38, 95% CI: 1.96–2.89, p < 0.01). Results for SNI were similar but were no longer statistically significant (OR 1.33, 95% CI: 0.99–1.79, p = 0.06).ConclusionsOf the infants who can be liberated from ECMO and undergo CDH repair, there is a potential survival benefit for delaying CDH repair until after decannulation.Type of StudyTreatment StudyLevel of EvidenceIII     

Effectiveness of telesimulation for pediatric minimally invasive surgery essential skills training

BackgroundIn the context of the COVID-19 pandemic and social distancing rules, access to in-person training activities had temporarily been interrupted, speeding up the implementation of telesimulation for minimally invasive surgery (MIS) essential skills training (T-ESTM, Telesimulation - Essential Skills Training Module) in our center. The aim of this study was to explore the effectiveness of T-ESTM.MethodsT-ESTM was scheduled into 2 sessions of 3 h through the Zoom® virtual meeting platform. The academic lectures, the tutorials for box-trainer set-up and 7 performance tasks were accessed through an online campus previous to the remote encounter for personalized guidance and debriefing.Initial (pre-telementoring) and final (post 6-hour telementoring) assessment scoring as well as timing for Task 2 (circle-cutting pattern), 3 (extracorporeal Roeder knot) and 5 (intracorporeal Square knot) were registered.Results61 participants were recruited. The mean age was 31±5 years. 65% were surgical residents. 48% performed low complexity procedures. 52% had previous experience with simulation training.In Task 2, there was a 21% improvement in the final score obtained, as well as a significant decrease in time of 33%; in Task 3, there was an increase of 39% in the scoring and a decrease of 49% in the timing; and in Task 5, participants improved their technique a 30% and decreased the performance time a 47%. All the differences were statistically significant.DiscussionOur data support T-ESTM as a reproducible and effective educational tool for remote MIS essential skills hands-on training.Level of Evidence: II     

Requirement and Duration of Tube Feed Supplementation among Congenital Diaphragmatic Hernia Patients

PurposeOral feeds pose a challenge for congenital diaphragmatic hernia (CDH) infants. Tube feed (TF) supplementation may be required to support the achievement of normal growth. The aim of this study was to determine the duration and factors associated with TF use in CDH infants at our institution.MethodsA single centre retrospective chart review was performed for CDH-born infants who underwent repair between 2000 to 2013 (REB #1000053124). Patient demographics, perinatal management, and feeding status of infants with at least 1-year follow-up were reviewed.ResultsOf 160 CDH infants, 32 (20%) were discharged on partial or complete TF, and an additional 5 (3.1%) patients started TF post discharge. CDH infants with TF were more likely to have initial arterial blood pH < 7.25, patch repair, ECMO support, and prolonged ICU stay (p < 0.05). Time to TF discontinuation did not differ significantly between those partially or fully TF at discharge. Twelve patients (33.3%) remained TF at their last known follow-up.ConclusionHigh risk CDH patients are likely to require TF to support their nutritional intake. Parents and caregivers need to be informed and properly supported. Long-term monitoring of CDH patient oral intake, growth, and development will be required.Level of Evidence/Type of StudyLevel III Retrospective Study.     

Morbidity in children after fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: Results from a multidisciplinary clinic

BackgroundAlthough fetoscopic endoluminal tracheal occlusion (FETO) was recently shown to improve survival in a multicenter, randomized trial of severe congenital diaphragmatic hernia (CDH), morbidity outcomes remain essentially unknown. The purpose of this study was to assess long-term outcomes in children with severe CDH who underwent FETO.MethodsWe conducted a prospective study of severe CDH patients undergoing FETO at an experienced North American center from 2015-2021 (NCT02710968). This group was compared to a cohort of non-FETO CDH patients with severe disease as defined by liver herniation, large defect size, and/or ECMO use. Clinical data were collected through a multidisciplinary CDH clinic. Statistics were performed with t-tests and Chi-squared analyses (p≤0.05).ResultsThere were 18 FETO and 17 non-FETO patients. ECMO utilization was 56% in the FETO cohort. Despite significantly lower median observed/expected lung-to-head ratio (O/E LHR) in the FETO group, [FETO: 23% (IQR:18-25) vs. non-FETO: 36% (IQR: 28-41), p<0.001], there were comparable survival rates at discharge (FETO: 78% vs. non-FETO: 59%, p = 0.23) and at 5-years (FETO: 67% vs. non-FETO: 59%, p = 0.53) between the two cohorts. At a median follow up of 5.8 years, metrics of pulmonary hypertension, pulmonary morbidity, and gastroesophageal reflux disease improved among patients after FETO. However, most FETO patients remained on bronchodilators/inhaled corticosteroids (58%) and were feeding tube dependent (67%).ConclusionsThese North American data show that prenatal tracheal occlusion, in conjunction with a long-term multidisciplinary CDH clinic, is associated with acceptable long-term survival and morbidity in children after FETO.Level of EvidenceLevel III     

Perioperative outcomes in minimally-invasive versus open surgery in infants undergoing repair of congenital anomalies

BackgroundThis study compared perioperative outcomes among infants undergoing repair of congenital anomalies using minimally invasive (MIS) versus open surgical approaches.MethodsThe ACS NSQIP Pediatric (2013–2018) was queried for patients undergoing repair of any of the following 9 congenital anomalies: congenital lung lesion (LL), mediastinal mass (MM), congenital malrotation (CM), anorectal malformation (ARM), Hirschsprung disease (HD), congenital diaphragmatic hernia (CDH), tracheoesophageal fistula (TEF), hepatobiliary anomalies (HB), and intestinal atresia (IA). Inverse probability of treatment weights (IPTW) derived from propensity scores were utilized to estimate risk-adjusted association between surgical approach and 30-day outcomes.Results12,871 patients undergoing congenital anomaly repair were included (10,343 open; 2528 MIS). After IPTW, MIS was associated with longer operative time (difference; 95% CI) (16 min; 9–23) and anesthesia time (13 min; 6–21), but less postoperative ventilation days (-1.0 days; -1.4- -0.6) and shorter postoperative length of stay (-1.4 days; -2.4- -0.3). MIS repairs had decreased risk of any surgical complication (risk difference: -6.6%; -9.2- -4.0), including hematologic complications (-7.3%; -8.9- -5.8). There was no significant difference in risk of complication when hematologic complications were excluded (RD -2.3% [-4.7%, 0.1%]). There were no significant differences in the risk of unplanned reoperation (0.4%; -1.5–2.2) or unplanned readmission (0.2%; -1.2–1.5).ConclusionsMIS repair of congenital anomalies is associated with improved perioperative outcomes when compared to open. Additional studies are needed to compare long-term functional and disease-specific outcomes.Mini-abstractIn this propensity-weighted multi-institutional analysis of nine congenital anomalies, minimally invasive surgical repair was associated with improved 30-day outcomes when compared to open surgical repair.Level of evidenceIII.     

Clinical outcomes following implementation of a management bundle for esophageal atresia with distal tracheoesophageal fistula

Background/PurposeThis study evaluated compliance with a multi-institutional quality improvement management protocol for Type-C esophageal atresia with distal tracheoesophageal fistula (EA/TEF).MethodsCompliance and outcomes before and after implementation of a perioperative protocol bundle for infants undergoing Type-C EA/TEF repair were compared across 11 children's hospitals from 1/2016–1/2019. Bundle components included elimination of prosthetic material between tracheal and esophageal suture lines during repair, not leaving a transanastomotic tube at the conclusion of repair (NO-TUBE), obtaining an esophagram by postoperative-day-5, and discontinuing prophylactic antibiotics 24 h postoperatively.ResultsOne-hundred seventy patients were included, 40% pre-protocol and 60% post-protocol. Bundle compliance increased 2.5-fold pre- to post-protocol from 17.6% to 44.1% (p < 0.001). After stratifying by institutional compliance with all bundle components, 43.5% of patients were treated at low-compliance centers (< 20%), 43% at medium-compliance centers (20–80%), and 13.5% at high-compliance centers (> 80%). Rates of esophageal leak, anastomotic stricture, and time to full feeds did not differ between pre- and post-protocol cohorts, though there was an inverse correlation between NO-TUBE compliance and stricture rate over time (ρ = ? 0.75, p = 0.029).ConclusionsCompliance with our multi-institutional management protocol increased 2.5-fold over the study period without compromising safety or time to feeds and does not support the use of transanastomotic tubes.Level of EvidenceLevel II.Type of StudyTreatment Study.     

Early CDH repair on ECMO: Improved survival but no decrease in ECMO duration (A CDH Study Group Investigation)

Purpose“Early on-ECMO” repair of CDH entails repair within 48–72 h of cannulation in an effort to optimize pulmonary physiology, shorten ECMO duration, and, ultimately, improve survival. This study evaluated the effect of early on-ECMO repair as compared to leaving patients unrepaired during ECMO.MethodsThe CDH Study Group database was queried for CDH patients requiring ECMO who either underwent repair within the first 72 h after cannulation or remained unrepaired on ECMO. Primary outcomes were survival to decannulation and ECMO duration.ResultsA total of 248 patients underwent early repair and 922 remained unrepaired on ECMO. The early repair group had increased risk factors for poor outcomes, including higher odds of cardiac defects and thoracic liver location, and lower odds of hernia sac presence. Nonetheless, ECMO survival for the early repair group was 87.1% compared to 78.4% in the unrepaired group (p = 0.002). However, the early repair group had a longer median ECMO duration than the unrepaired group (240.6 vs 196.8 h, p = 0.001).ConclusionWhile early ECMO repair does not shorten ECMO duration, it results in increased survival to decannulation as compared to those unrepaired on ECMO. This suggests that there may be a physiologic benefit leading to increased ECMO survival in a subset of patients undergoing on-ECMO repair over those designated to undergo post-ECMO repair.Level of evidenceLevel III.