Maryland's Global Budget Revenue Program and Equitable Access to Esophagectomy for Esophageal Cancer.

INTRODUCTION: We evaluated equity in access to esophagectomy after Maryland's 2014 "Global Budget Revenue" (GBR) implementation, which equalizes reimbursement rates irrespective of patient insurance and employs an annual hospital revenue ceiling to incentivize reductions in unnecessary resource utilization. We hypothesized that more traditionally underserved patients would undergo surgical treatment for esophageal cancers after GBR. METHODS: Using Maryland's Health Services Cost Review Commission database, we retrospectively analyzed patient demographics, insurance statuses, inflation-adjusted hospital charges, postoperative outcomes, and discharge dispositions for esophagectomies for neoplasms between 2012 and 2018. RESULTS: Four hundred eighty six patients were included: 22.0% (107) pre-GBR and 78.0% (379) post-GBR. The proportion of African-American patients increased post-GBR (5.6% versus 12.9%, P = 0.035) and subsequently exhibited year-over-year increases. While not statistically significant, the proportion of Medicaid patients increased from 4.7% to 10.0% (P = 0.085). The post-GBR era also saw patients from 10 new counties, six of which were in Maryland's bottom half of counties ranked by median household income, receive operative esophageal cancer treatment without losing representation from pre-GBR counties. Patient age and sex were comparable between the two groups, and there were no significant differences in mortality or 30-day readmissions. Inflation-adjusted hospital charges and length of hospital stay did not appreciably change post-GBR, including after adjusting for age, comorbidities, and surgical approach. CONCLUSIONS: GBR increased access to esophagectomy for African-Americans, those insured by Medicaid, and those from lower socioeconomic status counties. Contrary to prior studies of outpatient and emergency room settings, we found the GBR program's goal of reduction of resource utilization and cost were not apparent in this complex surgical population.

Rectus Abdominis Muscle Atrophy and Asymmetry After Pulmonary Lobectomy.

INTRODUCTION: Pulmonary lobectomy can result in intercostal nerve injury, leading to denervation of the rectus abdominis (RA) resulting in asymmetric muscle atrophy or an abdominal bulge. While there is a high rate of intercostal nerve injury during thoracic surgery, there are no studies that evaluate the magnitude and predisposing factors for RA atrophy in a large cohort. METHODS: A retrospective chart review was conducted of 357 patients who underwent open, thoracoscopic or robotic pulmonary lobectomy at a single academic center. RA volumes were measured on computed tomography scans preoperatively and postoperatively on both the operated and nonoperated sides from the level of the xiphoid process to the thoracolumbar junction. RA volume change and association of surgical/demographic characteristics was assessed. RESULTS: Median RA volume decreased bilaterally after operation, decreasing significantly more on the operated side (-19.5%) versus the nonoperated side (-6.6%) (P < 0.0001). 80.4% of the analyzed cohort experienced a 10% or greater decrease from preoperative RA volume on the operated side. Overweight individuals (body mass index 25.5-29.9) experienced a 1.7-fold greater volume loss on the operated side compared to normal weight individuals (body mass index 18.5-24.9) (P = 0.00016). In all right-sided lobectomies, lower lobe resection had the highest postoperative volume loss (Median (interquartile range): -28 (-35, -15)) (P = 0.082). CONCLUSIONS: This study of postlobectomy RA asymmetry includes the largest cohort to date; previous literature only includes case reports. Lobectomy operations result in asymmetric RA atrophy and predisposing factors include demographics and surgical approach. Clinical and quality of life outcomes of RA atrophy, along with mitigation strategies, must be assessed.

Debunking the July Effect in lung transplantation recipients.

Objective: The "July Effect" is a theory that the influx of trainees from July to September negatively impacts patient outcomes. We aimed to study this theoretical phenomenon in lung transplant recipients given the highly technical nature of thoracic procedures. Methods: Adult lung transplant hospitalizations were identified within the National Inpatient Sample (2005-2020). Recipients were categorized as academic Q1 (July to September) or Q2-Q4 (October to June). In-hospital mortality, operator-driven complications (pneumothorax, dehiscence including wound dehiscence, bronchial anastomosis, and others, and vocal cord/diaphragm paralysis, all 3 treated as a composite outcome), length of stay, and inflation-adjusted hospitalization charges were compared between both groups. Multivariable logistic regression was performed to assess the association between academic quarter and in-hospital mortality and operator-driven complications. The models were adjusted for recipient demographics and transplant characteristics. Subgroup analysis was performed between academic and nonacademic hospitals. Results: Of 30,788 lung transplants, 7838 occurred in Q1 and 22,950 occurred in Q2-Q4. Recipient demographic and clinical characteristics were similar between groups. Dehiscence (n = 922, 4% vs n = 236, 3%), post-transplant cardiac arrest (n = 532, 2% vs n = 113, 1%), and pulmonary embolism (n = 712, 3% vs n = 164, 2%) were more common in Q2-Q4 versus Q1 recipients (all P < .05). Other operator-driven complications, in-hospital mortality, and resource use were similar between groups (P > .05). These inferences remained unchanged in adjusted analyses and on subgroup analyses of academic versus nonacademic hospitals. Conclusions: The "July Effect" is not evident in US lung transplantation recipient outcomes during the transplant hospitalization. This suggests that current institutional monitoring systems for trainees across multiple specialties, including surgery, anesthesia, critical care, nursing, and others, are robust.

Transfection of hypoxia-inducible factor-1α mRNA upregulates the expression of genes encoding angiogenic growth factors.

Hypoxia-Inducible Factor-1α (HIF-1α) has presented a new direction for ischemic preconditioning of surgical flaps to promote their survival. In a previous study, we demonstrated the effectiveness of HIF-1a DNA plasmids in this application. In this study, to avoid complications associated with plasmid use, we sought to express HIF-1α through mRNA transfection and determine its biological activity by measuring the upregulation of downstream angiogenic genes. We transfected six different HIF-1a mRNAs-one predominant, three variant, and two novel mutant isoforms-into primary human dermal fibroblasts using Lipofectamine, and assessed mRNA levels using RT-qPCR. At all time points examined after transfection (3, 6, and 10 h), the levels of HIF-1α transcript were significantly higher in all HIF-1α transfected cells relative to the control (all p < 0.05, unpaired Student's T-test). Importantly, the expression of HIF-1α transcription response genes (VEGF, ANG-1, PGF, FLT1, and EDN1) was significantly higher in the cells transfected with all isoforms than with the control at six and/or ten hours post-transfection. All isoforms were transfected successfully into human fibroblast cells, resulting in the rapid upregulation of all five downstream angiogenic targets tested. These findings support the potential use of HIF-1α mRNA for protecting ischemic dermal flaps.

Racial disparities among patients on venovenous extracorporeal membrane oxygenation in the pre-Coronavirus Disease 2019 and Coronavirus Disease 2019 eras: A retrospective registry review.

Objectives: Although many studies have addressed such disparities caused by COVID-19, to our knowledge, no study has focused on the association of race on outcomes for patients with COVID-19 requiring venovenous extracorporeal membrane oxygenation support. The goal of this study was to assess association of race on death and duration on venovenous extracorporeal membrane oxygenation in both the pre-COVID-19 and COVID-19 eras. Methods: We retrospectively reviewed the Extracorporeal Life Support Organization registry and included adults (≥18 years) who required venovenous extracorporeal membrane oxygenation between January 2019 and April 2021. We performed descriptive statistics and multivariable logistic regression. Our primary outcomes were death and extracorporeal membrane oxygenation duration. Results: A total of 7477 patients were included after excluding 340 patients (4.3%) who were missing race data. In the COVID-19 era, 1474 of 2777 COVID-19-positive patients (53.1%) died. Our regression model suggested somewhat of a protective effect on death for Black and multiple race patients. Additionally, a diagnosis of COVID-19 and patients in the COVID-19 era in general, irrespective of COVID-19 diagnosis, had higher odds of death. Hispanic patients had the longest average venovenous extracorporeal membrane oxygenation run times. Conclusions: Our study using data from the international Extracorporeal Life Support Organization Registry provides updated data on patients supported with venovenous extracorporeal membrane oxygenation in the pre-COVID-19 and COVID-19 eras between 2019 and 2021 with a focus on race. Patients in the COVID-19 era group also had higher mortality compared with those in the pre-COVID-19 era even after being adjusted for COVID-19 diagnosis. Black and multiple races appeared somewhat protective in terms of death. Hispanic race was associated with longer venovenous extracorporeal membrane oxygenation duration.

National utilization, trends, and lung transplant outcomes of static versus portable ex vivo lung perfusion platforms.

BACKGROUND: This study compared utilization and outcomes of the 2 widely utilized ex vivo lung perfusion (EVLP) platforms in the United States: a static platform and a portable platform. METHODS: Adult (age 18 years or older) bilateral lung-only transplants utilizing EVLP between February 28, 2018, and December 31, 2022, in the United Network for Organ Sharing database were included. Predischarge acute rejection, intubation at 72 hours posttransplant, extracorporeal membrane oxygenation at 72 hours posttransplant, primary graft dysfunction grade 3 at 72 hours posttransplant, 30-day mortality, and 1-year mortality were evaluated using multivariable regressions. RESULTS: Overall, 607 (6.3%) lung transplants during the study period used EVLP (51.2% static, 48.8% portable). Static EVLP was primarily utilized in the eastern United States, whereas portable EVLP was primarily utilized in the western United States. Static EVLP donors were more likely to be donation after circulatory death (33.4% vs 26.0%; P = .005), have a >20 pack-year smoking history (13.5% vs 6.5%; P = .005), and be extended criteria donors (92.3% vs 85.0%; P = .013), whereas portable EVLP donors were more likely to be older than age 55 years (14.2% vs 8.0%; P = .02). Transplants utilizing the static and portable platforms had similar risk of acute rejection, intubation at 72 hours, extracorporeal membrane oxygenation at 72 hours, primary graft dysfunction grade 3 at 72 hours, and posttransplant mortality at 30 days and 1 year (all P values > .05). CONCLUSIONS: The static and portable platforms had significant differences in donor characteristics and geographic distributions of utilization. Despite this, posttransplant survival was similar between the 2 EVLP platforms.

Bigger pies, bigger slices: Increased hospitalization costs for lung transplantation recipients in the non-donation service area allocation era.

OBJECTIVE: On November 24, 2017, lung transplant allocation switched from donation service area to a 250-nautical mile radius policy to improve equity in access to lung transplantation. Given the growing consideration of healthcare costs, we evaluated changes in hospitalization costs after this policy change. METHODS: Lung transplant hospitalizations were identified within the National Inpatient Sample from 2005 to 2020. Recipients were categorized as donation service area era (August 2015 to October 2017) or non-donation service area era (December 2017 to February 2020). Median total hospitalization costs (inflation adjusted) were compared by era nationally and regionally. Multivariable generalized linear regression was performed to determine if the removal of the donation service area was associated with total hospitalization costs. The model was adjusted for recipient demographics, Charlson Comorbidity Index, hospitalization region, transplant type (single, double), and use of extracorporeal membrane oxygenation, ex vivo lung perfusion, and mechanical ventilation. RESULTS: We analyzed 12,985 lung transplant recipients (median age of 61 years, 66% were male): 7070 in the donation service area era and 5915 in the non-donation service area era. Demographics were not different between recipients in both eras. Non-donation service area era recipients had greater extracorporeal membrane oxygenation use, mechanical ventilation (<24 hours), and longer length of stay than donation service area era recipients. Median total hospitalization costs for non-donation service area versus donation service area era recipients increased by $24,198 ($157,964 vs $182,162, percentage change = 15.32%, P < .001). Median costs increased in East North Central ($42,281) and Mountain ($35,521) regions (both P < .01). After adjustment, median costs for non-donation service area versus donation service area era recipients still increased ($19,168, 95% CI, 145-38,191, P = .048). CONCLUSIONS: Hospitalization costs for lung transplant hospitalizations have increased from 2015 to 2020. The transition from donation service area-based allocation to the non-donation service area system may have contributed to this increase after 2017 by increasing access to transplant for sicker recipients.

Multi-institutional beta testing of a novel cervical esophagogastric anastomosis simulator.

Objective: A novel simulator developed to offer hands-on practice for the stapled side-to-side cervical esophagogastric anastomosis was tested previously in a single-center study that supported its value in surgical education. This multi-institutional trial was undertaken to evaluate validity evidence from 6 independent thoracic surgery residency programs. Methods: After a virtual session for simulation leaders, learners viewed a narrated video of the procedure and then alternated as surgeon or first assistant. Using an online survey, perceived value was measured across fidelity domains: physical attributes, realism of materials, realism of experience, value, and relevance. Objective assessment included time, number of sutures tearing, bubble test, and direct inspection. Comparison across programs was performed using the Kruskal-Wallis test. Results: Surveys were completed by 63 participants as surgeons (17 junior and 20 senior residents, 18 fellows, and 8 faculty). For 3 of 5 tasks, mean ratings of 4.35 to 4.44 correlated with "somewhat easy" to "very easy" to perform. The interrupted outer layer of the anastomosis rated lowest, suggesting this task was the most difficult. The simulator was rated as a highly valuable training tool. For the objective measurements of performance, "direct inspection" rated highest followed by "time." A total of 90.5% of participants rated the simulator as ready for use with only minor improvements. Conclusions: Results from this multi-institutional study suggest the cervical esophagogastric anastomosis simulator is a useful adjunct for training and assessment. Further research is needed to determine its value in assessing competence for independent operating and associations between improved measured performance and clinical outcomes.

Impact of dual thoracic recovery from circulatory death donors on heart and lung transplant outcomes.

OBJECTIVES: Concomitant heart and lung recovery can result in increased operative complexity, ischemic time, and competition for resources and anatomic territory. Dual thoracic recovery from circulatory death donors may have additional risks that are not fully understood. We investigated the effects of dual heart and lung recovery from circulatory death donors on thoracic transplant outcomes. METHODS: Using the United Network for Organ Sharing database, we categorized all adult thoracic circulatory death donor transplants from 2019 to 2023 by whether the donor heart, lung, or both (dual donors) were recovered. Heart and lung transplant outcomes were compared between dual recovery donors and heart-only or lung-only donors, respectively, using multivariable analyses. RESULTS: Of the 2513 donors included, 42.9% were heart-only, 45.0% were lung-only, and 12.0% were dual donors. Recipients of dual versus heart-only donors had similar likelihood of post-transplant dialysis (18.9% vs 18.3%, P = .84), likelihood of stroke (2.9% vs 4.7%, P = .34), and 2-year risk of mortality (adjusted hazard ratio, 1.15 [95% CI, 0.90-1.47], P = .26), but lower likelihood of acute rejection (10.2% vs 16.1%, P = .04). Recipients of dual and lung-only donors had similar likelihood of predischarge acute rejection (7.6% vs 8.5%, P = .70), intubation at 72 hours (38.9% vs 45.1%, P = .13), and extracorporeal membrane oxygenation at 72 hours (13.1% vs 18.1%, P = .11), as well as 2-year risk of mortality (adjusted hazard ratio, 1.16 [95% CI, 0.74-1.82], P = .52). CONCLUSIONS: Recovering both the heart and lungs from a circulatory death donor does not negatively impact transplant outcomes. Outcomes in this population should continue to be investigated as more data and longer-term follow-up become available.

Neoadjuvant nivolumab or nivolumab plus LAG-3 inhibitor relatlimab in resectable esophageal/gastroesophageal junction cancer: a phase Ib trial and ctDNA analyses.

Gastroesophageal cancer dynamics and drivers of clinical responses with immune checkpoint inhibitors (ICI) remain poorly understood. Potential synergistic activity of dual programmed cell death protein 1 (PD-1) and lymphocyte-activation gene 3 (LAG-3) inhibition may help improve immunotherapy responses for these tumors. We report a phase Ib trial that evaluated neoadjuvant nivolumab (Arm A, n = 16) or nivolumab-relatlimab (Arm B, n = 16) in combination with chemoradiotherapy in 32 patients with resectable stage II/stage III gastroesophageal cancer together with an in-depth evaluation of pathological, molecular and functional immune responses. Primary endpoint was safety; the secondary endpoint was feasibility; exploratory endpoints included pathological complete (pCR) and major pathological response (MPR), recurrence-free survival (RFS) and overall survival (OS). The study met its primary safety endpoint in Arm A, although Arm B required modification to mitigate toxicity. pCR and MPR rates were 40% and 53.5% for Arm A and 21.4% and 57.1% for Arm B. Most common adverse events were fatigue, nausea, thrombocytopenia and dermatitis. Overall, 2-year RFS and OS rates were 72.5% and 82.6%, respectively. Higher baseline programmed cell death ligand 1 (PD-L1) and LAG-3 expression were associated with deeper pathological responses. Exploratory analyses of circulating tumor DNA (ctDNA) showed that patients with undetectable ctDNA post-ICI induction, preoperatively and postoperatively had a significantly longer RFS and OS; ctDNA clearance was reflective of neoantigen-specific T cell responses. Our findings provide insights into the safety profile of combined PD-1 and LAG-3 blockade in gastroesophageal cancer and highlight the potential of ctDNA analysis to dynamically assess systemic tumor burden during neoadjuvant ICI that may open a therapeutic window for future intervention. ClinicalTrials.gov registration: NCT03044613 .

A dedicated robotic bedside physician assistant significantly enhances trainee console operating time in general thoracic surgery.

Objective: As trainees rotate through thoracic subspecialties within their curricula, a crucial portion of their robotic training consists of actual console operating time. The more time spent on the surgeon console, the greater the development will be through the course of their training. Implementing a physician assistant at the bedside may increase the operative console time for the trainee and develop robotic skills in a more expeditious rate. The objective was to evaluate the impact a designated robotic physician assistant can have on trainee console learning opportunity. Methods: Operating room data collected consisted of all robotic general thoracic surgical cases that trainees participated in with and without a physician assistant present. Metrics regarding case efficiency included anesthesia ready-to-incision, incision-to-console, and raw resident console times. By using PRISM software, a nonparametric t test was used to analyze each averaged data group compared between when a physician assistant was present and not present. Results: The mean resident console time without and with a physician assistant assist was 45.8 minutes and 80.9 minutes, respectively (P < .0001). The average portion of a case performed by a trainee similarly without and with a physician assistant present was 28.0% and 77.1%, respectively (P < .0001). Case efficiency metrics between physician assistant presence cohorts showed no difference. Conclusions: Thoracic surgical trainees have increased opportunity for robotic skill development within a fellowship or resident program curriculum when a designated robotic physician assistant is present in the operating room. These findings are significant for the improvement of residency and fellowship robotic training models moving forward by incorporating robotic-specialized physician assistants in academic institutions.