Wake Forest Baptist Medical Center Research Articles

High Ki67 Index Is Associated with Shorter Progression Free Survival in Follicular Lymphoma Patients Treated with Frontline Immunochemotherapy

Introduction The Follicular Lymphoma International Prognostic Index (FLIPI) is a commonly used prognostic tool in follicular lymphoma (FL). However, there is a need for better risk stratification to predict risk of progression after frontline chemoimmunotherapy. Ki67 proliferation index has prognostic value in many lymphomas and is widely available in clinical laboratories. However, the impact of Ki67 on outcomes in FL have not been conclusive. Studies have been limited by the method of quantifying Ki67 (entire specimen or intrafollicular [IF]), heterogeneous treatments, or small single institution studies. Moreover, the impact of Ki67 on predicting disease progression at 24 months (POD24) is unknown. We sought to study the predictive value of Ki67 on PFS in FL treated with Bendamustine Rituximab (BR) or RCHOP with or without Rituximab maintenance (RM) as first line therapy at 2 tertiary care centers. Methods This study was conducted with approval by the Wake Forest University Health Sciences IRB. We retrospectively analyzed 122 patients with FL (grade 1-3A) from 2010 to 2021 at Atrium Health (AH) Levine Cancer Institute (n=72) and AH Wake Forest Baptist Medical Center (n=50) who underwent first line therapy with BR or RCHOP and had tissue/slides available for analysis. Clinical data was collected through electronic medical record review. Archival slides and paraffin-embedded blocks were retrieved. Ki67 immunohistochemistry (IHC) (SP6, Cell Marque, Rocklin, CA), was performed if it was not available from the original work-up (8 cases). CD21 IHC (1F8, Dako, Denmark) was performed in select cases to confirm the presence of follicles in order to assess IF Ki67. Diagnosis, grade, and Ki67 stains were evaluated by 2 hematopathologists. The IF Ki67 index was determined by visual estimate to the nearest 10%. All cases with scores between 20-40% were re-reviewed to achieve a consensus score. Ki67 controls were exchanged between the two centers to ensure equivalent staining. Comparisons of patient characteristics were done by Kruskal-Wallis test for continuous variables (age) or Chi-square tests (categorical variables). Survival analysis was performed using Kaplan-Meier estimation and log-rank testing. Cox proportional hazards modeling was used for multivariable progression free survival (PFS) analysis. Results The clinical and pathologic characteristics are shown in Table 1. No differences in demographics [age, stage, cytologic grade, FLIPI, IF Ki67 status (<30 or ≥30) and treatment selection] were seen between the two centers. 100 cases were grade 1-2 (82.0%) and 22 were grade 3A (18.0%). Consistent with expected treatment patterns in FL, more patients were treated with BR (70.5%) compared to RCHOP (29.5%) and RCHOP was more frequently used in grade 3A compared to grade 1-2 FL patients. As expected, low FLIPI score (0-1) was associated with favorable PFS (P=0.02, Figure 1A), but not OS. However, treatment regimen (BR vs RCHOP), use of RM, and cytologic grade (grade 1-2 vs 3A) were not associated with PFS or OS. The IF Ki67 index was elevated (≥30%) in 46 cases (38%) and high IF Ki67 was associated with shorter PFS (P=0.002, Figure 1B), but was not associated with OS (P=0.11). When stratified by treatment regimen and IF Ki67, these results were maintained ( Figure 1C). There was no association between FLIPI and IF Ki67 (P=0.10). In a multivariable regression analysis, IF Ki67 ≥30 was associated with a significantly higher risk of progression (HR= 2.3, 95% CI 1.3 to 4, P=0.005) after accounting for the effect of FLIPI. In an exploratory analysis, a FLIPI/Ki67 (FKi) score was devised in which one point was given for either FLIPI ≥ 2 or IF Ki67 ≥ 30% giving a possible score of 0, 1 or 2. The FKi score was associated with PFS (P=0.0005, Figure 1D). Moreover, IF Ki67 ≥ 30 was associated with a higher risk of POD 24 (P=0.037). FLIPI ≥2 was also associated with POD24 (P=0.005). Conclusion Intrafollicular Ki67 ≥ 30% predicts for increased risk of progression independent of FLIPI in patients with FL treated with frontline immunochemotherapy. Addition of Ki67 to FLIPI is strongly associated with PFS in FL. Ki67 stains were done over an 11 year period in different laboratories, demonstrating the wide applicability and robustness of the Ki67 IHC technique. Larger studies incorporating IF Ki67 in risk stratification models are warranted in FL.

Abstract 17657: The Effect of Medical Therapy on Reducing the Risk of Pacing Induced Cardiomyopathy

Introduction: Right ventricular (RV) pacing results in left ventricular dyssynchrony that can lead to pacing induced cardiomyopathy (PICM). The risk of PICM increases with RV pacing burden. No prior trials have investigated the effect of medical therapy on preventing PICM in patients with high RV pacing burden. The goal of this study was to investigate whether ACE inhibitors (ACEI), angiotensin receptor blockers (ARB), and beta blockers (BB) reduce the risk of PICM in patients with high RV pacing burden. Methods: This was a retrospective study which included patients with normal ejection fraction (EF) and complete heart block who underwent single- or dual-chamber pacemaker placement at Wake Forest Baptist Medical Center between 1992 - 2013. Exclusion criteria were age <18 and myocardial infarction. The medical therapy group included patients who received ACEI/ARB, BB, or both. The control group included patients who received neither ACEI/ARB nor BB. The primary endpoint was PICM, which was defined as upgrade to a biventricular device or reduction in EF by ≥10% without another etiology identified. Follow-up was 10 years or until development of PICM. Kaplan-Meier and multivariable Cox proportional hazards ratio survival analysis was performed. Results: The study included 642 patients. Average age was 71 ± 14. Females were 51%. ACEI/ARB only was prescribed for 80 (12%), BB only was prescribed for 55 (9%), and both were prescribed for 114 (18%). PICM occurred in 12 out of a total of 249 in the medical therapy group (4.8%) and 28 out of a total of 393 in the control group (7.1%). The risk of PICM was significantly lower in the medical therapy group compared to the control group (HR 0.34, 95% CI 0.16 - 0.71, P<0.01) in a model fully adjusted for age, sex, hypertension, diabetes mellitus, chronic kidney disease, and atrial fibrillation. Conclusions: In patients who have high RV pacing burden, medical therapy with ACEI/ARB and BB appears to reduce the risk of PICM.

A Successful Gap-Year Clinical Research Technician (CRT) Program at an Academic Anesthesiology Department.

Many students elect to take gap years in between graduating college and matriculating into medical school. At an academic institution, investigators can be limited in conducting research due to clinical endeavors. Utilizing a structured, clinical research, gap-year program with students called clinical research technicians (CRTs) can aid both investigators conducting research and students applying to graduate health programs. In this original article, we sought to understand CRT and investigator perceptions of and experiences in the program. We distributed a survey to past and present CRTs and the investigators with whom they worked at Atrium Health Wake Forest Baptist Medical Center. We conducted thematic and sentiment analyses of the survey results. We also collected data on grant approvals, research funding awards, and CRT, clinical research nurse, and clinical research coordinator salaries. We received responses from 20/29 investigators and 21/22 CRTs. We identified five themes for the investigator survey, including research accuracy and precision; research output; alleviating responsibilities; cost; and likelihood of referral. We identified five themes for the CRT survey, including future career assistance; physician career insights; mentorship; likelihood of referral; and other. The majority of respondents strongly agreed or agreed with the survey statements. The majority of comments were coded as positive. All of CRTs were accepted into a graduate health profession program. Our program's success demonstrates how a structured, clinical research, gap-year program for premedical students can serve as a new educational tool and important research infrastructure resource for hospitals.

Incidence of Nonunion Following First Metatarsophalangeal Joint Arthrodesis for Hallux Valgus Deformity: A Retrospective Analysis of Four Different Constructs

Arthrodesis of the great toe joint is a valuable procedure for hallux valgus deformities. The primary aim of this study was to determine nonunion rates of a first metatarsophalangeal joint (MTPJ) arthrodesis for bunion deformity. This was a retrospective review of 166 consecutive limbs that underwent a first metatarsal phalangeal joint arthrodesis at Wake Forest Baptist Medical Center (WFBMC). Procedures were performed using 4 different constructs for the arthrodesis. Incidence of nonunion, intermetatarsal correction, infection, and recurrence were measured. Overall, 20 patients (12%) experienced nonunion following a first metatarsophalangeal joint arthrodesis. Eighty-seven patients (86%) of plate and screw patients achieved union while 14 (78%) of crossing screw patients achieved union. The minimum time of follow-up was 3 months and the maximum time was 15.4 months. The mean change in intermetatarsal and hallux valgus angle correction was 3.4° and 20.3°, with no statistical difference based on hardware construct or being diabetic. First metatarsophalangeal joint arthrodesis is a viable option for hallux valgus. However, the results of the present study suggest that there is a lower fusion rate of the first MTPJ using crossing screws for bunion deformities.

370 Correlation Between the Electronic Frailty Index and Hospitalization Mortality in Older Adults Infected with SARS-CoV-2

370 Correlation Between the Electronic Frailty Index and Hospitalization Mortality in Older Adults Infected with SARS-CoV-2

Intracranial approach for sub-second monitoring of neurotransmitters during DBS electrode implantation does not increase infection rate.

IntroductionCurrently, sub-second monitoring of neurotransmitter release in humans can only be performed during standard of care invasive procedures like DBS electrode implantation. The procedure requires acute insertion of a research probe and additional time in surgery, which may increase infection risk. We sought to determine the impact of our research procedure, particularly the extended time in surgery, on infection risk.MethodsWe screened 602 patients who had one or more procedure codes documented for DBS electrode implantation, generator placement, programming, or revision for any reason performed at Wake Forest Baptist Medical Center between January 2011 through October 2020 using International Classification of Diseases (ICD) codes for infection. During this period, 116 patients included an IRB approved 30-minute research protocol, during the Phase 1 DBS electrode implantation surgery, to monitor sub-second neurotransmitter release. We used Fisher’s Exact test (FET) to determine if there was a significant change in the infection rate following DBS electrode implantation procedures that included, versus those that did not include, the neurotransmitter monitoring research protocol.ResultsWithin 30-days following DBS electrode implantation, infection was observed in 1 (0.21%) out of 486 patients that did not participate in the research procedure and 2 (1.72%) of the 116 patients that did participate in the research procedure. Notably, all types of infection observed were typical of those expected for DBS electrode implantation.ConclusionInfection rates are not statistically different across research and non-research groups within 30-days following the research procedure (1.72% vs. 0.21%; p = 0.0966, FET). Our results demonstrate that the research procedures used for sub-second monitoring of neurotransmitter release in humans can be performed without increasing the rate of infection.

977-P: Utilization of Glucose Management Team–Conducted Remote Patient Visits Decreases Hospital Readmissions for Patients with Diabetes

Introduction: Hospital readmissions are more common in persons admitted with diabetes as a primary diagnosis, accounting for approximately 20% of unplanned readmissions.1 Poor clinical outcomes and higher costs result.2 Helping people remain out of the hospital with improved diabetes self-management is both patient-centered and cost effective.1 Remote patient care improves access to care, removes transportation as a barrier and lessens the time required versus in person diabetes visits.3 Methods: The glucose management team (GMT) at Atrium Health Wake Forest Baptist Medical Center, comprised of advanced practice providers and an endocrinologist, offered post-discharge telehealth visits within 7 days to patients with insulin treated complex diabetes from 1/1 - 3/24/21. Patients’ diabetes regimens and glucose readings were reviewed and recommendations for treatment changes were offered. Results: A total of 88 patients were scheduled for post-discharge visits, and 55.7% (n=49) participated in a scheduled telehealth visit, while 36.4% did not (n=32) . Of patients who no-showed, there were zero 30 day readmissions and fourteen 90 day readmissions (43.8%) . Of patients who had a telehealth visit, there were two 30 day readmissions (4%) and eleven 90 day readmissions (22.4%) . Odds ratio for 90 day readmission was 2.69 (p=0.042) in those who did not attend a post-discharge telehealth visit. Conclusion: While 30-day readmissions were higher in the group that had a telehealth visit, this may be due to global struggles with nonadherence in the no-show group. An odds ratio of over 2.5 for 90 day readmission compared to patients who completed a post-discharge telehealth visit supports this view. Post-discharge telehealth visits decreased unplanned readmissions at 90 days by providing access to expert clinicians for support, instruction on self-directed glucose management and treatment regimen recommendations. Disclosure A.Johns: None. C.E.Price: None. J.A.Aloi: Research Support; Abbott Diabetes, Medtronic. C.Burns: None.

Repeat Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy for Cancers with Peritoneal Metastasis: A 30-year Institutional Experience.

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) improves survival in abdominal cancer patients with metastatic disease limited to the peritoneal cavity. Patients are increasingly being offered repeat CRS-HIPECs for peritoneal recurrence. However, in this rare clinical scenario, the survival benefit of performing repeat CRS-HIPEC operations remains unclear. A retrospective review of the CRS-HIPEC database at Wake Forest Baptist Medical Center was performed over a 30-year timespan. From 1547 patients with appendix cancers, colorectal cancers, mesotheliomas, and other miscellaneous cancers, 156 received more than one CRS-HIPEC. Kaplan-Meier survival analysis was performed using overall survival (OS) from the time of surgery as the primary endpoint. Multi-variable Cox proportional hazards regression modelling was performed on pertinent clinical variables. Patients who received multiple CRS-HIPECs had significantly better median OS (10.7 years) versus those who received one CRS-HIPEC (2.5 years), with appendix cancers faring best (12.9 years). Resection status R2a or better was achieved in 76.4% of repeat CRS-HIPECs. There were no significant changes in complication rates after repeat CRS-HIPEC. On multivariate analysis of repeat CRS-HIPEC, patients with appendix and colorectal cancers, heart disease, and poor functional status were independently associated with poor OS. Factors not independently associated with OS were age, sex, body mass index, race, diabetes, lung disease, smoking history, and systemic chemotherapy between CRS-HIPECs. Performing multiple CRS-HIPEC operations on appropriate surgical candidates may significantly prolong survival. Appendix cancers derived the greatest benefit. Satisfactory resection margins and complication rates are comparable to first cases and achievable in repeat CRS-HIPEC procedures.

Abstract 11065: Continuation versus Discontinuation of Beta Blockers in Patients Admitted with Acute Decompensated Heart Failure Requiring Inotropes

Introduction: Heart failure is one of the leading causes of morbidity and mortality globally. The use of beta blockers (BB) in patients with chronic heart failure is the cornerstone of guideline directed medical therapy and is recommended by national guidelines. However, BB are often discontinued when a patient is admitted to the hospital with ADHF, especially when inotropic support is needed. Little is known about the effects of continuing BB therapy in patients with ADHF requiring inotropes. This study sought to compare the effect of BB continuation vs discontinuation on in-hospital mortality among patients admitted to the hospital in ADHF requiring inotropic therapy. Methods: A single center, retrospective, non-blinded study was conducted in patients hospitalized with ADHF requiring inotropes over a three-year period. Inclusion criteria were patients ≥ 18 years of age admitted with ADHF and treated with inotropes (milrinone, dobutamine) from 1/1/2017-1/1/2020 at Wake Forest Baptist Medical Center. We assessed BB continuation and discontinuation on admission. Continuation of BB was defined as BB given at least 50% of patient’s hospitalization time. A time to event analysis framework was implemented using Cox proportional hazards models to analyze the effect of BB use on in-hospital mortality. Results: A total of 449 patients were admitted with ADHF requiring inotropes who met study criteria. Of those patients, 206 (45.9%) were admitted and continued on BB therapy. Continuation of BB therapy was associated with significant improvements in survival compared with patients whose BB was discontinued. Compared with the BB discontinuation group, a 70% reduction in the likelihood of in-hospital mortality was observed among individuals that continued BB therapy [HR 0.30, 95% Cl: 0.18-0.61, p<0.002]. Conclusion: In our study, among patients admitted with ADHF requiring inotropes, those continued on BB therapy were 70% less likely to die during their hospitalization.

Pre-injury Anticoagulation and Antiplatelets Are Not Associated with Progression of Traumatic Hemothorax

Wake Forest Baptist Medical Center, Winston Salem, NC Wake Forest Baptist Medical Center, Wake Forest, NC

TU82. WHOLE EXOME SEQUENCING IN FAMILIES WITH SERIOUS MENTAL ILLNESSES IDENTIFIES POTENTIALLY DELETERIOUS RARE VARIANTS IN GENES IMPLICATED IN NEURODEVELOPMENT

Postoperative hypocalcemia is a well-described outcome following thyroid and parathyroid surgery with symptoms ranging from clinically insignificant laboratory findings to tetany and seizures. The aims of this study were 1. To identify the characteristics and management patterns of postoperative hypocalcemia in head and neck endocrine surgery patients and 2. To compare outcomes between patients treated with empiric calcium and patients treated using a biochemically driven calcium replacement algorithm. Clinical electronic medical record (EMR) data was collected from patients who had undergone total thyroidectomy, completion thyroidectomy, and/or parathyroidectomy at Wake Forest Baptist Medical Center (WFBMC), a tertiary referral and academic institution. Between July 1, 2016, and June 30, 2017, 298 adult patients underwent surgery by a WFBMC Head & Neck (H&N) endocrine surgeon. Objective calcium and parathyroid hormone levels, postoperative supplementation with calcium and Vitamin D, 30-day physician access line (PAL) phone call utilization, emergency department (ED) encounters, and readmission rates were queried. The overall rate of hypocalcemia was 17.4%. No statistically significant difference in PAL utilization, ED visits, or readmissions was found between the empiric supplementation group and those whose supplementation was biochemically directed (PAL 5.0% vs. 5.0% [p = 0.983], ED visit 3.3% vs. 2.5% [p = 0.744], Readmission 1.7% vs. 0% [p = 0.276]). The overall postoperative rates of hypocalcemia and hypoparathyroidism following H&N endocrine surgery were consistent with the reported literature. Neither method of calcium supplementation was superior in reducing PAL utilization, ED encounters, or readmission.

Redo-aortic valve replacement in prior stentless prosthetic aortic valves: Transcatheter versus surgical approach.

The objective was to compare outcomes of redo-aortic valve replacement (AVR) via surgical or transcatheter approach in prior surgical AVR with large percentage of prior stentless surgical AVR. With the introduction of transcatheter aortic valve replacement (TAVR), patients with increased surgical risks now have an alternative to redo surgical AVR (SAVR), known as valve-in-valve (ViV) TAVR. Stentless prosthetic aortic valves present a more challenging implantation for ViV-TAVR given the lack of structural frame. We performed a retrospective study of 173 subjects who have undergone SAVR (N=100) or ViV-TAVR (N=73) in patients with prior surgical AVR at Wake Forest Baptist Medical Center from 2009 to 2019. Our study received the proper ethical oversight. The average ages in redo-SAVR and ViV-TAVR groups were 58.03 ± 13.86 and 66.57 ± 13.44 years, respectively (p <0.0001). The redo-SAVR had significantly lower STS (2.78 ± 2.09 and 4.68 ± 5.51, p <0.01) and Euroscores (4.32 ± 2.98 and 7.51 ± 8.24, p <0.05). The redo-SAVR group had higher percentage requiring mechanical support (8% vs. 0%, p <0.05) and vasopressors (53% vs. 0%, p <0.0001), longer length of stay (13.65 ± 11.23 vs. 5.68 ± 7.64 days, p <0.0001), and inpatient mortality (16% vs. 2.78%, p <0.005). At 30-day follow-up, redo-SAVR group had higher rates of acute kidney injury (10% vs. 0%, p <0.01), however ViV-TAVR group had more new left bundle branch blocks (6.85% vs. 0%, p <0.05). No significant differences regarding re-hospitalization rates, stroke, or death up to 1-year. Although the ViV-TAVR group had higher risk patients, there were significantly fewer procedural complications, shorter length of stay, and similar mortality outcomes up to 1-year follow-up.

Telerehabilitation: Has Its Time Come?

Telerehabilitation: Has Its Time Come?

Use of Lactulose to Treat Hyperammonemia in ICU Patients Without Chronic Liver Disease or Significant Hepatocellular Injury.

To review ICU patients with elevated ammonia without a clear hepatic etiology, to compare outcomes between those who received lactulose and those who did not. Retrospective observational study. Medical, surgical, and subspecialty intensive care units at Wake Forest Baptist Medical Center, Winston-Salem, North Carolina between December 2012 and August 2016. Adults with ammonia levels above 50 μmol/L, excluding those with known chronic liver disease, inborn error of metabolism, active use of valproic acid, total bilirubin ≥ 2 μmol/L, or alanine aminotransferase ≥ 100 units/L. Comparison in ICU length of stay (LOS), hospital LOS, in-hospital mortality, and mortality at 30 and 90 days. Criteria for inclusion were met in 103 cases. Mean ammonia level was 75 μmol/L, with undetermined etiology in the majority of subjects. Lactulose was given in 48 cases (46.6%), with a median of 9.5 doses given. There were no significant differences in outcomes between the lactulose and non-lactulose groups. Among subjects with multiple data points, lactulose did not have a dose-dependent effect on ammonia level, and was not associated with faster ammonia normalization compared to non-lactulose. When analyzed separately, patients with moderate hyperammonemia (60-99 μmol/L) who received lactulose had longer hospital and ICU length of stay compared to non-lactulose (417.8 hours vs. 208.4 hours, P = 0.003, and 229.2 hours vs. 104.7 hours, P = 0.025; respectively), though confounders were present. Routine use of lactulose to treat mild to moderate hyperammonemia in this patient population was not associated with improved outcomes.

1267. Comparative activity of omadacycline against extended-spectrum beta-lactamase positive and negative Escherichia coli and Klebsiella pneumoniae strains recovered from urine specimens

BackgroundOmadacycline (OMC) is a novel tetracycline (TET) derivative antibiotic with activity against TET-resistant Enterobacterales. OMC is available in both oral and intravenous formulations and is has been studied as a treatment of uncomplicated urinary tract infection (UTI) and acute pyelonephritis. The purpose of this study was to evaluate OMC activity against extended-spectrum beta-lactamase (ESBL) positive and negative Enterobacterales strains recovered from urine specimens.MethodsUrine samples from patients with suspected UTI were quantitatively plated onto blood agar and MacConkey agar plates in the microbiology lab of Wake Forest Baptist Medical Center. After overnight incubation, colonies were identified to the species level by MALDI-TOF system. Susceptibility testing was performed for isolates of E. coli and K. pneumoniae. OMC and TET susceptibility testing was performed by disk diffusion and gradient strip methodologies. Results were interpreted in accordance with the Clinical and Laboratory Standards Institute (CLSI) or Food and Drug Administration breakpoints. Isolates were tested in triplicate. ESBL screening and susceptibility testing to oral antibiotics commonly prescribed for UTI were performed by the MicroScan WalkAway System. Susceptibility rates and MIC50/90 were calculated and subsets of isolates were analyzed using descriptive statistics.ResultsA total of 204 isolates, including 102 E. coli and 102 K. pneumoniae, were tested. All but 1 isolate (99.5%) exhibited categorical agreement in results generated by the strip (Table 1) and disk (data not shown) methods and this was considered a minor error involving an intermediate result. OMC MIC90 for E. coli and K. pneumoniae were 6 µg/mL and >32 µg/mL, respectively. OMC displayed increased susceptibility rates compared to TET regardless of isolate species or ESBL positivity (Table 2).Table 1. Omadacycline Minimum Inhibitory Concentrations (MICs, µg/mL) Table 2. Susceptibilities of Oral Antibiotics Used to Treat UTI (% S) ConclusionOMC exhibits promising antimicrobial activity against TET-resistant and ESBL-positive E. coli and K. pneumoniae. OMC displays superior activity to ESBL positive E. coli when compared to ESBL positive K. pneumoniae. These data support the development of OMC as a much needed option in the treatment of UTI caused by resistant Enterobacterales.Disclosures Tyler J. Stone, PharmD, Paratek (Research Grant or Support) Abdullah Kilic, MD, Paratek (Grant/Research Support) John Williamson, PharmD, Paratek (Research Grant or Support) Elizabeth Palavecino, MD, Paratek (Grant/Research Support)Paratek (Grant/Research Support)

1600. Closing the gap on moxifloxacin breakpoints for Stenotrophomonas maltophilia

BackgroundMoxifloxacin (MOX) has in vitro activity against Enterobacterales and Stenotrophomonas maltophilia (SM). Although MOX commonly displays lower minimum inhibitory concentration (MIC)50/90 values against SM when compared to levofloxacin, there are currently no established MOX breakpoints for treatment of SM. The Clinical and Laboratory Standards Institute (CLSI) has established interpretive categories and MIC breakpoints for levofloxacin (S ≤2µg/ml) against SM. The US Food and Drug Administration and European Committee on Antimicrobial Susceptibility Testing provide MOX breakpoints for Enterobacterales with susceptible MICs represented at ≤ 2 µg/mL and ≤ 0.25 µg/mL, respectively. The purpose of this study was to evaluate MOX MIC distribution against SM strains recovered from clinical specimens.MethodsClinical samples from patients with suspected infection during calendar year 2018 and 2019 were processed in the microbiology lab of Wake Forest Baptist Medical Center. After incubation, SM colonies were identified by MALDI-TOF system. MOX susceptibility testing was performed for these clinical isolates by gradient diffusion strip methodologies. Results were displayed as MIC (µg/mL) without interpretation. MIC50/90 and susceptibility rates at potential breakpoints were calculated.ResultsA total of 211 isolates were tested, 112 from 2018 and 99 from 2019. MOX MIC50 and MIC90 for all isolates was 0.25 µg/mL and 2 µg/mL, respectively. The range of MIC distribution was ≤ 0.006 µg/mL to ≥ 64 µg/mL. Percent susceptibilities at incremental MICs, including established MOX breakpoints against Enterobacterales and established levofloxacin breakpoints against SM, are represented in Table 1. MIC distribution was plotted in Figure 1.Table 1. Susceptibility rates of S. maltophilia to moxifloxacin at theoretical breakpoints Figure 1. Moxifloxacin MIC Distribution against All S. maltophilia Isolates ConclusionWith no established breakpoint, these data represent one of the largest samples of MOX MICs against SM in the United States. Using the CLSI breakpoint for levofloxacin in SM (MIC of ≤2ug/ml) the overall susceptibility rate is 93%. This finding highlights the importance of performing susceptibility testing to this agent by the microbiology laboratory and the critical need for MOX breakpoints in SM.Disclosures Tyler J. Stone, PharmD, Paratek (Research Grant or Support) John Williamson, PharmD, Paratek (Research Grant or Support) Elizabeth Palavecino, MD, Paratek (Grant/Research Support)Paratek (Grant/Research Support)

S0402 Esophagogastric Junction Outflow Obstruction Is Associated with Impaired Bolus Clearance Compared to Controls

INTRODUCTION: The manometric diagnosis of esophagogastric junction outflow obstruction (EGJOO) can be ambiguous and not indicate true functional obstruction at the lower esophageal sphincter (LES). The aim of our study was to identify the presence of impaired esophageal bolus clearance in patients with EGJOO diagnosed via high-resolution manometry (HRM), and compare to a group controls (patients with normal HRM studies) who presented with dysphagia and similar symptoms. METHODS: 12 months of High-Resolution Impedance Manometry (HRIM) results at a large academic center (Wake Forest Baptist Medical Center) were reviewed. Studies diagnostic for EGJOO based on the Chicago Classification of Esophageal disorders (CCv3) were identified. In the group of patients with EGJOO, those with impaired bolus clearance were identified. Impaired bolus clearance was defined as patients with bolus clearance <80%. As a control, a group of HRIM labeled as normal studies were also identified. Incidence of impaired bolus clearance in this group was also recorded, and later compared to that of the EGJOO group. RESULTS: After reviewing the HRIM results, 121 patients were found to have HRIM consistent with the diagnosis of EGJOO. Another 121 patients were identified as having normal manometries. Using the criteria for impaired bolus clearance (<80%), each group was divided into normal vs impaired clearance. In the EGJOO group, 64 (52.9%) patients were found to have impaired clearance, vs 57 (47.1%) which had normal bolus clearance. This was compared to the normal HRIM group, where 16 (13.2%) patients were found to have impaired bolus clearance, while 105 (86.8%) patients were found to have normal bolus clearance. Using a chi square calculation, results were found to be significant (P < 0.01). Table 1 summarizes demographics. Table 2 summarizes the bolus clearance data. CONCLUSION: Patients with EGJOO diagnosed with HRIM were found to have significantly impaired bolus clearance compared to normal subjects. Abnormal liquid bolus transit on impedance analysis may be a useful measure to define clinically significant outflow obstruction. Further investigation of these patients’ subsequent studies, such as timed barium esophagrams, is warranted to fully assess esophageal emptying.Table 1.: DemographicsTable 2.: Results

S0401 Higher Rates of Chronic Opioid Use Found in Patients With Esophagogastric Junction Outflow Obstruction Compared to Controls

INTRODUCTION: Esophagogastric junction outflow obstruction (EGJOO) is defined by the Chicago Classification of Esophageal disorders (CC) as an incomplete relaxation (elevated median IRP) along with an intact or weak peristalsis. There are a number of etiologies of EGJOO, from medication effects to mechanical processes. Preliminary studies have suggested that opioids may impair lower esophageal function. The aim of our study was to assess this in a patient population by comparing the frequency of chronic opioid use in patients diagnosed with EGJOO versus patients with normal manometries. METHODS: 12 months of High-Resolution Manometry (HRM) results from a single academic center (Wake Forest Baptist Medical Center) were reviewed. Studies were designated as normal or EGJOO based on CCv3. Retrospectively, all patient’s home medications were examined, with a focus on prescription opioids. Patients who were prescribed daily opioids for greater than 6 months leading up to their HRM were labeled as chronic opioid users. The number of chronic opioid users in the normal result group were compared to the number of chronic opioid users in the EGJOO group. RESULTS: After reviewing the HRM results, 121 patients had normal manometries and 121 patients were found to have HRM consistent with EGJOO. After reviewing patient’s medication lists, 9 of the normal manometry group were found to have chronic daily opioid use (7.44%), while 20 of the EGJOO group were found to have chronic opioid use (16.53%). Using a chi square analysis, it was found there was a statistically significant difference (P-value 0.0294, P < 0.05) in number of chronic opioid users found in the EGJOO group (16.53%) compared to the group with normal HRM findings (7.44%). Table 1 summarizes the demographics. Table 2 details the initial chief complaint of the patients. CONCLUSION: In our study, chronic opioid use was found to be more prevalent in patients with the manometric diagnosis EGJOO than those with normal manometries. These results support chronic opioid use as a suspected etiology in EGJOO. As daily opioid use has become more common in recent decades, disorders of esophageal motility are one of the many adverse effects. This supports a trial off opioids in patients diagnosed with EGJOO with dysphagia to assess if symptoms resolve. Identifying opiates as a potential etiology, and improvement of symptoms after discontinuation of medications could potentially prevent other unnecessary procedures or therapies.Table 1.: DemographicsTable 2.: Chief Complaints

S3219 Venous Thromboembolism Prophylaxis Adherence Rates in Hospitalized Inflammatory Bowel Patients at an Academic Medical Center

INTRODUCTION: Inflammatory Bowel Disease (IBD) is comprised of two distinct disorders: Crohn’s Disease (CD) and Ulcerative Colitis (UC). They are chronic inflammatory diseases that primarily affect the gastrointestinal (GI) tract, but they can also cause extraintestinal complications. Venous thromboembolism (VTE) is particularly prevalent in IBD patients (IBDP), especially during disease flares, and is associated with high risk of morbidity and mortality. However, IBDP also have a propensity for GI bleeding during IBD exacerbations. With risk for both VTE and GI bleed, the decision to start VTE prophylaxis (VTEP) in hospitalized IBD patients poses a conundrum. The American College of Chest Physicians currently recommends such patients receive VTEP as data from numerous randomized controlled trials demonstrates VTEP is not associated with major adverse events in IBDP. The goal of this study was to evaluate the rate of VTEP at our hospital. METHODS: A retrospective chart review was conducted following all IBDP admitted to Wake Forest Baptist Medical Center from 1/2019 to 6/2019. 150 patients were identified. Demographics, admission diagnosis, admission medications, presenting symptoms, and medical history were collected. RESULTS: Of the 150 IBDP, 57% received VTEP on admission. In admissions related to IBD (37%), 18.2% received VTEP, whereas in non-IBD related complaints 79% received VTEP. Among patients endorsing hematochezia on admission (15%), 22% received VTEP. Of the patients with a history of GI bleed (65%), 47% received VTEP. 50% of patients with a history of VTE (12%), received VTEP. Odds ratio estimates showed IBD related admissions, hematochezia, and history of GI bleed were negatively associated with VTEP. CONCLUSION: Our analysis demonstrated a statistically significant decrease in administration of VTEP in patients admitted for an IBD related complaint, patients endorsing hematochezia, and patients with a history of GI bleed. This shows a major deficit in our hospital’s adherence to the ACCP guidelines of VTEP administration to all IBDP admitted to the hospital. Future directions of these findings include implementation of a Best Practice Advisory (BPA) into the electronic medical record to encourage VTEP for IBDP. After a trial of this BPA, a similar analysis will be repeated to evaluate the efficacy of the measure.Figure 1

An Opportunity to Promote Health Equity: National Paid Family and Medical Leave

* Abbreviations: COVID-19 — : coronavirus disease 2019 FMLA — : Family and Medical Leave Act PFL — : paid family leave PFML — : paid family and medical leave > When my daughter was born prematurely at 27 weeks, I was faced with the agonizing choice of staying with her in the neonatal intensive care unit or going back to work at my federally qualified community health center. Even as a pediatrician who is familiar with the enormous benefits of kangaroo care and singing, talking, and reading to newborns, I returned to work within two weeks of her birth because of my own economic situation. At the time, the state I lived in, Massachusetts, did not offer paid family and medical leave (PFML), and the clinic I worked at offered unpaid leave options. As a physician, I am enormously privileged with respect to job protection and income. However, the families I care for are particularly vulnerable to the adverse impacts of unpaid leave. I have come to recognize PFML as a health equity crisis that requires an urgent national policy solution. > > Dr Kimberly Montez The United States is the only developed nation that fails to guarantee any kind of paid leave to workers. We lack a national paid family and medical leave (PFML) policy that encompasses: (1) paid parental leave, which would apply to both mothers and fathers after the birth of a child, adoption of a child, or fostering a child; (2) paid family leave (PFL), which would apply to caregivers of a hospitalized child, a medically complex child, or a family member such as a declining parent; and (3) paid medical or sick leave, which would allow one to manage personal or family illness. Although the 1993 Family and Medical … Address correspondence to Kimberly Montez, MD, MPH, Department of Pediatrics, Wake Forest Baptist Medical Center, 1 Medical Center Blvd, Winston-Salem, NC 27157. E-mail: kmontez{at}wakehealth.edu