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Study Design: Retrospective cohort study., Objective: This study aimed to compare perioperative outcomes of Rett syndrome and Cerebral palsy patients undergoing posterior spinal fusion for neuromuscular scoliosis., Summary of Background Data: Surgical correction in the treatment of scoliosis for patients with Rett syndrome (RS) has been shown to increase survival rate. Cerebral palsy (CP) patients, like RS patients, are often nonverbal, nonambulatory, with frequent surgical complications., Methods: Retrospective review of 36 RS and 80 CP patients undergoing PSF from 2005-2023. Data and x-ray measurements were collected pre- and post-operatively. Sub-analysis was performed comparing non-ambulatory patients (GMFCS IV-V). Wilcoxon-Rank Sum, Fisher's Exact, and Chi-square tests were utilized., Results: The primary outcome measure, complication rates, was similar between the groups (P=0.09). Preoperative Cobb angle, levels fused, fixation points, and LOS were similar (P>0.05). EBL was significantly higher in CP patients as was rate of transfusion (P=0.001) and surgical time (P=0.001). Postoperative Cobb angle (P=0.002) was significantly higher for CP patients. There was no significant difference between CP and RS patients in both preoperative (P=0.383) and postoperative (P=0.051) coronal decompensation. Nonambulatory status was associated with increased odds of having a postoperative complication (OR=6.17, 95% C.I. 1.36 - 28.04). Sub-analysis of non-ambulatory RS and CP patients revealed significantly higher postoperative Cobb (P=0.008), EBL (P=0.019) and surgical time (P=0.017) in CP patients compared to RS patients. There were no significant differences in preoperative Cobb, levels fused, fixation points, hospital stay, or complication rate (P>0.05)., Conclusion: RS patients are shown to have better outcomes to CP patients in terms of surgical, perioperative, and radiographic variables. Ambulatory status was identified as an independent risk factor for complications., Competing Interests: Conflicts of Interest and Source of Funding: Dr. Sarwahi received personal fees and royalties from Precision Spine, INC. outside the submitted work and not relevant to the study. All other authors declare they have no relevant financial or non-financial interests to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: The authors have disclosed that they do not have any potential conflicts of interest.

Ninerafaxstat is a novel mitotrope under investigation in 2 large clinical trials: IMPROVE-DiCE (a phase IIa trial investigating ninerafaxstat) and IMPROVE-hypertrophic cardiomyopathy (HCM). IMPROVE-DiCE is a single-center, open-label, phase 2a trial investigating the effectiveness of ninerafaxstat in diabetic cardiomyopathy. Ninerafaxstat significantly improved phosphocreatine/adenosine triphosphate median by 32% (P < 0.01) and reduced myocardial triglyceride content by 34% (P = 0.026). Magnetic resonance imaging (MRI) analysis showed improved left ventricular peak circumferential diastolic strain rate by 15% (P < 0.047) and peak left ventricular filling rate by 11% (P < 0.05). Pyruvate dehydrogenase flux was increased in 7 of 9 patients (P = 0.08), consistent with improved glucose utilization. IMPROVE-HCM (ninerafaxstat safe, effective for nonobstructive hypertrophic cardiomyopathy patients) is a phase 2, multicenter, randomized controlled and double-blinded study. From baseline to 12 weeks, ninerafaxstat was associated with a significantly improved ventilatory efficiency slope compared with placebo (P = 0.006). In a post hoc analysis with 35 patients with baseline Kansas City Cardiomyopathy Questionnaire score ≤80, changes in ventilatory efficiency slope favored ninerafaxstat versus placebo (P = 0.02). Left atrial size, a surrogate marker of diastolic dysfunction, was significantly decreased in patients on ninerafaxstat versus placebo (P = 0.01). These findings support a larger phase 3 study in symptomatic nonobstructive HCM patients to further investigate ninerafaxstat. Several drugs that also improve glucose utilization including fatty acid oxidation inhibitors, carnitine palmitoyltransferase I inhibitors, and glucagon-like peptide-1 receptor agonists are presently under investigation in clinical trials., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Sex disparities exist in the management and outcomes of various cardiovascular diseases. However, little is known about sex differences in cardiogenic shock (CS). We sought to assess sex-related differences in the characteristics, resource utilization, and outcomes of patients with CS., Methods: The Critical Care Cardiology Trials Network is a multicenter registry of advanced cardiac intensive care units (CICUs) in North America. Between 2018 and 2022, each center (N=35) contributed annual 2-month snapshots of consecutive CICU admissions. Patients with CS were stratified as either CS after acute myocardial infarction or heart failure-related CS (HF-CS). Multivariable logistic regression was used for analyses., Results: Of the 22 869 admissions in the overall population, 4505 (20%) had CS. Among 3923 patients with CS due to ventricular failure (32% female), 1235 (31%) had CS after acute myocardial infarction and 2688 (69%) had HF-CS. Median sequential organ failure assessment scores did not differ by sex. Women with HF-CS had shorter CICU lengths of stay (4.5 versus 5.4 days; P <0.0001) and shorter overall lengths of hospital stay (10.9 versus 12.8 days; P <0.0001) than men. Women with HF-CS were less likely to receive pulmonary artery catheters (50% versus 55%; P <0.01) and mechanical circulatory support (26% versus 34%; P <0.0001) compared with men. Women with HF-CS had higher in-hospital mortality than men, even after adjusting for age, illness severity, and comorbidities (34% versus 23%; odds ratio, 1.76 [95% CI, 1.42-2.17]). In contrast, there were no significant sex differences in utilization of advanced CICU monitoring and interventions, or mortality, among patients with CS after acute myocardial infarction., Conclusions: Women with HF-CS had lower use of pulmonary artery catheters and mechanical circulatory support, shorter CICU lengths of stay, and higher in-hospital mortality than men, even after accounting for age, illness severity, and comorbidities. These data highlight the need to identify underlying reasons driving the differences in treatment decisions, so outcomes gaps in HF-CS can be understood and eliminated., Competing Interests: Drs Berg, Bohula, Park, and Morrow are members of the TIMI Study Group, which has received institutional research grant support through Brigham and Women’s Hospital from Abbott, Abiomed, Amgen, Anthos Therapeutics, ARCA Biopharma, Inc, AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc, Daiichi-Sankyo, Eisai, Intarcia, Ionis Pharmaceuticals, Inc, Janssen Research and Development, LLC, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Inc, Roche, Siemens Healthcare Diagnostics, Inc, Softcell Medical Ltd, The Medicines Company, and Zora Biosciences. Dr Katz reports modest research funding from Abbott Corporation. The other authors report no conflicts.

Objectives: Multicenter studies reporting outcomes following tracheostomy in children with congenital heart disease are limited, particularly in patients with single ventricle physiology. We aimed to describe clinical characteristics and outcomes in a multicenter cohort of patients with single ventricle physiology who underwent tracheostomy before Fontan operation., Design: Multicenter retrospective cohort study., Setting: Twenty-one tertiary care pediatric institutions participating in the Collaborative Research from the Pediatric Cardiac Intensive Care Society., Patients: We reviewed 99 children with single ventricle physiology who underwent tracheostomy before the Fontan operation at 21 institutions participating in Collaborative Research from the Pediatric Cardiac Intensive Care Society between January 2010 and December 2020, with follow-up through December 31, 2021., Interventions: None., Measurements and Main Results: Death occurred in 51 of 99 patients (52%). Cox proportional hazard analysis was performed to determine factors associated with death after tracheostomy. Results are presented as hazard ratio (HR) with 95% CIs. Nonrespiratory indication(s) for tracheostomy (HR, 2.21; 95% CI, 1.14-4.32) and number of weeks receiving mechanical ventilation before tracheostomy (HR, 1.06; 95% CI, 1.02-1.11) were independently associated with greater hazard of death. In contrast, diagnosis of tricuspid atresia or Ebstein's anomaly was associated with less hazard of death (HR, 0.16; 95% CI, 0.04-0.69). Favorable outcome, defined as survival to Fontan operation or decannulation while awaiting Fontan operation with viable cardiopulmonary physiology, occurred in 29 of 99 patients (29%). Median duration of mechanical ventilation before tracheostomy was shorter in patients who survived to favorable outcome (6.1 vs. 12.1 wk; p < 0.001), and only one of 16 patients with neurologic indications for tracheostomy and 0 of ten patients with cardiac indications for tracheostomy survived to favorable outcome., Conclusions: For children with single ventricle physiology who undergo tracheostomy, mortality risk is high and should be carefully considered when discussing tracheostomy as an option for these children. Favorable outcomes are possible, although thoughtful attention to patient selection and tracheostomy timing are likely necessary to achieve this goal., Competing Interests: Dr. Mastropietro received funding from Telan, Meltz, Wallace, and Eide Law Firm, and Bioporto. Dr. Werho received funding from University of California San Diego; his institution received funding from the American Heart Association; and he disclosed that he is a board member of the Pediatric Cardiac Intensive Care Society and the Pediatric Cardiac Critical Care Consortium. Dr. Yates received funding from Alexion Pharmaceuticals. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Objectives: To inform development of a preintubation checklist for pediatric emergency departments via multicenter usability testing of a prototype checklist., Methods: This was a prospective, mixed methods study across 7 sites in the National Emergency Airway Registry for Pediatric Emergency Medicine (NEAR4PEM) collaborative. Pediatric emergency medicine attending physicians and senior fellows at each site were first oriented to a checklist prototype, including content previously identified using a modified Delphi approach. Each site used the checklist in 2 simulated cases: an "easy airway" and a "difficult airway" scenario. Facilitators recorded verbalization, completion, and timing of checklist items. After each simulation, participants completed an anonymous usability survey. Structured debriefings were used to gather additional feedback on checklist usability. Comments from the surveys and debriefing were qualitatively analyzed using a framework approach. Responses informed human factors-based optimization of the checklist., Results: Fifty-five pediatric emergency medicine physicians/fellows (4-13 per site) participated. Participants found the prototype checklist to be helpful, easy to use, clear, and of appropriate length. During the simulations, 93% of checklist items were verbalized and more than 80% were completed. Median time to checklist completion was 6.2 minutes (interquartile range, 4.8-7.1) for the first scenario and 4.2 minutes (interquartile range, 2.7-5.8) for the second. Survey and debriefing data identified the following strengths: facilitating a shared mental model, cognitively offloading the team leader, and prompting contingency planning. Suggestions for checklist improvement included clarifying specific items, providing more detailed prompts, and allowing institution-specific customization. Integration of these data with human factors heuristic inspection resulted in a final checklist., Conclusions: Simulation-based, human factors usability testing of the National Emergency Airway Registry for Pediatric Emergency Medicine Preintubation Checklist allowed optimization prior to clinical implementation. Next steps involve integration into real-world settings utilizing rigorous implementation science strategies, with concurrent evaluation of the impact on patient outcomes and safety., Competing Interests: Disclosure: Dr. Wing has received a Faculty Development grant from Brown Emergency Medicine to facilitate this study. Emily Greenwald is a paid consultant for Verathon, Inc, assisting in design of airway equipment for use in pediatric intubation. The other authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The REDISCOVER consensus conference aimed at developing and validating guidelines on the perioperative care of patients with borderline-resectable (BR-) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC)., Background: Coupled with improvements in chemotherapy and radiation, the contemporary approach to pancreatic surgery supports the resection of BR-PDAC and, to a lesser extent, LA-PDAC. Guidelines outlining the selection and perioperative care for these patients are lacking., Methods: The Scottish Intercollegiate Guidelines Network (SIGN) methodology was used to develop the REDISCOVER guidelines and create recommendations. The Delphi approach was used to reach a consensus (agreement ≥80%) among experts. Recommendations were approved after a debate and vote among international experts in pancreatic surgery and pancreatic cancer management. A Validation Committee used the AGREE II-GRS tool to assess the methodological quality of the guidelines. Moreover, an independent multidisciplinary advisory group revised the statements to ensure adherence to nonsurgical guidelines., Results: Overall, 34 recommendations were created targeting centralization, training, staging, patient selection for surgery, possibility of surgery in uncommon scenarios, timing of surgery, avoidance of vascular reconstruction, details of vascular resection/reconstruction, arterial divestment, frozen section histology of perivascular tissue, extent of lymphadenectomy, anticoagulation prophylaxis, and role of minimally invasive surgery. The level of evidence was however low for 29 of 34 clinical questions. Participants agreed that the most conducive means to promptly advance our understanding in this field is to establish an international registry addressing this patient population ( https://rediscover.unipi.it/ )., Conclusions: The REDISCOVER guidelines provide clinical recommendations pertaining to pancreatectomy with vascular resection for patients with BR-PDAC and LA-PDAC, and serve as the basis of a new international registry for this patient population., Competing Interests: S.G.B.: support from Flinders Foundation grant: 49358025, NHMRC Ideas Grant: 2021009, Pankind 21.R7.INV.CB.UOSA.6.2. F.M.: Tsumura, Inc., Scientific Advisory Board. M.D.C. is a co-PI of a Boston Scientific–sponsored study and he has been awarded an industry grant by Haemonetics, Inc. M.H.: Intuitive Surgical—teaches courses and proctors. The remaining authors report no conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: To compare rates of postoperative drainage and culture profiles in children with complicated appendicitis treated with the 2 most common antibiotic regimens with and without antipseudomonal activity [piperacillin-tazobactam (PT) and ceftriaxone with metronidazole (CM)]., Background: Variation in the use of antipseudomonal antibiotics has been driven by a paucity of multicenter data reporting clinically relevant, culture-based outcomes., Methods: A retrospective cohort study of patients with complicated appendicitis (7/2015-6/2020) using NSQIP-Pediatric data from 15 hospitals participating in a regional research consortium. Operative report details, antibiotic utilization, and culture data were obtained through supplemental chart review. Rates of 30-day postoperative drainage and organism-specific culture positivity were compared between groups using mixed-effects regression to adjust for clustering after propensity matching on measures of disease severity., Results: In all, 1002 children met the criteria for matching (58.9% received CM and 41.1% received PT). In the matched sample of 778 patients, children treated with PT had similar rates of drainage overall [PT: 11.8%, CM: 12.1%; odds ratio (OR): 1.44 (OR: 0.71-2.94)] and higher rates of drainage associated with the growth of any organism [PT: 7.7%, CM: 4.6%; OR: 2.41 (95% CI: 1.08-5.39)] and Escherichia coli [PT: 4.6%, CM: 1.8%; OR: 3.42 (95% CI: 1.07-10.92)] compared to treatment with CM. Rates were similar between groups for drainage associated with multiple organisms [PT: 2.6%, CM: 1.5%; OR: 3.81 (95% CI: 0.96-15.08)] and Pseudomonas [PT: 1.0%, CM: 1.3%; OR: 3.42 (95% CI: 0.55-21.28)]., Conclusions and Relevance: The use of antipseudomonal antibiotics is not associated with lower rates of postoperative drainage procedures or more favorable culture profiles in children with complicated appendicitis., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Anticytokine biologics are a promising anti-inflammatory therapy for recurrent pericarditis. Several studies have proved the efficacy and safety of interleukin-1 (IL-1) inhibitors, such as anakinra and rilonacept in patients with recurrent pericarditis. Treatment with goflikicept in a recent phase 2 and 3 trial significantly reduced the pericarditis recurrence rate compared with both the placebo and the allowed withdrawal of standard-of-care therapy. Patients with idiopathic recurrent pericarditis (IRP) achieved remission within the first 14 days of therapy. In rilonacept inhibition of interleukin-1 alpha and beta for recurrent pericarditis (phase 3 trial of interleukin-1 trap rilonacept in recurrent pericarditis), rilonacept led to a significantly lower risk of pericarditis recurrence than placebo (hazard ratio, 0.04; P < 0.001) and a rapid resolution of recurrent pericarditis episodes. However, 74% of patients in the placebo group demonstrated recurrence, compared with 7% in the rilonacept group. The efficacy of anakinra was demonstrated by the AIRTRIP (anakinra-treatment of recurrent idiopathic pericarditis) trial, which showed a reduction in the incidence of recurrent pericarditis in anakinra versus placebo-treated patients (18.2% vs 90%). In patients with recurrences, the mean time to flare was 28.4 days in the placebo group versus 76.5 days in the anakinra group. IL-1 inhibitors require further research and have the potential to decrease the use of first-line drug regimens for recurrent pericarditis that are not tolerated in specific patient groups., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Associations of early changes in vasoactive support with cardiogenic shock (CS) mortality remain incompletely defined., Methods: The Critical Care Cardiology Trials Network is a multicenter registry of cardiac intensive care units. Patients admitted with CS (2018-2023) had vasoactive dosing assessed at 4 and 24 hours from cardiac intensive care unit admission and quantified by the vasoactive-inotropic score (VIS). Prognostic associations of VIS at both time points, as well as change in VIS from 4 to 24 hours, were examined. Interaction testing was performed based on mechanical circulatory support status., Results: Among 3665 patients, 82% had a change in VIS <10, with 7% and 11% having a ≥10-point increase and decrease from 4 to 24 hours, respectively. The 4 and 24-hour VIS were each associated with cardiac intensive care unit mortality (13%-45% and 11%-73% for VIS <10 to ≥40, respectively; P trend <0.0001 for each). Stratifying by the 4-hour VIS, changes in VIS from 4 to 24 hours had a graded association with mortality, ranging from a 2- to >4-fold difference in mortality comparing those with a ≥10-point increase to ≥10-point decrease in VIS ( P trend <0.0001). The change in VIS alone provided good discrimination of cardiac intensive care unit mortality (C-statistic, 0.72 [95% CI, 0.70-0.75]) and improved discrimination of the 24-hour Sequential Organ Failure Assessment score (0.72 [95% CI, 0.69-0.74] to 0.76 [95% CI, 0.74-0.78]) and the clinician-assessed Society for Cardiovascular Angiography and Interventions shock stage (0.72 [95% CI, 0.70-0.74] to 0.77 [95% CI, 0.75-0.79]). Although present in both groups, the mortality risk associated with VIS was attenuated in patients managed with versus without mechanical circulatory support (odds ratio per 10-point higher 24-hour VIS, 1.36 [95% CI, 1.23-1.49] versus 1.84 [95% CI, 1.69-2.01]; P interaction <0.0001)., Conclusions: Early changes in the magnitude of vasoactive support in CS are associated with a gradient of risk for mortality. These data suggest that early VIS trajectory may improve CS prognostication, with the potential to be leveraged for clinical decision-making and research applications in CS., Competing Interests: Disclosures Drs Patel, Berg, Bohula, Park, and Morrow and V.M. Baird-Zars are members of the TIMI Study Group, which has received institutional research grant support through the Brigham and Women’s Hospital from Abbott, Abiomed, Amgen, Anthos Therapeutics, ARCA Biopharma Inc, AstraZeneca, Bayer HealthCare Pharmaceuticals Inc, Daiichi-Sankyo, Eisai, Intarcia, Ionis Pharmaceuticals Inc, Janssen Research and Development LLC, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals Inc, Roche, Siemens Healthcare Diagnostics Inc, Softcell Medical Limited, and Zora Biosciences. Dr Patel has received consulting fees from Janssen. Dr Berg has received honoraria from the Medical Education Speakers Network and USV Private Limited; consulting feeds from AstraZeneca, MobilityBio, Pfizer, and Youngene Therapeutics; and serves on clinical end point committees for studies sponsored by Beckman Coulter, Kowa Pharmaceuticals, and Tosoh Biosciences. Dr Bohula reports consulting fees from Novo Nordisk, Esperion, PriMed, Medscape, Amgen, and Servier and participation on clinical end point committees for studies sponsored by Kowa Pharmaceuticals. Dr Teuteberg reports the following fees: Abbott (consulting), Abiomed (ad board), Broadview Ventures (consulting), CareDx (ad board and speaking), Medtronic (ad board, speaking, and consulting), Paragonix (speaking), and Takeda (ad board). Dr Morrow has received consulting fees from Abbott Laboratories, ARCA Biopharma, Inflammatix, Merck and Co, Novartis, Regeneron, and Roche Diagnostics. The other authors report no relevant conflicts of interest.

Objective: Terminal extubation (TE) and terminal weaning (TW) during withdrawal of life-sustaining therapies (WLSTs) have been described and defined in adults. The recent Death One Hour After Terminal Extubation study aimed to validate a model developed to predict whether a child would die within 1 hour after discontinuation of mechanical ventilation for WLST. Although TW has not been described in children, pre-extubation weaning has been known to occur before WLST, though to what extent is unknown. In this preplanned secondary analysis, we aim to describe/define TE and pre-extubation weaning (PW) in children and compare characteristics of patients who had ventilatory support decreased before WLST with those who did not., Design: Secondary analysis of multicenter retrospective cohort study., Setting: Ten PICUs in the United States between 2009 and 2021., Patients: Nine hundred thirteen patients 0-21 years old who died after WLST., Interventions: None., Measurements and Main Results: 71.4% ( n = 652) had TE without decrease in ventilatory support in the 6 hours prior. TE without decrease in ventilatory support in the 6 hours prior = 71.4% ( n = 652) of our sample. Clinically relevant decrease in ventilatory support before WLST = 11% ( n = 100), and 17.6% ( n = 161) had likely incidental decrease in ventilatory support before WLST. Relevant ventilator parameters decreased were F io2 and/or ventilator set rates. There were no significant differences in any of the other evaluated patient characteristics between groups (weight, body mass index, unit type, primary diagnostic category, presence of coma, time to death after WLST, analgosedative requirements, postextubation respiratory support modality)., Conclusions: Decreasing ventilatory support before WLST with extubation in children does occur. This practice was not associated with significant differences in palliative analgosedation doses or time to death after extubation., Competing Interests: Dr. Pringle’s institution received funding from the National Institutes of Health (NIH) (Ul1TR001427); she received support for article research from the NIH. Dr. Winter received support for article research from the LK Whittier Foundation. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Study Design: Retrospective cohort study., Objective: The objective of this study is to determine differences in outcomes in patients with adolescent idiopathic scoliosis undergoing spinal deformity correction surgery using a posterior spinal fusion (PSF) approach versus single and triple-incision minimally invasive surgery (MIS)., Summary of Background Data: MIS increased in popularity as surgeons' focus moved towards soft tissue preservation, but it carries technical demands and increased surgical time compared with PSF., Patients and Methods: Surgeries performed from 2016 to 2020 were included. Cohorts were formed based on surgical approach: PSF versus single long-incision MIS (SLIM) versus traditional MIS [3-incision MIS (3MIS)]. There were a total of 7 subanalyses. Demographic, radiographic, and perioperative data were collected for the 3 groups. Kruskal-Wallis and χ 2 tests were used for continuous and categorical variables, respectively., Results: Five hundred thirty-two patients met our inclusion criteria, 294 PSF, 179 3MIS, and 59 SLIM.Estimated blood loss (mL) ( P < 0.00001) and length of stay (LOS) ( P < 0.00001) was significantly higher in PSF than in SLIM and 3MIS. Surgical time was significantly higher in 3MIS than in PSF and SLIM ( P = 0.0012).Patients who underwent PSF had significantly lower postoperative T5 to T12 kyphosis ( P < 0.00001) and percentage kyphosis change ( P < 0.00001). Morphine equivalence was significantly higher in the PSF group during total hospital stay ( P = 0.0042).Patients who underwent SLIM and 3MIS were more likely to return to noncontact ( P = 0.0096) and contact sports ( P = 0.0095) within 6 months and reported lower pain scores ( P < 0.001) at 6 months postoperation., Conclusion: SLIM has a similar operative time to PSF and is technically similar to PSF while maintaining the surgical and postoperative outcome advantages of 3MIS., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To develop a severity-adjusted, hospital-level benchmarking comparative performance report for postoperative organ space infection and antibiotic utilization in children with complicated appendicitis., Background: No benchmarking data exist to aid hospitals in identifying and prioritizing opportunities for infection prevention or antimicrobial stewardship in children with complicated appendicitis., Methods: This was a multicenter cohort study using NSQIP-Pediatric data from 16 hospitals participating in a regional research consortium, augmented with antibiotic utilization data obtained through supplemental chart review. Children with complicated appendicitis who underwent appendectomy from 07/01/2015 to 06/30/2020 were included. Thirty-day postoperative OSI rates and cumulative antibiotic utilization were compared between hospitals using observed-to-expected (O/E) ratios after adjusting for disease severity using mixed effects models. Hospitals were considered outliers if the 95% confidence interval for O/E ratios did not include 1.0., Results: 1790 patients were included. Overall, the OSI rate was 15.6% (hospital range: 2.6-39.4%) and median cumulative antibiotic utilization was 9.0 days (range: 3.0-13.0). Across hospitals, adjusted O/E ratios ranged 5.7-fold for OSI (0.49-2.80, P=0.03) and 2.4-fold for antibiotic utilization (0.59-1.45, P<0.01). Three (19%) hospitals were outliers for OSI (1 high and 2 low performers), and eight (50%) were outliers for antibiotic utilization (5 high and 3 low utilizers). Ten (63%) hospitals were identified as outliers in one or both measures., Conclusions: A comparative performance benchmarking report may help hospitals identify and prioritize quality improvement opportunities for infection prevention and antimicrobial stewardship, as well as identify exemplar performers for dissemination of best practices., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

CardiAMP Cell Therapy for Heart Failure trial is a prospective, multicenter, randomized, controlled, double-blinded trial that has been granted breakthrough designation by the United States Food and Drug Administration. This trial evaluates clinical outcomes of intramyocardial delivery of a high dose of autologous bone marrow mononuclear cells in chronic postmyocardial infarction heart failure patients. This trial represents the first attempt to personalize marrow-derived cell-based therapy for the treatment of ischemic heart failure with reduced ejection fraction. The roll-in cohort of 10 patients demonstrated improvements in 6-minute walk distance at 6 months (+47.8 m, P = 0.01), 12 months (+46.4 m, P = 0.06), and 24 months (+31 m), and improvements in New York Heart Association class at 3 months (P = 0.015) and 6 months (P = 0.037). Four patients were reduced to New York Heart Association class I at 24 months and Minnesota Living with Heart Failure Questionnaire score was improved in 6 of 10 patients at 24 months. The improved clinical outcomes demonstrated in CardiAMP are consistent with previous clinical trials including the Transendocardial Autologous Cells in Ischemic Heart Failure (TAC-HFT) trial, Prospective Randomized Trial of Direct Endomyocardial Implantation of Bone Marrow Cells for Treatment of Severe Coronary Artery Diseases (PROTECT-CAD), and REGENERATE-Ischemic Heart Disease trial., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

The target-hypertension (Target-HTN) trial investigated the efficacy and safety of lorundrostat, an aldosterone synthase inhibitor, as an antihypertensive. Cohort 1 of the trial includes patients with suppressed plasma renin activity and elevated aldosterone levels. Lorundrostat doses of 100 mg and 50 mg daily significantly decreased systolic blood pressure compared to the placebo group. Cohort 2 also demonstrated a reduction in systolic blood pressure with the 100 mg daily dose of lorundrostat. Lorundrostat is more selective for the inhibition of CYP11B2 versus CYP11B1, which makes it preferable to other aldosterone synthase inhibitors that inhibit cortisol synthesis, such as osilodrostat. Phase 3 trials are needed to validate the safety and efficacy of lorundrostat, and further research should be performed on other selective aldosterone synthase inhibitors such as baxdrostat, dexfadrostat, and BI 690517., Competing Interests: Disclosure: The authors declare no conflict of interest.., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To identify research priorities in the management, epidemiology, outcome, and pathophysiology of sepsis and septic shock., Design: Shortly after publication of the most recent Surviving Sepsis Campaign Guidelines, the Surviving Sepsis Research Committee, a multiprofessional group of 16 international experts representing the European Society of Intensive Care Medicine and the Society of Critical Care Medicine, convened virtually and iteratively developed the article and recommendations, which represents an update from the 2018 Surviving Sepsis Campaign Research Priorities., Methods: Each task force member submitted five research questions on any sepsis-related subject. Committee members then independently ranked their top three priorities from the list generated. The highest rated clinical and basic science questions were developed into the current article., Results: A total of 81 questions were submitted. After merging similar questions, there were 34 clinical and ten basic science research questions submitted for voting. The five top clinical priorities were as follows: 1) what is the best strategy for screening and identification of patients with sepsis, and can predictive modeling assist in real-time recognition of sepsis? 2) what causes organ injury and dysfunction in sepsis, how should it be defined, and how can it be detected? 3) how should fluid resuscitation be individualized initially and beyond? 4) what is the best vasopressor approach for treating the different phases of septic shock? and 5) can a personalized/precision medicine approach identify optimal therapies to improve patient outcomes? The five top basic science priorities were as follows: 1) How can we improve animal models so that they more closely resemble sepsis in humans? 2) What outcome variables maximize correlations between human sepsis and animal models and are therefore most appropriate to use in both? 3) How does sepsis affect the brain, and how do sepsis-induced brain alterations contribute to organ dysfunction? How does sepsis affect interactions between neural, endocrine, and immune systems? 4) How does the microbiome affect sepsis pathobiology? 5) How do genetics and epigenetics influence the development of sepsis, the course of sepsis and the response to treatments for sepsis?, Conclusions: Knowledge advances in multiple clinical domains have been incorporated in progressive iterations of the Surviving Sepsis Campaign guidelines, allowing for evidence-based recommendations for short- and long-term management of sepsis. However, the strength of existing evidence is modest with significant knowledge gaps and mortality from sepsis remains high. The priorities identified represent a roadmap for research in sepsis and septic shock., Competing Interests: Drs. De Backer, Pontes Azevedo, and Tissieres received funding from Baxter. Dr. De Backer received funding from Edwards Lifesciences, Phillips, and Viatris Pharmazz. Dr. Deutschman received funding from Elsevier, Siemens Healthcare Diagnostics (Tarrytown, NY), Enliven (Jerusalem, Israel), The Society of Critical Care Medicine, the National Institute of General Medical Sciences, and La Jolla Pharmaceuticals; he received support for article research form the National Institutes of Health (NIH); he received Giapreza (angiotensin II infusion) for experimental use from La Jolla Pharmaceuticals (La Jolla, CA); and he received honorarium for serving as Scientific Editor of the journal Critical Care Medicine. Dr. Ostermann received research funding from Baxter, Fresenius Medical, bioMerieux, and La Jolla Pharma. Dr. Talmor received funding from NIH, Clew Medical, Mindray, and STIMIT. Dr. Prescott’s institution received funding from the NIH, U.S. Department of Veterans Affairs, the Agency for Healthcare and Research and Quality, the U.S. Centers for Disease Control and Prevention, and Blue Cross Blue Shield Michigan; she disclosed government work. Dr. Antonelli received funding from General Electrics, Fisher & Paykel, Menarini, and Pfizer. Dr. Pontes Azevedo received funding from Merck Sharp Dohme (MSD) and Nestle. Dr. Loeches received funding from ThermoFisher, Polyphor, MSD, Fresenius Kabi, Gilead, Clinigen, Biotest, Accelerate, and bioMérieux. Dr. Tissieres received funding from Sanofi, bioMerieux, Abionic, Sedana, and ThermoFisher. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Right heart thrombi are a rare phenomenon associated with high mortality rates and embolization to the pulmonary bed. Diagnostic modalities include transthoracic echocardiography, contrast-enhanced echocardiography, and cardiac magnetic resonance imaging. Several treatment options for right ventricular thrombus have been described in case reports and observational studies including anticoagulation, thrombolysis, catheter-based procedures, and surgical embolectomy. Various studies have demonstrated that thrombolysis and surgical embolectomy have better survival outcomes than anticoagulation alone. Present management strategies are supported by observational studies, and further research is needed to guide therapy., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: Retrospective Review., Objective: The objective of this study was to determine differences in surgical and post-operative outcomes in AIS patients undergoing spinal deformity correction surgery using standard or large pedicle screw size., Summary of Background: Use of pedicle screw fixation in spinal deformity correction surgery is considered safe and effective. Still, the small size of the pedicle and the complex 3D anatomy of the thoracic spine makes screw placement challenging, with improper pedicle screw fixation leading to catastrophic complications including injuries to nerve roots, spinal cord, and major vessels. Thus, insertion of larger diameter screw sizes has raised concerns amongst surgeons, especially in the pediatric population., Materials and Methods: AIS patients undergoing PSF between 2013 and 2019 were included. Demographic, radiographic, and operative outcomes collected. Patients in the large screw size group (GpI) received 6.5 mm diameter screw sizes at all levels while standard screw size group (GpII) received 5.0 to 5.5 mm diameter screw sizes at all levels. Kruskall-Wallis and Fisher's exact test performed for continuous and categorical variables respectively.Subanalyses included (1) screw accuracy in patients with available CT scans, (2) stratified analysis of large- and standard-screw patients with ≥60% flexibility rate, (3) stratified analysis of large- and standard-screw patients with <60% flexibility rate, and (4) matched analysis of large- and standard-screw patients by surgeon and year of surgery., Results: GpI patients experienced significantly higher overall curve correction ( P <0.001), with 87.6% experiencing at least one grade reduction of apical vertebral rotation from preoperative to postoperative visit( P =0.008).Patients with larger screws displayed higher postoperative kyphosis. No patient experienced medial breaching., Conclusion: Large screw sizes have similar safety profiles to standard screws without negatively impacting surgical and perioperative outcomes in AIS patients undergoing PSF. Additionally, coronal, sagittal, and rotational correction is superior for larger-diameter screws in AIS patients., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate whether redosing antibiotics within an hour of incision is associated with a reduction in incisional surgical site infection (iSSI) in children with appendicitis., Background: Existing data remain conflicting as to whether children with appendicitis receiving antibiotics at diagnosis benefit from antibiotic redosing before incision., Methods: This was a multicenter retrospective cohort study using data from the Pediatric National Surgical Quality Improvement Program augmented with antibiotic utilization and operative report data obtained though supplemental chart review. Children undergoing appendectomy at 14 hospitals participating in the Eastern Pediatric Surgery Network from July 2016 to June 2020 who received antibiotics upon diagnosis of appendicitis between 1 and 6 hours before incision were included. Multivariable logistic regression was used to compare odds of iSSI in those who were and were not redosed with antibiotics within 1 hour of incision, adjusting for patient demographics, disease severity, antibiotic agents, and hospital-level clustering of events., Results: A total of 3533 children from 14 hospitals were included. Overall, 46.5% were redosed (hospital range: 1.8%-94.4%, P <0.001) and iSSI rates were similar between groups [redosed: 1.2% vs non-redosed: 1.3%; odds ratio (OR) 0.84, (95%,CI, 0.39-1.83)]. In subgroup analyses, redosing was associated with lower iSSI rates when cefoxitin was used as the initial antibiotic (redosed: 1.0% vs nonredosed: 2.5%; OR: 0.38, (95% CI, 0.17-0.84)], but no benefit was found with other antibiotic regimens, longer periods between initial antibiotic administration and incision, or with increased disease severity., Conclusions: Redosing of antibiotics within 1 hour of incision in children who received their initial dose within 6 hours of incision was not associated with reduction in risk of incisional site infection unless cefoxitin was used as the initial antibiotic., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Untangling the heterogeneity of sepsis in children and identifying clinically relevant phenotypes could lead to the development of targeted therapies. Our aim was to analyze the organ dysfunction trajectories of children with sepsis-associated multiple organ dysfunction syndrome (MODS) to identify reproducible and clinically relevant sepsis phenotypes and determine if they are associated with heterogeneity of treatment effect (HTE) to common therapies., Design: Multicenter observational cohort study., Setting: Thirteen PICUs in the United States., Patients: Patients admitted with suspected infections to the PICU between 2012 and 2018., Interventions: None., Measurements and Main Results: We used subgraph-augmented nonnegative matrix factorization to identify candidate trajectory-based phenotypes based on the type, severity, and progression of organ dysfunction in the first 72 hours. We analyzed the candidate phenotypes to determine reproducibility as well as prognostic, therapeutic, and biological relevance. Overall, 38,732 children had suspected infection, of which 15,246 (39.4%) had sepsis-associated MODS with an in-hospital mortality of 10.1%. We identified an organ dysfunction trajectory-based phenotype (which we termed persistent hypoxemia, encephalopathy, and shock) that was highly reproducible, had features of systemic inflammation and coagulopathy, and was independently associated with higher mortality. In a propensity score-matched analysis, patients with persistent hypoxemia, encephalopathy, and shock phenotype appeared to have HTE and benefit from adjuvant therapy with hydrocortisone and albumin. When compared with other high-risk clinical syndromes, the persistent hypoxemia, encephalopathy, and shock phenotype only overlapped with 50%-60% of patients with septic shock, moderate-to-severe pediatric acute respiratory distress syndrome, or those in the top tier of organ dysfunction burden, suggesting that it represents a nonsynonymous clinical phenotype of sepsis-associated MODS., Conclusions: We derived and validated the persistent hypoxemia, encephalopathy, and shock phenotype, which is highly reproducible, clinically relevant, and associated with HTE to common adjuvant therapies in children with sepsis., Competing Interests: Drs. Sanchez-Pinto, Bennett, and Shah’s institutions received funding from the National Institute of Child Health and Human Development. Dr. Sanchez-Pinto’s institution received funding from the National Institute of General Medical Sciences. Drs. Sanchez-Pinto, Bennett, Luo, Bubeck-Wardenburg, Faustino, Hall, Rogerson, Shah, Weiss, and Khemani received support for article research from the National Institutes of Health (NIH). Dr. Bennett’s institution received funding from the National Center for Advancing Translational Sciences and the National Heart, Lung, and Blood Institute. Drs. Luo, Bubeck-Wardenburg, Faustino, Hall, Rogerson, Weiss, and Khemani’s institutions received funding from the NIH. Dr. Bubeck-Wardenburg’s institution received funding from the National Institute of Allergy and Infectious Diseases; she disclosed that she has a financial relationship with Aridis Pharmaceuticals related to intellectual property owned by the University of Chicago. Dr. Hall received funding from Abbvie, Kiadis, and the American Board of Pediatrics. Dr. Khemani received funding from OrangeMed and Bayer. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Objective: We sought to evaluate symptomatic adverse event (AE) rates among patients with pancreatic cancer receiving neoadjuvant therapy on clinical trial (A021501) using the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)., Background: To date, pancreatic cancer clinical trials have measured AEs using standard physician reporting [Common Terminology Criteria for Adverse Events (CTCAE)]. Patient-reported symptomatic AEs have been incompletely characterized., Methods: A021501 (December 31, 2016-January 1, 2019) randomized patients with borderline resectable pancreatic ductal adenocarcinoma to 8 doses of mFOLFIRINOX (Arm 1) or 7 doses of mFOLFIRINOX+hypofractionated radiotherapy (Arm 2), followed by pancreatectomy and adjuvant FOLFOX6. Patients completed PRO-CTCAE assessments at baseline, on day 1 of each chemotherapy cycle, and daily during radiotherapy., Results: Of 126 patients, 96 (76%) initiated treatment and completed a baseline plus at least 1 postbaseline PRO-CTCAE assessment. Diarrhea and fatigue were the only symptomatic grade 3 or higher AEs identified in at least 10% of patients using CTCAE. At least 10% of all patients reported an adjusted PRO-CTCAE composite grade 3 AE during neoadjuvant treatment for 10 of 15 items: anxiety (10%), bloating of abdomen (16%), decreased appetite (18%), diarrhea (13%), dry mouth (21%), fatigue (36%), nausea (18%), generalized pain (16%), abdominal pain (21%), and problems tasting (32%). Decreased appetite was higher in Arm 2 than in Arm 1 ( P =0.0497); no other differences between study arms were observed., Conclusion: Symptomatic AEs during neoadjuvant therapy were common and were reported more frequently by patients using PRO-CTCAE than were recorded by clinicians using standard CTCAE., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Abstract: Type 2 diabetes and psychiatric illnesses have a bidirectional association, influencing each other in direct but independent ways. People with psychiatric illnesses are more likely than the general population to develop type 2 diabetes, in part because antipsychotic medications affect the metabolic system, disrupting glucose metabolism, and also because they lack diabetes self-management education and self-care skills. This study assessed the effectiveness of diabetes self-management education and support (DSMES) in patients with mental illness and diabetes using the Diabetes Self-Management Questionnaire. Analysis of paired responses to the pre- and post-DSMES survey questions showed a statistically significant increase in diabetes self-management knowledge after participation in the education sessions. These results emphasized the importance of DSMES in strengthening patients' knowledge and skills, with additional support from their psychiatrist and medical team., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Vitamin D (25-OHD) deficiency and insufficiency are reported in about half of all children. The literature on low 25-OHD and pediatric fracture risk presents inconsistent results. This study evaluates the association between pediatric fractures and 25-OHD, parathyroid hormone (PTH), and calcium., Methods: This is a prospective case-control study in 2 urban pediatric emergency departments (2014-2017). Patients aged 1 to 17 requiring intravenous access were enrolled. Demographics, nutrition, and activity information were recorded and levels of 25-OHD, calcium, and PTH were measured., Results: Two hundred forty-five subjects were enrolled: 123 fractures and 122 controls. Overall, the mean 25-OHD level was 23 ng/mL±8.5: 52 (21%) of patients were 25-OHD sufficient; 193 (79%) were not. Ninety-six percent of patients with lower extremity fractures had low 25-OHD versus 77% of patients with upper extremity fractures ( P =0.024). The fracture cohort was younger ( P =0.002), included more males ( P =0.020), and spent more time playing outdoor sports ( P =0.011) than the control cohort. The 25-OHD level (fracture 22.8 ng/mL±7.6 vs. nonfracture 23.5 ng/mL±9.3, P =0.494) and median calcium level (fracture 9.8 mg/dL vs. nonfracture 10.0 mg/dL, P =0.054) were similar between cohorts. The median PTH level was higher in the fracture than the control cohort (33 vs. 24.5 pg/mL; P <0.0005); PTH was elevated to hyperparathyroidism (>65 pg/mL) in 13% of fractures and 2% of controls ( P =0.006). Matched subgroup analysis of 81 fracture patients and 81 controls by age, gender, and race showed that PTH was the only variable independently associated with increased odds of fracture (odds ratio=1.10, 95% CI, 1.01-1.19, P =0.021) in a model adjusted for vitamin D sufficiency and time spent playing outdoor sports., Conclusions: Low 25-OHD is common in children with fractures but we found no difference in 25-OHD levels between fracture and nonfracture cohorts. This research can impact evidence-based guidelines on vitamin D level screening and/or supplementation after fracture., Level of Evidence: Diagnostic level IV-case-control study., Competing Interests: S.P. reports grants from POSNA, grants from OREF, and other financial disclosures from Stryker Spine and Medtronic Spine, none of which are pertinent to the submitted work. The remaining authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To determine the prevalence of the utilization of primary intensivists and primary nurses for long-stay patients in large, academic PICU and ascertain how these practices are operationalized and perceived., Design: A cross-sectional survey., Setting: U.S. PICUs with accredited Pediatric Critical Care Medicine fellowships., Subjects: One senior physician and one senior nurse at each institution., Intervention: None., Measurements and Main Results: Separate but largely analogous questionnaires for intensivists and nurses were created using an iterative process to enhance content/face validity and readability. Sixty-seven intensivists (representing 93% of the 72 institutions with fellowship programs and their PICUs) and 59 nurses (representing 82%) responded. Twenty-four institutions utilize primary intensivists; 30 utilize primary nurses; and 13 utilize both. Most institutions use length of stay and/or other criteria (e.g., medical complexity) for eligibility. Commonly, not all patients that meet eligibility criteria receive primaries. Primary providers are overwhelmingly volunteers, and often only a fraction of providers participate. Primary intensivists at a large majority (>75%) of institutions facilitate information sharing and decision-making, attend family/team meetings, visit patients/families regularly, and are otherwise available upon request. Primary nurses at a similar majority of institutions provide consistent bedside care, facilitate information sharing, and attend family/team meetings. A large majority of respondents thought that primary intensivists increase patient/family satisfaction, reduce their stress, improve provider communication, and reduce conflict, whereas primary nurses similarly increase patient/family satisfaction. More than half of respondents shared that these practices can sometimes require effort (e.g., time and emotion), complicate decision-making, and/or reduce staffing flexibility., Conclusions: Primary practices are potential strategies to augment rotating PICU care models and better serve the needs of long-stay and other patients. These practices are being utilized to varying extents and with some operationalization uniformity at large, academic PICUs., Competing Interests: Dr. Aponte-Patel received funding from the Columbia University Department of Psychiatry and NYP Weill Cornell. Dr. Baird received funding from I-PASS Patient Safety Institute. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Introduction: Anastomotic margin tissue perfusion is recognized as critical to successful colorectal anastomosis creation. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) is the most common modality used by surgeons as an adjunct to clinical assessment in confirming the adequacy of tissue perfusion. Tissue oxygenation as a surrogate for tissue perfusion has been described in a variety of surgical specialties but its use in colorectal surgery has been limited. Here, we report our experience using a handheld tissue-oxygen meter, IntraOx, for the evaluation of colorectal tissue bed oxygen saturation (StO 2 ) and compared its utility with NIR-ICG in identifying the viability of colonic tissue before anastomosis in a range of colorectal procedures., Materials and Methods: This was an institutional review board-approved multicenter trial consisting of 100 patients undergoing elective colon resections. After specimen mobilization, a clinical margin was chosen based on the oncologic, anatomic, and clinical assessment as per the clinicians' standard technique. The IntraOx device was then used to take a baseline reading of colonic tissue oxygenation on a normal segment of perfused colon. Following this, measurements were taken circumferentially at 5 cm intervals along the bowel proximally and distally to the clinical margin. A StO 2 margin was then determined based on the point at which the StO 2 dropped off by ≥10 percentage points. This was then compared with the NIR-ICG margin using the Spy-Phi system., Results: StO 2 was found to have a sensitivity and specificity of 94.8% and 93.1%, respectively, and a positive predictive value and negative predictive value of 93.5% and 94.5%, respectively when compared with NIR-ICG. At the 4-week follow-up, no significant complications or leaks were reported., Conclusions: The IntraOx handheld device was found to be similar to NIR-ICG in identifying a well-perfused margin of colonic tissue while having the added benefits of high portability and reduced costs. Further studies looking at the effect of the IntraOx on preventing colonic anastomotic complications such as leak and stricture are warranted., Competing Interests: D.S. is a consultant for Vioptix. The remaining authors declares no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Over 70% of pediatric organ donors are declared deceased by brain death (BD) criteria. Patients with these devastating neurologic injuries often have accompanying multiple organ dysfunction. This study was performed to characterize organ dysfunction in children who met BD criteria and were able to donate their organs compared with those deemed medically ineligible., Design: Retrospective cohort study., Setting: PICU at a quaternary care children's hospital., Patients: Patients with International Classification of Diseases , 9th Edition codes corresponding to BD between 2012 and 2018 were included., Measurements and Main Results: Demographics, comorbidities, Pediatric Risk of Mortality (PRISM)-III, and injury mechanisms were derived from the medical record. Organ dysfunction was quantified by evaluating peak daily organ-specific variables. Fifty-eight patients, from newborn to 22 years old, were included with a median PRISM-III of 34 (interquartile range [IQR], 26-36), and all met criteria for multiple organ dysfunction syndrome (MODS). Thirty-four of 58 BD children (59%) donated at least one organ. Of the donors (not mutually exclusive proportions), 10 of 34 donated lungs, with a peak oxygenation index of 11 (IQR, 8-23); 24 of 34 donated their heart (with peak Vasoactive Inotrope Score 23 [IQR, 18-33]); 31 of 34 donated kidneys, of whom 16 of 31 (52%) had evidence of acute kidney injury; and 28 of 34 patients donated their liver, with peak alanine transferase (ALT) of 104 U/L (IQR, 44-268 U/L) and aspartate aminotransferase (AST) of 165 U/L (IQR, 94-434 U/L). Organ dysfunction was similar between heart and lung donors and respective medically ineligible nondonors. Those deemed medically ineligible to donate their liver had higher peak ALT 1,518 U/L (IQR, 986-1,748 U/L) ( p = 0.01) and AST 2,200 U/L (IQR, 1,453-2,405 U/L) ( p = 0.01) compared with liver donors., Conclusions: In our single-center experience, all children with BD had MODS, yet more than one-half were still able to donate organs. Future research should further evaluate transplant outcomes of dysfunctional organs prior to standardizing donation eligibility criteria., Competing Interests: The authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Objective: Pediatric diagnoses of sex chromosome multisomies (SCMs) have increased as genetic testing has expanded. However, depending on SCM presentation, there may be significant delays between symptom recognition and diagnosis. We conducted a survey of parents of children diagnosed with SCMs to understand their experiences receiving an SCM diagnosis and their support needs., Methods: We conducted an inductive qualitative analysis of open-ended survey responses for iterative themes related to presenting symptoms, diagnostic odyssey, immediate and long-term support needs, and awareness of SCMs., Results: Of the 323 parents who completed the survey, 185 parents received a pediatric diagnosis (0-21 years) in a child. Many parents expressed feelings of relief when receiving the diagnosis, especially if it occurred after a lengthy diagnostic odyssey. Parents reported frustration that their child's nonmedical symptoms, including learning disabilities, speech delays, attention deficits, and behavioral issues, were not flagged as potential indications for SCMs and suggested that greater awareness of SCMs by pediatricians, educators, and other professionals involved in their child's care may lead to earlier diagnosis and intervention., Conclusion: This is the largest qualitative study to date examining parent and caregiver experiences with a pediatric diagnosis of SCMs. Increased knowledge and awareness of nonmedical SCM symptoms are needed among medical, education, occupational, and psychology professionals for early testing referral and improved support of children with SCMs., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Children endure a prolonged observation after xenobiotic ingestions, despite low associated morbidity and mortality. The primary objective was to describe the management and outcomes of acute xenobiotic exposures in asymptomatic pediatric patients presenting to the emergency department (ED). A secondary objective was to explore the impact of vital signs on the patients' management and outcomes., Methods: We conducted a retrospective review of asymptomatic children (younger than 18 years) presenting to a pediatric ED after a toxic ingestion from 2014 to 2018. Ingestions of hydrocarbons, acetaminophen, salicylates, sulfonylureas, caustic, and/or extended release agents were excluded. Demographic and clinical data were abstracted., Results: Of 2817 charts, we identified 109 asymptomatic patients with a mean age of 4.7 years. The average observation from registration to disposition was 4.06 hours. Five patients were admitted and were subsequently discharged within 24 hours. Of the discharged patients, 2 returned within 72 hours and were subsequently discharged home. A total of 321 asymptomatic patients presented with ≥1 abnormal vital signs (mean age, 6.6 years) and were observed in the ED for an average of 4.54 hours. They had a higher percentage of ingestions related to suicide attempts (odds ratio, 6.8). Twenty-two were admitted. Of those discharged home, 11 returned to the ED within 72 hours; all were subsequently discharged home., Conclusions: Prolonged observations may not be necessary after ingestions in asymptomatic children. Vital sign abnormalities at presentation did not impact disposition. Prospective studies are needed to determine the safety and efficacy of this shortened observation., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: The authors have no funding or conflicts of interest to disclose.

Background and Purpose: Chemotherapy followed by margin-negative resection (R0) is the treatment of choice for patients with localized pancreatic ductal adenocarcinoma (PDAC). Neoadjuvant multiagent chemotherapy (MAC) or MAC then radiotherapy (RT) may optimize surgical candidacy. The purpose of this study was to compare pathologic outcomes of MAC followed by conventionally fractionated radiotherapy (CRT) versus stereotactic body radiotherapy (SBRT) for patients with resected PDAC., Methods: Patients diagnosed with nonmetastatic PDAC between 2012 and 2017 and who received preoperative MAC or MAC+RT were identified in the National Cancer Database. Variables associated with R0 and overall survival were identified with logistic regression and Cox analysis (P<0.05)., Results: A total of 5273 patients were identified (MAC: 3900, MAC+CRT: 955, MAC+SBRT: 418). The median RT dose/fraction (fx) in the MAC+CRT and MAC+SBRT cohorts was 50.4 Gy/28 fx and 33 Gy/5 fx. Patients receiving MAC+CRT versus MAC+SBRT had similar rates of ypT3-T4 disease (54% vs. 58%, P=0.187), R0 (87% vs. 84%, P=0.168), and pathologic complete response (pathologic complete response; 6% vs. 4%, P=0.052), however, MAC+CRT was associated with less regional lymphatic disease (ypN+: 28% vs. 41%, P<0.001). The median overall survival of patients receiving MAC+CRT versus MAC+SBRT was 24.6 versus 29.5 months (P=0.045)., Conclusions: For patients with resected PDAC, MAC+CRT, and MAC+SBRT had similar rates of R0 and pathologic complete response, although MAC+CRT was associated with lower ypN+. Prospective evaluation of neoadjuvant RT regimens with attention to radiation therapy design is warranted., Competing Interests: M.C. has grant funding, receives payment or honoraria for speaking, receives support for travel, and has stocks or options, as described in his disclosure form. S.S. receives consulting fees and payment or honoraria for speaking, as described in her disclosure form. J.M.H. receives consulting fees, has patents planned, and has a leadership or fiduciary role in other board, as described in his disclosure form. C.J.A. has grants or contracts, receives payment for speaking, support for travel, and participates on a data safety monitoring or advisory board, as described in his disclosure form. S.J. has grants or contracts and receives consulting fees, as described in her disclosure form. K.R.J. receives payment or honoraria, as described in his disclosure form. The remaining authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Objectives: This study seeks to understand how sleep is affected in pregnant women with epilepsy (WWE) relative to healthy pregnant women during pregnancy and postpartum and to nonpregnant WWE during comparative periods. Sleep affects maternal health and mood during pregnancy. Maternal sleep disturbances are related to poor fetal growth and increased fetal deaths. Epilepsy is the most common neurologic condition in pregnancy. Sleep disruption can worsen epileptic seizures. The interplay between epilepsy, pregnancy, and sleep is poorly understood., Methods: The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is an NIH-funded, prospective, observational, multicenter study, enrolling women from December 2012 through January 2016. Sleep quality was assessed using the average Pittsburgh Sleep Quality Index collected during pregnancy, postpartum, or analogous periods. Sleep scores range from 0 to 21 with higher scores indicating worse sleep quality; scores >5 are associated with poor sleep quality., Results: Of 351 pregnant WWE, 105 healthy pregnant women, and 109 nonpregnant WWE enrolled in the MONEAD study, data from 241 pregnant WWE, 74 healthy pregnant women, and 84 nonpregnant WWE were analyzed. Pregnant WWE had worse sleep (a higher mean sleep score) during pregnancy compared with healthy pregnant women in unadjusted analysis ( p = 0.006), but no longer significant in adjusted analysis ( p = 0.062); pregnant WWE (least square mean sleep score [95% CI] = 5.8 [5.5-6.1]) vs healthy pregnant women (5.1 [4.6-5.7]). During postpartum period, WWE (5.6 [5.4-5.9]) had similarly impaired sleep compared with healthy women (5.7 [5.2-6.2]; adjusted p = 0.838). Sleep was significantly worse in pregnant WWE vs nonpregnant WWE (for comparable period) in pregnancy and postpartum in unadjusted and adjusted analyses; adjusted scores for pregnant WWE in pregnancy (5.7 [5.4-6.0]) and those in postpartum (5.7 [5.4-6.0]) compared with those for nonpregnant WWE (4.7 [4.2-5.3]; p = 0.002) and (4.1 [3.6-4.7]; p < 0.001), respectively. Sleep quality between pregnancy and postpartum varied only in healthy pregnant women (change in mean score = 0.8 [0.2-1.3]; p = 0.01), whose sleep was worse in postpartum., Discussion: Pregnant WWE had worse sleep during pregnancy and postpartum period than nonpregnant WWE during comparable periods in the adjusted analysis., Trial Registration Information: The study is registered at ClinicalTrials.gov as NCT01730170., (© 2022 American Academy of Neurology.)

Background and Objectives: Spinal muscular atrophy (SMA) was added to the Recommended Uniform Screening Panel in July 2018 largely on the basis of the availability and efficacy of newly approved disease-modifying therapies. New York State (NYS) started universal newborn screening for SMA in October 2018. The authors report the findings from the first 3 years of screening., Methods: Statewide neonatal screening was conducted using DNA extracted from dried blood spots using a real-time quantitative PCR assay. Retrospective follow-up data were collected from 9 referral centers across the state on 34 infants., Results: In the first 3 years since statewide implementation, nearly 650,000 infants have been screened for SMA. Thirty-four babies screened positive and were referred to a neuromuscular specialty care center. The incidence remains lower than previously predicted. The majority (94%), including all infants with 2-3 copies of survival motor neuron ( SMN) 2, have received treatment. Among treated infants, the overwhelming majority (94%; 30/32) have received gene replacement. All infants in this cohort with 3 copies of SMN2 are clinically asymptomatic posttreatment based on early clinical follow-up data. Infants with 2 copies of SMN2 are more variable in their outcomes. Electrodiagnostic outcomes data obtained from a subgroup of patients (n = 11) demonstrated either improvement or no change in compound muscle action potential (CMAP) amplitude at last clinical follow-up compared with pretreatment baseline. Most infants were treated before 6 weeks of age (median = 34.5 days of life; range 11-180 days). Delays and barriers to treatment identified by treating clinicians followed 2 broad themes: medical and nonmedical. Medical delays most commonly reported were the presence of AAV9 antibodies and elevated troponin I levels. Nonmedical barriers included delays in obtaining insurance and insurance policies regarding specific treatment modalities., Discussion: The findings from the NYS cohort of newborn screen-identified infants are consistent with other reports of improved outcomes from early diagnosis and treatment. Additional biomarkers of motor neuron health including EMG can potentially be helpful in detecting preclinical decline., (© 2022 American Academy of Neurology.)

Objectives: Open hand fractures may be difficult to recognize and treat. There is variability in management and administration of antibiotics for these types of injuries. Unlike open long bone fractures, there is no standardized protocol for antibiotic administration for open hand fractures in children. The objective of this study is to assess the variability of antibiotic management of open hand fractures in children., Methods: We performed a retrospective chart review at a tertiary hospital in New York of patients with hand injuries between ages 0 and 18 years presenting to the emergency department during January 2019 and December 2020. Patient encounters were reviewed for open fractures of the hand. Descriptive statistics were included for demographic and physical characteristics., Results: There were 80 encounters with open hand fractures, of which the most common being tuft fractures (77.5%). The mean age was 7.6 years (SD, 4.7 years) with male predominance (58.8%). Crush injuries were the most common mechanism of injury (78.8%). Bedside repair was performed on 62 encounters (77.5%), of which 45 (72.5%) required nail bed repair, 56 (90.3%) required suturing, and 24 (38.7%) required reduction. Antibiotics were given to 62 (77.5%) encounters, most commonly oral cefalexin (45.2%), oral amoxicillin-clavulanic acid (27.4%), and intravenous cefazolin (14.5%). Median time to antibiotics from emergency department registration to administration was 150 minutes (interquartile range, 92-216 minutes). Antibiotic prescriptions were sent for 71 encounters (88.8%). Seventy seven (96.3%) of the encounters were discharged home., Conclusions: Pediatric open hand fractures have a variability of type and timing to antibiotics. Future initiatives should attempt to create standardized guidelines for management of open hand fractures., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Pancreatic mass lesions are often solitary, although rarely synchronous pancreatic masses are encountered. No study has compared synchronous lesions with solitary lesions in the same population. The aim of the present study was to determine the prevalence, clinical, radiographic, and histologic findings of multiple pancreatic masses on consecutive patients undergoing endoscopic ultrasound (EUS) for pancreatic mass lesion., Methods: All patients undergoing EUS for pancreatic mass lesions with histologic sampling over a 5-year span were identified. Charts were abstracted for demographics, medical history, radiographic findings, EUS findings, and histology and were reviewed., Results: A total of 646 patients were identified, of which 27 patients (4.18%) had more than 1 pancreatic mass on EUS or cross-sectional imaging. The 2 groups were comparable with each other in terms of demographic factors and medical history. The 2 cohorts were comparable in location of the largest pancreas lesion and EUS characteristics. Patients with synchronous mass lesions were more likely to have metastatic lesions (P = 0.01). No other differences in histology were noted between the 2 groups., Conclusions: Patients with multiple pancreatic mass lesions were more likely to have metastatic lesions compared with patients with solitary lesions., Competing Interests: A.J.T. is a consultant for Lucid Diagnostics and Pentax Medical. All other authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: A retrospective review., Objective: The objective of this study was to determine whether fusing to touched vertebra (TV) on prone x-rays (XRs) with minimal rotation (Gd 0/1) allow for shorter fusion with optimal correction., Summary of Background: Previous studies have shown risk of "adding on" when TV is not selected as lowest instrumented vertebra (LIV). Fusion proximal to TV leads to suboptimal results but fusing to TV on standing XRs can result in longer fusions. On lying down XRs, TV moves proximally, and its rotation decreases by a grade., Methods: TV patients with minimal rotation were selected on prone (TVP) or standing XRs (TVS). Patients fused to rotated (Gd 2+) TV on standing or prone XRs were considered touched vertebra rotated (TVR). In the non-TV (NTV) group, LIV was fused proximal to TV. Disk wedging ≥5° determined risk of "adding-on." To compare patients fused to minimally rotated TV, to those that were not, patients in group A (TVP + TVS) were compared with group B (TVR + NTV).In part II: TVP, TVS, TVR, and NTV patients were compared. Subanalysis compared levels saved as the difference between predicted and real LIV in TVP and TVS patients. Another subanalysis was carried out for Lenke 1+2 and Lenke 3, 4, 5.In part III: XRs of nonoperative adolescents idiopathic scoliosis patients with Cobb <30 and Risser 4/5 were analyzed to determine "acceptable" end vertebra tilt and disc wedging and served as controls., Results: There were a significantly greater number of patients in group B patients(TVR + NTV) with final disk wedging ≥5°, final LIV translation ≥1 and ≥2 cm ( P <0.001).Utilizing prone XRs in TVP saved average 1 level, and 1.2 levels in TVS patients. TVP patients also had similar LIV tilt, disk wedging and coronal balance( P >0.05) to controls., Conclusion: Choosing minimally rotated (Gd 0/1) TV on prone XR saves levels without sacrificing radiographic outcomes., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The objective of this study was to systematically evaluate the data regarding the use of neoadjuvant, perioperative, surgical, and adjuvant treatment options in localized gastric cancer patients and to develop Appropriate Use Criteria recommended by a panel of experts convened by the American Radium Society., Methods: Preferred reporting items for systematic reviews and meta-analyses methodology was used to develop an extensive analysis of peer-reviewed phase 2/2R/3 trials, as well as meta-analyses found within the Ovid Medline database between 2010 and 2020. The expert panel then rated the appropriateness of various treatments in 5 representative clinical scenarios through a well-established consensus methodology (modified Delphi)., Results: For patients with medically operable locally advanced gastric cancer, the strongest recommendation was for perioperative chemotherapy based on high-quality data. Acceptable alternatives included surgery followed by either chemotherapy or concurrent chemoradiotherapy (CRT). For patients with upfront resection of stages I to III gastric cancer (no neoadjuvant therapy), the group strongly recommended adjuvant therapy with either chemotherapy alone or CRT, based on high-quality data. For patients with locally advanced disease who received preoperative chemotherapy without tumor regression, the group strongly recommended postoperative chemotherapy or postoperative CRT. Finally, for medically inoperable gastric cancer patients, there was moderate consensus recommending definitive concurrent CRT., Conclusions: The addition of chemotherapy and/or radiation, either in the neoadjuvant, adjuvant, or perioperative setting, results in improved survival rates for patients compared with surgery alone. For inoperable patients, definitive CRT is a reasonable treatment option, though largely palliative., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

PCDH19 -related epilepsy is a developmental and epileptic encephalopathy typically presenting with epilepsy and varying degrees of intellectual disability. Seizures typically present in clusters of focal or generalized seizures, sometimes in the setting of fever. We present the case of a 7-month-old girl presenting with new-onset refractory status epilepticus that followed routine vaccine administration and ensuing cytokine storm. She was diagnosed with a pathogenic variant in PCDH19 The patient required 5 antiseizure medications and pentobarbital-induced burst suppression for control of seizures. She was noted to have elevated serum cytokine levels (interleukin [IL]-2, IL-4, IL-10, IL-13, IL-17, IL-1, IL-1β, and IL-8) and CSF cytokine levels (IL-6 and IL-13). Anakinra was initiated and titrated based on serial cytokine levels, with doses ranging from 5 to 20 mg/kg/d resulting in reduction in cytokine levels and seizure reduction. By age 14 months, she was able to be maintained on 3 active antiseizure medications and ketogenic diet for seizure control., (© 2022 American Academy of Neurology.)

Objective: Prospective evaluation of 2 clinical-molecular models in patients with unknown pathology who underwent endoscopic ultrasound with fine-needle aspiration (EUS-FNA) for a cystic lesion of the pancreas., Summary of Background Data: Preoperative prediction of histologic subtype (mucinous vs nonmucinous) and grade of dysplasia in patients with pancreatic cystic neoplasms is challenging. Our group has previously published 2 clinical-molecular nomograms for intraductal papillary mucinous neoplasms (IPMN) that incorporated both clinical/radiographic features and cyst fluid protein markers (sFASL, CA72-4, MMP9, IL-4)., Methods: This multiinstitutional study enrolled patients who underwent EUS-FNA for a cystic lesion of the pancreas. Treatment recommendations regarding resection were based on standard clinical, radiographic, and endoscopic features. Predicted probabilities of high-risk IPMN (high-grade dysplasia/invasive cancer) were calculated using the previously developed clinical-molecular nomograms., Results: Cyst fluid was obtained from 100 patients who underwent diagnostic EUS-FNA. Within this group there were 35 patients who underwent resection, and 65 were monitored radiographically. Within the group that underwent resection, 26 had low-risk IPMN or benign non-IPMN lesions, and 9 had high-risk IPMN. Within the surveillance group, no patient progressed to resection or developed cancer after a median follow-up of 12months (range: 0.5-38). Using the clinical/radiographic nomogram alone, 2 out of 9 patients with high-risk IPMN had a predicted probability >0.5. In the clinical-molecular models, 6 of 9 patients in model 1, and 6 of 9 in model 2, had scores >0.5., Conclusions: This prospective study of patients with unknown cyst pathology further demonstrates the importance of cyst fluid protein analysis in the preoperative identification of patients with high-risk IPMN. Longer follow-up is necessary to determine if this model will be useful in clinical practice., Competing Interests: The authors report no conflicts of interest, (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Research on the utilization and effectiveness of antitumor necrosis factor (TNF) biologics in children with very early onset inflammatory bowel disease (VEOIBD) is urgently needed. Here we describe anti-TNF use and durability in a multicenter cohort., Methods: We performed a retrospective cohort study of patients diagnosed with VEOIBD (<6 years) between 2008 and 2013 at 25 North American centers. We performed chart abstraction at diagnosis and 1, 3, and 5 years after diagnosis. We examined the rate of initiation and durability of infliximab and adalimumab and evaluated associations between treatment durability and the following covariates with multivariate Cox proportional hazard regression: age at diagnosis, sex, disease duration, disease classification, and presence of combined immunomodulatory treatment versus monotherapy., Results: Of 294 children with VEOIBD, 120 initiated treatment with anti-TNF therapy and 101 had follow-up data recorded [50% Crohn disease (CD), 31% ulcerative colitis (UC), and 19% IBD unclassified (IBD-U)]. The cumulative probability of anti-TNF treatment was 15% at 1 year, 30% at 3 years, and 45% at 5 years from diagnosis; 56 (55%) were treated between 0 and 6 years old. Anti-TNF durability was 90% at 1 year, 75% at 3 years, and 55% at 5 years. The most common reason for discontinuation of anti-TNF were loss of response in 24 (57%) children. Children with UC/IBD-U had lower durability than those with CD (hazard ratio [HR] 0.17; 95% confidence interval [CI], 0.06-0.51; P = 0.001)., Conclusions: Utilization and durability of anti-TNF in VEOIBD is relatively high and comparable with older children. Having Crohn disease (compared with UC/IBD-U) is associated with greater durability., (Copyright © 2022 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

Background: Coronavirus disease 2019 (COVID-19) is associated with elevated rates of major and fatal thrombotic events, postulated to be the result of a hypercoagulable state mediated through inflammatory and immunomodulatory mechanisms. Early observational studies showed that disease severity and elevated serum D-dimer levels can predict thrombotic risk in patients hospitalized with COVID-19 and reported an alarming phenomenon of breakthrough thrombosis despite standard-of-care prophylaxis, suggesting the need for enhanced thromboprophylactic strategies., Areas of Uncertainty: Data on anticoagulant agent selection, dosing, and duration for COVID-19 inpatients are now poised to inform updated professional society guidance. However, there remains limited high-quality data regarding postdischarge and especially ambulatory patients with COVID-19., Data Sources: This review includes published, peer-reviewed, observational, and randomized controlled trial data and major professional society guidance informing thrombosis prevention and treatment in patients with COVID-19., Therapeutic Advances: There remains great variability in the approach to anticoagulation in COVID-19. This article will review pathogenesis of COVID-related thrombosis and the evidence guiding thromboprophylaxis particularly in inpatients, with attention to the INSPIRATION, ACTION, RAPID, HEP-COVID, and multiplatform trials. Emerging thromboprophylaxis data from the postdischarge setting (particularly the recently published MICHELLE trial), and the outpatient setting, will be examined. Finally, thrombosis treatment considerations will briefly be reviewed., Conclusions: Substantial high-quality data support practice changes to COVID-19 thromboprophylaxis. Risk stratification by setting, disease severity, and biomarkers such as D-dimer is critical in considering choice, dose, and duration of anticoagulants., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: There is increasing overlap in the urogynecologic and gynecologic oncologic patient populations. To improve patient advocacy and access to care, a collaborative surgical approach may benefit this cohort., Objective: The aim of the study was to evaluate surgeon attitudes toward performing concurrent urogynecologic and gynecologic oncology procedures. We hypothesized that most surgeons are amenable to collaboration., Study Design: We conducted a cross-sectional questionnaire of members of the Society of Gynecologic Oncology and the American Urogynecologic Society from August to November 2020. A 23-item online survey was created to assess surgeon demographics, practice and screening patterns, and attitudes toward surgical collaboration. We also evaluated obstacles to performing joint procedures and assessed whether attitudes could be influenced by new information., Results: A total of 338 surveys were included in the analysis, including 158 urogynecologists and 226 gynecologic oncologists (GOs). Most surgeons (77.8%) will recommend concurrent procedures with another specialty, and 97.8% of urogynecologists and 95.7% of oncologists currently perform joint surgical procedures. Male surgeons, regardless of specialty, were more likely to recommend staged procedures (44% vs 31%, P < 0.001), as were GOs (28% vs 10.1%, P < 0.001). However, oncologists were more likely than urogynecologists to initiate referrals for surgical collaboration (33.3% vs 14.4%, P < 0.001)., Conclusions: A total of 22.2% of urogynecologists and oncologists prefer staging surgical procedures. The most common barrier to a combined procedure was logistics. Urogynecologists were more concerned about the effects of cancer treatments on healing, the use of mesh implants, and financial reimbursements as compared with GOs. Treatment delay was a significantly greater concern for the oncologists., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Study Design: Systematic review., Objective: The aim of this review is to present an overview of robotic spine surgery (RSS) including its history, applications, limitations, and future directions., Summary of Background Data: The first RSS platform received United States Food and Drug Administration approval in 2004. Since then, robotic-assisted placement of thoracolumbar pedicle screws has been extensively studied. More recently, expanded applications of RSS have been introduced and evaluated., Methods: A systematic search of the Cochrane, OVID-MEDLINE, and PubMed databases was performed for articles relevant to robotic spine surgery. Institutional review board approval was not needed., Results: The placement of thoracolumbar pedicle screws using RSS is safe and accurate and results in reduced radiation exposure for the surgeon and surgical team. Barriers to utilization exist including learning curve and large capital costs. Additional applications involving minimally invasive techniques, cervical pedicle screws, and deformity correction have emerged., Conclusion: Interest in RSS continues to grow as the applications advance in parallel with image guidance systems and minimally invasive techniques., Irb Approval: N/A., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The goal of this study was to understand the effect of transition to telehealth care on follow-up visit attendance in a developmental-behavioral pediatric (DBP) practice in 2020 versus in-person care in 2019., Methods: This was a retrospective observational cohort study of follow-up visits occurring in a large DBP practice during a 6-week period in March/April of 2019 and 2020. The primary outcome was follow-up visit adherence, defined as completion of scheduled follow-up visit. The primary exposure was telehealth visit in 2020 versus in-person visit in 2019. Covariates included patient demographics and clinical characteristics. Data were analyzed using descriptive statistics and logistic regression., Results: The cohort included 2142 visits for 1868 unique patients. The patient mean age was 9.2 ± 4.8 years, with 73.4% male, 56.5% non-Hispanic, 51.4% White, and 68.3% commercial insurance. There were 470 telehealth visits from March to April 2020 and 1672 in-person visits from March to April 2019. Compared with in-person visits, telehealth visits were more likely to be completed (75.3% vs 64.4%, p < 0.001). After adjusting for age, sex, race, ethnicity, insurance, and week of visit (weeks 1-3 vs 4-6), odds of having a complete follow-up visit were higher for telehealth visits than for in-person visits (odds ratio = 1.57; 95% confidence interval [1.23-2.00], p < 0.001)., Conclusion: Follow-up visit attendance was higher for telehealth care in 2020 than in-person care in 2019. This association persisted after adjusting for insurance, age, race, and ethnicity, suggesting that telehealth is associated with increased follow-up visit attendance in DBP care. Further studies are needed to understand the impact of telehealth on DBP clinical outcomes in chronic disease management., Competing Interests: Disclosure: V. Chen was funded by the Northwell-Mentored Pediatric Service Line Research Grant for Early Career Investigators. The remaining authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Thymic carcinomas are rare aggressive mediastinal tumors with a median survival of 2 years., Observation: We present a pediatric patient who was diagnosed with metastatic thymic carcinoma and showed continuous improvement of his primary mass and lung metastases with a regimen of cisplatin/docetaxel followed by long-term maintenance therapy with sunitinib for over 5 years., Conclusions: This report demonstrates a long-term positive treatment effect using chemotherapy followed by sunitinib in an advanced thymic carcinoma. We are not aware of other reports of pediatric patients with metastatic thymic carcinoma treated with sunitinib maintenance who maintained a durable response for this prolonged period of time., Competing Interests: The authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Aims: Ionizing radiation exposure during endoscopic retrograde cholangiopancreatography (ERCP) is an important quality issue especially in children. We aim to identify factors associated with extended fluoroscopy time (FT) in children undergoing ERCP., Methods: ERCP on children <18 years from 15 centers were entered prospectively into a REDCap database from May 2014 until May 2018. Data were retrospectively evaluated for outcome and quality measures. A univariate and step-wise linear regression analysis was performed to identify factors associated with increased FT., Results: 1073 ERCPs performed in 816 unique patients met inclusion criteria. Median age was 12.2 years (interquartile range [IQR] 9.3-15.8). 767 (71%) patients had native papillae. The median FT was 120 seconds (IQR 60-240). Factors associated with increased FT included procedures performed on patients with chronic pancreatitis, ERCPs with American Society of Gastrointestinal Endoscopy (ASGE) difficulty grade >3, ERCPs performed by pediatric gastroenterologist (GI) with adult GI supervision, and ERCPs performed at non-free standing children's hospitals. Hispanic ethnicity was the only factor associated with lower FT., Conclusion: Several factors were associated with prolonged FTs in pediatric ERCP that differed from adult studies. This underscores that adult quality indicators cannot always be translated to pediatric patients. This data can better identify children with higher risk for radiation exposure and improve quality outcomes during pediatric ERCP., Competing Interests: Douglas Fishman – royalties, up-to-date; Michael Wilsey – consultant, Mead Johnson; Clifton Huang – Paid Speaker, Abbvie; Kulwinder Dua – consultant (speaker), Boston Scientific. The other authors report no conflicts of interest., (Copyright © 2021 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

This retrospective study investigates the relationship between the presence of a documented viral infection in children with sickle cell disease during their first splenic sequestration crisis and their odds of recurrence. Forty-eight children were admitted to our hospital between 2008 and 2018 with a splenic sequestration crisis. Thirty-six had respiratory viral panels done on admission, 13 of whom were positive. Two additional children were diagnosed with parvovirus B19 infection by serology. The recurrence rate was 52% (17/33) for those deemed negative for viral illness compared with 33% (5/15) among those with a positive documented viral illness, which was not statistically different (P=0.35). HbSC genotype decreased, and reticulocytosis increased the odds of recurrence. Further research is needed to substantiate these findings., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: Retrospective cohort study., Objective: This study aims to identify differences in perioperative outcomes between ambulatory patients with neuromuscular scoliosis (ANMS) and adolescent idiopathic scoliosis (AIS) following spinal fusion., Summary of Background Data: NMS patients have severe curves with more comorbidities and procedural complexity. These patients require extensive fusion levels, increased blood loss, and suffer increased periop complications. However, NMS patients have a variable severity spectrum, including ambulation status., Methods: Chart and radiographic review of NMS and AIS patients undergoing PSF from 2005 to 2018. NNMS included NMS patients who were completely dependent (GMFCS IV-V). ANMS consisted of community ambulators without significant reliance on wheeled assistive devices (GMFCS I-III). Subanalysis matched by age, sex, levels fused and preoperative Cobb angle was conducted as well. Wilcoxon Rank-Sum, Kruskal-Wallis, χ2, and Fisher exact tests were performed., Results: There were 120 patients in the NNMS group, 54 in ANMS and 158 in the AIS group. EBL was significantly lower for ANMS and AIS patients (P < 0.001). Complications within 30 days were similar between ANMS and AIS (P = 1.0), but significantly higher for NNMS (P < 0.001). Two (1.3%) AIS patients, (1.7%) nonambulatory NMS patients, and one (1.9%) ANMS patient required revision surgery (P = 1.0). However, all NMS patients had increased fusion levels, fixation points, and surgery time (P < 0.05). NNMS had significantly longer ICU (P < 0.001), hospital stay (P < 0.001), intraoperative transfusions (P < 0.001), and fewer patients extubated in the OR (P < 0.001) than ANMS and AIS patients. In the subanalysis, ANMS had similar radiographic measurements, EBL, transfusion, surgery time, extubation rate, and complication rate (P > 0.05) to AIS., Conclusion: Our data show radiographic outcomes, infections, revisions, and overall complications for ANMS were similar to the AIS population. This suggests that NMS patients who ambulate primarily without assistance can expect surgical outcomes comparable to AIS patients with further room for improvement in length of ICU and hospital stay.Level of Evidence: 4., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Recently, 40 comprehensive quality indicators in various management domains were created. The aim was to determine if these indicators could be used to audit the management of acute pancreatitis., Methods: A retrospective study of consecutive patients admitted with acute pancreatitis in 2018 was conducted. Adherence rates with the individual quality indicators were calculated and compared between services., Results: A total of 320 patients were included in this study. Twenty-eight of the 40 quality indicators (70%) could be used to audit management retrospectively. The medical service was found to have lower adherence rates for quality indicators 12 (initial assessment and risk stratification domain; 11% vs 22%, P = 0.009), 14 (initial management domain; 72% vs 88%, P = 0.003), and 33 (surgery domain; 83% vs 100%, P = 0.006). The surgical service was noted to have statistically significant lower adherence rates for quality indicators 4, 5, and 6 of the etiology domain (54% vs 72%, P = 0.002; 86% vs 96%, P = 0.004; and 45% vs 71%, P < 0.0001, respectively), and 21 of the nutrition domain (76% vs 93%, P < 0.0001)., Conclusions: We show that these quality indicators can be used to audit the management of acute pancreatitis in specific management domains., Competing Interests: A.J.T. was a consultant for Olympus America and Pentax Medical and received research support from Ninepoint Medical. The rest of the authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Understanding the clinical course and short-term outcomes of suspected myocarditis after the coronavirus disease 2019 (COVID-19) vaccination has important public health implications in the decision to vaccinate youth., Methods: We retrospectively collected data on patients <21 years old presenting before July 4, 2021, with suspected myocarditis within 30 days of COVID-19 vaccination. Lake Louise criteria were used for cardiac MRI findings. Myocarditis cases were classified as confirmed or probable on the basis of the Centers for Disease Control and Prevention definitions., Results: We report on 139 adolescents and young adults with 140 episodes of suspected myocarditis (49 confirmed, 91 probable) at 26 centers. Most patients were male (n=126, 90.6%) and White (n=92, 66.2%); 29 (20.9%) were Hispanic; and the median age was 15.8 years (range, 12.1-20.3; interquartile range [IQR], 14.5-17.0). Suspected myocarditis occurred in 136 patients (97.8%) after the mRNA vaccine, with 131 (94.2%) after the Pfizer-BioNTech vaccine; 128 (91.4%) occurred after the second dose. Symptoms started at a median of 2 days (range, 0-22; IQR, 1-3) after vaccination. The most common symptom was chest pain (99.3%). Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%), or no anti-inflammatory therapies (8.6%). Twenty-six patients (18.7%) were in the intensive care unit, 2 were treated with inotropic/vasoactive support, and none required extracorporeal membrane oxygenation or died. Median hospital stay was 2 days (range, 0-10; IQR, 2-3). All patients had elevated troponin I (n=111, 8.12 ng/mL; IQR, 3.50-15.90) or T (n=28, 0.61 ng/mL; IQR, 0.25-1.30); 69.8% had abnormal ECGs and arrhythmias (7 with nonsustained ventricular tachycardia); and 18.7% had left ventricular ejection fraction <55% on echocardiogram. Of 97 patients who underwent cardiac MRI at a median 5 days (range, 0-88; IQR, 3-17) from symptom onset, 75 (77.3%) had abnormal findings: 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria. Among 26 patients with left ventricular ejection fraction <55% on echocardiogram, all with follow-up had normalized function (n=25)., Conclusions: Most cases of suspected COVID-19 vaccine myocarditis occurring in persons <21 years have a mild clinical course with rapid resolution of symptoms. Abnormal findings on cardiac MRI were frequent. Future studies should evaluate risk factors, mechanisms, and long-term outcomes.