Mount Sinai Hospital Research Articles

Three-stage versus modified two-stage surgery for ulcerative colitis: a patient-centred treatment trade-off study.

There is ongoing debate about whether ileal pouch-anal anastomosis needs temporary diversion at the time of construction. Stomas may reduce risk for anastomotic leak (AL) but are also associated with complications, emergency department visits and readmissions. This treatment trade-off study aims to measure patients' preferences by assessing the absolute risk of AL and pouch failure (PF) they are willing to accept to avoid a diverting ileostomy. Fifty-two patients with ulcerative colitis, with or without previous pouch surgery, from Mount Sinai Hospital, Toronto, participated in this study. Standardized interviews were conducted using the treatment trade-off threshold technique. An online anonymous survey was used to collect patient demographics. We measured the absolute increased risk in AL and PF that patients would accept to undergo modified two-stage surgery as opposed to traditional three-stage surgery. Thirty-two patients (mean age 38.7 ± 15.3) with previous surgery and 20 patients (mean age 39.5 ± 11.9) with no previous surgery participated. Patients were willing to accept an absolute increased leak rate of 5% (interquartile range 4.5%-15%) to avoid a diverting ileostomy. Similarly, patients were willing to accept an absolute increased PF rate of 5% (interquartile range 2.5%-10%). Younger patients, aged 21-29, had lower tolerance for PF, accepting an absolute increase of only 2% versus 5% for patients older than 30 (P = 0.01). Patients were willing to accept a 5% increased AL rate or PF rate to avoid a temporary diverting ileostomy. This should be taken into consideration when deciding between modified two- and three-stage pouch procedures.

The COVID-19 Tracheostomy Experience at a Large Academic Medical Center in New York during the First Year.

Background: New York City was the epicenter of the initial surge of the COVID-19 pandemic in the United States. Tracheostomy is a critical procedure in the care of patients with COVID-19. We hypothesized that early tracheostomy would decrease the length of time on sedation, time on mechanical ventilation, intensive care unit length of stay, and mortality. Methods: A retrospective analysis of outcomes for all patients with COVID-19 who underwent tracheostomy during the first year of the COVID-19 pandemic at the Mount Sinai Hospital in New York City, New York. All adult intensive care units at the Mount Sinai Hospital, New York. Patients/subjects: 888 patients admitted to intensive care with COVID-19. Results: All patients admitted to the intensive care unit with COVID-19 (888) from 1 March 2020 to 1 March 2021 were analyzed and separated further into those intubated (544) and those requiring tracheostomy (177). Of those receiving tracheostomy, outcomes were analyzed for early (≤12 days) or late (>12 days) tracheostomy. Demographics, medical history, laboratory values, type of oxygen and ventilatory support, and clinical outcomes were recorded and analyzed. Conclusions: Early tracheostomy resulted in reduced duration of mechanical ventilation, reduced hospital length of stay, and reduced intensive care unit length of stay in patients admitted to the intensive care unit with COVID-19. There was no effect on overall mortality.

Investigating potential disparities by exploring time to surgical thyroid cancer treatment

(1) Delays in initial treatment have been a frequently used metric for assessing disparities in medicine; however, there has been sparse literature on treatment delays in thyroid cancer. We therefore aimed to assess disparities by investigating the association between race/ethnicity, insurance type, and socioeconomic status and time to surgical treatment of thyroid cancer. (2) A retrospective chart review was conducted to collect demographic and clinical data from 443 surgical thyroid cancer patients at Mount Sinai Hospital in 2018–2019. We investigated the time between thyroid cancer diagnosis and surgery by race/ethnicity, insurance, and income groups. (3) Univariate analysis showed that race/ethnicity, insurance type, and SES alone were not statistically significant predictors of earlier time to treatment (p = 0.766, 0.339, 0.435, respectively). On multivariable linear regression, time between diagnosis and surgical treatment was not significantly different for racial minorities compared to non-Hispanic White patients, patients with Medicare/Medicaid compared to private insurance, and patients with lowest income quartile (<$54,585) compared to those with the highest (≥$116,560). (4) Present study showed no significant delays in treatment for different racial/ethnic, insurance, and income groups.

Extensive Disease and Exposure to Multiple Biologics Precolectomy Is Associated with Endoscopic Cuffitis Post-Ileal Pouch-Anal Anastomosis in Patients With Ulcerative Colitis.

To better inform the risk of cuffitis in patients with ulcerative colitis (UC), we aimed to identify its occurrence and associated precolectomy factors in a large multicenter cohort of patients who underwent restorative proctocolectomy (RPC) with stapled ileal pouch-anal anastomosis (IPAA). This study was a retrospective cohort analysis of individuals diagnosed with UC or indeterminate colitis who underwent RPC with IPAA for refractory disease or dysplasia at Mount Sinai Hospital or the University of Chicago followed by at least 1 pouchoscopy with report of the pouch-anal anastomosis. The primary outcome was cuffitis defined as ulceration of the cuff as reported in each pouchoscopy report. The pouch-anal anastomosis was mentioned in the pouchoscopy reports of 674 patients, of whom 525 (77.9%) had a stapled anastomosis. Among these, cuffitis occurred in 313 (59.6%) patients a median of 1.51 (interquartile range 0.59-4.17) years after final surgical stage. On multivariable analysis, older age (hazard ratio [HR], 1.01; 95% confidence interval [CI], 1.01-1.02), extensive disease (HR, 1.34; 95% CI, 1.01-1.78), exposure to biologics before colectomy (HR, 2.51; 95% CI, 1.93-3.27), and exposure to at least 2 or more biologics before colectomy (HR, 2.18; 95% CI, 1.40-3.39) were significantly associated with subsequent cuffitis. In this multicenter study of patients who underwent RPC with stapled IPAA and at least 1 follow-up pouchoscopy, cuffitis occurred in approximately 60% and was significantly associated with extensive disease and exposure to multiple biologics precolectomy.

Internal Carotid Artery Stenosis and Ipsilateral Subretinal Drusenoid Deposits.

Subretinal drusenoid deposits (SDDs) in age-related macular degeneration (AMD) are strongly associated with vasculopathies such as myocardial infarction and ischemic stroke. This study evaluates ischemic stroke subjects for SDDs to determine whether ocular hypoperfusion from internal carotid artery (ICA) stenosis is associated with ipsilateral SDDs. A cross-sectional study at Mount Sinai Hospital recruited 39 subjects with ischemic stroke (aged 52-90; 18 women, 21 men); 28 completed all study procedures. Computed tomography (CT) of the head and neck evaluated 54/56 ICAs for stenosis criteria: none (n = 33), mild (n = 12), moderate (n = 3), severe (n = 3), and complete (n = 3). Spectral-domain optical coherence tomography (SD-OCT) scans were read to consensus by two masked graders for soft drusen, SDDs and choroidal thickness (CTh; choroidal thinning = CTh < 250µm). Univariate testing was done with Fisher's exact test. Multivariate logistic regression models tested age, gender, and ICA stenosis as covariates. Moderate or more ICA stenosis (≥50%-69%) was significantly associated with ipsilateral choroidal thinning (P = 0.021) and ipsilateral SDDs (P = 0.005); the latter were present distal to six of nine stenosed ICAs versus five of 33 normal ICAs. Mild ICA stenosis (≥1%-49%) was not significantly associated with ipsilateral SDDs. Multivariate regression found that older age (P = 0.015) and moderate or more ICA stenosis (P = 0.011) remained significant independent risks for ipsilateral SDDs. At least moderate ICA stenosis (≥50%-69%) is strongly associated with ipsilateral SDDs and choroidal thinning, supporting downstream ophthalmic artery and choroidal hypoperfusion from ICA stenosis as the mechanism for SDD formation. SDDs may thus serve as sensitive biomarkers for ischemic stroke and other vascular diseases.

A235 INFLAMMATORY BOWEL DISEASE AND PREECLAMPSIA: A PHYSICIAN SURVEY

Abstract Background Preeclampsia is a disorder of pregnancy recognized as the second cause of maternal mortality worldwide. The association between IBD and preeclampsia remains unclear, but the significant comorbid profile, and lack of treatment aside from urgent delivery, make primary prevention a priority. Aspirin was shown to halve preeclampsia rates and is recommended for primary prevention for women at risk. Despite high-quality evidence supporting Aspirin use and its well tolerated side effect profile, studies in non-IBD patients have demonstrated a knowledge-to-practice gap. Aims While there are no studies reported in women with IBD, prescribing rates may be even lower in this population, given that it may be incorrectly perceived to increase the risk of an IBD flare. Understanding physician perceptions could allow for a targeted educational approach to increase patient and physician awareness of the indications for Aspirin prophylaxis and its safety profile. Methods This is a cross-sectional survey study assessing physician perceptions and Aspirin prescribing patterns for preeclampsia prevention conducted from Mount Sinai Hospital. Demographic information, information on perceptions of preeclampsia risk in pregnant women with IBD, and on the perceived clinical benefit and risk of Aspirin prescribing were collected. Results A total of 38 Canadian healthcare professionals (HCPs) (15 Gastroenterologists, 14 Obstetricians, 5 General Practitioners, 2 General Internists, 1 nurse practitioner, and 1 midwife) were surveyed. Most HCPs were practicing for over 10 years (71%). In total, 68% of HCPs were comfortable with pregnancy-specific management of IBD. Most HCPs correctly identified all comorbidities associated with a high risk of preeclampsia including a history of preeclampsia (95%), renal disease (87%), and autoimmune disease (68%). A total of 55% of HCPs believed that pregnant patients with IBD were at increased risk of placental related diseases, and 56% agreed that these patients were at increased risk of preeclampsia specifically. Thirty-five percent of HCPs believed that IBD in remission, in the absence of other risk factors, was an indication for Aspirin prophylaxis. More so, 45% believed that IBD, with poor disease control, was an indication. Only 8% of HCPs believed that Aspirin, when used for preeclampsia prevention, was associated with an IBD flare. In patients whom Aspirin prophylaxis was indicated, 77% agreed with its use, even in patients in whom disease control was poor. Finally, 63% agreed that the Aspirin dose should be 162 mg daily, and more than half (58%) agreed that the prescriber should be the patient’s obstetrician. Conclusions Most HCPs agreed that IBD was a risk factor for preeclampsia and that Aspirin prophylaxis was effective and safe for primary prevention. High quality studies are needed to evaluate risk of preeclampsia in IBD, especially in patients with active disease. Funding Agencies CAG

A93 AN ANALYSIS OF POST-ENDOSCOPY EXPERIENCES WITHIN AN EARLY ADULT IBD PATIENT POPULATION AT A NATIONAL IBD CENTRE

Abstract Background Up to 25% of IBD patients are diagnosed before the age of 18, necessitating a process of transition from pediatric to early adult care. Poor endoscopy experiences have been described to jeopardize the overall patient experience with the healthcare system. There is a paucity of literature evaluating the endoscopy experiences of IBD patients during this pivotal point in their disease management. Aims The aim of this study is to describe the reported post-endoscopy experiences of early adult IBD patients (18 to 25 years old) compared to those in an adult model of care (26 years old, or above). Methods A retrospective analysis of patients with IBD treated at Mount Sinai Hospital from January 1st, 2017 to December 31st, 2021 who underwent an outpatient colonoscopy was performed. Qualitative and quantitative data were longitudinally collected from endoscopy records. The first phase of the study consisted of a comparison of outcomes between early adults (18 to 25 years) and adults (26 years, or above). The second phase consisted of a comparison of outcomes between sedation types (deep versus conscious). T-test was used to compare differences for continuous variables and Fisher exact test was used for categorical variables. Results In this initial pilot study of 171 patients, 12.9% of early adults underwent deep sedation compared to 11.4% of adults. Patients who underwent deep sedation were more likely to have Crohn’s disease compared to Ulcerative Colitis (95.2%, 57.7%, pampersand:003C0.01). There were no differences in mean procedure lengths in minutes (18.3, 18.6, p=0.80). Early adults who underwent conscious sedation required additional sedative medications during the procedure in 48.9% of cases compared to 32.3% in the adult cohort (p=0.04), however the mean total of conscious sedation medication used had no differences between the two groups (p=0.59). Nursing post-procedure subjective scoring measuring pain and nausea showed no significant difference (p=0.29). Physician narrative note descriptions of subjective procedural tolerance also showed no significant differences (p=0.78). Conclusions Patients with Crohn’s disease are more likely to require deep sedation for their adult colonoscopies compared to patients with Ulcerative Colitis. Gastroenterologists are not adequately prepared to gauge the amount of conscious sedation an early adult patient will require, necessitating top-up amounts peri-procedure more frequently. Current tools in the forms of subjective scoring and narrative documentation utilized by healthcare providers to measure procedural experience and tolerance are poor markers of actual patient experience. Future efforts should be focused on better understanding the endoscopic experience of the early adult IBD patient population and utilizing an innovative and collaborative approach. Funding Agencies Division of Gastroenterology, University of Toronto Faculty of Medicine Resident Research Grant

A237 ROTAVIRUS VACCINE SAFETY IN INFANTS EXPOSED TO BIOLOGICS IN UTERO IN AN INFLAMMATORY BOWEL DISEASE POPULATION: A PROSPECTIVE COHORT STUDY

Abstract Background Biologics, the mainstay of therapy in patients with moderate-to-severe inflammatory bowel disease (IBD), undergo placental transfer during the second trimester of pregnancy and may remain detectable in the blood of exposed infants for up to 12 months. Due to concerns regarding the risk of immunosuppression and adverse events following immunization with live attenuated vaccines in infants exposed to biologics in utero, current guidelines recommend avoiding live vaccines in the first 6 to 12 months of life. Aims This study investigates whether the live rotavirus vaccine can safely be administered in infants exposed to biologics in utero. Methods We conducted a single-centre prospective cohort study, which included infants exposed to biologics in utero and born to mothers with IBD between October 1, 2020 and June 30, 2022. Infants were included in the study if they were assessed by Paediatric specialists at the Special Immunization Clinic (SIC) at SickKids Hospital (Toronto, Ontario). Mothers were followed by Gastroenterologists at the Special Pregnancy IBD Clinic at Mount Sinai Hospital (Toronto, Ontario). Data were collected on biologic agent exposure history, infant immune function testing, SIC recommendations for rotavirus vaccination, rotavirus vaccine series completion, and adverse events after immunization. Adverse events following immunization included fevers, vomiting, diarrhea, and/or intussusception within 42 days following immunization. Results 22 infants were included in the study. Of the 22 infants, 5 (22.7%) were exposed to infliximab in utero, 10 (45.5%) were exposed to adalimumab, 3 (13.6%) were exposed to vedolizumab, and 3 (13.6%) were exposed to ustekinumab. Of the 22 infants, 18 (81.8%) were recommended to receive the rotavirus vaccine by the SIC. 1 (0.05%) was not recommended to receive the vaccine due to neutropenia and low CD54 count on lymphocyte testing. The recommendation given to 3 infants is unknown. Of the 18 infants who were recommended to receive the vaccine, 16 (88.9%) received the vaccine and had no adverse events following immunization. 1 (6%) infant did not receive the rotavirus vaccine despite it being recommended due to parental choice. The rotavirus vaccination status and response in 1 infant recommended to receive the vaccine, is unknown. Conclusions Administration of the rotavirus vaccine in biologic-exposed infants did not result in adverse events in our study cohort. Although guidelines currently advise against live vaccinations in infants exposed to biologics in utero, specialist assessment of infant immune function can help encourage safe live vaccination uptake. Funding Agencies None

A247 THE IMPACT OF BIOLOGICS ON MATERNAL AND NEONATAL OUTCOMES IN PREGNANT PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND THEIR ASSOCIATION WITH THERAPEUTIC DRUG LEVELS

Abstract Background Biologic therapies are at the backbone of managing moderate to severe IBD and maintaining clinical remission. The data on the effects of biologic therapy on maternal and neonatal outcomes continues to be limited. To our knowledge, there have been no previous studies specifically investigating whether biologic therapeutic drug levels in pregnant patients are related to maternal and neonatal outcomes. Aims The objective of this study is to determine whether biologic use in pregnancy is associated with adverse maternal and fetal outcomes, and if those outcomes correlate to specific therapeutic drug levels. Methods In this study, we retrospectively evaluate patients at a high-volume pregnancy and inflammatory bowel disease centre at Mount Sinai Hospital in Toronto between January 1st, 2017 to December 31st, 2022. Primary outcomes include maternal complications, such as induction of labour, cesarean section, peripartum infections, placental abruption, preterm labour and pre-eclampsia. Secondary outcomes include neonatal complications, such as preterm birth, low birth weight (ampersand:003C2500g), congenital anomalies and the presence of neonatal infection. These outcomes will be compared to therapeutic drug levels measured in preconception, during pregnancy and post-partum. Results A total of 312 patients were included in our study, of which 152 were on biologic treatment for IBD. Of the biologics population, the majority of patients are on Remicade, followed by Humira and Stelara (Table 1). Preliminary data analysis reveals that there was no significant difference in the rate of miscarriages (10% vs. 6%, P= 0.1), cesarean section (44% vs. 38%, P=0.3) and preterm deliveries (12% vs. 14%, P=0.7) between the biologics vs. non-biologics patient groups. Next round of analysis will include secondary outcomes and therapeutic drug levels. Conclusions Through this study, we hope to add to the literature on the possible safety of maintaining biologic therapy during pregnancy in those with inflammatory bowel disease. The data on proactive therapeutic drug monitoring in pregnant patients may bring to light the importance of its inclusion in clinical decision-making algorithms. Breakdown of therapies in the biologic patient group Funding Agencies None

Pediatric ECG-Based Deep Learning to Predict Left Ventricular Dysfunction and Remodeling.

Artificial intelligence-enhanced ECG analysis shows promise to detect ventricular dysfunction and remodeling in adult populations. However, its application to pediatric populations remains underexplored. A convolutional neural network was trained on paired ECG-echocardiograms (≤2 days apart) from patients ≤18 years of age without major congenital heart disease to detect human expert-classified greater than mild left ventricular (LV) dysfunction, hypertrophy, and dilation (individually and as a composite outcome). Model performance was evaluated on single ECG-echocardiogram pairs per patient at Boston Children's Hospital and externally at Mount Sinai Hospital using area under the receiver operating characteristic curve (AUROC) and area under the precision-recall curve (AUPRC). The training cohort comprised 92 377 ECG-echocardiogram pairs (46 261 patients; median age, 8.2 years). Test groups included internal testing (12 631 patients; median age, 8.8 years; 4.6% composite outcomes), emergency department (2830 patients; median age, 7.7 years; 10.0% composite outcomes), and external validation (5088 patients; median age, 4.3 years; 6.1% composite outcomes) cohorts. Model performance was similar on internal test and emergency department cohorts, with model predictions of LV hypertrophy outperforming the pediatric cardiologist expert benchmark. Adding age and sex to the model added no benefit to model performance. When using quantitative outcome cutoffs, model performance was similar between internal testing (composite outcome: AUROC, 0.88, AUPRC, 0.43; LV dysfunction: AUROC, 0.92, AUPRC, 0.23; LV hypertrophy: AUROC, 0.88, AUPRC, 0.28; LV dilation: AUROC, 0.91, AUPRC, 0.47) and external validation (composite outcome: AUROC, 0.86, AUPRC, 0.39; LV dysfunction: AUROC, 0.94, AUPRC, 0.32; LV hypertrophy: AUROC, 0.84, AUPRC, 0.25; LV dilation: AUROC, 0.87, AUPRC, 0.33), with composite outcome negative predictive values of 99.0% and 99.2%, respectively. Saliency mapping highlighted ECG components that influenced model predictions (precordial QRS complexes for all outcomes; T waves for LV dysfunction). High-risk ECG features include lateral T-wave inversion (LV dysfunction), deep S waves in V1 and V2 and tall R waves in V6 (LV hypertrophy), and tall R waves in V4 through V6 (LV dilation). This externally validated algorithm shows promise to inexpensively screen for LV dysfunction and remodeling in children, which may facilitate improved access to care by democratizing the expertise of pediatric cardiologists.

Prognostic impact of peripheral artery disease in patients with and without high bleeding risk undergoing percutaneous coronary intervention.

Peripheral artery disease (PAD) is associated with worse outcomes after percutaneous coronary intervention (PCI). The aim of this study was to assess the prognostic impact of PAD according to high bleeding risk (HBR) status. Consecutive patients undergoing PCI with drug-eluting stent implantation at a tertiary-care center (Mount Sinai Hospital) between 2012 and 2019 were stratified according to HBR and PAD status. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and stroke 1 year after PCI. Secondary outcomes included major bleeding. Out of 16,750 patients, 43% were HBR and 57% were no-HBR. Within the two groups, PAD patients were 14% and 6%, respectively, and were more likely to have comorbidities and to undergo complex PCI than no-PAD patients. Within the HBR group, PAD was associated with an increased risk of MACE (11.4% vs. 7.3%, hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.27-1.99, p < 0.001) and a numerical nonsignificant increase of major bleeding (8.5% vs. 6.9%, HR: 1.25, 95% CI: 0.98-1.59, p = 0.066) as compared with no-PAD. Among no-HBR patients, rates of MACE and major bleeding were numerically but not significantly higher in the PAD group. After multivariable adjustment, PAD was no longer a predictor of adverse outcomes, irrespective of HBR status. At 1-year after PCI, PAD was associated with increased 1-year risks of MACE in HBR patients. After adjustment for cardiovascular risk factors and comorbidities, the effect of PAD on adverse events was largely attenuated.

Impact of race-neutral eGFR calculations on African American kidney transplant candidate wait time: A single center retrospective analysis.

Race-inclusive estimated glomerular filtration rate (eGFR) could contribute to racial disparity in access to kidney transplantation. The Organ Procurement and Transplantation Network (OPTN) issued a policy allowing waiting time modification for candidates affected by race-inclusive eGFR calculations. Implementation of the new OPTN policy at the kidney transplant program of the Mount Sinai Hospital involved review of 921 African American candidates, of whom 240 (26%) candidates gained a median of 1year and 10months. The duration of time candidates gained varied from a minimum of 5days to a maximum of 12years and 3months; 45.4% gained at least 2years, and 12% gained at least 4years of wait time. Among those who gained wait time, 20 (8.3%) candidates received deceased donor kidney transplants. Candidates who gained wait time had similar sociodemographic characteristics as those who did not, except that the median age for the former was higher by 3years (59 vs. 56). Our early data suggest that the current policy on waiting time modification for candidates affected by race-inclusive estimation of GFR has the potential to improve racial disparity in access to kidney transplantation. However, the generalizability of our findings to other centers requires further study.

DECREASED HEALTHCARE UTILIZATION IN UNINSURED PATIENTS WITH PERIANAL CROHN’S DISEASE UNDERGOING PROCTECTOMY

Abstract INTRODUCTION Perianal Crohn's disease (CD) is a debilitating subtype affecting nearly 20% of CD patients, primarily characterized by the presence of perianal fistulas. It is associated with poor health outcomes, significantly decreased quality of life, and is an independent predictor of work disability. Proctectomy is generally reserved for patients with severe, refractory disease. Social determinants of health, including health insurance status, can impact the progression and outcomes of chronic diseases. Here we examine healthcare utilization and clinical characteristics of patients with perianal CD who undergo proctectomy for those with and without health insurance. METHODS This retrospective study follows perianal CD patients who underwent a proctectomy from 2008 to 2021 at Mount Sinai Hospital. We collected demographic, insurance status, and clinical data, such as diagnosis-to-surgery time, hospitalization rates, number of MRIs utilized, and number of medications utilized (Tables 1 and 2). Univariate analysis comparing patients with and without insurance was performed using Chi-Square or Fisher's Exact Tests. RESULTS Our study included 130 patients (50.8% female) with a mean age of 52.0 ± 14.9 years. The majority were insured (n = 106, 81.5%). Results were significant for a shorter diagnosis-to-surgery time in the uninsured group (6.9 vs. 11.1 years, p = 0.050), fewer hospitalizations (p = 0.002), MRIs (p = 0.008), clinic visits (p = 0.007), as well as reduced use of antibiotics (p = 0.016), and biologics (p =0.001) in the uninsured group (Tables 1 and 2). Data trended towards a later mean age at the time of diagnosis in the uninsured group (37.8 vs. 33.1 years, p=0.241). There was no statistical difference between the groups regarding race, comorbidities, extraintestinal manifestations, presence of skin tags, strictures, and fissures, presence of proctitis or abscess at proctectomy, age at proctectomy, surgical approach, number of lifetime GI surgeries, endoscopies, or corticosteroid treatments. DISCUSSION Our findings suggest that the uninsured patients with perianal CD have decreased utilization of healthcare resources compared to the insured group. This disparity, combined with the observed trend of older age at, and therefore likely delay of, CD diagnosis and treatment may contribute to a more rapid and severe CD course, ultimately leading to a shorter diagnosis-to-surgery interval. This study was limited by a small, single-center population sample, as well as other confounding factors associated with lack of insurance. Future research will include multivariate analysis to identify specific discrepancies in annual healthcare utilization between these populations, evaluate the contribution of race and language to this issue, and investigate the role that a decreased delay in diagnosis could play in preventing last resort proctectomy. Table 1 Patient Characteristics Table 2 Comparison of Healthcare Utilization by Insurance Status

INCREASING ACCESS TO INTERDISCIPLINARY IBD CARE FOR NEWLY DIAGNOSED IBD PATIENTS USING TELEMEDICINE: AN EXTENSION OF THE COMPASS-IBD PROGRAM

Abstract INTRODUCTION Interdisciplinary care is increasingly being recognized as important in the care of inflammatory bowel disease (IBD) patients. However, access to additional resources to do this are frequently only available in tertiary-care IBD centers. We piloted a telemedicine version of an interdisciplinary care program for recently diagnosed IBD patients. METHODS The Mount Sinai Health system has a well-established IBD center, located at the Mount Sinai Hospital in New York. Patients who were diagnosed with IBD in the last 18 months were identified by a primary gastroenterologist working at a community site within the Mount Sinai health system. Once identified, patients were referred electronically and enrolled in the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD) program. This existing program provides interdisciplinary care to newly diagnosed IBD patients. IBD patients have access to a physician who works at the IBD Center, a nutritionist specializing in IBD diets, an experienced IBD clinical pharmacist and a licensed clinical social worker dedicated to the mental and social needs of patients with IBD. After an initial assessment, these patients were then provided access as needed to the program experts. All appointments were done virtually using telemedicine. After completing intake, recommendations were consolidated and provided to the patient and the patient’s primary gastroenterologist electronically. The patient then followed up with his/her primary gastroenterologist. RESULTS For this pilot study, twelve newly diagnosed inflammatory bowel disease patients were identified at community sites within the Mount Sinai health system. Enrolled patients met with all members of the COMPASS- IBD program team for their initial intake. The referring gastroenterologist received summary recommendations for all patients who completed the intake. Participating patients were overall satisfied with the intervention and use of telemedicine as a primary modality. No major barriers to virtual program implementation were identified. DISCUSSION We demonstrated the feasibility of providing interdisciplinary care via telemedicine for recently diagnosed IBD patients. This supports a “hub and spoke” model for IBD care. We believe our pilot study shows a simple way for health systems to increase access to interdisciplinary IBD care for patients with limited access to tertiary-care IBD Centers. This approach may also help in achieving health equity for underserved IBD patient populations.

OP40 Transcriptomic signature of response to vedolizumab in patients with moderate-to-severe ulcerative colitis: Results from an international, multicentre, retrospective cohort study

Abstract Background Transcriptomic analysis has the potential to facilitate drug development and clinical decision making in inflammatory bowel disease. Current understanding of pharmacodynamic response to vedolizumab is limited by a lack of publicly available mucosal biopsy RNA samples/sequencing data and corresponding clinical information. We aimed to identify gene signatures associated with response to vedolizumab in ulcerative colitis (UC) patients by pooling data from 3 international sites. Methods Patients receiving vedolizumab for the treatment of moderate-to-severe UC at Hospital Clínic de Barcelona (IDIBAPS), Mount Sinai Hospital (MSH), and University of California, San Diego (UCSD) with baseline and post-treatment (week 14 [± 4 weeks]) mucosal biopsy RNA-sequencing data and Mayo Clinic endoscopic subscores (MCES) were eligible for inclusion. Endoscopic response was defined as an MCES &amp;lt;1. Demographic and clinical data were collected. Differential expressed genes (DEGs) between baseline and week 14 were identified using linear mixed models with a &amp;gt;1.5 or &amp;lt;-1.5-fold change (adjusted P-value &amp;lt;.05). Enrichment was performed using Reactome pathway analysis and a previously published UC gene signature (adjusted P-value &amp;lt;.05).1 Analyses were performed using R version 4.3.0. Results Twenty-three patients were included (IDIBAPS: n=12; MSH: n=8; UCSD: n=3). Site-specific differences in sex, surgical history, and corticosteroid use were observed (Table). Analysing data by site yielded a relatively small number of DEGs between baseline and week 14 (IDIBAPS=57 [27 up-regulated, 30 down-regulated]; MSH=0; UCSD=0) among endoscopic responders (IDIBAPS: n=5; MSH: n=7; UCSD: n=2). Combining data from the 3 sites increased the number of DEGs among endoscopic responders at week 14 (n=14) to 1162 (662 up-regulated and 500 down-regulated). The down-regulated DEGs were enriched for genes involved in 37 of 103 up-regulated Reactome pathways in UC, including neutrophil degranulation, interleukin-4 and interleukin-13 signalling, interleukin-10 signalling, and integrin cell surface interactions. The up-regulated DEGs were enriched for genes involved in 1 of 39 down-regulated Reactome pathways in UC (Drug ADME). Conclusion We defined a pharmacodynamic signature using mucosal biopsies from UC patients who had endoscopic response to vedolizumab at week 14. The signature was enriched for several, but not all, pathways involved in UC. In addition to providing insight into vedolizumab’s mechanism of action, we underscored the utility of multi-site collaboration to access data, increase statistical power, and enhance the generalizability of research findings. Reference: 1. Linggi et al. Sci Rep 2021;11:18243.

P664 Anti-TNF exposure is associated with an increased risk of urgent and one-year colectomy in Acute Severe Ulcerative Colitis

Abstract Background Acute severe ulcerative colitis (ASUC) affects up to 25% of patients with UC and is significantly associated with an increased risk of colectomy. Despite improvements in medical management, individual patient prognostication and risk stratification in ASUC remains clinically challenging. We explored clinical, biochemical, and endoscopic factors as potential predictors for colectomy in patients hospitalized with ASUC. Methods A retrospective analysis of patients with ASUC as defined by Truelove and Witts criteria admitted to the Mount Sinai Hospital between 2011 and 2020 was conducted. Patients with well-documented data on disease history, medication use, clinical symptoms, and laboratory results during admission for ASUC were included. Colectomy risk during hospitalization and within one year was assessed. Multivariable logistic regression analyses were performed to identify clinical, biochemical, and endoscopic parameters associated with colectomy risk in patients with ASUC. Results Out of the 158 patients included, 34 (21.5%) underwent colectomy during hospital admission, and 41 (25.9%) within one year after admission. On multivariable analysis, adjusting for age, sex, body mass index (BMI), and disease duration, prior anti-TNF exposure (odds ratio [OR] 4.59, 95% confidence interval [CI] 1.57-13.4, P=0.005) and the use of biologics (any type) at admission (OR 3.31, 95%CI: 1.14-9.63, P=0.028) were associated with an increased risk of 1-year colectomy. Conversely, the use of mesalamines at admission was associated with a decreased risk of 1-year colectomy (OR 0.31, 95%CI: [0.13-0.72], P=0.006). Furthermore, recent UC-related hospitalization (within one year of admission) (OR 2.72, 95%CI: 1.15-6.43, P=0.022) and increased number of bowel movements after 3 days of treatment (OR 1.18, 95%CI: 1.04-1.34, P=0.011) were associated with higher risk of 1-year colectomy. Biomarkers measured at admission including hemoglobin and albumin were associated with a decreased risk, while CRP was associated with an increased risk of urgent and 1-year colectomy. Patients with deep ulcerations observed at endoscopy tended to have an increased risk of urgent colectomy, although this was not statistically significant (univariable OR 3.36, P=0.081). Finally, treatment of ASUC with anti-TNF was strongly associated with a decreased risk of urgent (OR 0.30, 95%CI: 0.13-0.73, P=0.007) and 1-year colectomy (OR 0.31, 95%CI: 0.14-0.73, P=0.007). Conclusion In patients with ASUC, anti-TNF treatment is associated with a reduced risk of both urgent and 1-year colectomy. Conversely a history of anti-TNF exposure is linked to a higher risk of both urgent and 1-year colectomy. This data emphasizes the need for alternative therapies.

Biomarkers of Iron Are Associated with Anterior-Pituitary-Produced Reproductive Hormones in Men with Infertility.

Approximately 16% of North American couples are affected by infertility, with 30% of cases being attributable to male factor infertility. The regulation of reproductive hormones via the hypothalamic-pituitary-gonadal axis is important for spermatogenesis and subsequently male fertility. Maintaining iron homeostasis is critical to normal reproductive physiological function. This cross-sectional study's objective was to determine the association between serum biomarkers of iron and reproductive hormones. Men experiencing infertility (n = 303) were recruited from Mount Sinai Hospital, Toronto. Serum was analyzed for iron and ferritin as biomarkers of iron status and reproductive hormones (follicle-stimulating hormone, luteinizing hormone, testosterone, estradiol, and prolactin), which were the primary outcome. Associations were determined using non-parametric Spearman's rank correlation coefficient, linear regressions, and logistic regressions. A significant independent monotonic inverse relationship between serum iron and prolactin (p = 0.0002) was found. In linear regression analyses, iron was inversely associated with luteinizing hormone (unadjusted p = 0.03, adjusted p = 0.03) and prolactin (unadjusted p = 0.001 and adjusted p = 0.003). Serum ferritin was inversely associated with both gonadotropins, follicle-stimulating hormone (adjusted p = 0.03), and luteinizing hormone (adjusted p = 0.02). These findings suggest that biomarkers of iron are associated with pituitary-produced reproductive hormones, which play a role in the hypothalamic-pituitary-gonadal signaling pathway involved in spermatogenesis, testicular testosterone production, and male fertility.

CT Predictors of Visceral Pleural Invasion in Patients with Non-Small Cell Lung Cancers 30 mm or Smaller.

Background CT-defined visceral pleural invasion (VPI) is an important indicator of prognosis for non-small cell lung cancer (NSCLC). However, there is a lack of studies focused on small subpleural NSCLCs (≤30 mm). Purpose To identify CT features predictive of VPI in patients with subpleural NSCLCs 30 mm or smaller. Materials and Methods This study is a retrospective review of patients enrolled in the Initiative for Early Lung Cancer Research on Treatment (IELCART) at Mount Sinai Hospital between July 2014 and February 2023. Subpleural nodules 30 mm or smaller were classified into two groups: a pleural-attached group and a pleural-tag group. Preoperative CT features suggestive of VPI were evaluated for each group separately. Multivariable logistic regression analysis adjusted for sex, age, nodule size, and smoking status was used to determine predictive factors for VPI. Model performance was analyzed with the area under the receiver operating characteristic curve (AUC), and models were compared using Akaike information criterion (AIC). Results Of 379 patients with NSCLC with subpleural nodules, 37 had subsolid nodules and 342 had solid nodules. Eighty-eight patients (22%) had documented VPI, all in solid nodules. Of the 342 solid nodules (46% in male patients, 54% in female patients; median age, 71 years; IQR: 66, 76), 226 were pleural-attached nodules and 116 were pleural-tag nodules. VPI was more frequent for pleural-attached nodules than for pleural-tag nodules (31% [69 of 226] vs 16% [19 of 116], P = .005). For pleural-attached nodules, jellyfish sign (odds ratio [OR], 21.60; P < .001), pleural thickening (OR, 6.57; P < .001), and contact surface area (OR, 1.05; P = .01) independently predicted VPI. The jellyfish sign led to a better VPI prediction (AUC, 0.84; 95% CI: 0.78, 0.90). For pleural-tag nodules, multiple tags to different pleura surfaces enabled independent prediction of VPI (OR, 9.30; P = .001). Conclusions For patients with solid NSCLC (≤30 mm), CT predictors of VPI were the jellyfish sign, pleural thickening, contact surface area (pleural-attached nodules), and multiple tags to different pleura surfaces (pleural-tag nodules). © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Nishino in this issue.

Fetal spina bifida associates with dysregulation in nutrient-sensitive placental gene networks: Findings from a matched case-control study.

To improve outcomes in fetuses with spina bifida (SB), better understanding is needed of the molecular drivers of SB and its comorbidities. Pregnant peoplecarrying a fetus with isolated SB (cases; n = 12) or a fetus with no congenital anomalies (controls; n = 21) were recruited at Mount Sinai Hospital, Toronto, Ontario, Canada. Clinical data and placental samples were collected. Placental transcriptome was sequenced (Clariom D microarray) and a nutrient-focused gene expression analysis pipeline was applied to determine whether fetal SB associates with placental dysfunction. Of the 391 differentially expressed genes (DEGs) in cases, 11% (n = 42) had at least one nutrient cofactor, including B vitamins (n = 7 genes), iron/heme (n = 6), and zinc (n = 11). Cases had dysregulation in genes not previously known to associate with SB, and in placental genes that have known links to SB but have not been previously identified in the placenta. Cases also had downregulated nutrient transport and upregulated branching angiogenesis and immune/inflammatory processes. Five nutrient-dependent transcription regulators, collectively predicted to target 46% of DEGs in cases, were identified and were most commonly dependent on B vitamins (n = 3) and zinc (n = 2). Placental gene expression changes were most acute in cases with poor growth. Placentae from fetuses with SB have dysregulation in several gene networks, including those that are sensitive to multiple micronutrients beyond the well-known folic acid. An improved understanding of placental phenotype in fetuses with SB may help identify novel mechanisms associated with comorbidities in fetuses with SB, and reveal new targets to improve fetal outcomes in this population.

BRINGING GERIATRIC CARE INTO THE HIV PRIMARY CARE CLINIC: A COMBINED HIV/GERIATRIC MULTIDISCIPLINARY CLINIC MODEL

Abstract Persons living with HIV (PLWH) experience accelerated and accentuated aging, developing co-morbidities at earlier ages and with higher frequencies than those without HIV. Older persons with HIV (OPWH) also experience geriatric syndromes. In 2020 we developed a combined HIV/geriatrics multidisciplinary clinic at Mount Sinai Hospital in New York where a geriatrician and multidisciplinary team including a nurse, pharmacist, and social worker are embedded in an HIV primary care clinic. Patients are referred for comprehensive geriatric assessments. We conducted a retrospective chart review after the first 15 months of the program to describe this population of OPWH living in NYC who are referred to a geriatrician. From 9/2020-11/2021, there were 183 appointments scheduled of which 112 (61%) were new patient visits. Sixty-two percent of patients came to their appointment. The average age of patients was 67 years. Fifty-seven percent identified as male. The majority of referrals (50%) were for cognitive assessment followed by mobility assessment (25%), polypharmacy (14%), multimorbidity (8%), advance care planning (1%), and other (2%). Based on this data, we identified a need to improve the show rate to our clinic and implement cognitive screening in OPWH. We have incorporated a community health worker into our interdisciplinary team to assist in this goal and continue to educate patients and providers on geriatric syndromes. A geriatric approach to care is crucial to incorporate into existing HIV clinical practices and we hope to optimize this integration based on the needs of patients and providers.