Fulminant myocarditis following SARS-CoV-2 mRNA vaccination rescued with venoarterial ECMO: A report of two cases

Objectives: Cases of fulminant myocarditis after mRNA COVID-19 vaccination have been reported. The most severe may need venoarterial extracorporeal membrane oxygenation (V-A ECMO) support. Here we report two cases successfully rescued with V-A ECMO. Method(s): We included all the cases supported with V-A ECMO for refractory cardiogenic shock due to myocarditis secondary to a mRNA SARS-COV2 vaccine in the high-volume adult ECMO Program in Vall Hebron University Hospital since January 2020. Result(s): We identified two cases (table). One of them was admitted for out-of-hospital cardiac arrest. In both, a peripheral V-A ECMO was implanted in the cath lab. An intra-aortic balloon pump was needed in one case for left ventricle unloading. Support could be successfully withdrawn in a mean of five days. No major bleeding or thrombosis complications occurred. Definite microscopic diagnosis could be reached in one case (Image, 3). Treatment was the same, using 1000mg of methylprednisolone/day for 3 days. A cardiac magnetic resonance 10 days after admission showed a significant improvement in systolic function and diffuse oedema and subepicardial contrast intake in different segments (Image, 1-2). Both patients were discharged fully recovered. Conclusion(s): V-A ECMO should be established in cases of COVID-19 vaccine-associated myocarditis with refractory cardiogenic shock during the acute phase. (Table Presented).

Oxygen markers for predicting COVID-19 - related pneumonia mortality

Introduction: the value of oxygen as a prognostic maker of mortality due to COVID-19 pneumonia has not been evaluated at the Hospital General Docente "Dr. Agostinho Neto". Background: to identify the values of oxygenation markers for prognosing mortality caused by COVID-19 pneumonia at the Hospital General Docente "Dr. Agostinho Neto" de Guantanamo, Cuba, throughout period 2020-2021. Method: a cohort of 276 patients with COVID-19 pneumonia was studied. Peripheral oxygen saturation (SpO2), arterial oxygen saturation (SaO2), the difference between the oxygen concentration in the alveoli and arterial system (DA-aO2), arterial oxygen pressure ratio (PaO2) and inspired oxygen fraction (FiO2) [PaO2/FiO2] were studied. The association between variables and deceased discharge was determined using the Chi-square technique and the Odds Ratio (OR) calculation. Results: the variable with the highest positive predictive value was SpO2 (87.3%) with a value lower than 90 mmHg at admission. The highest negative predictive value was recorded for the DA-aO2 variable (95.6%), less than 20 mmHg at 48 hours after admission. Attributable risk was higher for PaO2/FiO2 ratio, less than 300 mmHg (0.59), at admission (0.52). Attributable risk percent was higher for the variable DA-aO2 20 mmHg at admission (95.8%) and at 48 hours after admission (95.3%). Conclusions: abnormal DA-aO2, PaO2/FiO2 ratio, SaO2 and SpO2, at admission and 48 hours after admission, are predictive markers of mortality in patients with COVID-19.

PD11-04 Primary results of SOLTI-1503 PROMETEO phase 2 trial of Combination of Talimogene Laherparepvec (T-VEC) with Atezolizumab in patients with residual breast cancer after standard neoadjuvant multi-agent chemotherapy

Background: Residual disease (RD) following neoadjuvant chemotherapy (NAC) in early HER2- negative breast cancer (BC) remains an unmet medical need. However, no therapies to date have tested their activity directly in chemo-resistant RD. Here, we hypothesized that combining an oncolytic virus such as T-VEC with atezolizumab may offer clinical benefit in patients (pts) with RD after standard NAC. To our knowledge, PROMETEO is the first trial that examines the activity of immunotherapy in pts with RD prior to surgery. Method(s): PROMETEO (NCT03802604) is a singlearm, open-label, multicenter phase II trial. Women with triple-negative BC (TNBC) or hormone receptor-positive/HER2-negative (HR+/HER2-) BC with baseline (i.e., before NAC) ki67 >= 20% were eligible. RD was confirmed with a magnetic resonance imaging (MRI) showing a tumor diameter >= 10 mm and a core-biopsy detecting the presence of invasive cells. Before surgery, T-VEC was administered intratumorally on week 1 (106 pfu/mL), then in week 4 and every 2 weeks thereafter (108 pfu/mL) for 4 injections. Atezolizumab (840 mg) was administered intravenously every 2 weeks for 4 infusions, starting at week 4. Surgery was performed in < 3 weeks after completing the treatment. The primary objective was to evaluate the efficacy of the combination, measured by the rate of residual cancer burden (RCB) class 0/1 at surgery. Tumor samples collected at 5 timepoints (before NAC, during screening period, after first dose of T-VEC, after first dose of T-VEC and atezolizumab and at surgery) were mandatory to assess gene expression, tumor-infiltrating lymphocytes (TILs), immune cells PD-L1 IHC (SP142), tumor mutational burden (TMB) by FoundationOne and other translational endpoints. Result(s): Between Dec 2018 to Feb 2022, 28 pts were enrolled: 20 pts with HR+/HER2- disease and 8 pts with TNBC. Median age was 47 (range 31-71) and 71% of pts were premenopausal. At diagnosis before NAC, clinical stage II disease represented 60.7%, cN+ 60.7%, median Ki-67 was 37.5% (range 20%-95%), high TILs (>=10%) 37%, median TMB was 3 (0-19) and only 1 of 27 pts (3.7%) had a PD-L1-positive tumor. After NAC, mean tumor size by MRI was 28.3 mm (10-93). Two pts discontinued from the trial (1 withdrawal of consent and 1 COVID infection). The completion of 5 cycles of treatment was achieved by 73% of pts. The overall RCB-0/1 rate was 25% (7 of 28, 95% IC 10.7 - 44.9%), all with RCB 0 (pathologic complete response [pCR]). The pCR rate was 30% in HR+/HER2- disease and 12.5 % in TNBC. Radiological response by MRI was achieved by 3 of 28 pts (10.7%). Interestingly, none of the 7 pts with a pCR had radiological response (stable disease n=5, progressive disease [PD] n=2). Six pts (21.4%) had radiological PD and had RCB 2/3. Overall, 27 (96%) patients had at least one treatment-emergent adverse event (TEAE) of any grade. Most common grade 1 or 2 AEs were fever (11 pts, 39.3%), ALT increased (9 pts, 32.1%), AST increased (8 pts, 28.6%), arthralgia (6 pts, 21.4%) and anemia (6 pts, 21.4%). Grade 3 reversible neutropenia occurred in 1 patient. Across all pts, significant increases (p< 0.001) in TILs, immune genes and immune PDL1+ cells were observed after 1 dose of TVEC, 1 dose of the combination and at surgery. Intrinsic subtype changes at surgery occurred in 73.1% of cases, mostly (46.1%) Luminal A/B converting to Normal-like. At surgery, 19 of 26 (73.1%) of tumors were PDL1+. Conclusion(s): Two months of T-VEC in combination with atezolizumab induced a pCR in a subgroup of pts with chemoresistant HER2- breast cancer. This effect is probably related to the immune activation provoked by the combined treatment. Interestingly, a high discrepancy was observed between the presurgical radiological imaging and the actual surgical pathological report. Pre-operative window-ofopportunity trials in this context might provide important clues regarding the activity of novel treatment strategies.

Identification of highly immunogenic epitopes in the SARS-CoV-2 Spike protein to produce monoclonal antibodies

Background: In outpatients, monoclonal antibodies to Spike protein reduce viral load and improve outcomes, with a greater effect in serum antibody-negative at baseline. The aim of this study was to find epitope candidates to produce neutralizing monoclonal antibodies (mAb) for COVID-19 treatment. Method(s): IgG COVID-19 patients (N=500) against SARS-CoV-2 was confirmed. Epitope mapping was performed by Luminex technology. A computational pipeline based in predictive models was designed to predict S protein epitopes most likely to be recognized by mAb from COVID-19 convalescent patients. Result(s): Validation Screening: 29 epitopes of the SARS-CoV-2 S protein were predicted by our pipeline and included in the Luminex panel. 40 serum samples from convalescent COVID-19 patients and 126 pre-pandemia negative controls were included in the validation screening. Epitope mapping: 500 serum samples were tested against the 8 epitopes selected in the validation screening. The two epitopes with the highest IgG of participants above the seropositivity cut-offs were selected. The two most immunogenic epitopes were screened in phage library containing 109 clones of antibodies anti-SARS-CoV-2 to produce mAbs by phage display technology. Conclusion(s): The two epitopes with the highest IgG reactivity validated against serum samples from 500 COVID-19 convalescent patients and phage library are good candidates for the production of new neutralizing mAbs against SARS-CoV-2 S protein.

The 2021 SIIM-FISABIO-RSNA Machine Learning COVID-19 Challenge: Annotation and Standard Exam Classification of COVID-19 Chest Radiographs.

We describe the curation, annotation methodology, and characteristics of the dataset used in an artificial intelligence challenge for detection and localization of COVID-19 on chest radiographs. The chest radiographs were annotated by an international group of radiologists into four mutually exclusive categories, including "typical," "indeterminate," and "atypical appearance" for COVID-19, or "negative for pneumonia," adapted from previously published guidelines, and bounding boxes were placed on airspace opacities. This dataset and respective annotations are available to researchers for academic and noncommercial use.

Going solo during the pandemic: a generational segmentation of solo female travellers

This paper is driven both by a growing appetite for solo female travel;as well as a knowledge gap in the market and literature. The aim is to identify generational differences in women's solo travel motivations, characterize the generational differences in their preferred destination attributes, and ascertain any generational differences in their perceived inhibiting factors to travelling solo post the COVID-19 pandemic. By using the push–pull framework theory as the overarching framework, a survey was administered and 1576 responses from experienced solo female travellers were analysed. The findings revealed the different generations of solo female travellers and their distinctive travel needs (push factor/motivation, pull factor/destination preference, and inhibiting factors/risk & constraint) during the COVID pandemic. © 2023 Informa UK Limited, trading as Taylor & Francis Group.

Topic Discovery About Economy During COVID-19 Pandemic from Spanish Tweets

Automatic topic discovery from natural language texts has been a challenging and widely studied problem. The ability to discover the topics present in a collection of text documents is essential for information systems. Topic discovery has been used to obtain a compact representation of documents for grouping, classification, and retrieval. Some tasks that can benefit from topic discovery: recommendation systems, tracking misinformation, writing summaries, and text clustering. However, topic discovery from Spanish texts has been somewhat neglected. For this reason, this work proposes analyzing the behavior of topic discovery tasks in texts in Spanish, specifically in tweets about the Mexican economy during the COVID-19 pandemic, under three different approaches. A comparison was conducted, achieving promising results because the topic coherence metric indicates coherent topics. The highest score of 1.22 was obtained using PLSA with 50 topics, concluding that the topics encompassed the study domain. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Resorting to Context-Aware Background Knowledge for Unveiling Semantically Related Social Media Posts

Social media networks have become a prime source for sharing news, opinions, and research accomplishments in various domains, and hundreds of millions of posts are announced daily. Given this wealth of information in social media, finding related announcements has become a relevant task, particularly in trending news (e.g., COVID-19 or lung cancer). To facilitate the search of connected posts, social networks enable users to annotate their posts, e.g., with hashtags in tweets. Albeit effective, an annotation-based search is limited because results will only include the posts that share the same annotations. This paper focuses on retrieving context-related posts based on a specific topic, and presents PINYON, a knowledge-driven framework, that retrieves associated posts effectively. PINYON implements a two-fold pipeline. First, it encodes, in a graph, a CORPUS of posts and an input post;posts are annotated with entities for existing knowledge graphs and connected based on the similarity of their entities. In a decoding phase, the encoded graph is used to discover communities of related posts. We cast this problem into the Vertex Coloring Problem, where communities of similar posts include the posts annotated with entities colored with the same colors. Built on results reported in the graph theory, PINYON implements the decoding phase guided by a heuristic-based method that determines relatedness among posts based on contextual knowledge, and efficiently groups the most similar posts in the same communities. PINYON is empirically evaluated on various datasets and compared with state-of-the-art implementations of the decoding phase. The quality of the generated communities is also analyzed based on multiple metrics. The observed outcomes indicate that PINYON accurately identifies semantically related posts in different contexts. Moreover, the reported results put in perspective the impact of known properties about the optimality of existing heuristics for vertex graph coloring and their implications on PINYON scalability.

STRATEGY AND RESULTS OF THE MASSIVE IMPLEMENTATION OF REIMBURSED CONTINUOUS GLUCOSE MONITORING IN PEOPLE WITH TYPE 1 DIABETES

Background and Aims: Widespread use of continuous glucose monitoring (CGM) in Type 1 Diabetes (T1D) under nationwide reimbursement, has shown an improvement in glucometrics, acute complications and patient satisfaction. Following the last phase of the reimbursement program for CGM in Catalonia (Spain), the feasibility and effectiveness of a decision tree algorithm addressed to its massive implementation was evaluated during COVID-19 pandemic. Methods: A straightforward decision tree algorithm was developed to systematically detect and categorize T1D patients from our Diabetes Unit. An administrative assistant, supported by healthcare-staff, contacted candidates and enrolled them into the program if willing to and according to: previous self-financing and digital skills. New users received information about the device, a contact number and 5 training webinars links. Patients unfamiliar with technology received a face-to-face education program. Results: Over a 3-month period, 1519 candidates were contacted by phone (52% women, mean age 43.82±15.29 years, mean HbA1c 7.71%±1.19, 19% of them were pump users). 320 (21%) self-financed CGM previously, 1045 patients (69%) initiated reimbursed CGM use, 331 (22%) declined the use of the device and we could not get in touch with 143 (9%) of patients. 292 patients (29%) joined the Diabetes educator-led webinars, while only 39 (3%) required face-to-face training. No major acute complication or relevant clinical issues were reported. Conclusions: Massive implementation of reimbursed CGMin T1D population in a short period of time is feasible, effective and safe using coordinated strategies between healthcare and nonhealthcare professionals including on-site, virtual visits and a web-site education package.

Assessment of the suitability of mock teleconsultation as a training tool for Nursing

Objective: to assess the suitability of the mock teleconsultation methodology as a tool for the teachinglearning process in the Nursing University degree, according to professors and students. Method: a cross-sectional descriptive study, including 32 mock teleconsultations with actors, with 48 students and 6 professors assigned to different arms of six students and a professor, where different subjects were dealt with. In order to assess the suitability of this methodology, two focus groups were conducted: one with six professors and another one with six students, who were encouraged to describe the strengths and weaknesses of remote interaction. The information was analyzed through noun coding, based on grounded theory, with open coding and selective coding, in order to extract central themes and subthemes. Results: two subthemes were generated from the analysis of the speech of students: collective training and limited learning. In the first one, the teacher-student relationship and interventions by other students stood out, as well as the ability to continue training during the COVID-19 pandemic;and as weaknesses, they highlighted that this was not a useful methodology for face-to-face activities, and that it did not help to acquire skills. Professors generated two subthemes: horizontal and collaborative learning, and limitation for comprehensive care. In the first one, it was highlighted that this tool should be implemented in the future as one more creative method within the teaching-learning process;it encouraged supervision and follow-up of the training process of students by professors, and the improvement in willingness and commitment of students was highlighted. As a limitation, professors stated their concern with the evaluation process for students, with the technological and connectivity quality of teleconsultations, and coincided with students in the lack of ability of this methodology to replace face-to-face physical examination processes. Conclusions: mock teleconsultations represent a useful methodology for training future Nursing professionals, but are not able to replace face-to-face care activities in some cases. © 2021 DAE Editorial, Grupo Paradigma. All rights reserved.

IMPACTS OF COVID-19 PANDEMIC ON ECOTOURISM SEGMENT IN AMAZONAS STATE, BRAZIL

The COVID-19 pandemic has affected tourism worldwide. This paper examines the impacts of pandemic on companies and professionals related to ecotourism in the state of Amazonas, Brazil. For this purpose, we sent online structured questionnaire to workers in the sector, whose participation was voluntary and anonymous. We had 44 responses from seven macro-regions in the state, most of which were guides and workers in the market for over 15 years. For 91% of respondents, the pandemic totally affected personal or company turnover. Strategies to minimize impacts were adopted in 97% of cases, such as cancellation or rescheduling. The turnover forecast for the remainder of 2020 was very high for 38.6% of respondents. The budget recovery forecast is of at least two years for 43.2% of the cases. The professionals related to ecotourism in Amazonas had their activities affected and the perspective is for a slow recovery, resulting in vulnerability for the activity. Brazil's current image abroad, referring to the weak implementation of actions to mitigate the effects of the pandemic, represents a risk to the activity in Amazonas. Public policies are of utmost importance to recover the ecotourism and the valorization of the different actors and companies related to this tourist segment.

Nutritional status in locally advanced or metastatic solid cancer patients in Spain: The NutriOncoSearch (NOS) study

Background: Malnutrition is a common issue in oncology patients, and negatively affects patients' evolution and their quality of life, increasing the incidence of infection, hospital stay, and mortality. New approaches to targeted therapy and immunotherapy represent the future in the field of oncology, making it essential to understand its effect on patients. Study endpoints were (a). To describe the percentage of nutritional counseling or nutritional support among those diagnosed as malnourished or at risk. And (b) to categorize the percentage and descriptive characteristics of cancer patients with mild, moderate, or severe malnutrition in Spain and descriptive characteristics of patients with malnutrition according to sociodemographic and clinical characteristics. Methods: From a total of 585 patients from 10 hospitals, two groups were established, group A, N: 408, patients undergoing immunotherapy, group B with patients with inmuno plus chemotherapy and/or radiotherapy (N: 204). The objective of this observational study was to determine the prevalence (or risk) of malnutrition in the Spanish population of outpatients receiving immunotherapy. To do this, it was proposed to explore the nutritional status of these patients using Nutritional risk (NutriScore), Nutritional Global Subjective Assessment, ECOG PS;type of cancer and nutritional treatment: chemo, type of chemo, and COVID-19 diagnosis. Results: In group A (Immuno only) 28.3% of the patients were at risk of malnutrition, compared to 58.5% in group B (combined Immuno plus Chem&RT) with a statistically significant difference (p<0.0001);27.4% were on nutritional therapy, 97 (42.9%) of patients who obtained a score ≥of 5 (at risk), and 63 (17.5%) %) of patients who obtained a score <5 (out of risk) in NutriScore (p<0.0001). Dietary advice was the most common type of nutritional therapy, present in 123 (76.9%) patients of 160 with nutritional therapy, followed by oral supplements (69 (43.1%)) and enteral nutrition (11 (6.9%)). Conclusions: Nutritional diagnosis is key in cancer patients. It allows determining the needs of the patient in each of the phases of the patient's evolution, improving the quality of life through different interventions, especially dietary education. Clinical trial identification: NCT04168814. Legal entity responsible for the study: Spanish Society of Oncology Nursing. Funding: Baxter Healthcare Corporation. Disclosure: All authors have declared no conflicts of interest.

Change in body composition measured by bioimpedance spectroscopy after covid19 lockdown in haemodialysis patients

BACKGROUND AND AIMS: Changes on body composition have an impact on the survival of haemodialysis (HD) patients. The aim of the study was to determine the impact of the reduction of physical activity due to COVID19 lockdown on body composition in HD patients. METHOD: Retrospective and observational study including 149 HD patients. Nutritional and Bioimpedance spectroscopy (BIS) data were recorded before and after COVID19 lockdown (mean of 148±20 days between determinations). RESULTS: Over the 49 days of COVID19 lockdown, we observed a decrease in normohydrated weight (NHW) of 1.01±3.59 kg mainly secondary to a reduction on total body water (TBW) 0.95±3.78 L (extracellular water 0.45±1.58 L and intracellular water 0.41±2.36 L). There was also a small loss on lean tissue index (LTI) of 0.28±2.42 kg/m2, with an increase of fat tissue index (FTI) 0f 0.02±2.82 kg/m2. Twenty-three patients presented COVID19 infection, of which 21 required admission (median of 10 [4-16] days). Patients who presented COVID19 were older (70.7±12.0 vs 64.9±16.6 years, NS) with higher Charlson index (7.48±2.77 vs 6.33±2.65, p = 0.07). Patients with COVID19 infection presented a greater loss on LTI (-1.18±3.15 bs-0.16±2.30 kg/m2;p = 0.22), FTI (-0.41±3.38 vs 0.06±2.74 kg/m2;p = 0.54);BMI (-1.49±2.14 vs-0.25±0.96 kg/m2;p = < 0.01) and NHW (-4.00±6.33 vs-0.62±2.90 kg;p = < 0.01) compared to patients without COVID19 infection. The length of hospitalization was associated with greater loss of BMI and NHW, resulting, therefore, in overhydration. There also had lower serum phosphorus (3.6±0.8 vs 5.2±0.8 mg/dl;p = 0.01) and serum albumin (3.5±0.4 vs 4.0±0.1 g/dl;p = 0.01). Seven patients died during hospitalization. Deceased patients were older (78.4±6.6 vs 67.4±12.4 years;p = 0.01), presented higher comorbidity (estimated by Charlson index 10.0 [8.0-11.0] vs 6.5 [4.3-8.0];p = 0.02) and were more overhydrated (3.4±3.6 vs 1.9±1.9;p = 0.34). Although not statistically different, they had lower LTI (10.4±2.1 vs 12.0±3.4 kg/m2;p = 0.18) and lower serum albumin (3.4±0.6 vs 3.9±0.4 g/dl;p = 0.08) compared to survivors. Patients who survived COVID19 infection had longer hospitalization (57% were discharged between twelfth and forty third day;mean hospitalization 14.6±11.5 days). Deceased patients died within the first 12 days of hospitalization (6.8±4.1 days). CONCLUSION: COVID19 lockdown induced a weight reduction on HD patients due to decrease in total body water. COVID19 infection increased this reduction, inducing greater loss on lean and fat tissue composition. Moreover, COVID19 impact on body composition was magnified with the length of hospitalization.

PREVALENCE AND IMPACT OF FRAILTY IN PATIENTS HOSPITALISED WITH COVID-19. THE SALFORD EXPERIENCE IN WAVES 1 AND 2

IntroductionThe COVID-19 pandemic has had an extensive impact on the frail older population, with significant rates of COVID-related hospital admissions and deaths amongst this vulnerable group. There is little evidence of frailty prevalence amongst patients hospitalised with COVID-19, nor the impact of frailty on their survival. MethodsProspective observational study of all consecutive patients admitted to Salford Royal NHS Foundation (SRFT) Trust between 27th February and 28th April 2020 (wave 1), and 1st October to 10th November 2020 (wave 2) with a diagnosis of COVID-19. The primary endpoint was in-hospital mortality. Patient demographics, co-morbidities, admission level disease severity (estimated with CRP) and frailty (using the Clinical Frailty Scale, score 1–3 = not frail, score 4–9 = frail) were collected. A Cox proportional hazards regression model was used to assess the time to mortality. ResultsA total of 693 (N = 429, wave 1;N = 264, wave 2) patients were included, 279 (N = 180, 42%, wave 1;N = 104, 38%, wave 2) were female, and the median age was 72 in wave 1 and 73 in wave 2. 318 (N = 212, 49%, wave 1;N = 106, 39%, wave 2) patients presenting were frail. There was a reduction in mortality in wave 2, adjusted Hazard ratio (aHR) = 0.60 (95%CI 0.44–0.81;p = 0.001). There was an association between frailty and mortality aHR = 1.57 (95%CI 1.09–2.26;p = 0.015). ConclusionFrailty is highly prevalent amongst patients of all ages admitted to SRFT with COVID-19. Higher scores of frailty are associated with increased mortality.