Abstract 4127513: Cardiopulmonary long-term effects 6, 18 and 30 months after severe covid-19 infection

Circulation, Volume 150, Issue Suppl_1, Page A4127513-A4127513, November 12, 2024. Background:SARS-CoV-2 infection affects the cardiopulmonary system in both the acute and long-term phase. This study aimed to comprehensively assess symptoms and potential long-term impairments 6, 18 and 30 months in patients previously hospitalized for severe Covid-19 infection.Methods:This prospective registry included patients hospitalized for PCR-confirmed Covid-19 infection. Approximately 6 months post-discharge, follow-up examination included patient history, clinical examination, echocardiography, electrocardiogram, cardiac magnetic resonance imaging (cMRI), chest computed tomography (CT) scan, pulmonary function test (PFT), six-minute walk test (6MWT) and a comprehensive laboratory panel. Patients with pathologic findings during the first visit underwent a second (at 18 months) and third (at 30 months) follow-up examination. Those without pathologic findings or who refused further medical examinations were contacted via phone to inquire about symptoms.Results:Between July 2020 and April 2022, 200 patients (91% general ward, 9% intensive care unit) were recruited. Due to dropouts, the second visit was conducted in 170 patients, and the third visit in 139 (74 in person, 65 via telephone). Long Covid criteria were fulfilled by 73% at 6 months, 52% at 18 months and 49% at 30 months post-discharge, with fatigue being the most common symptom (Figure 1). Echocardiography at 6 months showed impaired left ventricular function in 15 patients, with normalization in 80% at 18 months and further 66% at 30 months (Figure 2). cMRI revealed pericardial effusions in 28 patients at 6 months, which resolved in 47% at 18 months and in further 60% at 30 months. Signs of peri- or myocarditis were present in 7 patients at 6 months and were resolved in all 4 patients who attended control studies at 18 months. Chest CT scans at 6 months identified post-infectious residues in 41 patients, with full recovery in 20% at 18 months without further normalization after 30 months.The length of in-hospital stay was identified as a significant predictor for persisting Long Covid 6 months after discharge (95% CI: 1.005 – 1.12, p=0.03).Conclusion:While the prevalence of Long Covid decreased over time, a significant symptom burden persisted at 6, 18 and even 30 months after severe Covid-19 infection. Structural and functional abnormalities were less frequent compared to reported symptoms, posing a challenge in substantiating the causes of these symptoms.

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Abstract 4142421: The Impacts of Blood Pressure Variability on Clinical Outcomes in Patients with Out-of-hospital Cardiac Arrest

Circulation, Volume 150, Issue Suppl_1, Page A4142421-A4142421, November 12, 2024. Background:Out-of-hospital cardiac arrest (OHCA) is associated with unfavourable survival rates and neurological outcomes. Blood pressure control is crucial in intensive care management, yet there are limited studies highlighting the influence of blood pressure variability (BPV). This study aims to investigate the impact of BPV within the first 48 hours on the outcomes in patients experiencing OHCA.Methods:A retrospective analysis was conducted on data from OHCA patients. Blood pressure measurements were collected and categorised into four intervals: 0-12 hours, 13-24 hours, 25-36 hours, and 37-48 hours after ROSC. BPV was assessed using the standard deviation (SD) and coefficient of variation (CoV) of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP). Mortality and cerebral performance category (CPC) were utilized in the study to assess the clinical outcomes at 30 days post-OHCA event.Results:A total of 185 patients who survived more than 48 hours after ROSC were enrolled. Survivors (n = 98) exhibited significant differences in BPV measures compared to non-survivors (n = 86). Higher BPV of SBP and MAP were associated with increased mortality for all four time intervals. Higher BPV of MAP in the initial 12 hours after ROSC were identified as predictors of 30-day mortality (hazard ratio [HR] 1.052, 95% confidence interval [CI] 1.029-1.075, P < 0.001 for SD of MAP). Furthermore, higher BPV of MAP in the initial 12 hours after ROSC were also identified as predictors of poor neurological outcomes (odds ratio [OR] 1.163, 95% CI 1.081-1.252, P < 0.001 for SD of MAP). Overall, BPV within the first 48 hours after ROSC were correlated with higher 30-day mortality, and BPV within the first 36 hours after ROSC were correlated with poor neurological outcomes.Conclusion:Increased BPV within the first 48 hours after ROSC is a significant predictor of mortality and poor neurological outcomes in OHCA patients. These findings underscore the importance of monitoring and managing BPV in the early post-arrest period to improve patient outcomes.

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Abstract 4146022: Serology supportive of recent coxsackievirus B infection is correlated with Multisystem Inflammatory Syndrome in Children (MIS-C)

Circulation, Volume 150, Issue Suppl_1, Page A4146022-A4146022, November 12, 2024. Background:Rarely, SARS-CoV-2 will lead to myocarditis associated with Multisystem Inflammatory Syndrome in Children (MIS-C). It remains unclear why MIS-C only targets specific children. Coxsackieviruses (CV) are prevalent infections during childhood and, like SARS-CoV-2, can lead to viral myocarditis. To explore an association with MIS-C we investigated the sero-epidemiology of CV in admitted pediatric patients.Method:A retrospective case control study was performed by chart review of children (age ≤ 21) admitted to a tertiary care hospital with CV serological testing from January 2017 to August 2023. Clinical, laboratory and imaging findings were used to classify patients as MIS-C and CV-unlikely or CV-possible for non-MIS-C patients.Results:Out of 182 admissions (179 patients, median age 6), CVB complement fixation (CF) assay on serotypes B1-B6 and CVA immunofluorescence assay IgG on serotypes A7, A9, A16, and A24 were positive in at least one serotype in 59.2% and 80.7% of cases respectively. We observed a significant drop in CVB CF seropositivity during the peak of social distancing in 2020. The CVB titers in CV-possible cases and MIS-C were similar. The likelihood of elevated CVB CF titers was significantly higher in MIS-C than CV-unlikely group (OR: 1.92, 95% CI: 1.02-3.63,p: 0.04). CVB CF titer trended toward higher values in African Americans compared to Whites (OR: 1.57, 95% CI: 0.98-2.50,p-value:0.057). As previously shown, the frequency of MIS-C was considerably higher in African Americans than Whites (18.1%, versus 9%,p: 0.1).Conclusion:Higher likelihood of elevated CVB CF titers in patients with MIS-C and in African Americans along with a notable higher frequency of MIS-C in African Americans warrant further investigation into the role of CVB infection in MIS-C development.

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Abstract 4144997: Pro-B-Type Natriuretic Peptide Kinetics across Pre-, Index, and Post-Acute COVID-19 in Hospitalized Acute on Chronic Heart Failure Patients: A Learning Health System Science Initiative

Circulation, Volume 150, Issue Suppl_1, Page A4144997-A4144997, November 12, 2024. Introduction:Myocardial injury in patients hospitalized with acute on chronic heart failure concurrent with index SARS-CoV-2 (CoV-2) infection is well described, though studies incorporating pre- and post-acute COVID-19 (PAC) are lacking. We address this gap by estimating intensity of acutely decompensated heart failure (ADHF) using time-series pro-BNP levels across hospitalizations pre- vs. respectively index and initial readmission (PAC1).Hypothesis:Case time series analysis will reveal association (p

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Abstract 4142484: Mechanism of miR-203a-3p regulating the proliferation and migration of PASMCs through PIK3CA/PI3K/Akt pathway in PAH

Circulation, Volume 150, Issue Suppl_1, Page A4142484-A4142484, November 12, 2024. Background:Pulmonary arterial hypertension (PAH) is characterized by an elevation in pulmonary vascular resistance and arterial pressure, culminating in right ventricular failure and mortality. Excessive proliferation and accumulation of pulmonary artery smooth muscle cells (PASMCs), driven by aberrant gene expression, stand as hallmark pathologies of PAH. Among the regulatory elements implicated in this process, microRNAs (miRNAs) such as miR-203a-3p are crucial, influencing cellular proliferation and migration. Nevertheless, the precise role and mechanisms through which miR-203a-3p modulates PAH pathophysiology remain poorly defined.Objective:This study seeks to elucidate the expression patterns and functional roles of miR-203a-3p in idiopathic pulmonary arterial hypertension (IPAH) and in rodent models of PAH, with an emphasis on understanding the underlying molecular mechanisms.Methods:Expression levels of miR-203a-3p were quantified in plasma from IPAH patients and healthy controls via RT-qPCR at the Second Xiangya Hospital. Rodent models of PAH were generated using either Monocrotaline (MCT) or Su5416 in conjunction with chronic hypoxia. MiR-203a-3p expression in plasma and lung tissue was evaluated at predetermined intervals. Additionally, the effects of miR-203a-3p overexpression on primary PASMC functions were assessed, and therapeutic potential was explored through administration of an adeno-associated virus vector encoding miR-203a-3p prior to model induction.Results:Significantly reduced levels of miR-203a-3p were observed in both IPAH patients and PAH-model rats compared to healthy controls, correlating inversely with indicators of disease progression. Overexpression of miR-203a-3p inhibited PASMC proliferation and migration and attenuated disease phenotypes in experimental models. Molecular analysis revealed that miR-203a-3p directly targets PIK3CA, influencing the PI3K/Akt signaling pathway, a critical mediator of PASMC function.Conclusion:The downregulation of miR-203a-3p in IPAH and its regulatory impact on PASMC behavior via the PIK3CA/PI3K/Akt pathway highlight its potential utility as a biomarker and therapeutic target in PAH. These findings provide a foundation for further investigations into the therapeutic benefits of miR-203a-3p in the clinical management of PAH, supporting its development as a novel therapeutic strategy.

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Abstract 4146939: Impact of Diagnosis Timing (Early vs Late) on Atrial Fibrillation Progression in Patient with New Onset Atrial Fibrillation During COVID Illness

Circulation, Volume 150, Issue Suppl_1, Page A4146939-A4146939, November 12, 2024. Background:New onset AF during acute illness has a high rate of AF recurrence within 5-yr. However, little is known about AF progression in patients with new onset AF during COVID illness. It is also unknown whether the time of COVID diagnosis (early vs late) impacts AF progression. More specifically, did the potentially different immune and inflammatory responses during early vs late COVID produce structural and electrical cardiac remodeling that would increase the likelihood of AF progression.Objective:We sought to compare AF progression in patients with new onset AF during early vs late COVID and hypothesized that early COVID was associated with increased AF progression compared to late COVID.Methods:From Apr 2020 to Feb 2024, patients receiving a SARS-2-CoV test without a history of AF with new onset AF and at least 3-mo of follow up were included (N=11,767). Patients were subdivided based on pos vs neg SARS-2-CoV test and time of diagnosis. Early COVID diagnosis (n=3052) included Apr 2020-Aug 2021 and late COVID (n=8715) included Sep 2021-Feb 2024. AF progression endpoints at 3-, 6- and 12-mo included AF hospitalization, AF emergency department (ED) visit, cardioversion and AF ablation.Results:Patients with late COVID were more likely females with hypertension, coronary artery disease and hyperlipidemia compared to early COVID patients. At 3- and 6-mo follow-up there was no difference in AF progression between the early and late COVID groups for any endpoint. In contrast, at 12-mo follow up there was in increase in late diagnosis group AF ED visits (11% vs 7.6%,p

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Abstract 4147449: Endothelial microRNAs as New Biomarkers in Patients with Diabetes and INOCA: Insights From a Multicenter Study

Circulation, Volume 150, Issue Suppl_1, Page A4147449-A4147449, November 12, 2024. Background:Diabetes mellitus (DM) and hyperglycemia are known to drive endothelial impairment and coronary microvascular dysfunction. However, currently no established biomarkers of endothelial dysfunction in patients with “Ischemia with non-obstructive coronary artery” (INOCA). We evaluated the expression of circulating microRNAs (miRs) involved in the regulation of endothelial function in individuals with confirmed INOCA, comparing patients with and without DM.Methods:We evaluated consecutive INOCA patients referred for percutaneous coronary intervention (PCI) in a multicenter study. DM was defined according to the American Diabetes Association (ADA) guidelines. INOCA was defined based on symptoms of myocardial ischemia, non-obstructive coronary artery stenosis (0.80), objective evidence of myocardial ischemia, and impaired coronary microvascular function (coronary flow reserve ≤2.0, abnormal coronary microvascular resistance indices, coronary microvascular spasm, endothelial dysfunction with ≥20% luminal constriction during acetylcholine infusion, or coronary slow flow phenomenon). Circulating miRs were isolated from plasma samples using EDTA-containing tubes and the miRNeasy Serum/Plasma kit. Quality control included using the Agilent Small RNA Kit [33] and the RNA Spike-in kit (Qiagen) with synthetic RNA spike-ins (UniSp2, UniSp4, UniSp5) and UniSp6 spike-in and cel-miR-39-3p for cDNA synthesis control. Relative gene expression was determined using the 2-ΔΔCT method, with miRs miR-125a-5p and miR-19a-5p selected for normalization using bioinformatic algorithms. Hemolysis was assessed by measuring absorbance at 414 nm and ΔCq of miR-16-5p, miR-451a, and miR-23a-3p.Results:42 patients completed the study (28 without DM, 14 with DM). We measured the expression levels of validated miRs and found that in INOCA patients with DM, there was increased expression of miRs associated with endothelial dysfunction and reduced expression of miRs protective for endothelial function. Specifically, miR-363-5p was significantly downregulated (P

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Abstract 4140628: Guideline-Directed Medical Therapy Rates in Patients with Human Immunodeficiency Virus and Heart Failure with Reduced Ejection Fraction

Circulation, Volume 150, Issue Suppl_1, Page A4140628-A4140628, November 12, 2024. Introduction:Human immunodeficiency virus (HIV) infection increases the risk of heart failure, particularly Heart Failure with Reduced Ejection Fraction (HFrEF). Guideline-directed medical therapy (GDMT), including beta-blockers (BB), renin-angiotensin system inhibitors (RASi), mineralocorticoid receptor antagonists (MRAs), and sodium-glucose cotransporter-2 inhibitors (SGLT2i), has been shown to decrease morbidity and mortality in patients with HFrEF.Hypothesis:Lower GDMT prescription rates would be associated with higher 30-day readmission or mortality rates in patients with HIV and HFrEFAims:To assess GDMT prescription rates and their impact on short-term morbidity and mortality in patients with HIV and HFrEF.Methods:Patients diagnosed with HIV and HFrEF who were admitted with acute heart failure within Emory Healthcare from 2010 to 2020 were identified using ICD codes. Diagnoses were confirmed by physician review. Baseline demographics, CD4 count, viral load (VL), prescriptions for GDMT and antiretroviral medications at the time of admission were assessed. A simple GDMT score was created, assigning 1 point for each medication prescribed (0-3, excluding SGLT2i given the study timeframe). Multivariable logistic regression was used to determine the association of the GDMT score with 30-day readmission or death, adjusting for age, sex, race, hypertension, diabetes, estimated glomerular filtration rate (eGFR), and VL.Results:The study included 161 patients (mean age 56 years, 22.9% women, 86.3% Black, 55% with VL

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Abstract 4146682: Rarer Than Rare: AL Amyloidosis Presenting as Abdominal Amyloidomas

Circulation, Volume 150, Issue Suppl_1, Page A4146682-A4146682, November 12, 2024. Case:A 52-yr-old man with weight loss and urinary hesitancy for 4 months underwent a CT urogram. No urologic abnormalities were noted but there was an incidental finding of intraperitoneal nodules and a perigastric mass. Biopsy of the perigastric lymph nodes showed abundant amyloid deposits, consistent with amyloidoma. Systemic amyloidosis workup was started. Serum immunofixation showed an IgG lambda M spike of 0.1 g/dL, and serum free light chain ratio was 0.17 (k/l = 10/60, mg/L). The tumor board recommended biopsy of other abdominal sites to distinguish plasmacytoma from amyloidoma. Biopsy showed amyloidosis with benign reactive lymph nodes and small clusters of lambda restricted plasma cells suggesting amyloidoma/plasmacytoma. Bone marrow biopsy showed 15% plasma cells, confirming multiple myeloma/amyloidosis overlap. Daratumumab-cyclophosphamide-bortezomib-dexamethasone (DARA-CyBorD) induction therapy was initiated. Transthoracic echocardiogram (TTE) showed normal biventricular function and moderate concentric hypertrophy. A cardiac MRI (CMR) then confirmed features of early amyloidosis. Light chains normalized with therapy but repeat bone marrow biopsy showed 5% lambda restricted plasma cells. Given the biopsy results and cardiac amyloid, consolidative autologous stem cell transplant was pursued to achieve a deep hematological response.Discussion:AL amyloidosis is a rare but fatal disease. Cardiac involvement is seen in > 75% patients and degree of cardiac infiltration determines median survival. The initial presentation of intra-abdominal amyloidomas is highly unusual and only reported in case series in literature. A finding of amyloidoma should prompt workup for systemic amyloidosis. Cardiac workup should be undertaken even in the absence of overt symptoms. TTE findings in early cardiac amyloid are highly non-specific and can, therefore, be easily missed. A high index of suspicion is needed in this cohort with advanced imaging being pursued for any abnormality such as moderate concentric hypertrophy. Recognition of early cardiac involvement was key in deciding the chemotherapy regimen and in the decision to pursue autologous stem cell transplant for long term remission.

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Abstract 4147246: Establishing Correlation of Non-Invasive Monitoring Techniques in Xenotransplantation

Circulation, Volume 150, Issue Suppl_1, Page A4147246-A4147246, November 12, 2024. Introduction:Non-invasivesurveillance of cardiac allograft health has included biomarkers such as NT-proBNP, and donor-derived cell-free DNA (dd-cfDNA). It has previously been shown that these biomarkers when elevated, indicate graft complications such as rejection, coronary artery vasculopathy, or donor-specific antibody production. As xenotransplantation enters the arena as a potential option for those with advanced heart failure, noninvasive monitoring techniques need to be investigated. Our institution performed the second porcine to human cardiac xenotransplant with a 10 gene edited porcine cardiac xenograft under FDA compassionate use authorization. After requiring perioperative transfusions, by post operative day (POD) 13, endomyocardial biopsy (EMB) revealed antibody and complement deposition without damage. Hemodynamic decompensation on POD 29 prompted EMB, revealing antibody mediated rejection (AMR).Research Questions/Goals:The authors sought to investigate if NT-proBNP and dd-cfDNA positively correlate in the patient with cardiac xenograft.Methods/Approach:NT-proBNP was checked periodically and dd-cfDNA was assessed once to twice weekly post-transplant. A retrospective review was completed including Pearson’s correlation coefficient analysis.Results/Data:There was a weak negative correlation between the NT-proBNP and dd-cfDNA (r=-0.28). After the initial spike in the perioperative period, NT ProBNP levels declined. NT Pro-BNP did not rise as dd-cfDNA did at the time of biopsy proven antibody mediated rejection (AMR). See the graphic below for detailsConclusion:Noninvasive surveillance of cardiac xenografts needs further investigation. Biomarkers such as NT-proBNP negatively correlated with dd-cfDNA, which increased as expected at the time of biopsy proven antibody mediated rejection. Porcine xenografts are accustomed to a low-pressure circulatory system in contrast to the human recipient milieu. Despite this increased load to the xenograft, NT-proBNP levels decreased significantly after the initial postoperative phase. The NT proBNP values could have been lower than expected due to the effects of continuous renal replacement therapy. It is interesting to also note that the human assay detected xeno NT-proBNP.

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Abstract 4142506: Comparative Proteomic Analysis of Myocarditis: COVID-19 mRNA Vaccination vs. Pre-Pandemic Viral Etiologies

Circulation, Volume 150, Issue Suppl_1, Page A4142506-A4142506, November 12, 2024. Introduction:Myocarditis has been reported after mRNA-based COVID-19 vaccination, but the immune mechanisms remain unclear. This study aimed to identify the proteome-based immunopathogenesis of post-vaccination myocarditis compared to viral myocarditis in the pre-COVID-19 era.Methods:Proteomic analysis of right ventricle (RV) biopsy specimens was performed in myocarditis patients (pre-pandemic viral myocarditis: n=3, post-vaccination myocarditis: n=3) and controls (normal endomyocardial biopsy specimens of heart transplant recipients, n=4) using mass spectrometry. Differentially expressed proteins were analyzed with CIBERSORTx, Gene Ontology (GO) analysis, and Ingenuity Pathway Analysis (IPA). To examine the relationship between the SARS-CoV-2 spike protein and post-vaccination myocarditis, immunohistochemistry (IHC), mass spectrometry analysis of spike protein, and activation-induced marker (AIM) assay in T cells from RV samples were conducted.Results:In the proteomic analysis, 6,861 proteins were identified. Post-vaccination myocarditis showed increased extracellular matrix formation and cardiac fibrosis. Both pre-pandemic and post-vaccination myocarditis had elevated pro-inflammatory cytokine activities. However, post-vaccination myocarditis exhibited higher expression of interferon-alpha (IFNα) and pattern recognition receptor activation, including TLR3 and TLR7. Pre-pandemic myocarditis showed higher activation of the complement system, neutrophils, and NK cells, whereas post-vaccination myocarditis showed increased Th2 cell activation and classical macrophage activation. Spike protein and related T-cell activation were not detected.Conclusion:The immune activation in myocarditis after COVID-19 mRNA vaccination may be triggered by the mRNA in the vaccine via an IFNα-driven immune response, leading to autoimmune-like features. Further studies are necessary to validate whether these proteins correlate with clinical characteristics.

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Abstract 4147474: Global and regional burden of alcohol-related atrial fibrillation from 1990 to 2021: An analysis of GBD study 2021

Circulation, Volume 150, Issue Suppl_1, Page A4147474-A4147474, November 12, 2024. Background and Aims:Atrial fibrillation constitutes a major global public health issue, with its epidemiological patterns having changed significantly over the past decades. In this study, we aimed to analyze trends of mortality due to alcoholic atrial fibrillation from 1990-2021, including identifying the patterns in age-standardized death rates (ASDR), years of life lost (YLL), and disability-adjusted life years (DALY) over time, and raising awareness about the global health burden of alcoholic atrial fibrillation.Methods:Data on alcohol-related atrial fibrillation was extracted from the Global Burden of Diseases 2021 study, including ASDR, YLL, and DALY from 1990 to 2021. The dataset was globally divided and categorized by continents and World Bank income levels. Joinpoint regression analysis was performed to determine average annual percentage changes (AAPC) from 1990 to 2021.Results:Globally, the Age standardized death rates (ASDR) for alcohol-related atrial fibrillation had a constant trend from 1990-2021. The ASDR was determined to be 0.15 (95% UI 0.1-0.2) both in 1990 and 2021 (AAPC=-0.014; 95% CI -0.014 to -0.036). Although the overall trend is constant, a considerable spike in mortality rates was observed from 2000-2010 (APC=0.38). Globally, the disability-adjusted life-years (DALYs) and the age standardized years of life lost (YLL) have remained fairly constant with AAPCs of -0.052 (95% CI -0.063 to -0.036) and -0.07 (95% CI -0.098 to -0.047), respectively. In continent wise analysis, North America and Asia had intermittent spikes in ASDRs while Europe and Africa showed a constant trend throughout the analysis. From 1990 to 2021, North America had an AAPC of 1.26 (95% CI 1.23-1.29), showing a deviation from global trend with an incline. Similarly, Asia had an increasing trend with AAPC of 0.58 (95% CI 0.55-0.6). Africa also had a minutely increasing trend from 1990 to 2021 with an AAPC of 0.36 (95% CI 0.33 to 0.38). According to World Bank income levels, high-income countries had the highest death rates, followed by upper-middle income, lower-middle income and low-income countries in descending order.Conclusions:Although trends in the burden of alcohol-related atrial fibrillation have varied globally, the net change in years of life lost (YLL) and age-standardized death rates (ASDR) from 1990 to 2021 have been minimal. The data highlights the need for further research, to develop specific strategies that are targeted at specific populations.

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REASSURED evaluation of the Bioline HCV point-of-care testing for diagnosing hepatitis C virus infection in primary healthcare settings of Ghana: a study protocol

Introduction
Hepatitis C virus (HCV) infection is a silent epidemic that needs a comprehensive and contextualised approach to manage. Access to readily available, affordable and acceptable HCV point-of-care (POC) in vitro diagnostics (IVDs) is equally required to meet the global HCV goals. However, most guidelines for evaluating these IVDs such as the WHO prequalification process and country-specific standards disproportionately focus on diagnostic performance. The real-time connectivity, ease of specimen collection, affordability, sensitivity, specificity, user-friendliness, rapidity and robustness, equipment-free or simplicity and deliverability to end-users (REASSURED) criteria provide a holistic and user-oriented evaluation of the IVDs in the populations they are meant to be used. Therefore, as part of a multinational study in sub-Saharan Africa, we will conduct an evaluation of the Bioline HCV POC test for diagnosing HCV infection in primary healthcare settings of Ghana using the REASSURED criteria.

Methods and analysis
This field evaluation will be conducted in three phases. The first phase will use a cross-sectional field evaluation study design to evaluate the diagnostic performance of the Bioline HCV POC test. The second phase will use mixed methods to ascertain operational characteristics and users’ perceptions. In the third phase, a cross-sectional survey will be used to estimate the costs of accessing HCV diagnostics services using three proposed HCV testing models to inform the affordability of the testing pathways and linkage to care in the primary healthcare clinics. This phase will run concurrently with the second phase of the study. Thematic content analysis and quantitative data analysis will be performed using ATLAS.ti V.23.0.6 and StataCorp LLC’s Stata statistical software V.16.0, respectively.

Ethics and dissemination
The study protocol has been reviewed and fully approved by the Faculty of Health Sciences Research Ethics Committee, University of Pretoria (281/2023) and the Ghana Health Service Ethics Review Committee (GHS-ERC013/08/23). This diagnostic trial has also been registered in the Pan African Clinical Trial Registry (PACTR202410837698664). The findings of the study will be presented in relevant peer-reviewed journals, at local and international conferences, and to all stakeholders involved.

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Protocol for an ambidirectional cohort study on long COVID and the healthcare needs, use and barriers to access health services in a large city in Southeast Brazil

Introduction
Post-COVID-19 condition, or syndrome, also known as long COVID, is an infection-associated chronic condition that can develop after a SARS-CoV-2 infection and last at least 3 months to years. Despite representing a high burden for the Unified Health System (SUS), which has affected millions of Brazilians, it has received limited attention in Brazil. Prevalence studies to date have failed to include a broad representation of the population, and there has been insufficient exploration of the impact on people’s lives and the burden of and barriers to accessing health services. This article presents the research protocol for the quantitative component of a mixed methods project to produce evidence to inform SUS’s provision of care for long COVID. The protocol was designed to study long COVID in SUS patients hospitalised for COVID-19 in a large city in Southeast Brazil to capture symptoms and factors associated with the syndrome, effects on quality of life and employment, health needs, use of health services and barriers to accessing necessary healthcare.

Methods and analysis
An ambidirectional cohort study to capture data retrospectively and prospectively from adults previously discharged from SUS hospitals for COVID-19. The study involves up to two telephone surveys with the patients or proxies selected from a sampling plan for population estimates. Survey questions include baseline and follow-up data on demographic, socioeconomic, comorbidities, work status, health-related quality of life, vaccination status, long COVID symptoms, healthcare needs, use and barriers to access. Descriptive and appropriate multivariable analyses will be employed.

Ethics and dissemination
The project was approved by the Research Ethics Committees of participant institutions and by the Brazilian National Research Ethics Commission. All participants provided verbal consent. We plan to publish articles in scientific journals and multimedia resources for SUS professionals and the general population.

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