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Background: Complications associated with suboptimal pain management after pediatric cardiac surgery have increased interest in regional anesthesia (RA). We sought to evaluate national trends and explore the association of RA with postoperative outcomes following pediatric cardiac surgery., Methods: Patients <18 years in the Society of Thoracic Surgeons Congenital Cardiac Anesthesia Society Database from 01/2016-05/2023 were analyzed. Non-OR operations and records with missing data on RA were excluded. Data on patients, centers, operations, year, and RA type and medication were collected, and trends over the 8-year study period were analyzed. The association of RA with outcomes was analyzed with multivariable modeling in a subpopulation of children without preoperative risk factors who underwent index atrial and ventricular septal defect (ASD/VSD) repairs and Fontan procedures., Results: The cohort included 95,514 operations from 62 U.S., Centers: RA was used in 8.4 % (N = 7997) and increased annually from 6.1 % in 2016 to 12.5 % in 2023. Prevalence was highest in cases performed in children 1-11 years, characterized as low risk, and conducted low volume centers. There were statistically significant increases (p < 0.001) in RA use across all age groups and surgical risk categories during the study period. While the number of neuraxial techniques remained constant year-to-year, the number of non-neuraxial techniques (i.e., fascial plane blocks) increased sixfold during the study period. In the sub-analysis cohort (N = 7931), patients with RA for septal defect repairs and Fontan procedures were more likely to be extubated in the OR compared to non-RA patients (p < 0.001). ASD and VSD patients with RA were also more likely to have a short length of stay compared to those without RA (p < 0.001)., Conclusions: RA use is increasing in pediatric cardiac surgery in the U.S. and may be associated with surgery-specific outcome improvements., Competing Interests: Declaration of competing interest The authors declare no competing interests., (Copyright © 2025 Elsevier Inc. All rights reserved.)

Background: Prophylactic steroids are often used to reduce the systemic inflammatory response to cardiopulmonary bypass in infants undergoing heart surgery. The STRESS trial found that the likelihood of a worse outcome did not differ between infants randomized to methylprednisolone (n=599) versus placebo (n=601) in a risk-adjusted primary analysis (adjusted odds ratio [OR], 0.86; 95% CI, 0.71 to 1.05; P=0.14). However, secondary analyses showed possible benefits with methylprednisolone. To ensure that a potentially efficacious therapy is not unnecessarily avoided, we re-analyzed the STRESS trial using Bayesian analytics to assess the probability of benefit., Methods: Our Bayesian analysis used the original STRESS trial primary outcome measure, a hierarchically ranked composite of death, transplant, major complications and post-operative length of stay. We evaluated probability of benefit (OR<1) versus harm (OR>1) by comparing the posterior distribution of the OR assuming a neutral probability of benefit versus harm with weak prior belief strength (nearly non-informative prior distribution). Reference results were calculated under the vague prior distribution. To convey magnitude of effect we used model parameters to calculate a predicted risk of death, transplant or major complications for methylprednisolone and placebo. Analyses consisted of 10 Markov Chain Monte Carlo simulations, each consisting of 2000 iterations with a 1000 iteration burn-in to ensure proper posterior convergence. Sensitivity analyses evaluated pessimistic (5%-30% prior likelihood of benefit), neutral and optimistic (70%-95%) prior beliefs, and controlled strength of prior belief as weak (30% variance), moderate (15%) and strong (5%)., Results: In primary analysis, the posterior probability of benefit from methylprednisolone was 91% and probability of harm was 9%. Composite death or major complication occurred in 18.8% of trial subjects with an absolute risk difference of -2% (95% CI -3%, +1%) associated with methylprednisolone. Each of 9 sensitivity analyses demonstrated greater probability of benefit than harm in the methylprednisolone group with 8 of 9 demonstrating >80% probability of benefit and ≥1% absolute difference in risk of death, transplant or major complications., Conclusion: Probability of benefit with prophylactic methylprednisolone is high and harm is unlikely. This more in-depth analysis of the data expands the initial clinical evaluation of methylprednisolone provided by the STRESS trial.

Background: Children who undergo cardiac surgery may require postcardiotomy extracorporeal membrane oxygenation (ECMO). Although morbidities are considerable, our understanding of outcome determinants is limited. We evaluated associations between patient and perioperative factors with outcomes., Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for patients aged <18 years old who underwent postcardiotomy ECMO from January 2016 through June 2021. The primary outcome was survival to hospital discharge. The secondary outcome was survival without neurologic injury. Logistic regression for binary outcomes and competing risk analysis for survival were used to identify the most important predictors. Variables were selected by stepwise procedure using entry level P = .35. Those with P ≤ .1 were kept in the final model., Results: Postcardiotomy ECMO was used to support 3181 patients during the same hospitalization as cardiac surgery: (A) intraoperative initiation of ECMO, n = 1206; (B) early postoperative (≤48 hours), n = 936; and (C) late postoperative (>48 hours), n = 1039. The most common primary procedure of the index operation was the Norwood procedure. Of those with intraoperative ECMO, 57% survived to discharge vs 59% with early postoperative ECMO and 42% late postoperative ECMO (χ 2 (2)  = 64, P < .0001, V = 0.14). In all groups, postoperative septicemia, cardiac arrest, and new neurologic injury had the strongest association with mortality, whereas postoperative reintubation and unplanned noncardiac reoperation were associated with higher survival., Conclusions: Multiple risk factors impact survival in children who undergo cardiac surgery and postcardiotomy ECMO. ECMO initiated >48 hours after surgery is associated with the poorest outcomes. This is the first step in creating a predictive tool to educate clinicians and families regarding expectations in this high-risk population., Competing Interests: Disclosures Farhan Zafar reports a relationship with TransMedics Inc that includes: employment. David S. Cooper reports a relationship with Mallinckrodt LLC that includes: consulting or advisory and with Prolacta Bioscience Inc that includes: speaking and lecture fees. Ravi Thiagarajan reports a relationship with Extracorporeal Life Support Organization that includes: speaking and lecture fees and with the Society of Critical Care Medicine that includes: speaking and lecture fees. Jeffrey P. Jacobs reports a relationship with American Academy of Dermatology that includes: consulting or advisory and with SpecialtyCare that includes: consulting or advisory. Iki Adachi reports a relationship with Nipro Corporation that includes: speaking and lecture fees. Katsuhide Maeda reports a relationship with Abbott that includes: consulting or advisory and with Peca Labs that includes: consulting or advisory. David L.S. Morales reports a relationship with Abbott that includes: consulting or advisory; with Peca Labs that includes: consulting or advisory; with Berlin Heart that includes: consulting or advisory; and with SynCardia Systems LLC that includes: consulting or advisory. The other authors have no conflicts of interest to disclose., (Copyright © 2025 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Epilepsy is a common neurological disease affecting nearly 1% of the global population, and temporal lobe epilepsy (TLE) is the most common type. Patients experience recurrent seizures and chronic cognitive deficits that can impact their quality of life, ability to work, and independence. These cognitive deficits often extend beyond the temporal lobe and are not well understood. It has been proposed in the extended network inhibition hypothesis that repeated spread of seizure activity to the ascending reticular activating system (ARAS) may contribute to these deficits. Disease duration has been associated with other network changes in patients with TLE, but few studies have investigated the relationship between disease duration, ARAS connectivity, and cognitive deficits in TLE. Furthermore, epilepsy surgery can result in seizure freedom and cognitive improvement in some patients, but it is unclear how the surgery affects ARAS connectivity., Methods: Resting-state functional MRI data were collected for patients with TLE (preoperatively in 40 and postoperatively in 25), and for 40 age-matched healthy controls. Functional connectivity was computed between all regions. Functional connectivity and segregation, a graph-theory measure of network isolation, were compared across the age spectrum in patients and controls. These same measures were evaluated as a function of epilepsy duration by controlling for age using a linear model built on healthy control data., Results: The authors found that increases in epilepsy duration were associated with greater segregation of the ARAS and decreased functional connectivity between the pedunculopontine tegmental nucleus and the frontoparietal association cortex. Furthermore, patients with impaired neurocognitive function were noted to have longer epilepsy duration and higher ARAS segregation compared to patients with spared neurocognition. After surgery, completely seizure-free patients demonstrated ARAS connectivity patterns that resembled those found in controls, whereas patients with residual seizures had persistent abnormal connectivity., Conclusions: These findings suggest that recurrent seizures may contribute to isolation of critical subcortical activating structures, possibly impacting cognitive function. Furthermore, some ARAS functional connectivity abnormalities can be reversed if seizure freedom is achieved after epilepsy surgery. These results provide support for the extended network inhibition hypothesis, may lend insight into the progressive effect of recurrent seizures on arousal networks, and may lead to improved interventions to halt or reverse network impairments in patients with TLE.

Executive functions, including working memory, are typically assessed clinically with neuropsychological instruments. In contrast, computerized tasks are used to test these cognitive functions in laboratory human and animal studies. Little is known of how neural activity captured by laboratory tasks relates to ability measured by clinical instruments and, by extension, clinical diagnoses of pathological conditions. We therefore sought to determine what aspects of neural activity elicited in laboratory tasks are predictive of performance in neuropsychological instruments. We recorded neural activity from intracranial electrodes implanted in human epilepsy patients as they performed laboratory working memory tasks. These patients had completed neuropsychological instruments preoperatively, including the Weschler Adult Intelligent Scale and the Wisconsin Card Sorting test. Our results revealed that increased high-gamma (70-150 Hz) power in the prefrontal and parietal cortex after presentation of visual stimuli to be remembered was indicative of lower performance in the neuropsychological tasks. On the other hand, we observed a positive correlation between high-frequency power amplitude in the delay period of the laboratory tasks and neuropsychological performance. Our results demonstrate how neural activity around task events relates to executive function and may be associated with clinical diagnosis of specific cognitive deficits.

Background: Tricuspid atresia (TA) is the second most common form of functionally univentricular heart. For patients with TA and normally related great arteries (Type I), left ventricular outflow tract obstruction (LVOTO) is rare., Methods: From the Congenital Heart Surgeons' Society multi-institutional cohort of 445 patients with Type I TA enrolled from 1999 to 2024 from 42 sites, 14 infants (3%) had interventions for associated LVOTO, either at presentation or after their first TA-related intervention., Results: Of seven infants initially undergoing Norwood/Damus-Kaye-Stansel (DKS), six survived to Stage II, of whom five survived with one developing pulmonary hypertension and four achieving Fontan. An additional seven infants who were first managed with pulmonary artery band placement subsequently had bidirectional superior cavopulmonary anastomosis (BCPA) and a DKS procedure; there were six survivors, all achieving Fontan. All ten survivors who underwent the Fontan procedure had normal left ventricular and mitral valve function at the latest follow-up. The overall Kaplan-Meier survival estimate at 20 years for these 14 patients was 79% (70% CI, 66%-88%), and the median follow-up was 8.3 years (0.24-21.5)., Conclusions: While infants with TA and transposition of the great arteries are more likely to have LVOTO, this can also occur in the setting of normally related great arteries. Infants with Type I TA and LVOTO can be managed in the neonatal period with the Norwood procedure ensuring complete arch relief with acceptable outcomes. If LVOTO becomes evident after initial pulmonary artery band placement, a subsequent DKS procedure facilitates satisfactory success to Fontan., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Arterial switch operation (ASO) has supplanted physiologic repairs for transposition of the great arteries and related anomalies. As survival rates have increased, so has the potential need for cardiac reoperations to address ASO-related complications arising later in life., Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database (2010-2021) was reviewed to assess prevalence and types of cardiac reoperations for patients aged ≥10 years with prior ASO for transposition of the great arteries or double-outlet right ventricle/transposition of the great arteries type. A hierarchical stratification designating 13 procedure categories was established a priori by investigators. Each eligible surgical hospitalization was assigned to the single highest applicable hierarchical category. Outcomes were compared across procedure categories, excluding hospitalizations limited to pacemaker-only and mechanical circulatory support-only procedures. Variation during the study period in relative proportions of left heart vs non-left heart procedure category encounters was assessed., Results: There were 698 cardiac surgical hospitalizations for patients aged 10 to 35 years at 100 centers. The most common left heart procedure categories were aortic valve procedures (n = 146), aortic root procedures (n = 117), and coronary artery procedures (n = 40). Of 619 hospitalizations eligible for outcomes analysis, major complications occurred in 11% (67/619). Discharge mortality was 2.3% (14/619). Year-by-year analysis of surgical hospitalizations reveals substantial growth in numbers for the aggregate of all procedure categories. Growth in relative proportions of left heart vs non-left heart procedures was significant (P = .0029; Cochran-Armitage trend test)., Conclusions: This large multicenter study of post-ASO reoperations beyond early childhood documents year-over-year growth in total reoperations. Left-sided heart procedures recently had the highest rate of rise. These observations have implications for counseling, surveillance, and management., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Significant atrioventricular valve dysfunction can be associated with mortality or need for transplant in functionally univentricular heart patients undergoing staged palliation. The purposes of this study are to characterize the impact of concomitant atrioventricular valve intervention on outcomes at each stage of single ventricle palliation and to identify risk factors associated with poor outcomes in these patients. Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for functionally univentricular heart patients undergoing single ventricle palliation from 2013 through 2022. Separate analyses were performed on cohorts corresponding to each stage of palliation (1: initial palliation; 2: superior cavopulmonary anastomosis; 3: Fontan procedure). Bivariate analysis of demographics, diagnoses, comorbidities, preoperative risk factors, operative characteristics, and outcomes with and without concomitant atrioventricular valve intervention was performed. Multiple logistic regression was used to identify predictors associated with operative mortality or major morbidity. Results: Concomitant atrioventricular valve intervention was associated with an increased risk of operative mortality or major morbidity for each cohort (cohort 1: 62% vs 46%, P  < .001; cohort 2: 37% vs 19%, P  < .001; cohort 3: 22% vs 14%, P  < .001). Black race in cohort 1 (odds ratio [OR] 3.151, 95% CI 1.181-9.649, P  = .03) and preterm birth in cohort 2 (OR 1.776, 95% CI 1.049-3.005, P  = .032) were notable predictors of worse morbidity or mortality. Conclusions: Concomitant atrioventricular valve intervention is a risk factor for operative mortality or major morbidity at each stage of single ventricle palliation. Several risk factors are associated with these outcomes and may be useful in guiding decision-making., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: The increasing number of congenital heart disease patients undergoing reoperative cardiac surgery presents critical and growing challenges. Our objective was to evaluate the association between the number of prior cardiopulmonary bypass operations and operative mortality and morbidity in a national cohort., Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) was reviewed for index cardiac operations on cardiopulmonary bypass during 2016 to 2021. Infants and patients with functionally univentricular physiology were excluded. Multivariable logistic regression adjusted for covariates in the STS-CHSD Mortality Risk Model, the STS-European Association for Cardio-Thoracic Surgery (STAT) Mortality Category, and institutional volume., Results: Of 50,625 eligible operations, 22,100 (44%) were performed on patients with ≥1 prior cardiopulmonary bypass operations. Most common diagnoses were tetralogy of Fallot (4340 of 22,100 [19.6%]), pulmonary atresia/ventricular septal defect (1334 of 22,100 [6.0%]), and aortic stenosis (966 of 22,100 [4.4%]). Operative mortality correlated with number of prior cardiopulmonary bypass operations: 157 of 28,525 (0.6%) for 0, 127 of 13,488 (0.9%) for 1, 81 of 5,664 (1.4%) for 2, 61 of 2039 (3.0%) for 3, 35 of 623 (5.6%) for 4, 10 of 207 (4.8%) for 5, and 5 of 79 (6.3%) for ≥6 operations (P < .001). On multivariable analysis, patients with ≥3 prior cardiopulmonary bypass operations had higher risk of operative mortality (odds ratio, 2.31; P < .001) and major morbidity (odds ratio, 1.60; P < .001). Annual institutional volume and age were not associated with either outcome., Conclusions: Three or more prior cardiopulmonary bypass operations was an independent risk factor for operative mortality/morbidity, even after controlling for risk factors and institutional volume. Future research is needed to identify modifiable factors to optimize outcomes, particularly for those with ≥3 prior cardiopulmonary bypass operations., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Despite documented associations between social determinants of health and outcomes post-congenital heart surgery, clinical risk models typically exclude these factors., Objectives: The study sought to characterize associations between social determinants and operative and longitudinal mortality as well as assess impacts on risk model performance., Methods: Demographic and clinical data were obtained for all congenital heart surgeries (2006-2021) from locally held Congenital Heart Surgery Collaborative for Longitudinal Outcomes and Utilization of Resources Society of Thoracic Surgeons Congenital Heart Surgery Database data. Neighborhood-level American Community Survey and composite sociodemographic measures were linked by zip code. Model prediction, discrimination, and impact on quality assessment were assessed before and after inclusion of social determinants in models based on the 2020 Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model., Results: Of 14,173 total index operations across New York State, 12,321 cases, representing 10,271 patients at 8 centers, had zip codes for linkage. A total of 327 (2.7%) patients died in the hospital or before 30 days, and 314 children died by December 31, 2021 (total n = 641; 6.2%). Multiple measures of social determinants of health explained as much or more variability in operative and longitudinal mortality than clinical comorbidities or prior cardiac surgery. Inclusion of social determinants minimally improved models' predictive performance (operative: 0.834-0.844; longitudinal 0.808-0.811), but significantly improved model discrimination; 10.0% more survivors and 4.8% more mortalities were appropriately risk classified with inclusion. Wide variation in reclassification was observed by site, resulting in changes in the center performance classification category for 2 of 8 centers., Conclusions: Although indiscriminate inclusion of social determinants in clinical risk modeling can conceal inequities, thoughtful consideration can help centers understand their performance across populations and guide efforts to improve health equity., Competing Interests: Funding Support and Author Disclosures This work was supported by National Institutes of Health/National Heart, Lung, and Blood Institute (R01 HL150044), National Institutes of Health/National Institute of Mental Health (T32 MH019733), and Agency for Healthcare Research and Quality (T32 HS000055). The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the National Institutes of Health, Agency of Healthcare Research and Quality, or New York State Department of Health. Examples of analysis performed within this paper are only examples. They should not be used in real-world analytic products. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate indicators of potentially hazardous alcohol use among older adults living in a region with high substance use stigma., Methods: Patients at a university-affiliated geriatrics clinic in the Deep South of theUS completed behavioral health screenings including self-reported alcohol use, symptoms of depression or anxiety, and cognitive functioning between 2018 and 2022., Results: Participants ( N  = 278) averaged 76.04 years of age (SD = 9.25), were predominantly female (70.9%), and non-Hispanic white (84.5%), with an averageof 6.08 comorbid diagnoses (SD = 2.86). Race/ethnicity, age, and symptoms of anxiety were associated with alcohol use and hazardous alcohol use, with non-Hispanic whites, younger individuals, and those with more anxiety symptoms reporting more alcohol use. Notably, alcohol use and hazardous alcohol use were associated with cognitive functioning in the dementia range., Conclusion: Self-reported alcohol use is low in geriatric primary care in the Deep South, US, differs by race/ethnicity, and is predictive of cognitive impairment when alcohol use is hazardous. Issues of trust and stigma may play a role in self-report ofstigmatized behaviors., Clinical Implications: Self-reported alcohol intake must be considered within the cultural context of regional stigma. Recommendations to address this are provided.

Background: We aimed to evaluate the effect of age at operation on postoperative outcomes in children undergoing a Kawashima operation., Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for Kawashima procedures from January 1, 2014, to June 30, 2020. Patients were stratified by age at operation in months: 0 to <4, 4 to <8, 8 to <12, and >12. Subsequently, outcomes for those in whom the Kawashima was not the index operation and for those undergoing hepatic vein incorporation (Fontan completion or hepatic vein-to-azygos vein connection) were evaluated., Results: We identified 253 patients who underwent a Kawashima operation (median age, 8.6 months; median weight, 7.4 kg): 12 (4.7%), 0 to <4 months; 96 (37.9%), 4 to <8 months; 81 (32.0%), 8 to <12 months; and 64 (25.3%), >12 months. Operative mortality was 0.8% (n = 2), with major morbidity or mortality in 17.4% (n = 44), neither different across age groups. Patients <4 months had a longer postoperative length of stay (12.5 vs 9.3 days; P = .03). The Kawashima was not the index operation of the hospital admission in 15 (5.9%); these patients were younger (6.0 vs 8.4 months; P = .05) and had more preoperative risk factors (13/15 [92.9%] vs 126/238 [52.9%]; P < .01). We identified 173 patients undergoing subsequent hepatic vein incorporation (median age, 3.9 years; median weight, 15.0 kg) with operative mortality in 6 (3.5%) and major morbidity or mortality in 30 (17.3%)., Conclusions: The Kawashima is typically performed between 4 and 12 months with low mortality. Morbidity and mortality were not affected by age. Hepatic vein incorporations may be higher risk than in traditional Fontan procedures, and ways to mitigate this should be sought., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Cell-free gene expression (CFE) systems are powerful tools for transcribing and translating genes outside of a living cell. Synthesis of membrane proteins is of particular interest, but their yield in CFE is substantially lower than that for soluble proteins. In this paper, we study the CFE of membrane proteins and develop a quantitative kinetic model. We identify that ribosome stalling during the translation of membrane proteins is a strong predictor of membrane protein synthesis due to aggregation between the ribosome nascent chains. Synthesis can be improved by the addition of lipid membranes, which incorporate protein nascent chains and, therefore, kinetically compete with aggregation. We show that the balance between peptide-membrane association and peptide aggregation rates determines the yield of the synthesized membrane protein. We define a membrane protein expression score that can be used to rationalize the engineering of lipid composition and the N-terminal domain of a native and computationally designed membrane proteins produced through CFE.

Background: Registry-based trials have the potential to reduce randomized clinical trial (RCT) costs. However, observed cost differences also may be achieved through pragmatic trial designs. A systematic comparison of trial costs across different designs has not been previously performed., Methods: We conducted a study to compare the current Steroids to Reduce Systemic inflammation after infant heart surgery (STRESS) registry-based RCT vs. two established designs: pragmatic RCT and explanatory RCT. The primary outcome was total RCT design costs. Secondary outcomes included: RCT duration and personnel hours. Costs were estimated using the Duke Clinical Research Institute's pricing model., Results: The Registry-Based RCT estimated duration was 31.9 weeks greater than the other designs (259.5 vs. 227.6 weeks). This delay was caused by the Registry-Based design's periodic data harvesting that delayed site closing and statistical reporting. Total personnel hours were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design (52,488 vs 29,763 vs. 24,480 h, respectively). Total costs were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design ($10,140,263 vs. $4,164,863 vs. $3,268,504, respectively). Thus, Registry-Based total costs were 32 % of the Explanatory and 78 % of the Pragmatic design., Conclusion: Total costs for the STRESS RCT with a registry-based design were less than those for a pragmatic design and much less than an explanatory design. Cost savings reflect design elements and leveraging of registry resources to improve cost efficiency, but delays to trial completion should be considered., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Eric L. Eisenstein: Nothing to disclose. Kevin D. Hill, MD, MSCI: Nothing to disclose. Nancy Wood, BS: Nothing to disclose. Jerry L. Kirchner, BS: Nothing to disclose. Kevin J. Anstrom, PhD, MS: Merck, Bayer, the National Institutes of Health, and the. Patient-Centered Outcomes Research Institute. Christopher B. Granger, MD: Consulting fees for the following companies: Abbvie, Abiomed, Alnylam Pharmaceuticals, Anthos, Bayer Corporation, Boehringer Ingelheim, Boston Scientific Corporation, Bristol Myers Squibb, Cardionomics, CeleCor Therapeutics, Cadrenal, Janssen Pharmaceutical, Medscape, LLC, Medtronic, Inc., Merck, Nation Institutes of Health, Novo Nordisk, Novartis Pharmaceutical Company, Pfizer, Philips, REATA, NephroSynergy. He also has salary funded by Duke grants sponsored by: Boehinger Ingelheim, Bristol Myers Squibb, Food and Drug Administration, Janssen Pharmaceuticals, Lilly Pharmaceutical, Novartis Pharmaceutical Company, Pfizer, and Philips. He has Equity in Tenac. io. Sunil V. Rao, MD: Grants from National Heart, Lung, and Blood Institute, American College of Cardiology. H. Scott Baldwin, MD: Nothing to disclose. Jeffrey P. Jacobs, MD: Consultant to American Academy of Dermatology. Marshall L. Jacobs, MD: Nothing to disclose. Prince J. Kannankeril, MD, MSCI: Nothing to disclose. Eric M. Graham, MD: Multiple NIH grants to perform research involving congenital heart disease. Sean M. O'Brien, PhD: Nothing to disclose. Jennifer S. Li, MD MHS: Nothing to disclose., (© 2024 The Authors. Published by Elsevier Inc.)

Background: Pulmonary artery banding (PAB) in isolation or combined with a congenital cardiac surgical procedure is common and has important mortality. We aimed to determine patient characteristics, clinical outcomes, variation in clinical outcomes by diagnoses, and center variation in PAB use., Methods: Using The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD), this study evaluated outcomes of patients undergoing PAB across diagnoses, participating centers, and additional procedures. Patients were identified by procedure and diagnosis codes from 2016 to 2019. We separated patients into groups of main and bilateral PAB and described their outcomes, focusing on patients with main PAB., Results: This study identified 3367 PAB procedures from 2016 to 2019 (3% of all STS CHSD cardiovascular cases during this period): 2677 main PAB, 690 bilateral PAB. Operative mortality was 8% after main PAB and 26% after bilateral PAB. There was significant variation in use of main PAB by center, with 115 centers performing at least 1 main PAB procedure (range, 1-134; Q1-Q3, 8-33). For patients with main PAB, there were substantial differences in mortality, depending on timing of main PAB relative to other procedures. The highest operative mortality (25%; P < .0001) was in patients who underwent main PAB after another separate procedure during their admission, with extracorporeal membrane oxygenation being the most frequent preceding procedure., Conclusions: PAB is a frequently used congenital cardiac procedure with high mortality and variation in use across centers. Outcomes vary widely by banding type and patient diagnosis. Main PAB after cardiac surgical procedures, especially extracorporeal membrane oxygenation, is associated with very high operative mortality., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: To compare patient characteristics and overall survival for infants with critical left heart obstruction after hybrid palliation (bilateral pulmonary artery banding with or without ductal stenting) versus nonhybrid management (eg, Norwood, primary transplantation, biventricular repair, or transcatheter/surgical aortic valvotomy)., Methods: From 2005 to 2019, 1045 infants in the Congenital Heart Surgeons' Society critical left heart obstruction cohort underwent interventions across 28 institutions. Using a balancing score propensity analysis, 214 infants who underwent hybrid palliation and 831 infants who underwent nonhybrid management were proportionately matched regarding variables significantly associated with mortality and variables noted to significantly differ between groups. Overall survival between the 2 groups was adjusted by applying balancing scores to nonparametric estimates., Results: Compared with the nonhybrid management group, infants who underwent hybrid palliation had lower birth weight, smaller gestational age, and higher prevalence of in-utero interventions, noncardiac comorbidities, preoperative mechanical ventilation, absent interatrial communication, and moderate or severe mitral valve stenosis (all P values < .03). Unadjusted 12-year survival after hybrid palliation and nonhybrid management, was 55% versus 69%, respectively. After matching, 12-year survival after hybrid palliation versus nonhybrid management was 58% versus 63%, respectively (P = .37). Among matched infants born weighing <2.5 kg, 2-year survival after hybrid palliation versus nonhybrid management was 37% versus 51%, respectively (P = .22)., Conclusions: Infants born with critical left heart obstruction who undergo hybrid palliation have more high-risk characteristics and anatomy versus infants who undergo nonhybrid management. Nonetheless, after adjustment, there was no significant difference in 12-year survival after hybrid palliation versus nonhybrid management. Mortality remains high, and hybrid palliation confers no survival advantage, even for lower-birth-weight infants., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Considering that the examination of psychological flexibility measures among older adults is scant, this study explores the psychometric properties of the Acceptance and Action Questionnaire-II (AAQ-II) among outpatient geriatrics primary care clinic patients in a university-affiliated medical center in the Deep South., Methods: On average, patients who consented to participate in research ( N  = 119) were 75.42 ( SD  = 9.14) years old. Approximately 74% were women, 91% were non-Hispanic white, and 86% lived in urban areas. Measures included psychological inflexibility, subjective health literacy, depression, anxiety, and global cognitive functioning., Results: The AAQ-II demonstrated adequate internal reliability, Cronbach's α = 0.79, and good test-retest reliability, r (28) = .84, p  < .001. With the removal of item 4, confirmatory factor analysis demonstrated adequate construct validity for the use of AAQ-II with older adults. As predicted, the AAQ-II exhibited concurrent, predictive, discriminant, and incremental validity within this older adult sample., Conclusions: These results demonstrate meaningful scientific and clinical implications. This is the first study to examine the psychometric properties of the Acceptance and Action Questionnaire-II (AAQ-II) in an older adult sample., Clinical Implications: The AAQ-II is a psychometrically sound measurement that can be clinically used on older adults.

Background: Against the background of earlier studies, recent patterns in surgical management of tetralogy of Fallot (TOF) were assessed., Methods: A retrospective review of The Society of Thoracic Surgeons (STS) Congenital Database (2010-2020) was performed on patients aged <18 years with TOF or pulmonary stenosis and primary procedure TOF surgical repair or palliation. Procedural frequencies were examined by epoch. Demographics, clinical variables, and outcomes were compared between the initial palliation and primary repair groups. Among those operated on at 0 to 60 days of age, variation in palliation rates across hospitals was assessed., Results: The 12,157 operations included 11,307 repairs (93.0%) and 850 palliations (7.0%); 68.5% of all palliations were modified Blalock-Taussig-Thomas shunts. Of 1105 operations on neonates, 45.4% (502) were palliations. Among neonates, palliations declined from 49.0% (331 of 675) in epoch 1 (2010-2015) to 39.8% (171 of 430) in epoch 2 (2016-2020; P = .0026). Overall, the most prevalent repair technique (5196 of 11,307; 46.0%) was ventriculotomy with transanular patch, which was also used in 520 of 894 (58.2%) of repairs after previous cardiac operations. Patients undergoing initial palliation demonstrated more preoperative STS risk factors (50.1% vs 24.3% respectively; P < .0001) and more major morbidity and mortality than patients undergoing primary repair (21.2% vs 7.46%; P < .0001). In the 0- to 60-day age group, risk factor-adjusted palliation rates across centers varied considerably, with 32 of 99 centers performing significantly more or significantly fewer palliations than predicted on the basis of their case mix., Conclusions: Surgical palliation rates have decreased across all age groups despite increasing prevalence of risk factors. Ventriculotomy with transanular patch remains the most prevalent repair type. The considerable center-level variation in rates of palliation was not completely explained by case mix., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: We reviewed all 64 articles ever published by The Congenital Heart Surgeons' Society (CHSS) Data Center to estimate the academic impact of these peer-reviewed articles., Materials and Methods: The Congenital Heart Surgeons' Society has performed research based on 12 Diagnostic Inception Cohorts. The first cohort (Transposition) began enrolling patients on January 1, 1985. We queried PubMed to determine the number of publications that referenced each of the 64 journal articles generated by the datasets of the 12 Diagnostic Inception Cohorts that comprise the CHSS Database. Descriptive summaries of the data were tabulated using mean with standard deviation and median with range., Results: Sixty-four peer-reviewed papers have been published based on the CHSS Database. Fifty-nine peer-reviewed articles have been published based on the 12 Diagnostic Inception Cohorts, and five additional articles have been published based on Data Science. Excluding the recently established Diagnostic Inception Cohort for patients with Ebstein malformation of tricuspid valve, the number of papers published per cohort ranged from 1 for coarctation to 11 for transposition of the great arteries. The 11 articles generated from the CHSS Transposition Cohort were referenced by a total of 111 articles (median number of references per journal article = 9 [range = 0-22, mean = 10.1]). Overall, individual articles were cited by an average of 11 (mean), and a maximum of 41 PubMed-listed publications. Overall, these 64 peer-reviewed articles based on the CHSS Database were cited 692 times in PubMed-listed publications. The first CHSS peer-reviewed article was published in 1987, and during the 35 years from 1987 to 2022, inclusive, the annual number of CHSS publications has ranged from 0 to 7, with a mean of 1.8 publications per year (median = 1, mode = 1)., Conclusion: Congenital Heart Surgeons' Society studies are widely referenced in the pediatric cardiac surgical literature, with over 10 citations per published article. These cohorts provide unique information unavailable in other sources of data. A tool to access this analysis is available at: [https://data-center.chss.org/multimedia/files/2022/CAI.pdf].

The World Journal for Pediatric and Congenital Heart Surgery ( WJPCHS ) was established in 2009, as a means of advancing the educational and scholarship goals of the World Society for Pediatric and Congenital Heart Surgery. WJPCHS has grown steadily since the first issue was published in April 2010. In 2017, the Congenital Heart Surgeons' Society and the European Congenital Heart Surgeons Association both designated WJPCHS as the official journal of their respective organizations. The CHSS and ECHSA represent the face and the voice of congenital heart surgery in North America (United States and Canada) and in Europe, respectively. Each organization has advanced the science of surgical management of congenital heart disease through multicenter outcomes analyses, which have strongly and positively influenced the care of patients around the world.

Introduction: Many kidney transplant (KT) centers decline patients with a body mass index (BMI) ≥40 kg/m 2 . This study's aim was to evaluate KT outcomes according to recipient BMI., Methods: We performed a single-center, retrospective review of adult KTs comparing BMI ≥40 patients (n = 84, BMI = 42 ± 2 kg/m 2 ) to a matched BMI < 40 cohort (n = 84, BMI = 28 ± 5 kg/m 2 ). Patients were matched for age, gender, race, diabetes, and donor type., Results: BMI ≥40 patients were on dialysis longer (5.2 ± 3.2 years vs. 4.1 ± 3.5 years, p = .03) and received lower kidney donor profile index (KDPI) kidneys (40 ± 25% vs. 53 ± 26%, p = .003). There were no significant differences in prevalence of delayed graft function, reoperations, readmissions, wound complications, patient survival, or renal function at 1 year. Long-term graft survival was higher for BMI ≥40 patients, including after adjusting for KDPI (BMI ≥40: aHR = 1.79, 95% CI = 1.09-2.9). BMI ≥40 patients had similar BMI change in the first year post-transplant (delta BMI: BMI ≥ 40 +.9 ± 3.3 vs. BMI < 40 +1.1 ± 3.2, p = .59)., Conclusions: Overall outcomes after KT were comparable in BMI ≥40 patients compared to a matched cohort with lower BMI with improved long-term graft survival in obese patients. BMI-based exclusion criteria for KT should be reexamined in favor of a more individualized approach., (© 2023 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.)

Throughout the SARS-CoV-2 pandemic, limited diagnostic capacities prevented sentinel testing, demonstrating the need for novel testing infrastructures. Here, we describe the setup of a cost-effective platform that can be employed in a high-throughput manner, which allows surveillance testing as an acute pandemic control and preparedness tool, exemplified by SARS-CoV-2 diagnostics in an academic environment. The strategy involves self-sampling based on gargling saline, pseudonymized sample handling, automated RNA extraction, and viral RNA detection using a semiquantitative multiplexed colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay with an analytical sensitivity comparable with RT-qPCR. We provide standard operating procedures and an integrated software solution for all workflows, including sample logistics, analysis by colorimetry or sequencing, and communication of results. We evaluated factors affecting the viral load and the stability of gargling samples as well as the diagnostic sensitivity of the RT-LAMP assay. In parallel, we estimated the economic costs of setting up and running the test station. We performed > 35,000 tests, with an average turnover time of < 6 h from sample arrival to result announcement. Altogether, our work provides a blueprint for fast, sensitive, scalable, cost- and labor-efficient RT-LAMP diagnostics, which is independent of potentially limiting clinical diagnostics supply chains., (© 2023 The Authors. Published under the terms of the CC BY NC ND 4.0 license.)

Background: Understanding the longitudinal burden of health care expenditures and utilization after pediatric cardiac surgery is needed to counsel families, improve care, and reduce outcome inequities., Objectives: The purpose of this study was to describe and identify predictors of health care expenditures and utilization for Medicaid-insured pediatric cardiac surgical patients., Methods: All Medicaid enrolled children age <18 years undergoing cardiac surgery in the New York State CHS-COLOUR database, from 2006 to 2019, were followed in Medicaid claims data through 2019. A matched cohort of children without cardiac surgical disease was identified as comparators. Expenditures and inpatient, primary care, subspecialist, and emergency department utilization were modeled using log-linear and Poisson regression models to assess associations between patient characteristics and outcomes., Results: In 5,241 New York Medicaid-enrolled children, longitudinal health care expenditures and utilization for cardiac surgical patients exceeded noncardiac surgical comparators (cardiac surgical children: $15,500 ± $62,000 per month in year 1 and $1,600 ± $9,100 per month in year 5 vs noncardiac surgical children: $700 ± $6,600 per month in year 1 and $300 ± $2,200 per month in year 5). Children after cardiac surgery spent 52.9 days in hospitals and doctors' offices in the first postoperative year and 90.5 days over 5 years. Being Hispanic, compared with non-Hispanic White, was associated with having more emergency department visits, inpatient admissions, and subspecialist visits in years 2 to 5, but fewer primary care visits and greater 5-year mortality., Conclusions: Children after cardiac surgery have significant longitudinal health care needs, even among those with less severe cardiac disease. Health care utilization differed by race/ethnicity, although mechanisms driving disparities should be investigated further., Competing Interests: Funding Support and Author Disclosures This work was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute (R01 HL150044), the National Institutes of Health/National Institute of Mental Health (T32 MH019733), and The Agency for Healthcare Research and Quality (T32 HS000055). The views and opinions expressed in this paper are those of the authors and do not necessarily reflect the official policy or position of the National Institutes of Health, the Agency of Healthcare Research and Quality, or the New York State Department of Health. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Psychological flexibility/inflexibility (PF/PI) is a core component of the acceptance and commitment therapy (ACT) model, which is gaining more attention in the geropsychological literature. This scoping review examines the size and scope of the research on PF/PI in older adulthood related to age differences between older adult and younger samples, correlates relevant to psychological health, and changes with ACT., Methods: A systematic literature search was conducted using PubMed, CINAHL, and PsycINFO. Peer-reviewed articles available in English were included that: had a mean age ≥65 and a minimum age ≥60; and reported self-report measures of PF/PI. We categorized PF/PI into three domains: open, aware, and engaged., Results: Forty-six articles were included. Most studies measured open or aware domains; few measured the engaged domain. Older adults evidenced greater awareness compared to younger adults (9 of 13 analyses were significant). Openness and awareness consistently yielded medium to large correlations with anxiety and depression. PF/PI did not relate with positive affect and inconsistently correlated with quality of life measures., Conclusion: Despite emerging trends, variability and limitations were evident in the literature. Specifically, measurement issues, lack of conceptual clarity, and the omission of values and behavioral measures require future attention.

Assembling transmembrane proteins on organic electronic materials is one promising approach to couple biological functions to electrical readouts. A biosensing device produced in such a way would enable both the monitoring and regulation of physiological processes and the development of new analytical tools to identify drug targets and new protein functionalities. While transmembrane proteins can be interfaced with bioelectronics through supported lipid bilayers (SLBs), incorporating functional and oriented transmembrane proteins into these structures remains challenging. Here, we demonstrate that cell-free expression systems allow for the one-step integration of an ion channel into SLBs assembled on an organic conducting polymer, poly(3,4-ethylenedioxythiophene) polystyrenesulfonate (PEDOT:PSS). Using the large conductance mechanosensitive channel (MscL) as a model ion channel, we demonstrate that MscL adopts the correct orientation, remains mobile in the SLB, and is active on the polyelectrolyte surface using optical and electrical readouts. This work serves as an important illustration of a rapidly assembled bioelectronic platform with a diverse array of downstream applications, including electrochemical sensing, physiological regulation, and screening of transmembrane protein modulators.

Background: The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database was queried to document variation of patient characteristics, procedure types, and programmatic case-mix., Methods: All index cardiac operations in patients less than 18 years of age in the STS Congenital Heart Surgery Database (July 2016 to June 2020) were eligible for inclusion except patients weighing ≤2.5 kg undergoing isolated patent ductus arteriosus closure. At the hospital level, we describe variations in patient and procedural characteristics known from previous analyses to be associated with outcomes. We also report variations across hospitals of programmatic case-mix., Results: Data were analyzed from 117 sites (90 322 total operations, 87 296 total index cardiac operations eligible for STAT [STS-European Association for Cardio-Thoracic Surgery] 2020 Mortality Score). The median annual total index cardiac operations eligible for STAT 2020 Mortality Score per hospital was 157 (interquartile range [IQR], 94-276). Wide variability was documented in total annual index cardiac operations eligible for STAT 2020 Mortality Score per hospital (ratio 90th/10th percentile = 9.01), operations in neonates weighing <2.5 kg (ratio 90th/10th percentile = 4.09), operations in patients with noncardiac anatomic abnormalities (ratio 90th/10th percentile = 3.46), and operations in patients with preoperative mechanical ventilation (ratio 90th/10th percentile = 3.97). At the hospital level, the median percentage of all index cardiac operations in STAT 2020 Mortality Category 5 was 3.7% (IQR, 1.7%-4.9%), the median percentage of all index cardiac operations in STAT 2020 Mortality Category 4 or 5 was 24.4% (IQR, 19.0%-28.4%), the median hospital-specific mean STAT Mortality Category was 2.39 (IQR, 2.20-2.47), and the median hospital-specific mean STAT Mortality Score was 0.86 (IQR, 0.73-0.91)., Conclusions: Substantial variation of patient characteristics, procedure types, and case-mix exists across pediatric and congenital cardiac surgical programs. Knowledge about programmatic case-mix augments data about indirectly standardized programmatic observed-to-expected (O/E) mortality. Indirectly standardized O/E ratios do not provide a complete description of a given pediatric and congenital cardiac surgical program. The indirectly standardized programmatic O/E ratios associated with a given program apply only to its specific case-mix of patients and may represent a quite different case-mix than that of another program., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown., Methods: We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes. The infants were randomly assigned to receive prophylactic methylprednisolone (30 mg per kilogram of body weight) or placebo, which was administered into the cardiopulmonary-bypass pump-priming fluid. The primary end point was a ranked composite of death, heart transplantation, or any of 13 major complications. Patients without any of these events were assigned a ranked outcome based on postoperative length of stay. In the primary analysis, the ranked outcomes were compared between the trial groups with the use of odds ratios adjusted for prespecified risk factors. Secondary analyses included an unadjusted odds ratio, a win ratio, and safety outcomes., Results: A total of 1263 infants underwent randomization, of whom 1200 received either methylprednisolone (599 infants) or placebo (601 infants). The likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% confidence interval [CI], 0.71 to 1.05; P = 0.14). Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 (95% CI, 0.67 to 1.00) and a win ratio of 1.15 (95% CI, 1.00 to 1.32) in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P<0.001)., Conclusions: Among infants undergoing surgery with cardiopulmonary bypass, prophylactic use of methylprednisolone did not significantly reduce the likelihood of a worse outcome in an adjusted analysis and was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants than placebo. (Funded by the National Center for Advancing Translational Sciences and others; STRESS ClinicalTrials.gov number, NCT03229538.)., (Copyright © 2022 Massachusetts Medical Society.)

Hybrid membranes assembled from biological lipids and synthetic polymers are a promising scaffold for the reconstitution and utilization of membrane proteins. Recent observations indicate that inclusion of small fractions of polymer in lipid membranes can improve protein folding and function, but the exact structural and physical changes a given polymer sequence imparts on a membrane often remain unclear. Here, we use all-atom molecular dynamics simulations to study the structure of hybrid membranes assembled from DOPC phospholipids and PEO- b -PBD diblock copolymers. We verified our computational model using new and existing experimental data and obtained a detailed picture of the polymer conformations in the lipid membrane that we can relate to changes in membrane elastic properties. We find that inclusion of low polymer fractions induces transient packing defects into the membrane. These packing defects act as insertion sites for two model peptides, and in this way, small amounts of polymer content in lipid membranes can lead to large increases in peptide insertion rates. Additionally, we report the peptide conformational space in both pure lipid and hybrid membranes. Both membranes support similar alpha helical peptide structures, exemplifying the biocompatibility of hybrid membranes.

Background: Congenitally corrected transposition of the great arteries (ccTGA) has many management strategies, with the emergence of anatomic repair increasing the available surgical options. Contemporary surgical practices have not been described in multicenter analyses. This study describes the distribution of heart surgery in patients with ccTGA and defines contemporary outcomes in a large multicenter cohort., Methods: Index cardiovascular operations in patients with primary or fundamental diagnosis of ccTGA were identified in The Society of Thoracic Surgeons Congenital Heart Surgery Database from 2010 to 2019. Operations of interest were combined into mutually exclusive groups designating overall ccTGA management strategies. Outcomes were defined with standard Society of Thoracic Surgeons Congenital Heart Surgery Database definitions. Pearson χ 2 and Kruskal-Wallis tests were used for statistical comparisons., Results: One hundred one centers performed 985 index operations, with anatomic repair the most common approach. Twenty-six centers performed more than 10 operations. Atrial switch plus Rastelli operations had the highest rate of operative mortality (8.4%) and major complications (38.2%). Heart transplant operations had the longest postoperative length of stay among survivors (18 days [interquartile range, 13.5-26])., Conclusions: Patients with ccTGA remain a challenging cohort, with significant diversity in the operations used and a substantial burden of operative mortality and morbidity., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Patients after heart transplantation are at increased risk for malignancy secondary to immunosuppression and oncogenic viral infections. Most common among children is posttransplant lymphoproliferative disorder (PTLD), occurring in 5% to 10% of patients. We used a national database to examine the incidence and risk factors for posttransplant malignancy., Methods: The United Network for Organ Sharing database was queried for pediatric (<18 years) heart transplant recipients from October 1987 through November 2019. Freedom from malignancy after transplant was assessed with Kaplan-Meier analysis. Cox regression was performed to generate hazard ratios (HRs) and 95% CIs for risk of malignancy development., Results: Of 8581 pediatric heart transplant recipients, malignancy developed in 8.1% over median follow-up time of 6.3 years, with PTLD compromising 86.4% of the diagnosed cancers. The incidence of PTLD development was 1.3% at 1 year and 4.5% at 5 years. Older age at the time of transplant was protective against the development of malignancy (HR, 0.98; 95% CI, 0.96-0.99; P < .001), whereas a history of previous malignancy (HR, 1.9; 95% CI, 1.2-3.0; P = .007) and Ebstein-Barr virus (EBV) recipient-donor mismatch (HR, 1.7; 95% CI, 1.3-2.2; P < .001) increased the risk. Induction therapy, used in 78.9% of the cohort, did not increase malignancy risk (P = .355) nor did use of maintenance tacrolimus (P = .912)., Conclusions: PTLD occurred after 7% of pediatric heart transplants, with risk increased by younger age and EBV mismatch, highlighting the importance of PTLD monitoring in EBV-seronegative recipients. Induction therapy, used in most of the pediatric heart transplants, does not seem to increase posttransplant malignancy nor does tacrolimus, the most commonly used calcineurin inhibitor., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background Methohexital and propofol can both be used as sedation for direct current cardioversion (DCCV). However, there are limited data comparing these medications in this setting. We hypothesized that patients receiving methohexital for elective DCCV would be sedated more quickly, recover from sedation faster, and experience less adverse effects. Methods and Results This was a prospective, blinded randomized controlled trial conducted at a single academic medical center. Eligible participants were randomly assigned to receive either methohexital (0.5 mg/kg) or propofol (0.8 mg/kg) as a bolus for elective DCCV. The times from bolus of the medication to achieving a Ramsay Sedation Scale score of 5 to 6, first shock, eyes opening on command, and when the patient could state their age and name were obtained. The need for additional medication dosing, airway intervention, vital signs, and medication side effects were also recorded. Seventy patients who were randomized to receive methohexital (n=37) or propofol (n=33) were included for analysis. The average doses of methohexital and propofol were 0.51 mg/kg and 0.84 mg/kg, respectively. There were no significant differences between methohexital and propofol in the time from end of injection to loss of conscious (1.4±1.8 versus 1.1±0.5 minutes; P =0.33) or the time to first shock (1.7±1.9 versus 1.4±0.5 minutes; P =0.31). Time intervals were significantly lower for methohexital compared with propofol in the time to eyes opening on command (5.1±2.5 versus 7.8±3.7 minutes; P =0.0005) as well as at the time to the ability to answer simple questions of age and name (6.0±2.6 versus 8.6±4.0 minutes; P =0.001). The methohexital group experienced less hypotension (8.1% versus 42.4%; P <0.001) and less hypoxemia (0.0% versus 15.2%; P =0.005), had lower need for jaw thrust/chin lift (16.2% versus 42.4%; P =0.015), and had less pain on injection compared with propofol using the visual analog scale (7.2±9.7 versus 22.4±28.1; P =0.003). Conclusions In this model of fixed bolus dosing, methohexital was associated with faster recovery, more stable hemodynamics, and less hypoxemia after elective DCCV compared with propofol. It can be considered as a preferred agent for sedation for DCCV. Registration URL: https://www.clinicaltrials.gov/ct; Unique identifier: NCT04187196.

Objectives: This study evaluates the effects of treatment with mindfulness-based stress reduction (MBSR) compared to the active control, present-centered group therapy (PCGT), on morning plasma cortisol, interleukin-6 (IL-6), and C-reactive protein (CRP) in veterans diagnosed with post-traumatic stress disorder (PTSD)., Methods: In a post hoc exploratory analysis, we pooled biomarkers and clinical outcomes of mindfulness, PTSD, and depression from two randomized controlled trials comparing MBSR ( n = 104) to PCGT ( n = 106) in U.S. military veterans diagnosed with PTSD. Linear mixed-effects modeling was used to evaluate associations between changes in biomarkers and clinical outcomes from baseline to 9-week primary endpoint and 16-week follow-up endpoint., Results: Cortisol levels were inversely related to self-reported PTSD symptoms at baseline ( p = 0.02). Cortisol increased from baseline to 9-week endpoint for both groups, but significantly less so in the MBSR group compared to PCGT group (mean difference 1.69 ± 0.8 SE; p = 0.035). Changes in IL-6 and CRP did not differ between groups at either baseline or week 9. From baseline to week 9, increased mindfulness was significantly associated with increased cortisol ( p = 0.02) and decreased PTSD and depression severity ( p < 0.01). Increased IL-6 and CRP were significantly associated with decreased PTSD severity ( p < 0.05), but not depression. Pooled analysis corroborated earlier findings that MBSR is significantly better than PCGT in improving clinical outcomes. Increased mindfulness was strongly associated with improved symptoms., Conclusions: Increased mindfulness is associated with a recalibration of cortisol levels which may be indicative of therapeutic response, especially in patients with lower baseline cortisol. Furthermore, mindfulness-based practices improve symptoms of PTSD and depression in a significant correlation with self-reported levels of mindfulness., Clinical Trial Registration Clinicaltrialsgov: NCT01532999 and NCT01548742., Competing Interests: Conflict of Interest The authors declare no competing interests.

Purpose: The objective of this study was to develop a scalable approach for direct comparison of the analytical sensitivities of commercially available SARS-CoV-2 antigen point-of-care tests (AgPOCTs) to rapidly identify poor-performing products., Methods: We present a methodology for quick assessment of the sensitivity of SARS-CoV-2 AgPOCTs suitable for quality evaluation of many different products. We established reference samples with high, medium, and low SARS-CoV-2 viral loads along with a SARS-CoV-2 negative control sample. Test samples were used to semi-quantitatively assess the analytical sensitivities of 32 different commercial AgPOCTs in a head-to-head comparison., Results: Among 32 SARS-CoV-2 AgPOCTs tested, we observe sensitivity differences across a broad range of viral loads (9.8 × 10 8 to 1.8 × 10 5 SARS-CoV-2 genome copies per ml). 23 AgPOCTs detected the Ct25 test sample (1.6 × 10 6 copies/ml), while only five tests detected the Ct28 test sample (1.8 × 10 5 copies/ml). In the low-range of analytical sensitivity, we found three saliva spit tests only delivering positive results for the Ct21 sample (2.7 × 10 7 copies/ml). Comparison with published data supports our AgPOCT ranking. Importantly, we identified an AgPOCT widely offered, which did not reliably recognize the sample with the highest viral load (Ct16 test sample with 9.8 × 10 8 copies/ml) leading to serious doubts about its usefulness in SARS-CoV-2 diagnostics., Conclusion: The results show that the rapid sensitivity assessment procedure presented here provides useful estimations on the analytical sensitivities of 32 AgPOCTs and identified a widely-spread AgPOCT with concerningly low sensitivity., (© 2022. The Author(s).)

Background: Aortic root translocation (Nikaidoh), Rastelli, and réparation à l'etage ventriculaire (REV) are repair options for transposition of the great arteries (TGA) with ventricular septal defects and left ventricular outflow tract obstruction (VSD-LVOTO) or double outlet right ventricle TGA type (DORV-TGA)., Methods: This retrospective study using The Society of Thoracic Surgeons Congenital Heart Surgery Database evaluates surgical procedure utilization and outcomes of patients undergoing repair of TGA-VSD-LVOTO and DORV-TGA with a Nikaidoh, Rastelli, or REV procedure., Results: A total of 293 patients underwent repair at 82 centers (January 2010 to June 2019). Most patients underwent a Rastelli (n = 165, 56.3%) or a Nikaidoh (n = 119, 40.6%) operation; only 3.1% (n = 9) underwent a REV. High-volume centers performed the majority of the repairs. Fewer Nikaidoh than Rastelli patients had prior cardiac operations (n = 57 [48.7%] vs n = 102 [63.0%]; P = .004). Nikaidohs had longer median cardiopulmonary bypass time (227 [interquartile range (IQR), 167-299] minutes vs 175 [IQR, 133-225] minutes; P < .001) and median aortic cross-clamp times (131 [IQR, 91-175] minutes vs 105 [IQR, 82-141] minutes; P = .0015). Operative mortality was 3.1% (95% confidence interval [CI], 1.0%-7.0%; n = 5) for Rastelli, 4.4% (95% CI, 1.4%-9.9%; n = 5) for Nikaidoh, and 11.1% (95% CI, 0.3%-48.3%, n = 1) for REV. The rates of cardiac arrest, unplanned reoperation, mechanical circulatory support, prolonged ventilation, and permanent pacemaker placement were higher in the Nikaidoh population but with 95% CIs overlapping those of the other procedures., Conclusions: Rastelli and Nikaidoh procedures are the prevalent repair strategies for patients with DORV-TGA and TGA-VSD-LVOTO. Most are performed at high-volume institutions, and early outcomes are similar., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The influence of African American (AA) recipient race on outcomes following simultaneous pancreas-kidney transplantation (SPKT) is uncertain., Methods: From 11/01 to 2/19, we retrospectively studied 158 Caucasian (C) and 57 AA patients (pts) undergoing SPKT., Results: The AA group had fewer patients on peritoneal dialysis (30% C vs. 14% AA), more patients with longer dialysis duration (28% C vs. 51% AA), more sensitized (PRA ≥20%) patients (6% C vs. 21% AA), and more patients with pretransplant C-peptide levels ≥2.0 ng/ml (11% C vs. 35% AA, all P < .05). With a mean 9.2 year follow-up, patient survival (65% C vs. 77% AA, P = .098) slightly favored the AA group, whereas kidney (55% C vs. 60% AA) and pancreas (48% C vs. 54% AA) graft survival rates (GSRs) were comparable. Death-censored kidney (71% C vs. 68% AA) and pancreas (both 62%) GSRs demonstrated that death with a functioning graft (DWFG) was more common in C vs. AA patients (23% C vs. 12% AA, P = .10). The incidence of death-censored dual graft loss (usually rejection) was 7% C versus 21% AA (P = .005)., Conclusions: Following SPKT, AA patients are at a greater risk for dual immunological graft loss whereas C patients are at greater risk for DWFG., (© 2022 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.)

Background: Allograft nephrectomy (AN) has been associated with considerable perioperative morbidity. We aimed to determine if preoperative angiographic kidney embolization (PAKE) to induce graft thrombosis before AN improves outcomes., Study Design: We reviewed adult kidney transplant alone patients who underwent AN at a single center from 2002 to 2020 and compared perioperative outcomes for patients with and without PAKE., Results: Eighty patients underwent AN, including 54 (67.5%) with PAKE before AN and 26 (32.5%) with AN alone. PAKE was associated with significantly reduced blood loss (PAKE: mean 266 ± 292 mL vs AN alone: 495 ± 689 mL; p = 0.04) and reduced transfusion requirements (PAKE: mean 0.5 ± 0.8 packed red blood cell units vs AN alone: 1.6 ± 2.6 units; p = 0.004) despite similar preoperative hemoglobin levels. Mean operating time (PAKE: 142 ± 43 minutes vs AN alone: 202 ± 111 minutes; p = 0.001) and length of hospital stay (PAKE: 4.3 ± 2.0 days vs AN alone: 9.3 ± 9.4 days; p = 0.0003) also favored PAKE, as did the surgical complication rate (PAKE: 6/54 [11%] vs AN alone: 9/26 [35%], p = 0.02). Long-term patient survival after AN was comparable in both groups., Conclusions: PAKE was associated with lower intraoperative blood loss, fewer transfusions, reduced operating time, shorter length of stay, and fewer surgical complications compared with AN alone at our center., (Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: For the more than 40,000 children in the United States undergoing congenital heart surgery annually, the relationship between hospital quality and costs remains unclear. Prior studies report conflicting results and clinical outcomes have continued to improve over time. We examined a large contemporary cohort, aiming to better inform ongoing initiatives seeking to optimize health care value in this population., Methods: Clinical information (The Society of Thoracic Surgeons Congenital Database) was merged with standardized cost data (Pediatric Health Information Systems) for children undergoing heart surgery from 2010 to 2015. In-hospital cost variability was analyzed using Bayesian hierarchical models adjusted for case-mix. Quality metrics examined included in-hospital mortality, postoperative complications, postoperative length of stay (PLOS), and a composite., Results: Overall, 32 hospitals (n = 45,315 patients) were included. Median adjusted cost per case varied across hospitals from $67,700 to $51,200 in the high vs low cost tertile (ratio 1.32; 95% credible interval, 1.29 to 1.35), and all quality metrics also varied across hospitals. Across cost tertiles, there were no significant differences in the quality metrics examined, with the exception of PLOS. The PLOS findings were driven by high-risk The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery categories 4 and 5 cases (adjusted median length of stay 16.8 vs 14.9 days in high vs low cost tertile [ratio 1.13, 1.05 to 1.24]), and intensive care unit PLOS., Conclusions: Contemporary congenital heart surgery costs vary across hospitals but were not associated with most quality metrics examined, highlighting that performance in one area does not necessarily convey to others. Cost variability was associated with PLOS, particularly related to intensive care unit PLOS and high-risk cases. Care processes influencing PLOS may provide targets for value-based initiatives in this population., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)