Chronic Steroid Use Research Articles

The 5-Item Modified Frailty Index Independently Predicts Morbidity in Patients Undergoing Instrumented Fusion following Extradural Tumor Removal.

The management of spinal neoplasia consists of surgical, radiation, and systemic options. Little data exist to guide management based on overall health status, which is particularly challenging when patients who could benefit from surgery may be too frail for it. This study's objective was to evaluate the 5-Item Modified Frailty Index (mFI-5) as a predictor of 30-day morbidity in patients undergoing instrumented resection for metastatic extradural spinal tumors. Adults undergoing extradural tumor resection from the 2011 to 2019 National Surgical Quality Improvement Program datasets were identified by Current Procedural Terminology codes 63275-63278 with an adjunct instrumentation code (22840-22843). Patients were classified into frailty levels 0, 1, or 2+ based on mFI-5 scores of 0, 1, or 2-5, respectively. The primary outcome was morbidity. Secondary outcomes were readmission and reoperation. Multivariate modeling was utilized to analyze mFI-5 as a predictor of outcomes. The Akaike information criterion (AIC) was used to compare relative-model-fit based on frailty versus individual comorbidity variables to determine the optimal model. Chi-squared and Fisher's exact tests were used to establish significance between individual complications and frailty. There were 874 patients. Readmission, reoperation, and morbidity rates were 19.5%, 5.0%, 52.3%, respectively. In multivariate analyses, mFI-5=1 (OR: 1.45, SE: 0.31, p=0.036), mFI-5=2+ (OR: 1.41, SE: 0.40, p=0.036), operative time (OR: 1.18, SE: 0.03, p≤0.001), and chronic steroid use (OR: 1.56, SE: 0.42, p=0.037) independently predicted morbidity. Elective surgery (OR: 0.61) was protective. Frailty did not predict readmission or reoperation. Frailty was found to be significantly associated with respiratory complications, urinary tract infections, cardiac events, and sepsis/septic shock specifically. mFI-5=1 independently predicted 45% increased odds of morbidity. mFI-5=2+ independently predicted 41% increased odds of morbidity. Further, every 30 additional minutes of operative time predicted 18% increased odds of morbidity, suggesting an increased risk of site-related complication events. Taken together, the mFI-5 serves as a valid predictor of morbidity in patients with extradural tumor undergoing instrumented excision.

Association between chronic steroids and outcomes in hepatobiliary and pancreatic surgery

BackgroundChronic steroid use has been associated with increased postoperative complication; however, the association between chronic steroids and hepatobiliary and pancreatic surgery through all aspects of disease etiologies and types of surgery performed remains an area of active research. Therefore, this study analyzed the association of chronic steroids use with outcomes after hepatobiliary and pancreatic surgery. MethodsThe National Surgical Quality Improvement Program Participant Use Data Files for hepatobiliary and pancreatic surgeries performed between 2015 and 2019 were analyzed for chronic steroid use and postoperative adverse events. ResultsA total of 54,382 patients underwent hepatobiliary or pancreatic surgery during the study period, of which 1672 (3.1%) were on chronic steroids. In patients undergoing pancreatic surgery, steroid use was associated with higher rates of pneumonia (odds ratio [OR] 1.3, 95% confidence interval [95% CI] 1.2–2.2), unplanned intubation (OR 1.2, 95% CI 1.1–2.3), readmission (OR 1.4, 95% CI 1.3–2.4), intraoperative or postoperative transfusions (OR 1.5, 95% CI 1.2–2.3), being more likely to remain on a ventilator for greater than 48 h (OR 1.4, 95% CI 1.2–1.9), and greater mortality (OR 1.2, 95% CI 1.1–3.1) when compared to those, not on chronic steroids. In patients undergoing hepatobiliary surgery, chronic steroid use was associated with higher rates of sepsis (OR 1.3, 95% CI 1.2–2.9), unplanned intubation (OR 1.4, 95% CI 1.2–2.7), intraoperative or postoperative transfusions (OR 1.5, 95% CI 1.3–2.3), and readmission (OR 1.2, 95% CI 1.0–1.9). There was no difference in pancreatic fistula rates or post-hepatectomy liver failure rates after pancreatic and hepatobiliary resections, respectively. ConclusionChronic steroids use was associated with higher rates of poor outcomes both perioperatively and postoperatively in pancreatic and hepatobiliary surgery. These results will allow clinicians to be better equipped to counsel patients on surgery's increased risks and establish various perioperative protocols for chronic steroid users.

Association of Comorbidities and Functional Level With Mortality in Geriatric Bowel Perforation

IntroductionSpontaneous bowel perforation is associated with high morbidity and mortality. This entity remains understudied in the geriatric patient. We sought to use a national surgical sample to uncover independent predictors of mortality in elderly patients undergoing emergent operation for perforated bowel. MethodsUsing the American College of Surgeons National Surgical Quality Improvement database, years 2007 to 2017, all geriatric patients (age ≥65 y) who underwent emergency surgery and who had a postoperative diagnosis of bowel perforation were included. Univariate and multivariable analyses were used to identify independent predictors of 30-d mortality. ResultsA total of 8981 patients were included. The median (interquartile range) age was 75 y (69, 82), and 59.0% were female. Twenty-one percent of patients were partially or totally dependent, and 25.2% were admitted from sources other than home. Overall, 30-d mortality rate was 22.1%. Independent predictors of mortality included the following: age 70-79 y (odds ratio [OR]: 1.59, P < 0.001), age ≥80 y (OR: 3.23, P < 0.001), American Society of Anesthesiologists ≥3 (OR: 4.74, P < 0.001), admission from chronic care facility (OR: 1.61, P < 0.001), being partially or totally dependent (OR: 1.50, P < 0.001), chronic steroid use (OR: 1.36, P < 0.001), and preoperative septic shock (OR: 3.74, P < 0.001). Having immediate fascial closure was protective against mortality (immediate fascial closure only, OR: 0.55, P < 0.001; -immediate closure of all surgical site layers, OR: 0.44, P < 0.001). ConclusionsIn geriatric patients, functional status and chronic steroid therapy play an important role in determining survival following surgery for bowel perforation. These factors should be considered during preoperative counseling and decision-making.

Preoperative Malnutrition and Metabolic Markers May Predict Periprosthetic Fractures in Total Hip Arthroplasty

BackgroundPeriprosthetic fractures are a devastating complication of total hip arthroplasty (THA) and are associated with significantly higher mortality rates in the postoperative period. Given the strain that periprosthetic fractures place on the patient as well as the healthcare system, identifying and optimizing medical comorbidities is essential in reducing complications and improving outcomes. MethodsAll THA with primary indications of osteoarthritis from 2007 to 2020 were queried from the National Surgical Quality Improvement Program database. Demographic data, preoperative laboratory values, medical comorbidities, hospital course, and acute complications were collected and compared between patients with and without readmission for a periprosthetic fracture. A multivariate logistic regression analysis was performed to determine associated independent risk factors for periprosthetic fractures after index THA. ResultsThe analysis included 275,107 patients, of which 2539 patients were readmitted for periprosthetic fractures. Patients with postoperative fractures were more likely to be older (>65 years), females, BMI >40, and increased medical comorbidities. Preoperative hypoalbuminemia, hyponatremia, and abnormal estimated glomerular filtration rates were independent risk factors for sustaining a periprosthetic fracture and readmission within 30 days. Modifiable patient-related factors of concurrent smoking and chronic steroid use at the time of index THA were also independent risk factors for periprosthetic fractures. Inpatient metrics of longer length of stay, operative time, and discharge to rehab predicted postarthroplasty fracture risk. Readmitted fracture patients subsequently had increased risks of developing a surgical site infection, urinary tract infection, and requiring blood transfusions. ConclusionsPatients with hypoalbuminemia, hyponatremia, and abnormal estimated glomerular filtration rate are at increased risk for sustaining periprosthetic fractures after THA. Preoperative optimization with close monitoring of metabolic markers and modifiable risk factors may help not only prevent acute periprosthetic fractures but also associated infection and bleeding risk with fracture readmission.

Hospital-acquired infection following spinal tumor surgery: A frailty-driven pre-operative risk model

BackgroundHospital-acquired infection (HAI) after spinal tumor resection surgery contributes to adverse patient outcomes and excess healthcare resource utilization. This study sought to develop a predictive model for HAI occurrence following surgery for spinal tumors. MethodsThe National Surgical Quality Improvement Program (NSQIP) 2015–2019 database was queried for spinal tumor resections. Baseline demographics and preoperative clinical characteristics, including frailty, were analyzed. Frailty was measured by modified frailty score 5 (mFI-5) and risk analysis index (RAI). Univariate and multivariable analyses were performed to identify independent risk factors for HAI occurrence. A logit-based predictive model for HAI occurrence was designed and discriminative power was assessed via receiver operating characteristic (ROC) analysis. ResultsOf 5883 patients undergoing spinal tumor surgery, HAI occurred in 574 (9.8 %). The HAI (vs. non-HAI) cohort was older and frailer with higher rates of preoperative functional dependence, chronic steroid use, chronic lung disease, coagulopathy, diabetes, hypertension, tobacco smoking, unintentional weight loss, and hypoalbuminemia (all P < 0.05). In multivariable analysis, independent predictors of HAI occurrence included severe frailty (mFI-5, OR: 2.3, 95 % CI: 1.1–5.2, P = 0.035), nonelective surgery (OR: 1.7, 95 % CI: 1.1–2.4, P = 0.007), and hypoalbuminemia (OR: 1.5, 95 % CI: 1.1–2.2, P = 0.027). A logistic regression model with frailty score alongside age, race, BMI, elective vs. non-elective surgery, and pre-operative labs have predicted HAI occurrence with a C-statistic of 0.68 (95 % CI: 0.64–0.72). ConclusionsHAI occurrence after spinal tumor surgery can be predicted by standardized frailty metrics, mFI-5 and RAI-rev, alongside routinely measured preoperative characteristics (demographics, comorbidities, pre-operative labs).

The Effects of Chronic Steroid Use on Postoperative Complications Following Thyroidectomy.

Patients undergoing thyroidectomy are sometimes on chronic steroids for underlying disease. This study examined the postoperative risk profile of thyroidectomy patients on chronic steroids. Patients in the National Surgical Quality Improvement Program (NSQIP) database who underwent thyroidectomy were sorted by presence or absence of chronic steroid use. Clinicodemographics, comorbidities, and postoperative complications were recorded and compared between the two. Univariate and multivariate analyses compared the groups and calculated odds ratios (OR). We identified 42,857 patients. 41,903 (97.8%) patients were not on chronic steroids, while 954 (2.2%) were. Most underwent total thyroidectomy (18,748, 43.75%) or total lobectomy (16,323, 38.09%). Following univariate and multivariate analyses, patients on chronic steroids had increased risk of postoperative bleeding and transfusions (OR = 0.375, p = 0.046, 95% CI 0.223-0.988), open wound infection (OR = 0.226, p < 0.001, 95% CI 0.117-0.437), pulmonary embolism (OR = 0.312, p = 0.034, 95% CI 0.106-0.918), and ventilator use > 48h (OR = 0.401, p < 0.008, 95% CI 0.205-0.785). Chronic steroid use prior to thyroidectomy is an independent risk factor for multiple postoperative complications, namely postoperative bleeding and transfusions, open wound infection, pulmonary embolism, and ventilator use over 48h. Patients on chronic steroids should be medically optimized before thyroidectomy to reduce the risk of potentially life-threatening complications.

Incidence and risk factors for surgical site infection (SSI) after primary hip hemiarthroplasty: an analysis of the ACS-NSQIP hip fracture procedure targeted database

IntroductionPrimary hip hemiarthroplasty (HHA) is frequently utilized to treat geriatric hip fractures, which are associated with significantly higher morbidity and mortality. While not particularly common, surgical site infection (SSI) is a major complication that frequently requires revision surgery in a frail population. The objective of this study was to determine the incidence of and risk factors for SSI after HHA in hip fracture patients.Materials and methodsThis retrospective cohort study was performed using the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database. Geriatric patients (65+) who underwent HHA for non-pathologic, traumatic hip fractures between 2016–2017 were included. Demographic variables, comorbidities, operative variables, and complications were compared between "SSI" and "non-SSI" groups. Multivariate regression identified independent risk factors for postoperative SSI. Significance was set at P = 0.05.ResultsA total of 6169 patients were included. The overall incidence of SSI was 1.3%. SSI was significantly associated with body mass index (BMI), preoperative functional status, congestive heart failure, chronic corticosteroid use, intraoperative time, sepsis, wound dehiscence, readmission within 30-days, and reoperation. On multivariate analysis, chronic steroid use (OR: 2.30, 95% CI: 1.13–4.70), BMI ≥ 35 kg/m2 (OR: 3.59, 95% CI: 1.57–8.18), and intraoperative time ≥120 mins (OR: 2.15, 95% CI: 1.08–4.27) were found to be independent risk factors.ConclusionsPostoperative SSI is a serious complication that is responsible for prolonged hospital stays, increased mortality, and greater healthcare costs. Here, we identified multiple risk factors for SSI after primary HHA in the US elderly population.

Role of Aspergillus Specific IgG Titres as a Therapeutic Target for Chronic Pulmonary Aspergillosis: A Longitudinal Study

Introduction: Chronic Pulmonary Aspergillosis (CPA) continues to be an enigma to clinicians in regions with a high prevalence of pulmonary tuberculosis and is often misdiagnosed as the latter, attributable to the significant overlap in symptoms and radiology. Moreover, although the diagnostic criteria for CPA have been standardised, the role of serological markers in monitoring disease activity and response to therapy is still not well characterised. Aim: To understand the characteristics, risk factors and treatment outcomes in patients developing CPA and to determine the role of serological markers as indicators of disease activity. Materials and Methods: The present longitudinal study was conducted in the Department of Respiratory Medicine, University College of Medical Sciences and its associated Guru Teg Bahadur Hospital, Delhi, India from February 2021 to June 2022. Study included 46 patients suspected of harbouring CPA attributable to their clinico-radiological presentation. The diagnosis of CPA was made using the established criteria. Patients with a confirmed diagnosis of CPA received oral azole antifungals for 6 months and were monitored at 3-monthly intervals for reduction in baseline parameters to determine treatment success/failure. Paired and unpaired parametric variables were compared using the t-test and non parametric methods were compared using the Chisquare test. Results: The diagnosis of CPA was established in 31 (67.4%) patients of whom 77.6% were males and the mean age was 47.3±2.2 years. These patients had been symptomatic for 5.8±1.2 years. Underlying risk factors (such as the history of tuberculosis, chronic obstructive pulmonary disease, diabetes mellitus, history of long-term glucocorticoid use etc.) had been present for 6.9±1.3 years. Patients harboured an average of two risk factors with tuberculosis and diabetes mellitus being the most common local and systemic affliction, respectively. Patients with tuberculosis (p-value=0.001) and chronic steroid use (p-value=0.029) were significantly at higher risk of developing CPA. 6 months of azole therapy led to significant reduction in specific IgG titres (p-value=0.001), and serum precipitins (p-value=0.004). Two patients on itraconazole relapsed within 12 months but were successfully treated with voriconazole. Conclusion: Tuberculosis was the most significant local risk factor leading to the development of CPA, which developed soon after diagnosis of another systemic risk factor. Six months of azole therapy was adequate to induce remission of the disease, activity of which can be monitored though the measurement of serum IgG antibody titres.

The effect of preoperative steroids for at least 10 days on complications following craniotomy for tumor resection: A database, retrospective cohort study

IntroductionThe effect of chronic steroid therapy on postoperative outcomes after craniotomy for tumor resection remains understudied. Research questionThis study aimed to fill this gap and to identify risk factors of postoperative morbidity and mortality among patients on chronic steroid use undergoing craniotomy for tumor resection. Materials and methodsData from the American College of Surgeons National Surgical Quality Improvement Program were used. Patients who underwent craniotomy for tumor resection between 2011 and 2019 were included. Perioperative characteristics and complications were compared among patients with and without chronic steroid therapy, defined as steroid use for at least 10 days. Multivariable regression analyses were conducted to assess the impact of steroid therapy on postoperative outcomes. Subgroup analyses involving patients on steroid therapy were conducted to explore risk factors of postoperative morbidity and mortality. ResultsOf 27,037 patients, 16.2% were on steroid therapy. On regression analyses, steroid use was significantly associated with any postoperative complication, infectious complication, urinary tract infection, septic shock, wound dehiscence, pneumonia, non-infectious, pulmonary, and thromboembolic complications, cardiac arrest, blood transfusion, unplanned reoperation, readmission, and mortality. On subgroup analysis, risk factors for postoperative morbidity and mortality among patients on steroid therapy included older age, higher American Society of Anesthesiology physical status, functional dependence, pulmonary and cardiovascular comorbidities, anemia, dirty/infected wounds, prolonged operative time, disseminated cancer, and a diagnosis of meningioma. Discussion and conclusionPreoperative brain tumor patients on steroids for 10 or more days are at a relatively high risk of postoperative complications. We recommend a judicious use of steroids in brain tumor patients, both in terms of dosage and duration of treatment.

Incidence and Predictive Factors of Lower Extremity Deep-vein Thrombosis in Patients with Neurological Diseases in a Sub-Saharan Tertiary Hospital

Background: Deep-vein thrombosis (DVT) is a major cause of morbidity among patients with neurological disease and is implicated in 50%–90% of pulmonary embolisms (PE). Aim: This study aims to identify the incidence and predictive factors of lower extremity (LE) DVT in high-risk neurological patients. Materials and Methods: All patients with neurological diseases who were confined to bed for three days or more, or had elevated D-dimer over a 22 months were included in the study. They all had routine mechanical and chemical prophylaxis. Serial color duplex ultrasonography of the LE was performed for all the patients, and the results were used to stratify them into two groups: DVT positive and DVT negative, and their clinical parameters were recorded and utilised for statistical analysis. Multivariate logistic regression analysis was used to determine the predictive risk factors. Results: A total of 611 patients were admitted, and 107 met the inclusion criteria. The mean age was 57 ± 17 years, with a male-to-female ratio of 1.7:1. Forty-four (41.4%) patients had DVT (overall incidence was 7.2%). Primary intracranial tumours and craniocerebral trauma accounted for 27.2% and 20.5% of aetiology, respectively. The comparative DVT-positive versus DVT-negative group D-dimer levels were 7.9 versus 4.9 mg/L (P = 0.0065), duration of immobility 65.0 versus 35.3 days (P = 0.0001), and length of hospital (LOH) stay 32.5 versus 18.2 days (P = 0.0001). The proximal LE vessels were involved in 64.2%. The PE risk was 0.98%, with three mortalities. The predictive factors on multivariate logistic regression were elevated D-dimers (odds ratio [OR] 2.02, 95% confidence interval [CI] 1.1–4.45 P = 0.030) and preoperative immobility &gt;seven days ([OR] 2.38, 95% [CL] 1.28–4.39 P = 0.042). Gender, C-reactive protein, Glasgow Coma Scale, comorbidities, LOH, and chronic steroid use were not predictive. Conclusion: The overall incidence of DVT and mortality from PE were low among patients with neurological diseases. Most thrombi involved proximal LE veins. Elevated D-dimers and preoperative immobility &gt;seven days were predictive factors for LE DVT.

Early Gestational Diabetes Screening Based on ACOG Guidelines.

A recent randomized controlled trial suggested that early gestational diabetes mellitus (GDM) screening in patients with obesity (body mass index [BMI] ≥30 kg/m2) does not improve perinatal outcomes. The American College of Obstetrics and Gynecology currently recommends early screening for gestational diabetes in patients who are overweight with one or more additional risk factors. We evaluated the effect of screening based on the number of additional risk factors for development of gestational diabetes. This was a secondary analysis of a multicenter randomized controlled trial of obese patients with singleton nonanomalous fetuses comparing early (14-20 weeks' gestation) with routine (24-28 weeks' gestation) GDM screening. Exclusion criteria were pregestational diabetes, major medical illnesses, bariatric surgery, chronic steroid use, and prior cesarean. Early versus routine GDM screening groups were compared and stratified by the number of additional risk factors for GDM (0, 1, 2, and ≥3). The primary outcome was an adverse perinatal composite outcome composed of: macrosomia, primary cesarean delivery, hypertensive disorders of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia. Analyses examined effects of early versus routine screening by the number of additional risk factors and their possible interaction on the incidences of the primary outcome and GDM. Of 913 patients, 5% had 0, 52% had 1, 33% had 2, and 10% had ≥3 additional risk factors. Baseline characteristics, including the number and type of risk factors, were similar between early and routine screening groups. Breslow-Day test for interaction between early versus routine screening and the number of additional risk factors was not significant for either the primary outcome (p = 0.37) or the diagnosis of GDM (p = 0.28). The incidence of GDM and the adverse perinatal composite outcome increased as the number of risk factors increased (p < 0.001). In patients with BMI ≥30 kg/m2 and additional risk factors, early GDM screening does not prevent adverse outcomes. · The ACOG currently recommends early screening for gestational diabetes if patients have risk factors.. · Even in patients with multiple risk factors, early screening for GDM does not improve outcomes.. · Patients with three or more risk factors may have worse outcomes if they undergo early screening..

728: OUTCOMES AND TIMING OF STRESS-DOSE HYDROCORTISONE IN PEDIATRIC SEPTIC SHOCK

Introduction: Sepsis is a major contributor to pediatric morbidity and mortality worldwide. Pediatric sepsis is defined as systemic inflammatory response syndrome (SIRS) in the presence of suspected or confirmed infection. Pediatric septic shock is defined as sepsis with cardiovascular organ dysfunction. In vasoactive-inotropic recalcitrant septic shock, stress dose corticosteroids are often administered for presumed critical illness related corticosteroid insufficiency (CIRCI). However, there is not consistent data to support the use of stress dose hydrocortisone (HCT) in septic shock. To further investigate clinical outcomes related to timing of HCT, we hypothesized that children with vasoactive-inotropic recalcitrant septic shock who received early HCT (< 6 hours) would have lower vasoactive-inotropic scores (VIS) in the first 48 hours, a decreased length of stay (LOS) and increased ventilator-free days (VFD). Methods: A retrospective chart review was performed from November 2017 to December 2021 of subjects 0 to < 18 years, admitted to the pediatric intensive care unit (PICU) meeting the definition for septic shock, requiring vasopressors and/or inotropes and given HCT for CIRCI. We measured VIS, PICU and hospital LOS and VFD. Subjects with chronic steroid use or who received etomidate were excluded. Results: Of 227 subjects screened, 23 met criteria for analysis. Seven subjects received HCT within 6 hours of vasopressor initiation (early group), while 16 received HCT >6 hours (late group). Initial VIS average was 10.96 in the early group and 10.78 in the late group. At 48 hours, average VIS in the early group was 9.51 and 1.44 in the late group. Average PICU LOS was 15.58 for the early group and 10.82 for the late group. Average hospital LOS was 37.47 for the early group and 19.76 for the late group. VFD average was 15.32 in the early group and 16.61 in the late group. Pediatric Index of Mortality 3 (PIM-3) average in the early group was 2.02 and 1.61 in the late group. Mortality incidence was 2 in 7 in the early group, and 4 in 16 in the late group. Conclusions: Preliminary data suggests there is an increased VIS at 48 hours, increased PICU and hospital LOS, and decreased VFD with early administration of HCT. Although PIM-3 scores were higher in the early group, mortality was similar between groups.

Phase II Study of Pembrolizumab and Fractionated External Beam Radiotherapy in Patients with Relapsed and Refractory Large B-Cell Lymphoma

Background: Relapsed/refractory (R/R) large B-cell lymphoma (LBCL) poses a therapeutic challenge, however immune based interventions are changing the landscape of salvage therapy. Manipulation of immune checkpoint pathways involving programmed cell death protein 1 (PD-1) and its ligands PD-L1/PD-L2 can trigger anti-tumor effects in LBCL. However, results with checkpoint inhibitor monotherapy for LBCL have been disappointing with reported overall response rates (ORR) of 10% for patients who experienced relapse after autologous stem cell transplantation (ASCT) and 3% for those ineligible for ASCT (Lesokhin AM et al J Clin Oncol. 2016). Radiation therapy (RT) is highly effective in R/R LBCL and may enhance response when coupled with immune based therapy. We sought to evaluate the efficacy of RT combined with pembrolizumab among patients with R/R non-Hodgkin Lymphoma (NHL) treated with RT to 1-2 sites of refractory disease with at least one index lesion excluded from the RT field for evaluation of abscopal effect. Methods: We conducted a single center, open label, phase II trial of patients with R/R NHL with progressive lymphoma after 2 or more lines of therapy. Eligible patients had PET avid disease amenable to RT and at least one distinct lesion outside of the planned RT field that would serve as the index (abscopal) lesion(s) by which the response to therapy would be defined. Patients were administered a fixed dose of 200 mg of pembrolizumab intravenously every 21 days beginning on day 2 of RT planned for 24 months or until progression. External beam RT was planned to dose of 40-50 Gy in ≤3 Gy fractions. The primary endpoint was ORR (defined as complete and partial response) of the unirradiated lesion(s) at 3 months (after completion of RT and 3 cycles of pembrolizumab). Secondary endpoints included safety, progression free survival (PFS) and overall survival (OS). ORR and dose limiting toxicity (DLT) were monitored simultaneously using Bayesian stopping boundaries based on an ORR of at least 35% at 3 months and DLT rate at cycle one below 30%. A sample size of 20 was planned. Results: Between February 2018 and November 2020, 17 patients were enrolled on the study and received at least 1 cycle of pembrolizumab and at least 1 fraction of RT. The median age was 66 years (range 24 - 83); 29% (n=5) of patients were female. Most patients had LBCL (88%, n=15, double hit, n=5), one patient had PMBCL (6%) and one patient had NK T-cell lymphoma (6%). The median number of prior therapies was 3 (range 2-13) with 53% (n=9) of patients having received ≥3 prior lines of treatment. Eighteen percent (n=3) of patients received prior ASCT and 53% (n=9) received CAR-T cell therapy prior to enrollment. The median number of unirradiated lesions excluded from the RT field was 2 (range 1-24). The median diameter of the largest unirradiated lesion was 2.4 cm (range 1.1 - 8.0 cm). The median RT dose delivered was 45 Gy (range 22.5 -50). The median follow up for the 17 patients was 34.75 months. Sixteen patients had a response assessment, one patient suffered from a stroke and response was not assessed. The ORR was 28% (CR 23% [n=3] and PR 15% [n=2]). Local control within the radiated field was achieved in 11 of the 16 patients (69%). For all 17 patients, the median PFS and OS were 2.7 months and 6.3 months respectively. The 2 year PFS and OS rates were 11.8% and 23.5% respectively (Figure 1). There were 13 deaths, 12 due to lymphoma and 1 due to stroke. For the five responding patients, the median duration of response was 13.3 months (range 5.0 - 50.5 months). Two patients remain in CR 37.6 (PMBCL) and 50.5 (double hit LBCL) months after protocol therapy. The trial was terminated early due to poor accrual. Treatment was generally well tolerated. One of the long term survivors with a history of chronic steroid use experienced grade 4 avascular necrosis in the RT field. Conclusion: In this single center, phase II trial of pembrolizumab and concurrent RT among patients with highly refractory LBCL, local control within the radiation field was encouraging however abscopal responses were minimal. Further exploration of the mechanism behind the exceptional responses in two patients treated with RT and pembrolizumab in this high-risk population is warranted. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Chronic steroid use: An overlooked impact on patients with inflammatory bowel disease.

Steroids have long been used in inducing remission of inflammatory bowel disease (IBD). Chronic use, defined as therapy greater than 3 months, has been implicated in complications including increased hospital length of stay (LOS), infections, and even death. In our retrospective study, we aim to identify the complications of chronic steroid use in patients with IBD. The fourth quarter of 2015-2019 National Inpatient Sample (NIS) was used in this study. International Classification of Diseases (ICD-10) codes were used to identify patients with a diagnosis of IBD and chronic steroid use. Adverse outcomes of chronic steroid use in IBD patients were analyzed, such as osteoporosis, opportunistic infections, mortality rate, and LOS. Cohorts were weighted using an algorithm provided by the NIS allowing for accurate national estimates. A total of 283 970 patients had a diagnosis of IBD. Of those, 18 030 patients had concurrent chronic steroid use. Racial disparities existed, with 77.4% White, 12.7% Black, and 6.0% Hispanic. Patients with a history of IBD and chronic steroid use were found to have higher odds of developing osteoporosis, opportunistic infections, and acute thromboembolic events but did not have higher odds of mortality. There is much controversy about whether IBD patients should be on chronic steroids for maintenance therapy and this study highlights the importance of this decision as patients on chronic steroid use had higher odds of developing adverse effects. These results stress the importance of monitoring patients on steroids and avoiding chronic use.

Abstract 14335: Vascular Complications and Outcomes Following Transcatheter Aortic Valve Replacement in Patients on Chronic Steroids Therapy. A Meta-Analysis

Introduction: Chronic steroids therapy was reportedly linked to increased vascular complications (VC) following invasive vascular procedures. However, its association with VC after transcatheter aortic valve replacement (TAVR) remained uncertain, with conflicting results being reported. We aimed to compare the rate of vascular complications and outcomes between patients with and without chronic steroid use after TAVR. Methods: We conducted a comprehensive literature search in PubMed, Embase and Cochrane databases for relevant studies. Endpoints were described according to Valve Academic Research Consortium-2 definitions and were assessed within 30 days of TAVR. Effect sizes were pooled using the DerSimonian and Laird random-effects model as risk ratio (RR) with 95% confidence intervals (CI). Results: 5 studies with 6136 patients undergoing TAVR (328 steroids, 5808 non-steroids) were included in the analysis. Patients on chronic steroids were younger (mean age 80.2 vs 82.3 years) and were more likely to be female (56% vs 54%). Patients on chronic steroids had a higher risk of major vascular complications (RR 2.32, 95% CI 1.73-3.11, p&lt;0.001), major bleeding (RR 1.61, 95% CI 1.27-2.05, p&lt;0.001) and aortic annulus rupture (RR 4.66, 95% CI 1.67-13.01, p&lt;0.001). There was no significant difference in terms of minor vascular complications (RR 1.43, 95% CI 1.00-2.04, p=0.05), in-hospital mortality (RR 1.86, 95% CI 0.74-4.70, p=0.19) and 30-day mortality (RR 1.14, 95% CI 0.53-2.46, p=0.74) between both groups. Conclusion: Chronic steroid therapy is associated with increased rate of major VCs, major bleeding and aortic annulus rupture following TAVR. Further randomized controlled trials were encouraged to confirm these findings.

Comparing Patient Selection and 30-day Outcomes Between Single Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass: a Retrospective Cohort Study of 47,384 Patients.

Single anastomosis gastric bypass (SAGB) offers a novel bariatric procedure with increasing popularity. However, its adoption, patient selection, and short-term safety remain poorly characterized. The 2020 Metabolic and Bariatric Accreditation and Quality Improvement Program (MBSAQIP) was analyzed comparing SAGB to Roux-en-Y gastric bypass (RYGB). Bivariate analysis and multivariable logistic regression models compared difference between groups and factors associated with 30-day serious complications and mortality. Overall, 47,384 patients were evaluated, with 1344 (2.8%) undergoing SAGB. SAGB patients had a higher BMI (45.2 ± 7.6kg/m2 vs 44.6 ± 7.9kg/m2, p = 0.006) and younger age (44.3 ± 12.1years vs. 45.4 ± 11.5years, p = 0.0008) than RYGB patients respectively. SAGB patients were less likely to have GERD (42.6% SAGB vs. 45.7% RYGB, p = 0.02), sleep apnea (37.8% SAGB vs. 41.1% RYGB, p = 0.02), and chronic steroid use (1.3% SAGB vs. 2.2% RYGB, p = 0.04). There were no significant difference in diabetes, hypertension, or dyslipidemia rates. Operative length for SAGB was significantly less than for RYGB (101 ± 53.7min SAGB vs. 131.5 ± 63.3min RYGB, p < 0.0001). SAGB was independently associated with decreased serious complications (4.7% vs. 8.4%, p < 0.0001) within 30days compared to RYGB. Additionally, SAGB patients were less likely to experience reoperation (1.6% vs. 2.6%, p = 0.03), and readmission (2.2 vs. 5.8%, p < 0.0001) compared to RYGB respectively. Compared to RYGB, patients undergoing SAGB were younger with marginally higher BMI. After adjusting for comorbidities, SAGB was associated with decreased odds of serious complications. Ongoing prospective studies analyzing long-term outcomes following SAGB remain needed.

RF09 | PSAT83 Diagnosis of Adrenal Insufficiency Based on Peak Stimulated Cortisol Levels Between 14 and 18 mcg/dL on High Dose Cosyntropin Stimulation Testing

Abstract Background Traditionally, stimulated serum cortisol &amp;lt; 18 mcg/dL at 30 or 60 minutes has been used as the cutoff for diagnosis of adrenal insufficiency (AI) during high dose cosyntropin stimulation testing (CST). Recent studies suggest that a cutoff of 14-15 mcg/dL is more accurate when using more specific monoclonal immunoassays (IAs). In February 2017, our institution switched from a polyclonal IA to a monoclonal IA. Despite this change, providers were diagnosing AI based on the 18 mcg/dL cutoff. Long term glucocorticoid use has several unwanted pleiotropic effects such as impaired glucose tolerance or diabetes mellitus (DM), hypertension (HTN), and increased risk of infection. Our study aims to evaluate patients with peak stimulated cortisol levels between 14-18 mcg/dL diagnosed with AI and placed on steroids. Methods We retrospectively reviewed charts of patients with peak cortisol levels 14-18 mcg/dL at 30 or 60 minutes on high dose CST with 250 mcg cosyntropin between February 2017 and August 2021. Cortisol levels were assessed using the monoclonal IA Roche Elecsys Cortisol II. Data regarding type and etiology of AI as well as patient demographics, comorbidities, steroid regimen, and follow up cortisol testing was collected. Worsening HTN and DM were defined as increase in blood pressure and HgbA1c respectively and/or intensification of medications between baseline at time of CST and last follow up while on steroids. Results 41 patients met inclusion criteria. 29 (71%) patients were female and mean age at CST was 52 years (range 21-86). Most patients were diagnosed with secondary (71%) or partial secondary (19%) AI by provider. Most common etiologies were pituitary disease (45%), chronic steroid use (24%), and unilateral adrenalectomy (19%). Mean follow up was 23 months (range 0.5-57). 33 (80%) patients were started or continued on glucocorticoid replacement. Remaining patients who were never started on steroids had a peak cortisol ≥ 15.6 mcg/dL. 21/33 (64%) of patients started on steroids had repeat adrenal function testing a mean of 18 months (range 2-42) after the initial CST. Based on testing or clinical judgement, 19/33 (58%) were taken off steroids. In patients treated with steroids, 64% developed weight gain, 42% worsening HTN, and 6% worsening DM. Additionally, 48% developed an infection, 24% insomnia, and 15% psychiatric illness. Conclusions The majority of patients with peak stimulated cortisol between 14-18 mcg/dL on high dose CST had secondary AI. Over 50% of patients started on steroids were later able to stop. Steroid-related complications were observed, but this may not differ significantly from the general population. This study underscores the importance of interpreting CST results in the context of the cortisol assay used and evaluating patients with secondary AI for recovery of the hypothalamic-pituitary-adrenal axis. Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m., Saturday, June 11, 2022 1:06 p.m. - 1:11 p.m.

EOSINOPHILIC CYSTITIS IN A PEDIATRIC PATIENT WITH X-LINKED CHRONIC GRANULOMATOUS DISEASE

<h3>Introduction</h3> Pediatric Eosinophilic Cystitis is an uncommon inflammatory disease associated with X-linked Chronic Granulomatous Disease (X-CGD)¹. We present a rare case of a teenage patient with refractory eosinophilic cystitis. <h3>Case Description</h3> Patient is a 14-year-old male with X-CGD, colitis, and complications from chronic steroid use, including bilateral cataracts, osteoporosis, and adrenal insufficiency. His colitis was well-controlled with vedolizumab when he presented for evaluation of new onset dysuria and intermittent scrotal pain that improved with voiding. Infectious workup was unrevealing. CT of abdomen and pelvis demonstrated asymmetric, irregular thickening, nodularity and enhancement of the left bladder wall and bladder base. Pathology from cystoscopy was significant for scattered eosinophils, suspicious for eosinophilic cystitis. He demonstrated mild peripheral eosinophilia (0.63 K/µL). He was started on intravesical dexamethasone 10mg, to minimize complications from systemic steroid use, and oral loratadine 5mg on intravesical treatment days. However, his symptoms did not resolve and intravesical dexamethasone was increased to 25mg then to 50mg. Loratadine was increased to 10mg daily. His bladder ultrasound normalized after 12 doses of intravesical dexamethasone and daily 10mg loratadine. Three weeks after loratadine was weaned to every other day, his urinary symptoms returned. Loratadine was increased to 10mg daily and he remained asymptomatic off steroids. <h3>Discussion</h3> Reported cases of pediatric eosinophilic cystitis are mostly in young children, only requiring a short course of intravesical steroids and oral antihistamine, unlike our patient^2,3. More research is needed to elucidate the history, optimal diagnosis and guide appropriate management of eosinophilic cystitis in pediatric X-CGD patients.

Prevalence and risk factors for Candida esophagitis among human immunodeficiency virus-negative individuals.

Candida esophagitis (CE) is among the commonest esophageal infections and is known as an opportunistic fungal infection mostly affecting people living with the human immunodeficiency virus (HIV). However, some medical conditions might predispose HIV-negative individuals to esophageal candidiasis. The epidemiology and associated endoscopic findings of CE among people without HIV have rarely been reported. To investigate the prevalence of CE among HIV-negative persons, and determine risk factors predicting CE. Between January 2015 and December 2018, all consecutive outpatients who underwent routine esophagogastroduodenoscopy as part of health check-ups at their own expense at the Health Check-up Center of the Kaohsiung Veterans General Hospital, Taiwan, were recruited in this study. Those with positive HIV serology results were excluded. Sociodemographic and clinical characteristics including age, gender, economic status, smoking history, alcohol consumption, tea and coffee consumption, underlying diseases, body fat percentage, body mass index, endoscopic findings, and Helicobacter pylori infection status were carefully reviewed. CE was confirmed by endoscopic biopsy and pathological assessment with hematoxylin and eosin and periodic acid-Schiff staining. To evaluate independent factors predicting the development of CE, we conducted a univariate analysis of clinical characteristics. The variables found to be significant via univariate analysis were subsequently included in a multivariable analysis of potential risk factors for CE development. A total of 11802 participants were included in this study. Forty-seven (0.4%) were confirmed as having CE by pathological examination. Univariate analysis identified older age, the presence of chronic kidney disease, alcohol consumption, and steroid use (P = 0.023, < 0.001, 0.033, and 0.004, respectively) as significantly associated with CE. Multivariable analysis revealed older age [adjusted odds ratio (OR) = 1.027; 95%CI: 1.001-1.053; P = 0.045], chronic kidney disease (adjusted OR = 13.470; 95%CI: 4.574-39.673; P < 0.001), alcohol consumption (adjusted OR = 2.103; 95%CI: 1.151-3.844; P = 0.016), and steroid use (adjusted OR = 24.255; 95%CI: 5.343-110.115; P < 0.001) as independent risk factors for CE development. The presence of dysphagia was associated with severe CE (P = 0.021). The prevalence of CE among HIV-negative persons was 0.4% in Taiwan. Independent risk factors for CE were older age, chronic kidney disease, alcohol consumption, and steroid use.

Comparing Trends in Urethral Sling Procedures Performed by Urologists and Gynecologists: Is There Anything Significantly Different?

INTRODUCTION: Sling procedures, the most common surgical treatment for stress urinary incontinence, are performed by both urologists and gynecologists. Our study aims to examine differences in operative times and surgical metrics based on surgeon subspecialty training. METHODS: This study is a retrospective review of the 2005 to 2015 National Surgical Quality Improvement Program database. Patients who underwent a sling operation as their primary procedure were identified. Chi-square analysis and independent t-tests were used for statistical comparisons. RESULTS: A total of 21,040 patients were included. Urologists completed 38.8% of the cases, and gynecologists completed 61.2%. Urologists had shorter operative times (45.93 vs 54.21 minutes; p < 0.001; 95% CI –9.66 to –6.91), were more likely to complete the procedure outpatient (85.4% vs 83.5%; p < 0.001), and performed fewer concomitant procedures (16.1% vs 32.3%; p < 0.001) such as pelvic prolapse repairs. Length of hospital stay was similar between specialties (0.40 vs 0.46 days; p = 0.078). Patients under 60 years saw gynecologists more frequently, while those 61 to 80 years saw urologists more often (p < 0.001). Urological patients had increased likelihood of having comorbidities, including obesity, diabetes, hypertension, smoking history, dyspnea, decreased functional status, chronic obstructive pulmonary disease, and chronic steroid use (p < 0.001; Table). Urologists were less likely to have a resident or fellow present (37.3% vs 42.8%; p < 0.001). CONCLUSION: Urologists were associated with shorter operative times for midurethral slings. They were more likely to operate outpatient, while gynecologists were more likely to perform concomitant procedures and have a trainee present. Urologists operated on older patients who tended to have more comorbidities and had similar lengths of hospital stay. Table. - Comparison of Patient Comorbidities Variable Urology (%) Gynecology (%) p Value Obesity 50.6 47.5 <0.001 Diabetes 12.3 9.5 <0.001 Hypertension 38.9 33.0 <0.001 Current Smoker 15.9 13.0 <0.001 Dyspnea 6.1 4.2 <0.001 Decreased functional status 0.9 0.4 <0.001 COPD 3.8 2.3 <0.001 Chronic steroid use 2.1 1.4 <0.001