Characteristics of cardiotocography in pregnant women with mild COVID-19 in the third trimester.

Objective. To study the characteristics of cardiotocography (CTG) and pregnancy outcomes in patients who had a mild coronavirus infection in the third trimester. Patients and methods. The parameters and variations of CTG and pregnancy outcomes were analyzed in 32 low-risk pregnant women who experienced mild COVID-19 in the third trimester (the study group) and in 30 pregnant women (matched pairs) who had no coronavirus infection (the comparison group). Results. A total of 375 CTGs were analyzed: 221 in the study group and 154 in the comparison group. Normal CTG recordings were found in 87% of pregnant women in the study group, which was significantly less frequent than in those without COVID-19 (97%) (p = 0.02), and suspicious CTG in 10 and 1.3%, respectively, which was 3.38-fold more frequent than in the comparison group (p = 0.04). Pathological CTG recordings were observed only in two women in the study group. The features of CTG in women who had a mild form of COVID-19 in the third trimester were a significant decrease in the number of accelerations, short-term variation (STV) in the range of 3 to 5 ms, long-term variation (LTV) <50 ms, a tendency toward tachycardia and low heart rate variability (<5 ms), and prolonged decelerations. The frequency of fetal asphyxia and neonatal morbidity was higher in the study group. Conclusion. COVID-19 even in its mild form may have a negative effect on the fetus, increasing the frequency of fetal hypoxia and neonatal asphyxia.Copyright © 2023, Dynasty Publishing House. All rights reserved.

Long-term mayor adverse cardiovascular events after COVID-19 infection: A clinical score from a cohort of 2575 patients enrolled in the multicenter international HOPE 2 registry

Background: Long-term consequences of COVID-19 infection are still partly known. According to some studies several patients may experience long term symptoms;however, predictors of long-term mayor adverse cardiovascular events among (MACE) patients with previous COVID-19 infection are . Aim of the study: To derive a simple clinical score for risk prediction of long-term MACE among patients with previous covid-19 infection. Method(s): 2575 consecutive patients were enrolled in a multicenter, international registry (HOPE-2) from February 2020 to April 2021, and followedup at long-term. A risk score was developed using a stepwise multivariable regression analysis. Result(s): Out of 2575 patients enrolled in the HOPE-2 registry, 1481 (58%) were male, with mean age of 60+/-16 years. At long-term follow-up overall rate of MACE was 7.9% (202 of 2545 pts, 3.3% death, 2.4% inflammatory myocardial disease, 1.3% arterial thrombosis, 0.7% venous thrombosis). After multivariable regression analysis, independent predictors of MACE were used to derive a simple prognostic score: The HOPE-2 prognostic score may be calculated by giving: 1/2 point for every 10 years of age, 2 points for previous cardiovascular disease, 1 point for increased troponin serum levels during hospitalization, 2.5 points for heart failure and 3 points for sepsis during hospitalization, -1.5 points for vaccination at followup. Score accuracy at receiver operating characteristic curve analysis was 0.81. Stratification into 3 risk groups (0-2, 3-5, and >5 points) classified into low, intermediate and high risk. The observed MACE rates were 0.5% for low-risk patients, 4% for intermediate-risk patients, and 19.5% for high-risk patients (log-Rank p<0.001, Figure 1). Conclusion(s): The HOPE-2 prognostic score may be useful for long-term risk stratification in patients with previous COVID-19 infection. High-risk patients may require a strict cardiological follow-up. (Figure Presented).

Vaccines for the prevention of infections in adults with haematological malignancies

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the benefits and adverse effects of vaccines for the prevention of infections in adults with haematological malignancies.Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Survey of Current Transplant Center Practices Regarding Covid-19 Vaccine Mandates in the United States

Purpose: We surveyed current policies of transplant centers regarding a COVID-19 vaccine mandate, and rationales for or against a mandate policy. Method(s): An electronic survey was distributed to clinicians at U.S. solid organ transplant programs from 2020-2021. Result(s): 56.4% of transplant programs representing 78.5% of all kidney transplant volume and 82.4% of liver transplant volume in the US from 9/1/20-9/1/21 responded to the survey. 35.7% of centers reported implementing a vaccine mandate, while 60.7% reported not that vaccination was not required and 3.6% were uncertain. Centers without a vaccine mandate policy cited administrative, equity, and legal considerations (Figure A). Centers with a vaccine mandate cited clinical evidence supporting the efficacy of pre-transplant vaccination (82.0%) and stewardship obligations to ensure organs were transplanted into the lowest risk patients (64.0%) (Figure B). Among centers with a mandate, few required confirmation of vaccine responsiveness through antibody testing (2.6%), required a support person (10.0%) or co-habitants (5.0%) to be vaccinated. 42.5% of centers with a mandate also required living donor candidates to be vaccinated. There was no correlation between the presence or absence of a vaccine mandate and the point prevalence rate of COVID-19 vaccination by the home State of the transplant center. Conclusion(s): Solid organ transplant centers in the US exhibit significant heterogeneity in the requirement for a COVID-19 vaccination prior to receiving an organ. While all centers encourage vaccination, most programs do not require all candidates and living donors to receive the COVID-19 vaccine prior to surgery, citing administrative opposition, legal prohibitions, and concern about equity in access to transplants. Among the minority of centers mandating COVID-19 vaccination for candidates, few centers also mandate vaccination for support persons or co-habitants, require additional testing to demonstrate adequate vaccine responsiveness, and less than half of these centers also mandate vaccination for living donor candidates. (Figure Presented).

POTENTIAL OVERUSE OF DIAGNOSTIC TESTS FOR EVALUATION OF PULMONARY EMBOLISM

SESSION TITLE: All About the CLOT: VTE SESSION TYPE: Original Investigations PRESENTED ON: 10/16/2022 10:30 am - 11:30 am PURPOSE: Pulmonary embolism (PE) is a disorder of coagulation that results in significant morbidity, mortality and emergency department visits. The usage of advanced imaging for the diagnosis of PE has increased greatly, almost 400% from 1998 to 2008. The Well’s Criteria for PE uses historical features, clinician gestalt, and heart rate to risk stratify patients for PE. The score ranges from 0-12.5 and is broken down into low risk 0-2, intermediate risk 3-6, and high risk 7+. The current American College of Emergency Physician guidelines advise that a patient suspected to be at risk for PE with a low or intermediate risk can undergo age adjusted D-Dimer testing. A further addition was the PERC rule. This rule applies 8 questions to the low risk PE patient and 8 negative responses mean the clinician can forgo D-Dimer testing. How well are we adhering to this guidance, and are deviations leading to unnecessary testing which could expose our patients to harm? METHODS: 280 sequential patients receiving diagnostic testing for PE were evaluated and 156 were excluded due to known, suspected, or history of COVID-19 infection. The work-up for the included patients was reviewed and Well’s criteria and the PERC rule were applied by retrospective review. Descriptive statistics were used to describe the proportion of patients evaluated with tests not suggested for their risk strata. RESULTS: Of the 124 patients evaluated, 31/124 (25%) had potentially unnecessary testing. 18 low risk patients underwent advanced imaging—17 CTAs and 1 VQ scan– without being tested by D-Dimer. 11 low risk, PERC rule negative patients still received D-Dimers–all negative, and 1 underwent CTA. One negative age-adjusted D-Dimer still lead to a CTA. One patient with a negative D-Dimer received CTA. These 18 CTAs and 1 VQ scan were all interpreted negative for PE. CONCLUSIONS: Patients undergoing evaluation in emergency departments in the United States may be undergoing unnecessary diagnostic testing based on current guidelines and the summation of the highest quality evidence available for directing the choice of how best to evaluate this patient population. CLINICAL IMPLICATIONS: The utilization of CTA for the diagnosis of PE is not without risk. Some estimate 20 additional breast cancers per 100,000 women undergoing the test. CTA studies for PE also pose the risk of unnecessary anticoagulation. A meta-analysis of imaging for PE showed an over diagnosis rate as high as 60% for subsegmental PE when these studies were re-reviewed by a panel of expert chest radiologists. This is quite high, but even more modest meta-analyses have shown a 10% false positive rate. Patients placed on anticoagulation have an annual bleeding risk attributed to anticoagulation of 7% and mortality attributed to anticoagulation of 0.4%. Creative strategies aimed at reducing unnecessary testing can help mitigate some of this risk and protect our patients. DISCLOSURES: No relevant relationships by Parth Gandhi research support relationship with Bristol Myers Squibb Please note: 2021-2022 Added 03/31/2022 by Jason Nomura, value=Grant/Research Consultant relationship with Philips Please note: 2020-2022 Added 03/31/2022 by Jason Nomura, value=Consulting fee No relevant relationships by Dustin Slagle

Triaging Two Week Wait Referrals According to ABS Guidelines Established During the COVID-19 Pandemic Is Safe Practice

Aim: CoVid-19 has affected healthcare globally, disrupting cancer care. Two weeks wait (2ww) breast cancer referrals were triaged according to Association of Breast Surgery (ABS) guidelines with patients with no red flag symptoms deemed low risk and able to be discharged back to their GP. This study aimed to assess the safety and efficacy of implementing these guidelines. Method: A database was established to prospectively collect 2ww breast cancer referrals from the outset of CoVid-19. Two Consultants triaged the referrals and if there was disagreement, a third Consultant arbitrated. Data were recorded for patient age, gender, presenting complaint, assessment, investigations, diagnosis, and outcome and also time from initial referral to discharge letter to the GP. Results: 188 patients were referred via the 2ww pathway to St Bartholomew's Hospital from 22/03/2020 to 08/04/2020. 43 (22.9%) were discharged with a median age of 34 (22-83 years) at the time of referral. The mean time from referral receipt to response was 12.1 (0 - 60 days). 15 (34.9%) patients were subsequently re-referred. Mean time from re-referral to one-stop clinic assessment was 9.1 (2 - 22 days), in keeping with NICE two week wait criteria. Of the patients re-referred, all patients underwent imaging in the form of mammogram and/or ultrasound scan. No patients were found to have pre-invasive or invasive disease. Conclusions: Triaging patients based on GP referrals is a safe way of streamlining low risk patients. This has the potential to become standard practice worldwide but requires larger multi-centre studies prior to implementation.

IBRUTINIB AND RITUXIMAB AS FIRST LINE THERAPY FOR MANTLE CELL LYMPHOMA: A MULTICENTRE, REAL-WORLD UK STUDY

Background: Ibrutinib (IBR) is an oral covalent Bruton tyrosine kinase inhibitor (BTKi), licensed for treatment of relapsed or refractory mantle cell lymphoma (MCL). Under NHS interim Covid-19 agreements in England, IBR with or without rituximab (R) was approved for the frontline treatment for MCL patients (pts) as a safer alternative to conventional immunochemotherapy. Although recent phase 2 studies have reported high response rates in low-risk patients for this combination in the frontline setting, randomised phase 3 and real-world data are currently lacking. Aims: To describe the real-world response rates (overall response rate (ORR), complete response (CR) rate) and toxicity profile of IBR +/-R in adult patients with previously untreated MCL. Methods: Following institutional approval, adults commencing IBR +/-R for untreated MCL under interim Covid-19 arrangements were prospectively identified by contributing centres. Hospital records were interrogated for demographic, pathology, response, toxicity and survival data. ORR/CR were assessed per local investigator according to the Lugano criteria using CT and/or PET-CT. Results: Data were available for 66 pts (72.7% male, median age 71 years, range 41-89). Baseline demographic and clinical features are summarised in Table 1. 23/66 pts (34.8%) had high-risk disease (defined as presence of TP53 mutation/deletion, blastoid or pleomorphic variant MCL, or Ki67%/MiB-1 ≥30%). IBR starting dose was 560mg in 56/62 pts (90%) and was given with R in 22/64 pts (34%). At a median follow up of 8.7 months (m) (range 0-18.6), pts had received a median of 7 cycles of IBR. 19/60 pts (32%) required a dose reduction or delay in IBR treatment. New atrial fibrillation and grade ≥3 any-cause toxicity occurred in 3/59 pts (5.8%) and 8/57 (14.0%) respectively. For the whole population and high-risk pts only, ORR was 74.4% and 64.7% respectively (p=0.2379), with a median time to response of 3.8m, coinciding with the first response assessment scan. Seven pts (16.7%), of whom 2 had highrisk disease, attained CR at a median of 6.0m. ORR for pts receiving vs not receiving R were 84.2% and 66.7% respectively (p=0.1904). IBR was discontinued in 20/61 pts (32.8%) at a median time to discontinuation of 4.1m, due to progressive disease (PD, 19.7%), toxicity (4.9%), death (3.3%;1 pt each of Covid-19 and E. coli infection), pt choice (3.3%) and other unspecified reasons (1.6%). 15/66 pts (22.7%) overall and 7/23 (30.4%) with high-risk disease progressed on IBR at a median time to PD of 4.0m. No pts underwent autologous stem cell transplantation consolidation during the study period. 12/57 pts (21.1%) received second line treatment (R-chemotherapy n=7, Nordic MCL protocol n=2, VR-CAP n=2, pirtobrutinib n=1). Response to second line treatment was CR in 4/11 pts, PD in 7/11. Of the 2 Nordic-treated patients, 1 had CR after cycle 2 and 1 PD. Fourteen pts (21.2%) died during the follow up period, due to MCL (n=11), Covid-19 (n=2) and congestive cardiac failure (n=1). Overall survival was lower for patients with high-risk disease (HR 0.55, p=0.038). Image: Summary/Conclusion: In this real-world UK cohort of pts receiving first-line IBR +/-R for MCL, including older and high-risk pts, we report high ORR rates in a similar range to the phase II Geltamo IMCL-2015 study of combination IBR-R in an exclusively low-risk population. Documented CR rates were lower, possibly reflecting a low usage of rituximab in the Covid-19 pandemic as well as CT assessment of response. Treatment was generally well tolerated, with low rates of toxicityrelated treatment discontinuation. The study is ongoing.

USING MACHINE LEARNING TO DEVELOP MODELS FOR THE PREDICTION OF UPPER GASTROINTESTINAL CANCERS

Introduction Machine learning methods have been used to develop predictive models in gastroenterology.1 Previously we identified features including age, history of psychological disorders and severity of dysphagia symptoms which were correlated with upper gastrointestinal (UGI) cancers.2 We sought to create a machine learning based model which could be used to predict the presence of UGI in patients referred for endoscopy. Methods Patients were recruited as part of the Saliva to Predict rIsk of disease using Transcriptomics and epigenetics (SPIT) study. Patients were recruited from 2-week wait suspected UGI pathway referrals at 20 hospitals in the United Kingdom. We enriched the cohort with additional patients admitted with confirmed oesophageal adenocarcinoma. 60% of the data was used for model generation with 10-fold cross validation, while the models were tested on the remaining 40% of the data. We used seven methods to generate our models: Linear Discriminant Analysis (lda), Classification and Regression Tree (cart), k-Nearest Neighbour (knn), Support Vector Machines (svm), Random Forest (rf), Logistic Regression (glm) and Regularised Logistic Regression (glmnet). Model performance was assessed using area under the receiver operating characteristic curve (AUC) and DeLong test was used for model comparison. Results 93 cancer and 715 non-cancer patients were included. The best three models with 18 features were glmnet, lda and glm which all achieved an AUC of greater than 0.80 (figure 1). For the testing dataset, AUC was 0.75 (95%CI: 0.67- 0.83), 0.74 (95%CI: 0.66-0.82) and 0.75 (95%CI: 0.68-0.83) (p=ns for all 3 pairwise comparisons) respectively. When applying a cost function, the three models all achieved a sensitivity of 0.973 and a specificity of 0.234 to 0.388 for the testing dataset. Conclusions Our models compare favourably with the Edinburgh Dysphagia Scale, which has a sensitivity and specificity of 0.984 and 0.093 respectively.3 Our models have the advantage of an improved specificity, which could equate to fewer endoscopies being performed for low risk patients. Given rising waiting lists as a direct result of COVID-19, our tool could be used to prioritise patients who should be investigated sooner.4 We plan next to validate our models on a validation cohort to assess its generalisability.

Patient Experience Survey: Antepartum Care During the First and Second Waves of the COVID-19 Pandemic

Objectives: To assess 5 domains of patient satisfaction with the novel format of antenatal care delivered during the first and second waves of COVID-19 pandemic. Methods: We distributed an anonymous online survey to assess patients experience with antenatal care delivered at The Ottawa Hospital between April 2020 and April 2021. Multiple choice and Likert-scale questions evaluated 5 distinct quality of care domains: access to care, satisfaction with telemedicine, communication, overall patient satisfaction, and perception of safety. Data were analyzed with descriptive statistics and ANOVA. Results: A total of 101 patients completed the survey (37% first wave and 63% second wave). Demographics were equivalent between 2 samples. The majority were patients at the maternal–fetal medicine clinic (62%) and were seen at low-risk (38%). Overall, respondents considered new policies affecting access to care a positive change. Aproximately 58% of respondents indicated to be satisfied with telemedicine. Communication of new policies was considered effective by 90% of high-risk and 71% of low-risk patients (P = 0.02). When assessing their perception of safety, overall 81% affirmed to feel protected by the new policies, and there was no significant difference between groups during first and second waves of the pandemic (87% vs. 78%, P = 0.25). Of the 38% that answered new policies negatively affected their antenatal care, 76% felt safe and protected by new policies (P = 0.02). Conclusions: Despite new strategies that strongly impacted patients experience, our survey showed that overall, patients felt protected and safe during their antenatal care. These results were consistent during first and second waves of the pandemic. Keywords: patient safety;quality initiative;antenatal care;COVID-19 pandemic

INNOVATIVE USE OF TELEHEALTH TO MANAGE COVID-19 INFECTED OUTPATIENTS BY A VETERANS HEALTH CARE CENTER

STATEMENT OF PROBLEM/QUESTION: In the spring of 2020 during the initial outbreak of COVID-19, the Rocky Mountain Regional VA (RMR) was tasked with ensuring the health of infected veterans. The RMR COVID-19 Telehealth Clinic was developed to support veterans in the community diagnosed with COVID-19, identify those with clinical deterioration requiring a higher level of care, and encourage appropriate isolation protocols. DESCRIPTION OF PROGRAM/INTERVENTION: Patients were stratified by risk factors (obesity, CHF, DM, cancer, CAD, HTN, age > 64) and clinical status into 3 tiers, with high-risk (Tier 3) receiving daily telehealth, moderate-risk (Tier 2) telehealth every other day, and low-risk (Tier 1) telehealth every three or more days. Providing care seven days a week, Tier 1 veterans were contacted by nurses and advanced practitioners, while Tier 2 and 3 veterans were managed predominantly by resident physicians and attendings, who provided clinical care for exacerbations of chronic disease as well as comprehensive care of COVID-19 infection. Hypoxic patients were provided oxygen and closely monitored with pulse oximeters. MEASURES OF SUCCESS: Between April 13 to October 5, 2020, 351 veterans testing positive for COVID-19 were followed. Thirty-eight were excluded (26 were outside study dates, 7 covid negative, 5 never received care). Charts for the remaining 313 patients were retrospectively evaluated for demographic data, comorbid conditions, duration of follow-up, and interventions provided, including prescribing and managing medications, referrals for emergency services, and escalating tiers. FINDINGS TO DATE: Of the cohort, 88% were male, 43% obese, 34% over age 64, 40% HTN, and 27% DM. Veterans were followed for 10.4 days on average. Approximately 54% were assigned to Tier 1, 29% to Tier 2, and 16% to Tier 3. Medications were prescribed for 45% and 27% of Tier 3 and Tier 2 patients respectively, and emergency care was advised for 22% and 20% of Tier 3 and Tier 2 veterans. Of Tier 1 patients, medications were ordered on 5%, emergency care recommended for 3%, and only 7% were escalated to Tier 2. Of the five deaths that occurred, two were directly attributed to COVID-19. KEY LESSONS FOR DISSEMINATION: A dedicated telehealth clinic for veterans with Covid-19 appropriately identified patients into low, moderate, and high-risk categories based on risk factor assessment. Low-risk patients were safely followed with intermittent telehealth emphasizing self-care and isolation, avoiding unnecessary Emergency Department visits. More frequent monitoring of symptoms and pulse oximetry in moderate to high-risk patients facilitated identification of patients with clinical deterioration requiring emergency evaluation and avoiding admissions for at-risk clinically stable patients. Tiered management resulted in judicious utilization of health care resources during a critical time marked by scarcity of hospital beds and personal protective equipment.

UTILISATION OF THE CYTOSPONGE DEVICE AS A TOOL FOR RISK STRATIFICATION IN PATIENTS WITH BARRETT'S OESOPHAGUS WHO ARE OVERDUE ENDOSCOPIC SURVEILLANCE DUE TO THE COVID-19 PANDEMIC

Introduction: At the onset of the COVID-19 pandemic, all patients undergoing endoscopic surveillance for Barrett's Oesophagus (BE) in the UK were indefinitely postponed. As well as the potential for missed progression to dysplasia, the negative impact on patients' quality of life is immeasurable. The Cytosponge® is a minimally invasive cell sampling device which has been researched in screening for BE. We describe the first worldwide use of the Cytosponge® outside of a clinical trial to support the triage of BE patients unable to undergo endoscopic surveillance due to COVID-19. Aims and Methods: Consecutive patients with non-dysplastic BE (NDBE) or those deemed to be low risk after previous treatment for BErelated dysplasia, DBE (more than 18 months after completion of therapy with no visible BE and no intestinal metaplasia/dysplasia at last endoscopy) with no prior history of stenosis who were overdue endoscopy (OGD) were invited to have the Cytosponge®. The sample was analysed for TFF3 (a marker of intestinal metaplasia), cellular atypia and p53. Fisher's test was used to examine the association between the overall cytosponge result and its individual components with follow-up OGD outcomes. Results: To date, 153 patients (mean age 66 years, 126 male) have undergone the Cytosponge® procedure. The median maximal length of BE was 3cm (1-15cm). Three patients were unable to swallow the device and 19 (12%) needed a repeat procedure as no columnar cells were present suggesting that the sponge had not entered the stomach. 87 patients (80%) with NDBE had a either a low-risk result (TFF3 positive only – 62) or required a repeat Cytosponge® routinely (TFF3/atypia/ p53 negative – 25). The remaining 21 patients (20%) needed an OGD within 3 months, 17 of which have since had an OGD. Of these 17 patients, 4 had a new diagnosis of dysplasia (indefinite - 2, low grade dysplasia – 1, intramucosal cancer - 1) and 2 a new diagnosis of cancer. 18/87 patients in the low-risk NDBE cohort have undergone follow-up OGD (NDBE 17/18, high grade dysplasia 1/18). Of the 23 patients in the post-treatment BE cohort, 1 patient had a high-risk result and subsequent OGD confirmed HGD (Table 1). A high-risk cytosponge result and the presence of both p53 and typia were all associated with a positive OGD result. Over-expression of p53 appeared to be the most sensitive marker (Table 2). In treatment naive patients, a low-risk cytosponge result was closely associated with no dysplasia detected at follow-up OGD with a negative predictive value of 94%. Conclusions: Cytosponge® has proved to be a useful non-endoscopic tool for patients with BE under surveillance where OGD is not possible. Preliminary data are promising to help triage patients and may in turn offer a less invasive approach to monitoring patients compared to endoscopy, particuarly for low risk patients. (Table Presented) (Table Presented)

Increasing Use Of ED Chest Pain Triage With Coronary CTA Does Not Devolve Into Low-risk Imaging

Introduction: Coronary CT angiography (CCTA) is a Class I recommendation for patients with acute chest pain. However, as with any Emergency Department (ED) imaging algorithm, there is often a decline in the pre-test probability of coronary artery disease (CAD) over time, producing a preponderance of low-risk patients. Methods: 6121 patients presented to a single ED with acute chest pain and underwent CCTA from 2016 to 2021. These patients were categorized, as normal coronary artery, non-obstructive or obstructive CAD. Obstructive CAD was defined ≥ 50% stenosis. Results: The number of patients triaged with CCTA more than tripled over 6 years: from 418 in 2016 to a 1453 in 2021, even during COVID-19 pandemic (see figure). Despite this, there was no significant change in the prevalence of CAD by CCTA. No significant CAD ranged from 83% to 88% with no significant trend over time. Among patients with no significant CAD, normal coronary study ranged from 46% to 54% and non-obstructive CAD ranged from 12% to 17%. Conclusions: The prevalence of CAD remained constant, despite more than a triple increase in triage CCTA with no regression to low-risk patients. [Formula presented]

Discharging Low-risk Pulmonary Embolism from An Emergency Room

Background and Objectives: Patients with PE are traditionally admitted on parenteral agents, despite increasing literature that sPESI negative patients can be safely discharged from the ED. Our quality improvement initiative is focused on outpatient treatment for ED-diagnosed pulmonary emboli (OTPE) and our objective is to assess LOS, readmissions and to describe findings of our follow-up phone calls. Methods: This is an actively enrolling prospective study from 7/2020 at a single site with >500 PE cases per year with a PE Response Team (PERT). All ED PE patients are screened for OTPE. Exclusion criteria include sPESI ≥ 1, ESC high or intermediate, bleeding ≤ 30 days, hemoglobin < 8, platelet < 50,000, pregnancy, prior VTE, concomitant COVID-19, recent major surgery and social factors. Patients identified are discussed with PERT and ED physicians. If agreed upon, patients are discharged on DOAC with follow-up within one week. Patients receive calls on days 3, 7, and 30 from the OTPE team to assess AE relating to the DOAC or PE. LOS metrics are reported as mean with standard deviations, and readmissions are reported as percentages. Results: Ninety-eight low-risk patients were identified, of which 50 were OTPE-eligible with mean age 44.5 ± 16.9 years of age and 58% female. When comparing OTPE to low-risk admissions, there are no differences in age (p=0.35) and sex (p=0.72). For OTPE, the follow-up calls on day 3, 7, and 30 revealed no patient reported recurrent VTE, major bleeding or death. There was a similar ED provider to disposition LOS (p=0.74). Low-risk admissions had a higher rate of readmission than OTPE (p=0.19). Conclusion: Our OTPE process does not increase ED provider to disposition LOS, readmissions, or adverse outcomes. Future work will examine financial implications of OTPE and barriers to adoption of the process. As this is actively enrolling quality improvement initiative, we will continue to track postimplementation to optimize our process.

Bebtelovimab, Alone and Together with Bamlanivimab and Etesevimab, as a Broadly Neutralizing Monoclonal Antibody Treatment and a Slow Intravenous Push Option for Ambulatory COVID-19

RATIONALE: Bebtelovimab is a potent, fully human monoclonal antibody targeting the S-protein of SARS-CoV-2, with broad neutralizing activity to all variants of concern (including Omicron), based on non-clinical assays. This study aimed to evaluate the efficacy and safety of bebtelovimab alone (BEB) or together with bamlanivimab (BAM) and etesevimab (ETE) for the treatment of mild-tomoderate COVID-19, delivered via slow intravenous push.METHODS : This portion of the phase 2 BLAZE-4 trial (NCT4634409) enrolled 706 patients (between May and July 2021) with mild-tomoderate COVID-19 within 3 days of first laboratory diagnosis of SARS-CoV-2 infection. Patients at low-risk for severe COVID-19 were randomized 1:1:1 (double-blinded) to placebo, BEB 175 mg, or BEB 175 mg+BAM 700 mg+ETE 1400 mg (BEB+BAM+ETE). Patients at high-risk for severe COVID-19 were randomized 1:1 (open-label) to BEB or BEB+BAM+ETE;a subsequent treatment arm enrolled patients to BEB+BAM+ETE using CDC expanded criteria for high-risk. All treatments were administered intravenously over ≥30 seconds (open-label BEB) or ≥6.5 minutes (all other treatment arms). For the placebo-controlled population (termed low-risk), the primary endpoint was the proportion of patients with persistently high viral load (PHVL) (log viral load >5.27) on Day 7. For the open-label population (termed high-risk), the primary endpoint was safety outcomes and statistics were descriptive. RESULTS : Baseline sequencing data was available for 611 patients, 90.2% (n=551) aligned with a variant of interest or concern (WHO designation), with the majority infected with Delta (49.8%) and Alpha (28.6%) variants. For the low-risk population, active treatment arms had a numerically lower proportion of patients with PHVL compared to placebo, albeit not at a level of statistical signficance (see Table). Viral load-area under the curve analysis from baseline to Day 11 showed signficant reduction for patients treated with BEB compared to placebo. Time to sustained symptom resolution was significantly improved among patients who received BEB relative to placebo. As expected, the incidence of COVID-19-related hospitalization or all-cause deaths by day 29 were similar within the low-risk population. Overall, results were similar between patients in low-risk and high-risk populations receiving active treatment (see Table). The majority of treatment emergent adverse events (AEs) were mild-to-moderate in low-risk (n=36/380,9.5%) and high-risk patients (n=46/326,14.1%). Serious AEs were reported in 7/326 (2.1%) high-risk patients;none were reported in low-risk patients.CONCLUSION: The safety and efficacy data support the further development of bebtelovimab delivered via slow intravenous push of at least 30 seconds. (Table Presented).

Virtual cardiac rehabilitation during the COVID-19 pandemic: a tertiary site experience

Background: The COVID-19 pandemic resulted in the abrupt suspension of centre-based cardiac rehabilitation (CR). Multidisciplinary virtual CR (VCR) with the use of digital, telephone, and video communication was implemented for continued care access. Exercise therapy was delivered through synchronous video-supervised sessions, pre-recorded sessions, and self-directed physical activity. Purpose: To describe patient characteristics, completion rates, and safety outcomes in a real-world VCR population. Methods: Prospective observational study of a tertiary academic CR program. VCR was implemented at pandemic onset (March 2020). Patients who were enrolled in, and either completed or dropped out, during the study period were included. Completers were defined as completing 6 months of virtual enrolment and an exit assessment. Risk was defined by the AACPVR 2020 risk categorization. Adverse cardiovascular events were defined as a patient-initiated event requiring medical assessment and stratified as exercise or non-exercise related. Continuous variables are presented as means and SD or medians and IQR. Student's t-test was used for between group comparisons. Categorical variables are presented as n (%) and compared using the χ2 test or Fischer's exact test. A p-value <0.05 was considered significant. Results: Between March 13th, 2020, and August 31st, 2021, 222 [mean age 61.8 years (SD, 12.6) 77% male], were enrolled and discharged from the VCR program (Table 1). There were 160 completers and 62 non-completers (completion rate 72%). Among the non-completers 26 attended the MD intake assessment only. The remaining 36 completed a median of 85 days (IQR 25-197). This cohort included 21 (9%) high-risk and 35 (16%) moderate risk patients. Those at moderate risk were more likely to be non-completers and those at low risk were more likely to be completers (Table 1). Two exercise and 17 non-exercise adverse events were observed (median clinical surveillance 217 days [IQR 205-240]) (Table 2). Exercise related adverse events included neurally mediated syncope during a synchronous video exercise session in a low risk patient. This was responded to as per centre developed virtual safety protocols. A second syncope related to heart block occurred in a moderate risk patient during independent physical activity and required permanent pacemaker insertion. Both patients completed the program. Three non-exercise adverse cardiac events resulted in cessation of participation included one death and two heart failure hospitalizations (Table 2). One stroke and 13 emergency department visits for cardiac symptoms occurred in completers. Conclusion: Real world VCR is feasible, including in those at moderate to high risk. Modest completion rates and a low exercise related adverse event rate were observed. Synchronous video exercise sessions with video monitoring and safety protocols may improve response to adverse exercise related events. (Table Presented).

The prognostic accuracy of neutrophillymphocyte ratio in COVID-19 patients

Aims/Objectives/Background COVID-19 is a newly emerging pandemic viral disease. Multiple management guidelines were introduced;nevertheless, their efficacy is still under debate. Thus, the presences of prognostic factors are essential for predicting which patients will need more invasive treatments. The study aims to investigate the prognostic accuracy of neutrophil-lymphocyte ratio in COVID-19 infection. Methods/Design This is a prospective study done in Al-Ain Hospital in the United Arab Emirates. All the Covid-19 patients presenting to the hospital were enrolled over one month from 20/3 to 20/4/2020. We gathered information about their age, sex, mode of transmission and calculated their Neutrophils/Lymphocytes ratio (NLR) from the first complete blood picture on admission. We divided the patients into two groups: those aged 50 years and above and those aged less than 50 years. We chose the best NLR cutoff value based on the Youden index and receiver operating characteristic (ROC) curve analysis. The target endpoint was the presence or absence of intensive care unit (ICU) admission. Results/Conclusions The study revealed that 48 patients (14%) needed ICU admission, while 296 patients (86%) were admitted to a ward or quarantine facilities. When the patient's age was > 50, and NLR was ≥ 3.10, it showed a sensitivity of 95.24% and a specificity of 92.86% for predicting the need for ICU admission. When NLR was ≥ 4.21, and the patient's age was < 50, the sensitivity and specificity were 70.3% and 93.7%, respectively. NLR proved to be highly specific and sensitive in helping to identify patients who need more invasive care among people over 50 years of age with COVID-19. Additionally, it can be used as a ruling out gadget for low-risk patients among people under 50 years old.

Zero prophylactic antibiotics in local anaesthetic transperineal prostate biopsy under antibiotics stewardship initiative;our institutional experience

Introduction & Objectives: More evidence is emerging with regards to the low sepsis rate in relation to Local Anaesthesia Transperineal (LATP) prostate biopsy. The acceptable rate for sepsis is 2% in relation to prostate biopsy procedure in general. LATP biopsy upon latest systematic reviews and peer evidence has a sepsis rate of 0.16 percent which is relatively low which allows for conversion of this procedure into forgoing the use of prophylactic antibiotics. We present our study, a retrospective analysis of outcome of selected low risk patients who has had LATP prostate biopsy initiated in the BHRUT trust without the need for antibiotics prophylactically in line with the antibiotic stewardship initiative of the Urology department during Covid era. Materials & Methods: Data from 23.12.2020 to 10.05.2021 was collected from electronic medical recordings of 160 consecutive LATPs without antibiotics using PrecisionPoint™ Transperineal Access System performed under local anaesthesia in King George Hospital Goodmayes, London. Various parameters like PSA, pain score, number of cores, MRI findings, histology findings, MDT outcome and complications, focusing more on infection rates were analysed. Results: Of the 160 consecutive LATPs without antibiotics, the mean for age, PSA, cores and average visual analog scale scores were 65 years, 10.9ng/mL, 26 cores and 1.6, respectively. The overall cancer detection rate was 58%, and for Likert scores 3-5, the cancer detection rates were 40%, 79%, and 95%, respectively. Complication rates of sepsis, acute urinary retention, clot retention, and perianal abscess were 0%(0/160), 1%(1/ 160), 1.25%(2/160) and 0%(0/160) respectively. Conclusions: Our study group of patients undergoing TP biopsy under local anaesthesia without antibiotic administrations has no complications of post biopsy sepsis. So, is it safe to perform LATP in a selected group of low risk patient without prophylactic antibiotics with implementation of antibiotic stewardship. With rising antibiotics resistance LATP may avoid use of antibiotics.

Joint Modeling of EHR and CXR Data to Predict COVID-19 Deterioration

Background. Infectious respiratory-track pathogens are a common trigger of healthcare capacity strain, e.g. the COVID19 pandemic. Patient risk stratification models to identify low-risk patients can help improve patient care processes and allocate limited resources. Many existing deterioration indices are based entirely on structured data from the Electronic Health Record (EHR) and ignore important information from other data sources. However, chest radiographs have been demonstrated to be helpful in predicting the progress of respiratory diseases. We developed a joint EHR and chest x-ray (CXR) model method and applied it to identify low-risk COVID19+ patients within the first 48 hours of hospital admission. Methods. All COVID19+ patients admitted to a large urban hospital between March 2020 and February 2021 were included. We trained an image model using large public chest radiograph datasets and fine-tuned this model to predict acute dyspnea using a cohort from the same hospital. We then combined this image model with two existing EHR deterioration indices to predict the risk of a COVID19+ patient being intubated, receiving a nasal cannula, or being treated with a vasopressor. We evaluated models' ability to identify low-risk patients by using the positive predictive value (PPV). Results. The image-augmented deterioration index was able to identify 12% of 716 COVID-19+ patients as low risk with 0.95 positive predictive value in the first 48 hours of admission. In contrast, when used individually, the EHR and CXR models each identified roughly 3% of the patients with a PPV of 0.95. Predicting Low Risk Patients Aggregated predictions for COVID19 positive patients within the first 48 hours of admission, shown with exponential weight moving average and 95% CIs. Each plot shows the number of patients flagged as low-risk by lowest aggregated prediction and the resulting accuracy for that fraction of patients. The bottom plot compares the MCURES fused model to the MCURES model. The top plot compares the EDI fused model to the EDI model. Conclusion. Our multi-modal models were able to identify far more patients at low-risk of COVID19 deterioration than models trained on either modality alone. This indicates the importance of combining structured data with chest X-rays when creating a deterioration index performance for infectious respiratory-track diseases.

MULTIVARIABLE PREDICTION MODELS FOR HOSPITALIZATION, VENTILATION, AND DEATH FROM COVID-19 IN IBD PATIENTS

Background: Risk calculators can be an important tool for enabling shared decision making between patients and their health care providers. Demographics, comorbidities, medication use, geographic region, and other factors may increase the risk for complications from COVID-patients with inflammatory bowel disease (IBD). We developed a prognostic risk prediction tool for estimating the probability of hospitalization, intensive care unit (ICU) admission, and death due to COVID-19 in patients with IBD. Methods: Based on reports to Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) from March to October 2020, we modeled the probability of Hospitalization+ (a composite outcome of hospitalization, ICU and/or death), ICU+ (a composite outcome of ICU admission, intubation, and/or death) and Death separately using the Least Absolute Shrinkage and Selection set consisting of a random sample of cases reported between March 2020 and a pre-set cutoff date. Model validation was conducted using a test data set consisting of the remaining cases not in the training data plus all additional cases from one month past the cutoff date. We assessed the resulting models' discrimination using the area under the curve (AUC) of the receiver-operator characteristic (ROC) curves and corresponding 95% confidence intervals. Results: Overall, 2709 cases from 59 countries were included (mean age 41.3 years (s.d. 633 (24%) were hospitalized, 137 (5%) were admitted to ICU or intubated, and 69 (3%) died. The models have excellent discrimination, with an AUC and associated 95% confidence interval estimated on the test data set of 0.79 (0.75, 0.83) for Hospitalization+, 0.88 (0.82, 0.95) for ICU+, and 0.95 (0.91, 0.99) for Death. Age, comorbidities, corticosteroid use, and male sex were associated with higher risk of death while use of biologic therapies was associated with a lower risk of death (Figure 1). The online risk calculator is free and publicly available at https://covidibd.org/covid-19-riskcalculator/ for health care providers to facilitate discussion of the risk from COVID-19 with their IBD patients (Figure 2). After the physician inputs patient information, the prediction tool numerically and visually summarizes the patient’s probabilities of adverse outcomes intervals. Conclusion: Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of IBD patients. The risk calculator could provide a basis for distinguishing between high and low-risk patients to aid in personalizing clinical guidance.