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1.
Journal of Hepatology ; 77:S217-S218, 2022.
Article in English | EMBASE | ID: covidwho-1967497

ABSTRACT

Background and aims: To validate an innovative eradication model for HCV infection in undocumented migrants and low-income refugees living Southern Italy. Method: a prospective, multicenter, collaborative study was started in June 2018 with The studywas stopped in February 2020 due to the outbreak of SARS-CoV-2 infection in Italy and was resumed in February 2021. At the six 1st level centers participating to the study volunteer associations that deal with the first needs of disadvantaged people performed the enrolment and the screening for anti-HCV, HBsAg and anti-HIV;epidemiological data were collected in an electronic database. Anti-HCV-positive subjects were sent to two 3rd level centers for the clinical, virological and therapeutic evaluation. For the HCV-RNA-positive subjects HCV genotyping and a clinical, biochemical and ultrasound staging was performed. The HCV RNApositive subjects have been treated with sofosbuvir-velpatasvir for 12 weeks and followed for 12 months from the end of therapy. Results: Of the 3, 991 migrants observed in the study period, 3, 897 (97.6%) accepted to be screened. They were young (median age 26 years), predominantly male (85.9%) and came from North Africa (3.8%), from Sub-Saharan Africa (68.4%), from Eastern Europe (8.1%), from Indo-Pakistan (17%) and from other countries (2.7%). Of the 3, 897 enrolled subjects, 185 (4.7%) resulted anti-HCV positive. The Figure shows the HCV-cure cascade. All the 185 anti-HCV-positive subjects were linked to care at 3rdID and tested for HCV RNA and 53 (28.6%) resulted HCV-RNA positive. Of these, 46 (86.8%) started DAA regimen with sofosbuvir plus velpatasvir (15 with GT 1b, 10 with 1a, 16 with 3, 3 with 4 and 2 with 2). Forty-two completed the follow-up and 4 was still pending. Of these 42 subjects, 41 (97.6%) showed a SVR12 and SVR 24, and one dropped-out in follow-up after the stop of DAA treatment. No subject had adverse event. (Figure Presented) Conclusion: This model seems to be effective to eradicate HCV infection among a difficult-to-manage population, such as undocumented migrants and low-income refugees

2.
Journal of Hepatology ; 77:S142, 2022.
Article in English | EMBASE | ID: covidwho-1967495

ABSTRACT

Background and aims: In trials conducted in India, recombinant granulocyte colony stimulating factor (GCSF) improved survival in alcohol-associated hepatitis (AH). The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States. Method: This prospective, open label trial randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8. SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient’s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30, 000/mm3 on Day 8. Primary outcomewas survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections. Results: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC>30, 000/ mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval {CI}: 0.57–0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44–0.89];p > 0.05). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and therewere no serious adverse events attributed to pegfilgrastim. Conclusion: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.

3.
Journal of Hepatology ; 77:S49-S50, 2022.
Article in English | EMBASE | ID: covidwho-1967493

ABSTRACT

Background and aims: A global study with equitable participation for cirrhosis and chronic liver disease (CLD) outcomes is needed. We initiated the Chronic Liver disease Evolution And Registry for Events and Decompensation (CLEARED) study to provide this global perspective. Aim to evaluate determinants of inpatient mortality and organ dysfunction in a multi-center worldwide study. Method: We prospectively enrolled pts with CLD/Cirrhosis >18 years without organ transplant or COVID-19 who were admitted non-electively. To maintain equity in outcome analysis, a maximum of 50 pts/site were allowed. Data for admission variables, hospital course, and inpatient outcomes (ICU, death, organ dysfunction [ODF]) were recorded. This was analyzed for death and ODs using significant variables on admission and including World Bank classification of low/middle-income countries (LMIC). A model for in-hospital mortality for all variables during the hospital course, including ODs) was analyzed. Results: 1383 pts (55 ± 13 yrs, 64% men, 39% White, 30% Asian, 10% Hispanic, 9% Black, 12% other) were enrolled from 49 centers (Fig A). 39% were from high-income while the rest were from LMICs. Admission MELDNa 23 (6–40) with history in past 6 months of hospitalizations 51%, infections 25%, HE 32%, AKI 23%, prior LVP 15%, hydrothorax 8% and HCC 4%. Leading etiologies were Alcohol 46% then NASH 23%, HCV 11% and HBV 13%. Most were on lactulose 52%, diuretics 53%, PPI 49% and statins 11%, SBP prophylaxis 16%, beta-blockers 35% and rifaximin 31%. 90% were admitted for liver-related reasons;GI bleed 30%, HE 34%, AKI 33%, electrolyte issues 30%, anasarca 24% and 25% admission infections. In-hospital course: Median LOS was 7 (1–140) days with 25% needing ICU. 15% died in hospital, 3% were transplanted, 46% developed AKI,15% grade 3–4 HE, 14% shock, 13% nosocomial infections and 13% needed ventilation. Logistic Regression: Fig B shows that liver-related/unrelated factors on admission which predicted in-hospital mortality and development of organ dysfunction with MELDNa and Infections being common among all models. Nosocomial infections and organ dysfunctions predicted mortality when all variables were considered. High-income countries had better mortality outcomes likely due to transplant and ICU availability. AUCs were >0.75 (Figure Presented) Conclusion: In this worldwide equitable experience, admission cirrhosis severity and infections are associated with inpatient outcomes, which are greater in low-income settings. Liver-related and unrelated factors and regional variations are important in defining critical care goals and outcome models in inpatients with cirrhosis.

4.
Radiotherapy and Oncology ; 170:S1235-S1236, 2022.
Article in English | EMBASE | ID: covidwho-1967481

ABSTRACT

Purpose or Objective A growing number of elderly patients every year is treated with radiation therapy (RT), but little is known about side effects and outcome of irradiation in this potentially frail population. The identification of predictive factors of toxicity and frailty could offer a personalized treatment approach, thanks also to a multidisciplinary management of patients with increased risk of adverse outcomes. In this study we investigated the correlation of patient parameters with acute toxicities in elderly aged > 75 years treated with curative RT. Materials and Methods A prospective observational study was designed in our Center for patients with > 75years, candidate for curative RT. To these patients the radiation oncologist submitted the Geriatric 8 questionnaire (G8q) before and at the end of RT. Patients with G8 score < 14 were then evaluated by a multidimensional geriatric assessment, investigating cognitive (MMSE, GDS), functional (ADL, IADL, Tinetti) and nutritional (MNA short) domains, to define the frailty phenotype. In this setting, we retrospectively analyzed parameters like body mass index (BMI), number of comorbidities, total blood count, neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR) and basal G8 score, and correlated these parameters to acute toxicity. Results G8q was administered to 150 patients from December 2019 to April 2021. In this study we included 98 patients who started and completed RT in our Unit in this period. Of them, 38 (38.8%) had a baseline G8 score < 14 (range 4-14) and 23 agreed to underwent a multidimensional assessment, while 15 could not be evaluated due to COVID-19 dispositions or their refusal. Eleven patients resulted fit, while 12 patients were classified as vulnerable. Acute toxicity grade was < grade 2 in 67 patients (68.4%) (Table 1). We evaluated associations between BMI, number of comorbidities, total blood count, NLR, PLR, G8 score and acute toxicity (Table 2). Total blood count, NLR, PLR and G8 score resulted not significantly correlated to toxicity. Instead, a higher BMI was associated with worse acute toxicity (p=0.031): considering the 31 patients reporting toxicity > grade 2, 17 patients were over-weighted (54.8%), 1 patient was under-weighted (3.2%). Overall, the 63.3% of population (62 patients) was over-weighted, with a median BMI of 26.3. (Table Presented) (Table Presented) Conclusion Although G8q considers under-weight as a possible responsible of frailty, our study suggested that attention should be paid to over-weight too, due to its prevalence in elderly patients. Furthermore our results suggested that in elderly patients > 75years the BMI correlates with worse acute toxicity, according to literature data. The 38.8% of patients needed a multidimensional evaluation;this approach resulted useful in order to obtain compliance to the treatment without increased toxicity. The study is still ongoing and further analysis will be done.

5.
Radiotherapy and Oncology ; 170:S906-S907, 2022.
Article in English | EMBASE | ID: covidwho-1967469

ABSTRACT

Purpose or Objective RTQA practice is known to have significant variation amongst institutions worldwide. It is critical to maintaining patient safety, treatment effectiveness and accuracy. However there is no standard practice, with often only target volume delineation reviewed alone and performed retrospectively. Previous studies have highlighted higher rates of changes made in more complex techniques and subsites. This study aims at evaluating our prospective structured peer review process in a proton beam therapy (PBT) centre. Materials and Methods We reviewed the RTQA cases of all patients treated at The Christie Proton Beam Centre since its opening in November 2018 until February 2021. The RTQA process is carried out weekly, is subsite specific and every case has their target volumes and plans reviewed in detail in the presence of consultants, fellows, physicists and dosimetrists. Since the COVID-19 pandemic, the peer review meetings are now virtual. Every peer review has a standardised RTQA form filled. We classified the peer reviews as having major/minor or no change. A major change was one where the target volumes (GTV and/or CTV) were too small or big;dose fractionation was incorrect to that of the prescription treated and any plan that was changed. A minor change was one where there were minor modifications to the target volumes, OARs or non-essential suggestions in relation to the plan that didn’t result in the plan being altered eg. addition of an OAR. Results There was a total of 1,209 peer reviews for 462 patients. 100% of cases had both volumes and plans peer reviewed prospectively. 591 were reviews of target volumes and 618 were plan reviews. In total there were 208 (17%) major changes, 194 (16%) minor and 807 (67%) with no changes. Of the major changes 137 (66%) were target volumes and 71 (34%) plans. Of the minor changes 174 (90%) were target volumes and 20 (10%) plans. There were more major and minor changes in the brain and head & neck subsites possibly due to their complexity. When diagnoses in the brain were categorised (Table 1) and reviewed against changes using a chi-squared test the resulting p-value = 0.027 suggests a significant relationship between type of diagnoses and likely need for change following peer review.(Table Presented) Conclusion Target volume delineation and radiotherapy plans particularly in brain, head & neck as well as other complex subsites require mandatory prospective review as highlighted above. We have shown this to be practically achievable and successful despite challenging times

6.
Radiotherapy and Oncology ; 170:S682-S683, 2022.
Article in English | EMBASE | ID: covidwho-1967462

ABSTRACT

Purpose or Objective To assess the pattern of response on dynamic contrast enhancement magnetic resonance imaging (DCE-MRI) of presumed local lesions in the setting of salvage radiotherapy (sRT) after radical prostatectomy (RP). Materials and Methods The present prospective study (NCT04703543) was conducted at a single Institution between August 2017 and June 2020. Eligibility criteria were: undetectable prostate specific antigen (PSA) after RP;biochemical recurrence (2 consecutive PSA rises to 0.2 ng/ml or greater);a presumed local failure at DCE-MRI (early/fast enhancing discrete lesion on DCE sequences);no distant metastases at choline-PET/CT;no previous history of androgen deprivation therapy and/or RT. Accrued patients underwent sRT as it follows: 66-69 Gy/30 fractions to the prostatic bed, 73.5 Gy/30 fractions to the local failure at DCE-MRI, 54 Gy/30 fractions to the pelvic nodes (when treated). All patients were offered DCE-MRI 3 months after sRT, and repeated at 3-month intervals until complete disappearance or a maximum of 4 scans. The endpoint of the study, complete response (CR), was defined as the complete disappearance of the target lesion at DCE-MRI. In case of misses before CR, the observation was considered as a persisting partial response (PR). Results 62 patients with 72 nodules at DCE-MRI were accrued. All patients underwent the 1st DCE-MRI at a median of 3.3 months (IQR: 3.1-4.1) after sRT, 33 patients (53.2%) presented a CR, 27 (43,5%) a PR, 2 (3.2%) no response. One patient, implanted with a cardiac device, did not undergo further MRI. Three more patients declined further testing after the 1st (N=2) or the 2nd (N=1) re-evaluation due to the COVID-19 pandemic. Twenty-eight patients underwent a 2nd DCE-MRI after a median of 6.8 months (IQR: 6.5-7.6) from sRT, 20 had a CR, 8 had a PR. After a median time of 10.7 months (IQR: 10.6-12.6), 6 patients were scanned for a 3nd DCE-MRI: 4 CR, 2 PR. The last patient reported a CR after 16.7 months. The majority (94.3%, 95%CI: 88.0-100.0%) of lesions had completely disappeared by the 3rd re-evaluation or a median time of 10.7 months from the end of sRT (Figure).(Figure Presented) Independent predictors of CR at 1st re-evaluation on multivariable analysis were: the volume of the lesion at pre-sRT DCEMRI (OR 0.076, 95%CI 0.009-0.667;p=0.02), the time of re-evaluation from treatment (OR 3.39, 95%CI 1.156-9.993;p=0.026) and the PSA percent decrease at the 5th week of sRT (OR 1.02, 95%CI 0.999-1.050;p= 0.058) (Table). (Table Presented) Receiver-operating characteristic curve (ROC) analysis identified the best cut-off on CR for baseline volume at 0.545 cc, AUC 0.683 (95%CI: 0.548-0.818, p=0.014). The probability of a CR for lesions larger than the cut-off identified at ROC analysis was only around 75% at 10.7 months. Conclusion The vast majority of local lesions disappears at DCE-MRI after sRT, though larger lesions may require more than 10 months from treatment end.

7.
Radiotherapy and Oncology ; 170:S120-S121, 2022.
Article in English | EMBASE | ID: covidwho-1967460

ABSTRACT

Purpose or Objective The role of perioperative treatment in radiation-induced and in-field recurrent sarcomas (RIS/IFRS) is unknown. Reirradiation may be associated with a risk of significant toxicity;thus, it is rarely used. We hypothesized that the combination of preoperative or definitive 12x 3 Gy radiotherapy (RT) with or without integrated 3.5 Gy to 42 Gy boost combined with regional hyperthermia twice a week will enable satisfactory local control without significant late toxicity in patients with RIS/IFRS. Materials and Methods A prospective phase II, single-arm clinical trial was conducted. We included patients with locally advanced RIS/IFRS without distant metastases. Treatment combined three weeks of radiotherapy, four fractions per week, 3 or 3.5 Gy per fraction, with regional hyperthermia, followed by surgery or observation. The choice of the boost or no-boost regimen was based on resectability (Figure 1). The intervention would be deemed tolerable if significant RT-related (grade 3+ CTCAE 5.0) late adverse events occur in less than 20% of patients. We planned to enroll 20 patients based on Wilson’s method for calculation of confidence intervals. (Figure Presented) Results We recruited 20 patients. All patients completed the treatment without interruptions. Eight of them had RIS whereas twenty were diagnosed with IFRS. Patients’ characteristics were provided in Table 1. Twelve patients from planned 15 underwent surgery. Two patients with potentially resectable tumors did not undergo surgery due to COVID-related reasons. One patient preferred not to undergo surgery after the preoperative no-boost regimen. The remaining five patients were deemed unresectable at the enrollment and received the simultaneous boost. In five patients who underwent resection, we observed extensive pathological response according to the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group recommendations for pathological examination and reporting, namely grade A in two cases and grade C in three cases. In four patients we observed complete radiological response. The median follow-up was 13 months. In 14 patients we noted mild or moderate radiation dermatitis. One patient experienced grade 2 gastrointestinal toxicities. From the late toxicities, we observed restricted limb mobility (grade 1) in one patient and chronic skin ulceration (grade 2) in one patient. None of the patients who developed grade 3 or higher late toxicity. Two patients who received the no-boost regimen and did not undergo resection developed local progression. One patient experienced borderline local relapse after surgery. None of the patients who received the boost regimen developed local progression. Three patients developed distant metastases. One patient was lost to follow-up. (Figure Presented) Conclusion Preliminary data suggest that the tolerance of the regimen is acceptable;however, data regarding late toxicity may change during the follow-up period. Boost may play a significant role in achieving local control in non-resected tumors.

8.
Gastroenterology ; 162(7):S-1345, 2022.
Article in English | EMBASE | ID: covidwho-1967450

ABSTRACT

INTRODUCTION The purpose of surveillance after resection of colorectal liver metastases (CLM) is to detect and treat recurrence using axial imaging, biomarker measurement, and a history/physical examination. In response to COVID-19 pandemic, telemedicine was used as a risk mitigation strategy to replace in-person visits, including for cancer surveillance. The objective of the study was to measure the uptake of telemedicine for cancer surveillance and outcomes following telemedicine surveillance after resection of CLM. METHODS Data from a prospective database was combined with real world data obtained from electronic health records using a cloud-based, data integration tool (Palantir Foundry) to identify patients in active surveillance following first surgical resection for CLM between April 2017 and April 2021. Telemedicine surveillance visit was defined as a follow-up visit >90 days following surgery using video or telephone. Recurrence was defined as detection of a new lesion. Bivariate statistical testing was performed using Student's t-test or chi-squared test. Retrospective chart review was used to validate identification of recurrence using the Foundry platform (100% interobserver agreement). RESULTS A total of 1,057 surveillance visits (306 patients) met our inclusion criteria. Prior to April 2020, 0% (0/686) visits utilized telemedicine. After April 2020, an average of 47.3% of visits per month utilized telemedicine (range 33.0 – 69.0%). The overall rate of identifying a recurrence during surveillance visit was 18.1% (191/1,057). There was no difference when comparing detection of recurrence using in-person (17.6%, 154/872) versus telemedicine visits (20.0%, 37/185, P=.371). The management of recurrence did not differ whether it was identified with an in-person or telemedicine visit;surgery, 36 (23%) vs. 10 (27%);ablation, 26 (17%) vs. 8 (22%);systemic therapy, 83 (54%) vs. 16 (43%);other, 9 (6%) vs. 3 (8%), respectively (P=.699). CONCLUSION Telemedicine was used in almost half of surveillance visits for CLM during the COVID- 19 pandemic. Detection and treatment of recurrence was similar for both telemedicine and in-person visits. Telemedicine-based follow-up is a safe and effective approach for surveillance after resection of CLM, supporting continued utilization beyond the pandemic.

9.
Gastroenterology ; 162(7):S-1284, 2022.
Article in English | EMBASE | ID: covidwho-1967448

ABSTRACT

BACKGROUND: Turmeric (curcumin) is a commonly used over-the-counter herbal product whose uses include diarrhea, arthritis, cancer and even COVID-19. Recently turmeric has been implicated in cases of clinically apparent liver injury with jaundice. The aim of this case series is to describe the clinical, histologic and human leukocyte antigen (HLA) associations of turmeric-associated hepatotoxicity as seen in the U.S. Drug Induced Liver Injury Network (DILIN) Prospective Study. METHODS: All adjudicated cases enrolled in DILIN between 2003-2020 with turmeric as an implicated product were reviewed. Causality was assessed using a 5-point expert opinion score. Available products were collected and analyzed for the presence of turmeric using ultra-high-performance liquid chromatography. Genetic analyses included HLA sequencing. RESULTS: Of 1697 cases of drug-induced liver injury judged to be definite, highly likely or probable (high confidence), nine (0.5%) were attributed to turmeric, all of which were enrolled since 2012, and 6 since 2017 (Figure). The 9 cases included 7 women, 8 whites, with a mean age of 51 years (range, 35-62 years) and BMI 25 kg/m2 (range, 15-40). Seven patients used alcohol, but none to excess, and none had underlying liver disease. Turmeric was used for an average of 102 days before onset of injury (range, 30-425 days). Initial mean ALT was 1179 U/L (range, 328-2245), ALP 211 U/L (41-441), total bilirubin 5.9 mg/dL (1.2-10.8), and INR 1.0 (0.9-1.2). Six patients developed jaundice, and serum bilirubin peaked at 9.6 mg/dL (0.8-26), and INR 2.3 (1.0- 9.7). Liver injury was hepatocellular in 8 patients (mean R = 22). Five patients had elevated antinuclear antibody (ANA) titer and two anti-smooth muscle (ASM) antibody, but none were treated with corticosteroids. Liver biopsy in 5 patients showed portal and lobular mixed inflammatory infiltrates with lymphocytes and eosinophils typical of drug-induced liver injury. Five patients were hospitalized, and one patient died of acute liver failure. Chemical analysis confirmed the presence of turmeric in all 7 products analyzed;3 also contained piperine (black pepper), and none contained green tea. Of 7 patients with HLA typing available, 4 carried HLA-B*35:01, a class I HLA allele previously implicated in both green tea and Polygonum multiflorum hepatotoxicity. CONCLUSION: Liver injury due to turmeric appears to be increasing, perhaps, reflecting usage patterns or increased combination with black pepper, which increases its absorption. Turmeric liver injury, similar to that caused by other polyphenolic herbal products, is typically hepatocellular, with a latency of 1 to 6 months, and is linked to HLA-B*35:01. While most cases are self-limited, the injury can be severe and result in death or liver transplantation.

10.
Gastroenterology ; 162(7):S-1252, 2022.
Article in English | EMBASE | ID: covidwho-1967441

ABSTRACT

Introduction We sought to evaluate the longitudinal serological response from the second to third dose of SARS-CoV-2 vaccine in liver transplant recipients at our institution. This study is ongoing and the total N will increase. Methods We prospectively enrolled 54 LT patients who received Pfizer-BioNTech or Moderna vaccine in two doses 3-4 weeks apart at our institution and an additional third dose after CDC approval in August 2021. 6 patients were excluded because of a positive nucleocapsid Ab after the third dose that indicated prior COVID infection. Recipients had semi-quantitative spike IgG and nucleocapsid IgG titers tested between 30 and 75 days after receiving a second vaccine dose. Serological responses to both spike and nucleocapsid antigens indicated COVID-19 infection. All recipients had spike and nucleocapsid Ab titers checked at least 14 days after receiving the third dose. Recipients who had a positive spike Ab titer and negative nucleocapsid titer after a second vaccine dose had repeat spike and nucleocapsid Ab testing within 1 week prior to receiving their third vaccine dose. Results Among 48 LT recipients that met inclusion criteria, seropositivity for spike Ab increased from 47.9% after the second dose to 81.3% after the third dose. 9 patients who were seronegative after a third dose had failed to develop detectable spike Ab after their second dose. The median interval between the second and third doses was 5.9 months. After the third dose, 69% of seropositive recipients had a high spike Ab titer. In 25 recipients who were seronegative after a second dose, 64% produced spike Abs after their third dose. Recipients who remained seronegative after 3 vaccine doses had significantly higher mean tacrolimus trough concentrations. To assess whether spike Ab titers waned after the second vaccine dose, we retested spike Ab titers within one week prior to the third dose in 14 out of 23 recipients who were seropositive after their second dose. All 14 patients had a decline in their spike Ab titers after their second dose. Previously detectable spike Ab titers became undetectable in 5 recipients. However, all five of these patients regained detectable spike Ab after the third vaccine. Discussion We demonstrate that a third dose of mRNA SARS-CoV-2 vaccine in LT recipients was effective. Minimizing immunosuppression by lowering tacrolimus trough thresholds is one potential strategy to improve immune responses. Our results also provide useful information about the optimal interval between the second and third vaccine doses in SOT recipients. Our cohort received the third vaccine dose after a longer delay of 6 months. With this delay, we demonstrated higher seropositivity and seroconversion rates than those reported after shorter interval dosing. A shorter delay between doses is a practical approach to help mitigate the immediate risk in this population. (Table Presented)

11.
Gastroenterology ; 162(7):S-1249, 2022.
Article in English | EMBASE | ID: covidwho-1967435

ABSTRACT

Background: The presence of comorbidities has been associated with worse outcomes in patients with SARS-CoV2 virus infection. It has been reported that patients with cirrhosis and COVID-19 showed higher mortality rates than patients without cirrhosis. This study aims to analyze the case fatality rate (CFR) in patients with cirrhosis and COVID-19, as well as the implications that this infection has on the incidence of acute decompensations. Methods: A multicenter prospective cohort study was conducted in 13 COVID-19 centers in Mexico. Patients with cirrhosis and COVID-19 were compared with randomly selected age- and sex-matched controls with COVID-19 without cirrhosis. The characteristics and development of decompensation in patients with cirrhosis were analyzed. Results: A total of 96 patients with cirrhosis and COVID-19 and 193 controls with COVID-19 were studied. Age (56.80 vs. 56.45 years, respectively;P=0.80) and male sex proportion (65.6% vs. 65.6%, respectively;P=0.98) was comparable between the two groups. Patients with cirrhosis and COVID-19 had a higher CFR than patients without cirrhosis (29.2% versus 19.2%, respectively, P=0.05) (Figure 1). There were no differences in the use of invasive mechanical ventilation, vasopressors, or the hospitalization length. The most common decompensations were worsening ascites (43%), encephalopathy (42%), and variceal bleeding (13%). Acute kidney injury occurred in 60% of patients with cirrhosis and 30% fulfill criteria of hepatorenal syndrome. Conclusion: Cirrhosis may impose a significant death risk factor in moderateto- severe COVID-19. Moreover, COVID-19 might be an important trigger of acute decompensation of cirrhosis, which could influence short-term CFR. (Figure Presented)

12.
Gastroenterology ; 162(7):S-1246, 2022.
Article in English | EMBASE | ID: covidwho-1967426

ABSTRACT

Background Frailty is defined as a clinical state of increased vulnerability to health and age associated stressors. The liver frailty index (LFI), composed of grip strength, chair stand and balance testing, is an accepted predictor of morbidity and mortality in cirrhosis. With the need for COVID-19 related social distancing, many appointments are being carried out virtually. The chair stand subcomponent of the LFI has the potential to be evaluated virtually, with a high reliability as compared to in-person testing noted in other disease populations. Objective To determine if the chair stand test is an independent predictor of morbidity and mortality in patients with cirrhosis. Methods 822 adult patients with cirrhosis were prospectively enrolled from five centers (3 in Canada, 1 in the United States, and 1 in India). Inclusion criteria included adult patients with cirrhosis. 787 of these patients completed a chair stand test at baseline, measured as the time (seconds) a patient takes to rise from sitting with their arms folded across their chest five times (measured in-person). The times were divided into 3 categories: >15 seconds, between 10 and 15 seconds, and <10 seconds. Patients who could not complete 5 chair stands were classified in the >15 seconds category. Primary outcome was all-cause mortality. Secondary outcome was unplanned all-cause hospital admission. Fine-Gray proportional hazard regression models were used to evaluate the association between the chair stand time and the outcomes. We adjusted for baseline age, sex, and MELD score and accounted for liver transplantation as a competing risk. Cumulative incidence functions were used to create a graphical representation of the survival analysis. Results Patients were divided into three groups: group 1, <10 seconds (n = 276);group 2, 10-15 seconds (n = 290);and group 3, >15 seconds (n = 221). Mortality was increased in group 3 in comparison to group 1 (HR 3.21, 95% CI: 2.16-4.78, p<0.001). Similarly, the hazard of non-elective hospitalizations was higher in group 3 in comparison to group 1 (HR 2.24, 95% CI: 1.73-2.91, p<0.001). Overall, patients with chair stand times greater than 15 seconds had increased all-cause mortality (HR 2.78, 95% CI 2.01-3.83, p<0.001) and non-elective hospitalizations (HR 1.84, 95% CI 1.48-2.29, p<0.001) when compared to patients with times less than 15 seconds. Conclusion A time to complete 5 chair stands of >15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform. (Figure Presented)

13.
Gastroenterology ; 162(7):S-1146-S-1147, 2022.
Article in English | EMBASE | ID: covidwho-1967418

ABSTRACT

BACKGROUND: Telemedicine is an essential part of healthcare delivery and has grown exponentially as a result of the COVID-19 pandemic. However, data on optimal utilization and implementation of telemedicine in solid organ transplant care remains limited. We aimed to evaluate patient, provider, and clinic staff perspectives on telemedicine use and potential barriers in solid organ transplant clinics. METHODS: We prospectively enrolled adults seen via telemedicine (video or telephone) in solid organ transplant clinics at a single academic transplant center between 9-10/2021. Patients completed a survey administered either online or via phone following their visit. Providers and clinic staff involved in telemedicine completed online surveys. Surveys were customized to patient, provider, and clinic staff to assess specific concerns, barriers, and satisfaction with telemedicine. RESULTS: Survey response rate was 21% for patients (175 of 853), 57% for providers (70 of 122) and 31% for clinic staff (20 of 64). 95% of telemedicine visits were video and were from liver (39%), kidney (40%), lung (16%) and heart transplant (5%) clinics. The majority of patients were male (51%) with a median age of 62, English-speaking (95%), and had some college experience (84%). Descriptions of telemedicine use among patients and providers are shown in Figure 1. Most patients were not concerned about privacy (86%), lack of physical exam (76%), audio/video difficulties (89% and 93%), or assistance with setup (82%). The majority were satisfied with the ease of video visit (85%) and quality of care (80%). Compared to traditional in-person visits, most patients felt their telemedicine visit was similar (66%) if not better (16%). Among providers, the majority were satisfied with ease of video visits (74%), quality of care (60%), and overall use of video visits (64%), but 48% were dissatisfied with telephone visits. Most providers reported spending time assisting patients (72%) with 7% requiring assistance from clinic staff to aid patients with video visits. 90% of providers identified appropriate software/hardware functioning prior to visits as a key feature to improve telemedicine use. Among clinic staff, 50% reported spending additional time assisting patients with setting up their initial visit due to needing to instruct how to use telemedicine software (60%) and providing additional instructions to caregiver(s) (20%). CONCLUSION: Telemedicine via video is an effective and convenient method of healthcare delivery across the continuum of solid organ transplant care according to patients, providers and clinic staff. However, concerns about time assisting with setup were highlighted by providers and clinic staff. Additional resources and support are needed to improve navigation of telemedicine for patients and to improve efficiency with telemedicine for providers and clinic staff. (Figure Presented)

14.
Gastroenterology ; 162(7):S-1143, 2022.
Article in English | EMBASE | ID: covidwho-1967415

ABSTRACT

Background and aim Telehealth (TH) interventions may improve access to care, diseasespecific and general quality outcomes in chronic liver diseases (CLD). Given the current COVID-19 pandemic, TH interest has grown exponentially. We aimed to systematically evaluate outcomes of TH interventions in a variety of CLD. Methods We used key terms and searched PubMed/EMBASE from inception to 12/5/2020 for observational studies or clinical trials. Two authors independently screened s. We included any type of CLD, including post-transplant patients. Disagreements were solved by a third reviewer. We excluded s, case-reports, and reviews. We extracted the outcomes defined by the authors for each CLD (chronic hepatitis C or B, decompensated cirrhosis, hepatocellular carcinoma-HCC-, liver transplant referral and readmission/rejection after transplantation or weight loss in nonalcoholic fatty liver disease-NAFLD). No meta-analysis was planned due to the heterogeneity of the data. Results Of a total of 3567 studies screened, 29 met inclusion criteria (Table 1). Of these, 17 reported on HCV treatment outcomes [14 video telemedicine, 2 remote specialist consultation, and one texting based intervention]. All studies showed no statistically significant differences between sustained virological response (SVR) rates in telehealth intervention groups compared to control groups or historic general population. 4 retrospective studies examined decompensated cirrhosis/liver transplant referral, followup after transplant, and showed a reduction in time to transplant (138.8 days vs 249 day, P<0.01), mortality or readmission following transplant (28% vs 58%, P=0.004), and improved referral timing (0% immediate rejections of transplant referral vs 41%, P<0.001). Other important outcomes measured also demonstrated benefit in favor of telemedicine incorporation including autoimmune hepatitis remission (100% vs 77.3%, P=0.035). One study assessed chronic hepatitis B outcomes and had no difference in development of hepatocellular carcinoma, ALT fluctuation or cirrhosis over 2 years of follow-up. Finally, two studies assessed weight loss in nonalcoholic fatty liver disease: the prospective study showed no change in weight loss while the randomized clinical trial did. Conclusion TH interventions in patients with CLD shows consistent equivalent or improved clinical outcomes compared to traditional encounter. Similar SVR, decreased time to liver transplant referral and mortality outcomes were observed in the TH groups. In CHB, development of HCC, cirrhosis or biochemical remission was similar as well. In the NAFLD clinical trial, the TH group had 5%+ weight loss over 3 months compared to the control group. In the light of the ongoing COVID19 pandemic, TH in CLD should be the bridge to improve clinical outcomes when face-to-face encounters are not possible. (Table Presented) Abbreviations: DOC: Department of Corrections, TH: Telehealth, SVR: sustained virological response, SVR12: sustained virological response for 12 weeks, SVR24: sustained virological response for 24 weeks, GP: general practitioner, RCT: randomized controlled trial *Sterling et al, 2018 compared patients with private insurance in clinic vs indigent patients in clinic vs patients in the department of corrections using telemedicine. †Lepage et al, 2020 compared patients in outpatient clinic vs mixed delivery including clinic and telemedicine vs telemedicine only. ††These studies reported rates of SVR in their cohort and compared to historical rates of SVR in similar cohorts.

15.
Gastroenterology ; 162(7):S-1112, 2022.
Article in English | EMBASE | ID: covidwho-1967410

ABSTRACT

Background: Vedolizumab (VDZ) is effective in inducing and maintaining remission in patients with Inflammatory bowel disease (IBD), but limited data exists in the youngest patients diagnosed <6, known as very early onset (VEO)-IBD. We aimed to evaluate the efficacy and safety of VDZ in this cohort. Methods: This was a retrospective study of patients with VEO-IBD followed at the Children's Hospital of Philadelphia, treated with VDZ for >6 months. Data collected included demographics, disease characteristics, medications, hospitalizations, growth, surgeries, and labs. Disease activity was measured using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and Pediatric Crohn Disease Activity Index (PCDAI) at baseline and 6 months. Primary outcome was clinical response defined as a decrease in PUCAI>20 or PCDAI>15 at 6 months. Secondary outcomes included improvement in growth, labs, steroid use and hospitalizations. Continuous variables were analyzed using the Friedman test followed by the Wilcoxon signed-rank test. Nominal data was analyzed using McNemar's test. Results: Thirty-three children with VEO-IBD, 66% male, treated with VDZ were included. Median age of diagnosis was 3.7 years (range 1.2-6 years), with a median baseline disease duration of 3 years (range 0.1-18.5 years). IBDU was classified in 61%, and CD in 39%. Disease location was 70% colonic, 27% ileocolonic and 3% small bowel. Seven patients had prior surgeries, including diverting ileostomies (n=6) and subtotal colectomy (n=1). Nineteen (58%) patients were biologic naïve. VDZ was used as combination therapy in 6 (18%) patients (methotrexate n=4, rapamycin n=1, tacrolimus n=1). Bridge therapy was initiated in 78% of patients, with steroids (n=8) and antibiotics (n=18). Clinical response at 6 months was achieved in 19 patients (58%) with improvement in median PUCAI from 25 to 5 (p<0.01) and median PCDAI from 18.75 to 5 (p<0.05). BMI for age Z-score improved from -0.325 to 0.65 (p<0.001). Steroids and antibiotics were tapered off in 6/8 (75%) and 14/18 (78%, p<0.001) respectively. Hospital length of stay decreased significantly during the 12 months after initiating VDZ compared to 3 months prior to initiation (p<0.05). 2 patients underwent surgery including a subtotal colectomy for colonic stricture and diverting ileostomy within 2 months of starting VDZ. Adverse effects included COVID-19 infection (n=2), influenza (n=2), upper respiratory infection (n=2), pneumonia (n=1), tracheitis (n= 1), cellulitis (n=1), molluscum (n=1), and pityriasis rosea (n=1). Conclusion: VDZ is effective at inducing clinical remission in a subset of children with VEO-IBD primarily with colonic disease. It has a favorable safety profile with minimal reported adverse events observed in this study. This study is limited by small sample size and retrospective design. Larger prospective studies are warranted.

16.
Gastroenterology ; 162(7):S-1031-S-1032, 2022.
Article in English | EMBASE | ID: covidwho-1967399

ABSTRACT

Background/Aim Since the beginning of the COVID-19 pandemic, gastroenterology divisions have reorganized their operations and modified their protocols to limit high-risk procedures and direct patient contact. In parallel, concerns about contracting COVID-19 have led patients to avoid medical care. This study aims to assess the impact of the COVID-19 pandemic on the presentation and outcomes of GIB in a tertiary care center in Lebanon. Methods We conducted a prospective cohort study of all patients admitted with overt GIB during two periods, the first prior to the COVID-19 pandemic (April 1, 2018, to April 1, 2019), and the second during the COVID-19 pandemic (April 1, 2020 to April 1, 2021), to the American University of Beirut Medical center. Severe GIB was defined as the presence of the following: SBP <100mmHg, >2 units of blood transfused, or ≥2 units drop in hemoglobin (Hb). In-hospital mortality and end of follow-up rebleeding rates were compared between the two periods. Bivariate analysis was done to identify the factors associated with severe hemorrhage. Multivariate analysis was used to determine independent predictors of severe hemorrhage, using variables that were found to be significant on bivariate analysis. Results A total of 171 patients were admitted during both periods, with 67 (39.1%) admitted during the pandemic. Patients admitted during the pandemic were more likely to present with severe hemorrhage and to have a drop of Hb of ≥ 2 g/dL (Table 1). During the pandemic, the origin of GIB was more likely to remain unknown. Outcomes including length of hospital stay, in-hospital mortality and end of follow-up rebleeding did not differ significantly between the two periods (Table 1). Compared to patients who presented with non-severe hemorrhage, those with severe hemorrhage had a higher initial BUN level and were more likely to be admitted during the pandemic (Table 2). In the multivariate analysis admission during the pandemic was associated with an increased risk of severe hemorrhage (HR 2.08, [1.07-4.05]). Conclusion During the COVID-19 pandemic, patients with GIB were more likely to present with more severe hemorrhage. This could be related to delays in access to healthcare due to patient or healthcare system issues. These indirect effects of the pandemic must be addressed, and efforts should be directed to minimize their impact. (Table Presented) (Table Presented)

17.
Gastroenterology ; 162(7):S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967395

ABSTRACT

Background: Patients with inflammatory bowel diseases (IBD) are commonly treated with immunosuppressive agents. Following the novel corona virus (SARS-CoV-2) pandemic, these patients received early the currently EMA approved vaccines. Data on efficacy and safety of SARS-CoV-2 vaccination on this population are lacking. Methods: Greek IBD patients, from 10 tertiary referral centres, who had completed the initial vaccination protocol with the available anti-COVID-19 vaccines (BNT162b2, mRNA-1273, Ad26.CoV2.S, ChAdOx1) at least two weeks before enrolment, were prospectively studied. Demographic and safety data were collected and blood samples were drawn for serum Anti-S1 IgG measurement [Euroimmun Anti-SARS-CoV-2 QuantiVac ELISA (IgG)]. Results: In total 403 IBD patients (59% Crohn's disease, median age 45 years, 53% male) and 124 healthy controls (HC) were included (Table 1). Antibody testing was conducted after a median of 31 (IQR, 23-46) days post-vaccination. Following a full vaccination regimen, 98% of IBD patients seroconverted (anti-S1 IgG³11 RU/ml). In total, IBD patients had lower anti-S1 levels than HC (RU/ ml 108 vs 133 RU/ml, P=0.00009) Administration of mRNA vaccines resulted in higher seroconversion rates and higher antibody titers than viral vector ones (98.6% vs 93.6%, P= 0.02 and 111.2 RU/ml vs 76 RU/ml, P<0.0001, respectively). Treatment with vedolizumab monotherapy was associated with higher antibody levels than anti-TNFα or ustekinumab monotherapy (P=0.02 and P=0.03). Longer timing between vaccination and antibody measurement was independently associated with impaired vaccine response. In multivariable analysis, specifically in mRNA-vaccinated cohort, older age, anti-TNFα treatment and treatment with biologics plus IMMs were significantly associated with lower antibody response (P=0.01, P=0.008, and P=0.02 respectively). Patients with prior COVID-19 infection showed numerically higher levels of antibodies. All vaccines were safe in IBD patients. Conclusions: Patients with IBD have high seroconversion rates to anti-SARS-CoV-2 vaccines. However, they demonstrate impaired antibody responses compared to HC. Patients receiving viral vector vaccines, and those on anti-TNFα or combination treatment may have further response impairment and it is important to consider booster vaccination in those low-response groups. (Table Presented)

18.
Gastroenterology ; 162(7):S-1006, 2022.
Article in English | EMBASE | ID: covidwho-1967392

ABSTRACT

BACKGROUND Little is known about the impact of immunosuppressants on COVID-19 vaccination in patients with immune-mediated inflammatory diseases (IMID). Although humoral response may be attenuated in patients using immunomodulators (IMM) and TNFinhibitors (anti-TNF), data regarding cellular response are scarce and conflicting. This study was aimed to identify immune response to COVID-19 vaccination in IMID patients. METHODS A prospective observational multicentre cohort study was conducted to examine the immunogenicity of mRNA vaccines to SARS-CoV-2 in adult IMID patients using immunosuppressive therapy (anti-TNF, IMM, anti-TNF+IMM, anti-IL12/23, anti-IL-17, anti-IL-23) or no therapy as compared to healthy controls (HC). Patient details and vaccination history were recorded. Blood samples were drawn at 3 time points: before, 3-4 weeks after first and 2 weeks after second vaccination. Humoral immune response to S and RBD proteins were assessed by ELISA. Neutralization was tested against 4 variants of SARS-CoV-2 by surrogate neutralization ELISA. Cellular immune responses were determined based on analysis of 9 secreted cytokines and cytotoxic molecules after stimulation of PBMC with S peptide pools. Response to N protein was used to assess SARS-CoV-2 exposure. RESULTS A total of 159 subjects (133 IMID patients and 26 HC) were included in this study (median age 42 years [IQR 30-53], 52% male). Of 133 IMID patients, 87 had inflammatory bowel disease, 23 psoriatic arthritis, 18 psoriasis, 11 ankylosing spondylarthritis and 4 rheumatoid arthritis. Of these, 44 used anti-TNF, 9 IMM, 18 anti-TNF+IMM, 33 anti-IL-12/23, 9 anti-IL-17, 10 anti-IL-23 therapy and 10 no therapy. All subjects received 2 doses of mRNA vaccines (2x Pfizer, 2x Moderna or mixed) between December 2020 and September 2021. The vast majority of subjects had minimal binding antibody and T cell responses to N, indicating they were COVID-19 naïve. After dose 1, anti-TNF group had lower IL-2 vs untreated IMID (p<0.01), and the anti-IL-23 group had lower IFN-g vs HC (p<0.01), though there was wide variation in responses within groups. Following dose 2, median responses between groups were mostly similar, but antibody responses were significantly lower in patients on anti-TNF as compared to HC in subjects that received two doses of Pfizer (p=0.01). Pooled data for all subjects combined show a higher response to Moderna over Pfizer in ELISA, neutralization and T cell readouts, and a lower response for those over 60 years of age after dose 2. Longer follow-up is in process to monitor the durability of these responses over time and after third dose. CONCLUSION Immune responses after 2 doses of mRNA vaccines in immunocompromised IMID patients largely reach the level of that of HC albeit antibody responses in the anti-TNF group are weaker and with wide variability between subjects within some groups

19.
Gastroenterology ; 162(7):S-1005, 2022.
Article in English | EMBASE | ID: covidwho-1967390

ABSTRACT

Background: Immune responses to the SARS-CoV-2 vaccination may be influenced by immunomodulatory drugs (IMDs). We investigated the immune responses and safety in fully vaccinated Japanese patients with IBD. Subjects and Methods: IBD patients and control subjects at 39 institutes were invited to participate in the study from March to October 2021. Blood sample collections to measure anti-SARS-CoV-2 spike IgG antibody titers were planned pre-1st vaccination, pre-2nd vaccination, and at 4 weeks, 3 months and 6 months post-2nd vaccination. Immune responses were compared between groups, considering baseline characteristics and IMD treatments. (UMIN000043545) The interim analyses presented here include mainly data from the 4-weeks post-2nd vaccination time-point. Results: In total, 679 IBD patients and 203 controls were enrolled (Table 1). The IBD group received the BNT162b2 vaccine (86.2%) and the mRNA-1273 vaccine (12.5%), and the control group received the BNT162b2 vaccine (86.9%) and the mRNA-1273 vaccine (12.1%). Only 4 cases (0.7%) in the IBD group and 2 (1.0%) in the control group were infected with COVID-19. Adverse events of 2nd vaccination occurred in 48.4% of the IBD group and 35.1% of the control group. Comparison between administrated and non-administrated IBD patients for each IMD revealed an attenuated genomic mean titer (GMT [U/mL]) in those taking systemic steroids (18.85 vs 31.24), anti-TNF monotherapy (28.31 vs 42.99), anti- TNF therapy+ immunomodulator (IM) (12.86 vs 35.26), vedolizumab+IM (19.49 vs 30.39), ustekinumab+IM (20.44 vs 30.79), and tofacitinib (9.54 vs 32.08), but not in those taking oral 5-ASA (29.50 vs 32.40), or vedolizumab (41.85 vs 40.20) and ustekinumab (55.56 vs 39.26) monotherapies. Estimated least square means of the GMT by a multiple linear regression model are shown in Table 2. GMTs were significantly influenced by increasing age and allergy (51.2, 95%CI 42.1-62.3;p=0.0293), and tended to be influenced by COVID- 19 infection (139.1, 41.0-472.2;p=0.0572). Sex, smoking, drinking, IBD, and adverse events of 2nd vaccination did not affect the GMT. The GMT was significantly higher for mRNA- 1273 (90.3 [60.8-134.1]) than for BNT162b2 (39.6 [35.2-44.6], p= 0.0001). Systemic steroids (22.9 [13.9-37.7], p=0.0119), IM (24.2 [18.7-31.4], p<0.0001), anti-TNF agents (20.8 [15.3-28.3], p<0.0001), vedolizumab (25.2 [15.0-42.2], p=0.0409), ustekinumab (28.9 [18.5-45.0], p=0.0754), and tofacitinib (5.5 [2.8-10.9], p<0.0001), but not oral 5- ASA (39.1 [31.9-47.9], p=0.3225), attenuated GMTs at 4 weeks post-2nd vaccination (Table 2). Conclusion: Aging and most IMD options attenuated immunogenicity in fully vaccinated IBD patients. Prioritization of a booster vaccination should be considered for IBD patients treated with IMDs. (Table Presented) (Table Presented)

20.
Gastroenterology ; 162(7):S-685, 2022.
Article in English | EMBASE | ID: covidwho-1967364

ABSTRACT

Background With the COVID-19 pandemic there was an acute drop in procedural volume for trainees, highlighting the need and potential of simulation-based training (SBT). Prior to the pandemic, the uptake of simulation was poorly categorized and inconsistent across programs despite the variety of endoscopic simulators available. We aimed to evaluate the current state of endoscopy training internationally in the wake of the pandemic as perceived by trainees. Methods This cross-sectional study utilized a survey composed of 21 questions eliciting demographic data, COVID-19-related training experiences, and experience with SBT. This survey was distributed internationally (USA, Canada, EU, Philippines, Singapore) to gastroenterology trainees between August 2021 to October 2021. Results The questionnaire was completed by 182 fellows, with 55 (30.2%) from the USA and 127 (69.8%) from other countries. Of the respondents, 79.1% were fellows during the first year of the pandemic. A majority (69.2%) found endoscopy training in general to be negatively impacted. Of those who reported a negative impact from the pandemic, 75.0% attributed it to a decline in endoscopic volume, 40.0% to institutional/regional guidelines, 25.0% to a shortage of personal protective equipment. Overall, 47.2% of respondents believed COVID-19 will negatively affect their endoscopic proficiency upon fellowship completion. A total of 71 respondents (39.0%) had experienced SBT before or during fellowship, with 27 from the USA (49.1% of respondents from USA) and 44 from other countries (34.6% of respondents from other countries). In the USA, 63.0% had used virtual reality (VR), 37.0% mechanical models, and 37.0% animal models compared to 47.7% VR, 68.2% mechanical models, and 27.3% animal models in other countries. Respondents agreed that SBT was most helpful with developing technical skills such as ergonomic handling, torque steering, and fine tip control. A majority (52.1%) found SBT appropriate to their level of training. Respondents believed increased access to SBT (43.7%) and mentored training (54.9%) would improve the experience. Conclusion While current data supports the use of SBT early in training, the cumulative uptake of SBT across programs before and during the COVID-19 pandemic remained low. In the USA and abroad, fellows perceive a negative impact of COVID-19 on their training and proficiency upon graduation. Compared to other countries, the USA had higher utilization of VR and lower utilization of mechanical models. Decrease in endoscopic volume was reported as the main factor negatively impacting endoscopic training. This survey highlights the potential benefit of SBT with low case volumes and further prospective evaluation of SBT in achieving endoscopic competence. (Table Presented)

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