Single-Center Experience Using the Cardiohelp System for Neonatal and Pediatric Extracorporeal Membrane Oxygenation.

OBJECTIVES: Extracorporeal membrane oxygenation (ECMO) systems have continued to evolve and improve with the development of smaller and portable systems. The Cardiohelp (Maquet Getinge Cardiopulmonary AG, Rastatt, Germany) portable life support device is a compact ECMO system used widely in adults and for ECMO transport. Reports of its use in neonatal and pediatric centers remain limited. In this single-center retrospective review, we describe our institutional experience with the Cardiohelp. DESIGN: Single-center retrospective review. SETTING: Neonatal ICUs and PICUs in a tertiary-care children's hospital. PATIENTS: Seventeen pediatric patients on ECMO. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Median (interquartile range, IQR) of patient age was 0.5 years (0-7 yr). Eleven of 17 patients were on veno-arterial ECMO, five on veno-venous ECMO, and one on veno-venoarterial ECMO. All veno-venous and veno-venoarterial runs ( n = 6) were accomplished with bicaval, dual-lumen cannulae. Median duration on Cardiohelp was 113 hours (IQR 50-140 hr). Median anti-Xa level for patients was 0.43 IU/mL (IQR 0.35-0.47 IU/mL), with median heparin dose of 23.6 U/kg/hr (IQR 17.6-28.1 U/kg/hr). Median plasma-free hemoglobin was 41.4 mg/dL (IQR 30-60 mg/dL). Circuit change was required in three cases. Fourteen patients survived ECMO, with 13 patients surviving to discharge. CONCLUSIONS: We have used the Cardiohelp system to support 17 neonatal and pediatric ECMO patients, without complications. Further studies are warranted to compare complications, outcomes, and overall cost with other institutions and other existing ECMO systems.

Pediatric extracorporeal life support for refractory status asthmaticus: ELSO Registry trends from the past decade.

BACKGROUND: Extracorporeal life support (ECLS) for status asthmaticus (SA) is rare. Increased safety and experience may increase utilization of ECLS for SA. METHODS: We reviewed pediatric (<18 years old) patients requiring ECLS for SA between 1998 and 2019 within the Extracorporeal Life Support Organization (ELSO) Registry and Nemours Children's Health (NCH) system. We compared patient characteristics, pre-ECLS medications, clinical data, complications, and survival to discharge between Early (1988-2008) and Late (2009-2019) eras. RESULTS: From the ELSO Registry, we identified 173 children, 53 in Early and 120 in Late eras, with primary diagnosis of SA. Pre-ECLS hypercarbic respiratory failure was similar between eras (median pH 7.0 and pCO2 111 mm Hg). Venovenous mode (79% vs. 82%), median ECLS time (116 vs. 99 h), time to extubation (53 vs. 62 h), and hospital survival (89% vs. 88%) also remained similar. Intubation to cannulation time significantly decreased (20 vs. 10 h, p = 0.01). ECLS without complication occurred more in the Late era (19% vs. 39%, p < 0.01), with decreased hemorrhagic (24% vs. 12%, p = 0.05) and noncannula-related mechanical (19% vs. 6%, p = 0.008) complications. Within NCH, we identified six Late era patients. Pre-ECLS medication favored intravenous beta agonists, bronchodilators, magnesium sulfate, and steroids. One patient died from neurological complications following pre-ECLS cardiac arrest. CONCLUSIONS: Collective experience supports ECLS as a rescue therapy for pediatric SA. Survival to discharge remains good, and complication rates have improved. Pre-ECLS cardiac arrest may potentiate neurologic injury and impact survival. Further study is needed to evaluate causal relationships between complications and outcomes.

The Effect of Cardiac Mass and Venous Return in Children with Postural Orthostatic Tachycardia Syndrome: A Prospective, Observational Study.

Low left ventricular mass index (LVMI) is thought to limit exercise tolerance in adult patients with postural orthostatic tachycardia syndrome (POTS). This finding has not been studied in children. We evaluated the effect of LVMI and hemodynamics at baseline and during exercise in POTS versus controls. POTS and control subjects aged 12-18 years were prospectively enrolled. POTS patients underwent autonomic studies. An echocardiogram was performed on all patients at baseline and during exercise. LVMI, venous return from inferior vena cava (IVC-VTI), left ventricular dimension, and cardiac output were assessed at baseline and during exercise. Generalized linear modeling with mixed effects was used to perform repeated measures testing between POTS and controls. Eighteen POTS patients (14 female, aged 15.4 ± 1.4 years) and nine control subjects (six female, aged 15.0 ± 1.3 years; p = 0.44) were enrolled. At baseline, LVMI was similar in both groups. During exercise, IVC-VTI, left ventricular end-diastolic dimension and volume, and stroke volume were lower in POTS patients. Peak heart rate was higher in POTS patients, but cardiac output was similar in both groups. Exercise time was higher in the control group (11.4 ± 2.7 min vs 9.2 ± 2.1, p = 0.024). Lower venous return resulted in smaller cardiac dimension and stroke volume during exercise. Higher heart rate in POTS may compensate to achieve similar cardiac output compared with control subjects. Lower ventricular filling and earlier time to peak heart rate may explain lower exercise capacity in pediatric POTS.

Idiopathic Pericardial Effusions in Children: Workup and Final Diagnoses.

Pediatric idiopathic pericardial effusions are common and often have a prolonged clinical course. We hypothesized that these effusions have no standardized diagnostic workup, and ultimately have a final etiology not initially appreciated. To test these hypotheses, a hospital system-wide retrospective (1/1/1990-10/1/2019) cohort study of pericardial effusions in children (< 18 years) was conducted. Effusions were grouped by etiology and patients receiving an initial idiopathic diagnosis were further analyzed. Effusion size, diagnostic workup, final diagnosis, and time to resolution were abstracted. In total, 42/366 effusions were initially diagnosed as idiopathic. Workup was not standardized and included up to six laboratory tests including pericardial fluid analysis and infectious, metabolic, rheumatologic and thyroid workups. Treatment course involved 1 readmission in 24%, and > 1 readmission in 12%. Resolution of effusion occurred in 83% of patients within a median of 1 admission (range 1-4). Of those effusions initially deemed idiopathic, 12/42 (29%) were later found to have an underlying etiologic diagnosis including: autoimmune (7, 58%), neoplastic (2, 16%), infectious (2, 16%), and renal (1, 8%). Children initially diagnosed with idiopathic pericardial effusions have an underlying etiologic diagnosis 29% of the time, and a standardized workup may prevent delays in definitive diagnosis and treatment.

A shifting landscape: Practice patterns and outcomes of cystic fibrosis and non-cystic fibrosis pediatric lung transplantation.

BACKGROUND: New drugs may further decrease the need for lung transplant (LTx) in pediatric patients with cystic fibrosis (CF), but few studies highlight pediatric non-CF LTx characteristics and outcomes. METHODS: The ISHLT registry was used to report morbidity, graft failure, and survival for primary pediatric (<18 years) LTx performed 1990-2017. Recipient/donor characteristics and long-term outcomes were analyzed for CF and non-CF recipients. Survival was assessed using Kaplan-Meier curves. RESULTS: Of 2232 primary LTx, (43% in males), 918 (41%) were performed for non-CF indications; most commonly pulmonary hypertension (43%). Non-CF patients were younger (median age 11 vs. 15, p < .001), and more frequently on inotropes and/or extracorporeal membrane oxygenation (15% vs. 2.4%, p < .001) at transplant, compared to CF recipients. In-hospital major complications more commonly affected CF LTx recipients (57% vs. 48%, p = .003), but 30-day mortality was higher in the non-CF group (9% non-CF vs. 5% CF, p < .001). One-, five-, and ten-year mortality was 18%, 50%, and 65% for CF recipients, respectively, and 21%, 45%, and 58% for non-CF recipients (p = .01 at 10 years). Five-year survival was significantly better for non-CF females versus CF females (56% vs. 48%, p = .013), but was similar between groups for males (55% vs. 54%, p = .305). While age was a late outcomes risk factor, pulmonary hypertension and later transplants eras were protective. CONCLUSIONS: Early mortality is higher and late mortality is lower in non-CF LTx. Current non-CF LTx outcomes leave room for improvement. Further study is needed to evaluate the effects of center volume and pediatric-specific experience on outcomes.

Physician experiences of workplace racial and gender microaggressions.

OBJECTIVES: To investigate racial and gender-specific microaggressions that are experienced by pediatric otolaryngologists at work. METHODS: An anonymous web-based survey consisting of 18 questions was sent to American Society of Pediatric Otolaryngology (ASPO) members via an email link. The survey included questions from the Workplace and School Microaggressions component of the Racial and Ethnic Microaggressions (REM) Scale. RESULTS: 125 out of 610 ASPO members completed the survey for a response rate of 20.5%. 28% of respondents reported experiencing a racial/ethnic microaggression in the last six months. Respondents who identified as Asian American Pacific Islander had significantly higher REM scores when compared with Caucasian respondents (p < 0.05). There was no significant difference in scores when comparing the other Race categories. Female respondents reported significantly higher gendered-microaggression scores compared to those identifying as male (p < 0.001). 66% of female respondents experienced some form of gender-based microaggression in the last six months. CONCLUSION: By providing evidence that pediatric otolaryngologists continue to report experiences of discrimination in the form of microaggressions, this study aims to increase awareness and inspire a more inclusive work environment.

Effusion Prevalence at Tympanostomy During COVID-19: Follow-Up.

OBJECTIVE: We previously reported pandemic year (2020) intraoperative middle ear effusion (MEE) rate at time of bilateral myringotomy tube (BMT) placement was 18% lower compared to pre-pandemic year (2019). After mandatory stay at home orders (MSHO) and pandemic social distancing precautions were relaxed, we aimed to assess the impact of a persistent pandemic with new COVID-19 variants on MEE presence during BMT. METHODS: This study is a retrospective chart summary exempted by Nemours institutional review board at a single tertiary children's hospital. Children < 18 years who underwent BMT during March 1, 2019-June 31, 2019 (pre-COVID), March 1, 2020-June 31, 2020 (PY1), and March 1, 2021-June 31, 2021 (PY2) were included. Statistical analysis included chi-squared and KruskalWallis. RESULTS: A total of 1069 BMTs were reviewed: 551 (52%) during pre-COVID, 227 (21%) during PY1, and 291 (27%) during PY2. There were no significant differences in age, sex, or BMI across comparison groups. Intraoperative MEE was significantly higher pre-COVID (83%) compared to PY1 (65%) and PY2 (69%) (P < .001) despite a small rebound in PY2. CONCLUSION: Intraoperative MEE remains lower in subsequent pandemic years despite relaxed public health measures and may be impacted by persistent public health measures like masking, lower return to daycare, variable social distancing, and/or change to access to health care.

Educating Surgeons to Construct Valved Conduits: What Does It Take to Achieve Reproducible Results?

BACKGROUND: Despite the demonstrated utility of surgeon-fashioned polytetrafluoroethylene (PTFE) valved conduits, methods for educating surgeons to reproducibly construct these conduits are lacking. We present a surgeon education process and early outcomes for children receiving surgeon-fashioned PTFE valved conduits during the initial learning curve. METHODS: The educational curriculum included 4 hours of proctored instruction/supervised valve construction, followed by 2 hours of individual practice. A surgeon with prior mastery of the technique provided templated designs, videos, and follow-up consultation. A retrospective medical record review (2017-2022) described early outcomes and valve function for patients receiving surgeon-fashioned PTFE right ventricle-to-pulmonary artery conduits. RESULTS: Two surgeons were educated using the method described. Fifteen valved conduits were implanted in 14 patients (median patient age, 38 months; conduit size range, 10-24 mm). At discharge, no patient had more than mild stenosis or regurgitation, and 12 of 15 valves (80%) had none or trivial regurgitation. Median follow-up was 14 months (range, 1-52 months). At the last follow-up, median peak conduit gradient of the 15 valves was low (18 mm Hg), 1 (7%) had moderate stenosis, and 1 (7%) had mild-moderate regurgitation. Two conduits were replaced concomitantly during repair of associated lesions at 14 and 38 months (sizes 10 and 12 mm, respectively). There were no deaths and no infectious complications. CONCLUSIONS: Four hours of proctored surgeon education plus deliberate practice is an effective method for teaching valved PTFE conduit construction and is associated with excellent early valve function. This study provides educational methods and initial evidence of safety for congenital surgeons wishing to learn and adopt this technique.

Predictors of Mediastinal Exploration While on Extracorporeal Membrane Oxygenation After Pediatric Cardiac Surgery.

Cardiac surgical patients requiring extracorporeal membrane oxygenation (ECMO) are at increased risk for hemorrhage due to necessary anticoagulation, in-situ cannulas, and disturbed hemostasis. We performed a retrospective, cross-sectional study of patients 0-18 years old in our cardiac intensive care unit (CICU) cannulated to ECMO within 48 h of cardiopulmonary bypass. The 69 patients included in the study were divided into three analysis groups based on serial chest tube output per hour: no bleeding (NB) on admission to the CICU (21/69, 30%), bleeding stopped (BS) with medical management (26/69, 38%), bleeding requiring emergent mediastinal exploration (BME) (22/69, 32%). The NB group had a more favorable coagulation profile upon admission to the CICU (PTT 53 s NB, 105 s BS, 83 s BME p < 0.001, ACT 169 s NB, 225 s BS, 211 s BME, p =0.013). Only chest tube output during the first three postcannulation hours remained associated with the need for mediastinal exploration by multivariable analysis. An average chest-tube output of 11.6 mL/kg/h during the first three hours had the highest percentage of patients classified correctly (84%) for requiring mediastinal exploration during their ECMO run (sensitivity 91%, specificity 81%).

Development of a Novel Society of Thoracic Surgeons Adult Congenital Mortality Risk Model.

BACKGROUND: Operative mortality risk models for adults with congenital heart disease (ACHD) undergoing cardiac operations are essential, given the growing population of these patients, yet they are currently unavailable. Existing adult Society of Thoracic Surgeons (STS) models exclude congenital procedures, whereas existing congenital models exclude operations for acquired disease. We aimed to develop an STS mortality risk model for ACHD patients undergoing cardiac operations. METHODS: Leveraging a comprehensive list of diagnostic and procedure codes, ACHD patients who underwent cardiac operations were identified from the STS Adult Cardiac Surgery Database (versions: v2.73, v2.81, and v2.9) between 2011 and 2019. The model was developed and validated in the ACHD population using a 60/40 development/validation split. Univariate analyses and clinical expertise informed the addition of ACHD-relevant procedure and diagnosis variables to existing STS adult risk model variables. Model performance was assessed overall and in 38 subgroups based on patient demographics, procedures, and diagnoses. RESULTS: Forty-seven procedure and diagnosis variables relevant to ACHD were added to existing STS adult risk model variables. The derived ACHD model for operative mortality was well calibrated within demographic, procedural, and diagnosis subgroups and the overall ACHD population, and discrimination in the validation cohort was excellent (C statistic, 0.815) compared with the model using only existing STS adult risk model variables (C statistic, 0.79; P < .0001). CONCLUSIONS: A novel, high-performing STS ACHD mortality risk model has been developed on the basis of contemporary patient data. The ACHD risk model represents an important expansion of the STS portfolio. Implementation with an online risk calculator is planned.

In vivo PEG modification of vascular surfaces for targeted delivery.

OBJECTIVE: Thrombosis and restenosis remain problematic for many intravascular procedures. Previously, it has been demonstrated that modifying an injured vascular surface with a protein-reactive polymer could block undesirable platelet deposition. As an added benefit, it would be advantageous if one could target therapeutics to the injured site. This study investigates a site-specific delivery system to target microspheres to vascular surfaces modified with a reactive polyethylene glycol tagged with biotin. METHODS: Rabbit femoral arteries were injured with a 2F embolectomy catheter. Modification of the vascular surface was achieved using a channeled balloon catheter or small-diameter tube. Microspheres were injected intravenously through catheterization of the ear vein. Polymer modification on the injured surface and delivery of microspheres was quantified using epifluorescence microscopy at 0, 24, 48, and 72 hours. RESULTS: Polymer modification of the vascular surface could be achieved using a channeled drug delivery catheter or small-diameter tube with similar results. Maximum polymer coverage occurred at 0 hours and decreased to 85% maximal at 24 hours, 72% at 48 hours, and 67% at 72 hours. The initial number of microspheres per mm(2) binding to modified, injured arteries was 304 versus 141 for the unmodified, damaged control (P < .01). At subsequent times, the number of adherent microspheres to modified, injured arteries decreased by 50%, 70%, and 84% at 24, 48, and 72 hours, respectively; while nonspecific binding to unmodified, injured arteries quickly decreased by 93%. Initial microsphere binding to modified, healthy arteries was 153 microspheres/mm(2) as opposed to 26 microspheres/mm(2) for the unmodified, healthy controls (P < .01). CONCLUSIONS: Chemical modification of injured vessels following intravascular procedures can be readily accomplished in vivo to create a substrate for targeted delivery systems. As a proof of concept, targeted microspheres preferentially adhered to polymer-modified surfaces as opposed to injured, unmodified, or healthy vascular surfaces.

Activated partial thromboplastin time is a better trending tool in pediatric extracorporeal membrane oxygenation.

OBJECTIVES: To determine whether activated partial thromboplastin times are a better heparin management tool than activated clotting times in pediatric extracorporeal membrane oxygenation. DESIGN: A single-center retrospective analysis of perfusion and patient records. SETTING: Academic pediatric tertiary care center. PATIENTS: Pediatric patients (<21 yrs old) requiring extracorporeal membrane oxygenation support initiated at Children's Hospital of Pittsburgh. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Point-of-care activated clotting time and activated partial thromboplastin time values, clinical laboratory activated partial thromboplastin time values, weight-normalized heparin administration (units/kg/hr), and reported outcomes were collected for pediatric patients treated for cardiac and/or respiratory failure with extracorporeal membrane oxygenation. Spearman's ranked correlations were performed for each coagulation test compared to heparin dosage. The Bland-Altman test was used to determine the validity of the point-of-care activated partial thromboplastin time. Hazard analysis was conducted for outcomes and complications for patients whose heparin management was based on the clinical laboratory activated partial thromboplastin time or the activated clotting time. Only the clinical laboratory activated partial thromboplastin time showed a correlation (ρ = 0.40 vs. ρ = -0.04 for activated clotting time) with the heparin administration (units/kg/hr). Point-of-care activated partial thromboplastin time and activated partial thromboplastin time values correlated well (ρ = 0.76), with <5% of samples showing a difference outside 2 SDs, but differences in their absolute values (Δactivated partial thromboplastin time = 100 secs) preclude them from being interchangeable measures. Furthermore, despite no effective change in the mean activated clotting time, cardiac patients showed a significantly improved correlation to heparin dose for all coagulation tests (e.g., point-of-care activated partial thromboplastin time ρ = 0.60). Management of patients with the clinical laboratory activated partial thromboplastin time did not significantly affect patient survival rates but did significantly reduce bleeding complications and significantly increased clotting in the extracorporeal membrane oxygenation circuit. A hazard analysis demonstrated that bleeding complications were associated with an increased risk of mortality, whereas clotting complications in the extracorporeal membrane oxygenation circuit were not. CONCLUSIONS: The activated clotting time is not an accurate monitoring tool for heparin management in pediatricextracorporeal membrane oxygenation. The point-of-care activated partial thromboplastin time correlates well with the clinical laboratory activated partial thromboplastin time but cannot be substituted for the clinical laboratory activated partial thromboplastin time values. Management of pediatric extracorporeal membrane oxygenation patients with the clinical laboratory activated partial thromboplastin time reduced bleeding complications which are associated with increases in mortality.

Coagulation and hemolysis complications in neonatal ECLS: Role of devices.

Neonatal extracorporeal life support (ECLS) has enjoyed a long history of successful patient support for both cardiac and respiratory failure. The small size of this patient population has provided many technical challenges from cannulation to pumps and oxygenators. This is further complicated by the relatively meager commercial options for equipment owing to the relatively low utilization of neonatal ECLS compared to adults, which has exploded following the H1N1 epidemic and the availability of the polymethylpentene oxygenator. This paper focuses on the impact of equipment choices on thrombosis and hemolysis in neonatal ECLS and the underlying mechanisms behind them. Based upon the available evidence, it is clear neonatal ECLS requires careful attention to the selection and operation of all parts of the ECLS system. Practitioners should also be aware of the factors that increase blood cell fragility, which can impact decisions around equipment and subsequent operation.

Extracorporeal Life Support for Status Asthmaticus: Early Outcomes in Teens and Young Adults.

Extracorporeal life support (ECLS) may be life saving for patients with status asthmaticus (SA), a difficult-to-treat, severe subset of asthma. Contemporary ECLS outcomes for SA in teens and young adults are not well described. The Extracorporeal Life Support Organization (ELSO) Registry was reviewed (2009-2019) for patients (15-35 years) with a primary diagnosis of SA. In-hospital mortality and complications were described. Multivariable logistic regression was used to identify independent risk factors for hospital mortality. Overall, 137 patients, (26 teens and 111 young adults; median age 25 years) were included. Extracorporeal life support utilization for SA sharply increased in 2010, coinciding with increased ECLS utilization overall. Median ECLS duration and length of stay were 97 hours and 11 days, respectively. In-hospital mortality and major complication rates were 10% and 11%, respectively. Nonsurvivors were more likely to have experienced ECLS complications, compared to survivors (86% vs. 42%, p = 0.003). Independent risk factors for in-hospital mortality included pre-ECLS arrest and any renal and/or neurologic complication. Prospective studies designed to evaluate complications and subsequent failure to rescue may help optimize quality improvement efforts.

Hearing outcomes in children with Congenital Cytomegalovirus: A multi-center, single-enterprise experience.

BACKGROUND: Cytomegalovirus (CMV) is the most common cause of non-genetic sensorineural hearing loss (SNHL) in the United States; yet screening for congenital CMV (cCMV) remains controversial. CMV related SNHL can be present at birth, or develop in a delayed manner, and it is a consistent feature in children with either symptomatic or asymptomatic disease. A retrospective chart review was performed to determine the characteristics of patients diagnosed with cCMV and SNHL. METHODS: The electronic database warehouse of the Nemours Children's Health System (NCHS) was queried from 01/01/2004 to 10/05/2019. ICD 9 (771.1) and ICD 10 (B25.9, P35.1) diagnostic codes were used to identify patients throughout the system with a diagnosis of cCMV infection. Patient demographics including gender, race/ethnicity, age of diagnosis, results of newborn hearing screening (NBHS), detection and progression of hearing loss, presence of antiviral therapy, and frequency of monitoring were collected, and descriptive statistics performed. RESULTS: Of the 170 patients confirmed to have cCMV, 153 (90%) were symptomatic and 17 (10%) were asymptomatic. CNS involvement (63.5%), radiographic evidence of disease present (69.4%), and SNHL (50.6%) were the most common manifestations of the disease. Of these 170 patients, 83 (48.8%) were determined to have SNHL eligible for evaluation. For these patients with SNHL, the average time of hearing monitoring was 50.6 months. At the time of initial reported detection 63 of 83 (76%) had bilateral hearing loss and 20 (24%) had unilateral loss. Over the study period 3 (15%) progressed from unilateral to bilateral involvement, and 32 (47%) had a deterioration in hearing, with severe to profound SNHL in at least one ear identified at the last visit in 53 (64%) patients. Newborn hearing testing results were available for 69 (83%) of those with hearing loss and 26 patients passed initial testing. However, of the 26 patients who passed, 22 (85%) eventually developed SNHL by their last visit. Within our cohort, females with cCMV were significantly more likely to have SNHL than males with cCMV (62.3% versus 37.6%; p < 0.01). CONCLUSION: In the absence of targeted or universal cCMV screening, the majority of children identified with this condition present symptomatically. Approximately one half of children with symptomatic cCMV failed NBHS at birth while at least 25% develop SNHL later in life. Children with cCMV are at high risk of delayed onset loss and such children, particularly females, should be monitored closely.

A Minimal Opioid Postoperative Management Protocol in Congenital Cardiac Surgery: Safe and Effective.

There is evidence that reducing opioid exposure in children undergoing cardiac surgery may enhance postoperative recovery. We aimed to describe a minimal opioid postoperative management protocol in children undergoing cardiac surgery and our early outcomes with this strategy. We reviewed the medical records of children (6 months-18 years) who underwent elective cardiac surgery through a median sternotomy with cardiopulmonary bypass at our institution between 2016 and 2018. All patients were managed postoperatively using a standardized protocol. 101 children (median age 5 years) were included and 85% were extubated in the operating room. Although most patients (96%) received opioids postoperatively, opioid requirements decreased steadily over time, with 88%, 58%, and 18% of children receiving opioids on postoperative day 1, 2, and 3, respectively; 41% received no opioids after postoperative day 1. The median cumulative opioid exposure was 0.25 morphine milligram equivalents per kg (interquartile range, 0.10-0.75). Greater than mild pain was rare (<10%) at each time point. The rates of operative mortality and major complication were 0% and 3%, respectively. The median postoperative length of stay was 3 days, and 13% required readmission within 30 days. Age, cardiopulmonary bypass time, and number of benzodiazepine doses were independently associated with cumulative opioid exposure. Any complication, chest tube time, and higher STAT Category were independently associated with prolonged postoperative length of stay. A minimal opioid postoperative management protocol can be safe and effective in children undergoing cardiac surgery. Future prospective studies are needed to determine optimal practice and patient selection.

Development of a Standardized Assessment of Simulation-based Extracorporeal Membrane Oxygenation Educational Courses.

Background: In 2020, the Extracorporeal Life Support Organization education task force identified seven extracorporeal membrane oxygenation (ECMO) educational domains that would benefit from international collaborative efforts. These included research efforts to delineate the impact and outcomes of ECMO courses. Objective: Development of a standardized online assessment tool to evaluate the effectiveness of didactic and simulation-based ECMO courses on participants' confidence, knowledge, and simulation-based skills; participant satisfaction; and course educational benefits. Methods: We performed a prospective multicenter observational study of five different U.S. academic institution-based adult ECMO courses that met Extracorporeal Life Support Organization endorsement requirements for course structure, educational content, and objectives. Standardized online forms were developed and administered before and after courses, assessing demographics, self-assessment regarding ECMO management, and knowledge examination (15 simple-recall multiple-choice questions). Psychomotor skill assessment was performed during the course (time to complete prespecified critical actions during simulation scenarios). Self-assessment evaluated cognitive, behavioral, and technical aspects of ECMO; course satisfaction; and educational benefits. Results: Out of 211 participants, 107 completed both pre- and postcourse self-assessment forms (97 completed both pre- and postcourse knowledge forms). Fifty-three percent of respondents were physician intensivists, with most (51%) practicing at academic hospitals and with less than 1 year of ECMO experience (50%). After the course, participants reported significant increases in confidence across all domains (cognitive, technical, and behavioral, P < 0.0001, 95% confidence interval [CI], 1.2-1.5; P < 0.0001, 95% CI, 2.2-2.6; and P = 0.002, 95% CI, 1.7-2.1, respectively) with an increase in knowledge scores (P < 0.001; 95% CI, 1.4-2.5). These findings were most significant in participants with less ECMO experience. There were also significant reductions in times to critical actions in three of the four scored simulation scenarios. The results demonstrated participants' satisfaction with most course aspects, with more than 95% expressing that courses met their educational goals. Conclusion: We developed and tested a structured ECMO course assessment tool, demonstrating participants' self-reported benefit as well as improvement in psychomotor skill acquisition, course satisfaction, and educational benefits. Course evaluation is feasible and potentially provides important information to improve ECMO courses. Future steps could include national implementation, addition of questions targeting clinical decision making to further assess knowledge gain, and multilanguage translation for implementation in international courses.

Capturing Adult Congenital Heart Disease: Framework for Development of an Adult Congenital Heart Disease Mortality Risk Model.

BACKGROUND: As a formative step toward development of adult congenital heart disease (ACHD) risk-adjusted metrics, we describe The Society of Thoracic Surgeons (STS) ACHD population, procedural frequency, and early mortality. METHODS: Adults (≥18 years) with CHD (2014-2019) were identified in the STS Adult Cardiac Surgery (ASCD) and the Congenital Heart Surgery (CHSD) Databases. After deduplication, variable mapping, data concatenation, and harmonization of preprocedure factors, procedures were grouped, and unadjusted mortality was catalogued for the overall cohort and the cohort excluding patients with an isolated bicuspid aortic valve (BAV). RESULTS: Among 171 186 ACSD and 18 281 CHSD records, 152 731 unique records met inclusion criteria. Twenty-eight congenital diagnoses accounted for 86% of the overall cohort, and prevalence of ACHD increased over the study time frame. ACHD patients underwent operations to treat both acquired and CHD. Most common procedures overall and after excluding isolated BAV were aortic valve replacement (AVR), ascending aortic surgery, and coronary artery bypass grafting (CABG). After excluding isolated BAV, major procedure combinations occurred in 46% (31% had 2 major procedures and 3% had ≥4), and the most prevalent combinations included AVR + CABG (n = 2352), AVR + subaortic stenosis repair (n = 1481), and AVR + ascending aortic surgery (n = 1239). Unadjusted 30-day mortality was procedure dependent, 2.8% overall and 3.6% with isolated BAV excluded. CONCLUSIONS: The ACHD surgical population is heterogenous, and patients undergo surgery for CHD-related and adult/acquired procedure combinations. Early mortality is variable and influenced by surgical complexity. Excluding isolated BAV patients and developing procedure-based ACHD mortality risk models may be ideal but will require empirically derived grouping and collaboration.

Platelet activation in ovines undergoing sham surgery or implant of the second generation PediaFlow pediatric ventricular assist device.

The PediaFlow pediatric ventricular assist device (VAD) is a magnetically levitated turbodynamic pump under development for circulatory support of small children with a targeted flow rate range of 0.3-1.5 L/min. As the design of this device is refined, ensuring high levels of blood biocompatibility is essential. In this study, we characterized platelet activation during the implantation and operation of a second generation prototype of the PediaFlow VAD (PF2) and also performed a series of surgical sham studies to examine purely surgical effects on platelet activation. In addition, a newly available monoclonal antibody was characterized and shown to be capable of quantifying ovine platelet activation. The PF2 was implanted in three chronic ovine experiments of 17, 30, and 70 days, while surgical sham procedures were performed in five ovines with 30-day monitoring. Blood biocompatibility in terms of circulating activated platelets was measured by flow cytometric assays with and without exogenous agonist stimulation. Platelet activation following sham surgery returned to baseline in approximately 2 weeks. Platelets in PF2-implanted ovines returned to baseline activation levels in all three animals and showed an ability to respond to agonist stimulation. Late-term platelet activation was observed in one animal corresponding with unexpected pump stoppages related to a manufacturing defect in the percutaneous cable. The results demonstrated encouraging platelet biocompatibility for the PF2 in that basal platelet activation was achieved early in the pump implant period. Furthermore, this first characterization of the effect of a major cardiothoracic procedure on temporal ovine platelet activation provides comparative data for future cardiovascular device evaluation in the ovine model.

Middle ear effusion prevalence at time of tympanostomy before and during COVID-19 pandemic.

BACKGROUND: Management of pediatric otitis media with effusion (OME) and recurrent otitis media typically includes observation up to 3 months. Bilateral myringotomy and tube (BMT) placement is performed due to persistent effusion with associated symptoms such as decreased hearing. With the COVID-19 pandemic and mandatory stay at home orders (MSHO), children were quarantined at home and many remained home after MSHO. We reviewed the prevalence of middle ear effusion (MEE) at the time of BMT during similar time periods in the year before, during and after MSHO in this pandemic year. STUDY DESIGN: Retrospective summary of BMT cases at a single tertiary children's hospital. METHODS: All children <18 years who underwent BMT between March 1, 2020 and July 1, 2020 and between March 1, 2019 and July 1, 2019 were included. Statistical analysis included chi-squared and Mann-Whitney U tests. RESULTS: A total of 778 cases were reviewed; 551 (71%) were performed pre-pandemic and 227 (29%) during onset of pandemic (N = 778). There were no significant differences in gender, age, and BMI between groups, but significantly fewer Caucasians (58% vs. 45%, p < 0.05) and more Hispanics (20% vs. 33%, p < 0.05) during-COVID. The prevalence of intraoperative effusion during-COVID was significantly lower compared to pre-COVID (65% vs. 83%, p < 0.001). CONCLUSION: Pandemic and COVID-19 MSHO were associated with significantly lower intraoperative OME prevalence. Further research may elucidate the impact of face covering, social distancing, and virtual schooling on the incidence of pediatric ROM, OME, and ENT symptoms.