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1.
Healthline, Journal of Indian Association of Preventive and Social Medicine ; 13(4):307-312, 2022.
Article in English | GIM | ID: covidwho-20242714

ABSTRACT

Introduction : Coronavirus disease 2019 (COVID-19) saw an overhaul in the biomedical waste management (BMWM) practices. Waste handlers were at the brunt of these changes. If the challenges pertaining to BMWM at the ground level are better understood, more effective measures to overcome them can be formulated. Objectives: 1. To identify myths and concerns regarding BMWM in the context of COVID-19 pandemic. 2. To explore the challenges faced in BMWM amidst the COVID-19 pandemic. 3.To explore opportunities and future perspectives of BMWM. Method: In-depth interviews were conducted among 17 purposively selected Class IV health care workers during August to November 2021 in a tertiary care institute in Mumbai. Data was reported using thematic analysis. Results: Three major themes - challenges and concerns faced by BMW handlers, enablers/motivators, opportunities and future practices were generated from the transcripts. Various challenges faced by waste handlers were- difficulties in segregation and transport of BMW, exhaustion from PPE usage and fear of acquiring and spreading COVID-19 from work, stigma faced from public, and handling COVID-19 deaths. Support from family and colleagues, incentives and a positive change in public perception enabled them to work. Forming redressal committees, addressing job security concerns and timely provision of good quality equipment can improve hospital waste management measures in the future. Conclusion: It is of utmost importance to address challenges faced by waste handlers in BMWM. Onus should also be on periodic training in BMWM.

2.
Advances in Health and Disease Volume 67 ; : 45-70, 2023.
Article in English | Scopus | ID: covidwho-20242713

ABSTRACT

The World Health Organization (WHO) declared an international public health concern on January 30, 2020, in response to the idiopathic Coronavirus disease 2019 (COVID-19) pandemic outbreak. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of the disease being identified as the third human Coronavirus, was discovered in Wuhan, Hubei Province, China. Coronavirus belongs to the Coronaviridae family, Coronavirinae subfamily which according to their genetic structures, are grouped into alphaCoronavirus (aCoV), betaCoronavirus (bCoV), gamma Corona¬virus (yCoV) and deltaCoronavirus (dCoV) of order Nidovirales. Coronaviruses are enveloped, positive-sense, single-stranded RNA viruses invading a wide variety of host species. SARS-CoV-2 belongs to extensively. Angiotensin¬converting enzyme 2 (ACE2) is imperative for Novel SARS-CoV-2 to enter host cells as a substrate receptor. With a high mortality rate in the elderly, immune-compromised, diabetic, and patients with cardiovascular and respiratory diseases, COVID-19 is an extremely contagious disease. Patients who are afflicted experience fever, a nonproductive cough, lethargy, dyspnea, and occasionally diarrhoea as well as radiographic signs of pneumonia. A cytokine storm is a result of the immune system's aggressive response to a virus that has propagated inside the body. Genetic recombination and mutation are the main drivers of the emergence of novel SARS-CoV-2 variants. Variants of concern (VOCs) are used to describe some variants having significant virulence and transmission rates, such as the Omicron variants now. RT-LAMP, RT- qPCR, and High-Resolution Computed Tomography, among other new cutting-edge techniques, are effective at diagnosing SARS-CoV-2 infected patients. Standard treatments involving compounds like Lopinavir/Ritonavir, paxlovid, and molnupiravir have shown to be efficacious to some extent against even the newly emerging strains when it comes to treatment approaches. Additionally, immunization is a crucial strategy for preventing the disease or lessening its impact. Live attenuated vaccines, DNA- and RNA-based vaccines, protein subunit vaccines, and amplifying viral vector vaccines are among the molecular frameworks used in the production of vaccines against SARS-CoV-2. Comirnaty by Pfizer-BioNTech, SpikeVax by Moderna, and Vaxzevria by Oxford- AstraZeneca are three extensively incorporated and validated COVID-19 vaccines. In a similar vein, a variety of vaccinations have been created with varying degrees of potency against VOCs. Nanotechnology and artificial intelligence (AI) advancements may help in the provision of an effective and dependable remedy for the eradication of SARS-CoV-2. Definitive diagnosis, community engagements, and united scientific approaches have effectively addressed public health issues amid the pandemic. Although COVID-19 has presented a significant challenge to the healthcare system, it has also provided a chance for the development of novel and creative roles that could have significant effects on the healthcare system. This pandemic has highlighted the value of prompt diagnosis, the value of universal healthcare as well as the need for cutting-edge methods to contain pandemics around the world. © 2023 Nova Science Publishers, Inc. All rights reserved.

3.
HIV Medicine ; 24(Supplement 3):71, 2023.
Article in English | EMBASE | ID: covidwho-2324764

ABSTRACT

Background: England is committed to ending HIV transmission by 2030. The HIV Action Plan (2021) set an interim ambition to reduce HIV transmission by 80% to 600 new diagnoses first made in England by 2025. Here we present the progress between 2019 (baseline) and 2021, interpreted in the context of the COVID-19 pandemic. Method(s): People newly diagnosed with HIV were reported to the HIV and AIDS Reporting Section (HARS). The annual number of people having an HIV test in all sexual health services (SHS) including online testing were reported using GUMCAD. HIV diagnoses among people previously diagnosed abroad were excluded (25%). Result(s): New HIV diagnoses first made in England fell by 32% from 2,986 in 2019 to 1,987 in 2020, but plateaued in 2021 (2,023). Among gay/bisexual men, HIV diagnoses plateaued in 2021 (721) after a fall of 45% between 2019 and 2020, from 1,262 to 699. After a fall in HIV testing in 2020 (from 156,631 in 2019 to 144,800 in 2020), the number of people tested in 2021 (178,466) exceeded pre-COVID-19 levels. This suggests a decline in HIV incidence supported by a CD4 back calculation model (80% probability of a decline for the period 2019-2021), but at a slowing rate. Among heterosexual adults, new HIV diagnoses first made in England in 2021 also plateaued (798) following a 31% decrease (from 1,109 in 2019 to 761 in 2020). However, HIV testing coverage has not recovered to pre- COVID-19 levels (628,607 in 2019, 441,017 in 2020 and 489,727 in 2021). This provides no evidence of a fall in incidence in this population. Conclusion(s): A reduction by 360 new diagnoses first made in England year on year from 2022 onwards is required to meet the HIV Action Plan ambition. Despite an estimated 4,500 people with undiagnosed HIV and extremely high levels of antiretroviral therapy and viral suppression, PrEP access remains unequal. HIV testing numbers, which were affected by COVID-19 pandemic, have recovered in gay/bisexual men, but not among heterosexual adults. While the interim ambition is within reach for gay/bisexual men, PrEP and testing levels must be scaled up in heterosexual adults.

4.
17th International Conference on Indoor Air Quality and Climate, INDOOR AIR 2022 ; 2022.
Article in English | Scopus | ID: covidwho-2322794

ABSTRACT

Increased usage of chemical disinfectants during the COVID-19 pandemic may impact the chemical composition of indoor air in residential and commercial buildings. This study characterized gas-phase concentrations of volatile organic compounds (VOCs) during multi-surface disinfection activities in a tiny house research facility. This unique facility provided a controlled, yet realistic environment for simulating whole-building disinfection events. VOCs were measured in real-time (1 Hz) in the bulk air of the tiny house with a proton transfer reaction time-of-flight mass spectrometer (PTR-TOF-MS). In addition, particle number (PN) size distributions were measured with a high-resolution electrical low-pressure impactor (HR-ELPI+). PTR-TOF-MS measurements demonstrate that chemical disinfectant spray products applied to multiple surfaces can substantially increase indoor VOC concentrations. © 2022 17th International Conference on Indoor Air Quality and Climate, INDOOR AIR 2022. All rights reserved.

5.
HIV Medicine ; 24(Supplement 3):68-69, 2023.
Article in English | EMBASE | ID: covidwho-2326196

ABSTRACT

Background: The National HIV Mortality Review (NHMR) was launched by UK Health Security Agency (UKHSA) and British HIV Association to better recognise causes of death and preventable death, and to describe end-of-life care, among people with HIV. Method(s): UK HIV services submitted data on all known deaths among people with HIV under their care in 2021 through a secure online form. Cause of death was categorised by an epidemiologist and four clinicians using the Coding Causes of Death in HIV protocol. Result(s): In 2021, 101 services reported 606 deaths among people with HIV to NHMR. In 2019, 74 services reported to the NHMR while 121 reported in 2020. Median age at death was 58 [interquartile range (IQR): 56-59] and most (76%) were male. Death cause was ascertainable for 78% (n=475), with the most common being non-AIDS-related cancers (26%), followed by non-AIDS-defining infections (19%), cardiovascular disease (16%), AIDS (9%), substance misuse (8%), respiratory disease (4%), accident/suicide (3%), liver disease (2%) and other causes (11%). COVID- 19 caused or contributed to 11% of all deaths. Thirtythree people (5%) died within a year of HIV diagnosis, 90% of these were diagnosed late (CD4<350 cells/mm3), 80% very late (CD4<200 cells/mm3), 54% diagnosed with AIDS and 33% had documented missed opportunities for earlier diagnosis. Viral suppression (<200 copies/mL) (87%) and treatment coverage (98%) was high with the median time on treatment 13 years [IQR: 8-20]. Common lifestyle risk factors in the preceding year included smoking (33%;n=179), excessive alcohol use (20%;n=103). Other factors included drug use (non-injecting and injecting) and opioid substitution therapy. Death had been expected for 298 (49%) individuals, of whom 230 had discussed end-of-life care and 108 had a documented advanced end-of-life care plan in place. Conclusion(s): Over half of people living with diagnosed HIV are aged over 50. Most deaths were not AIDS related however, one in eleven people with diagnosed HIV in the UK died from AIDS. Of people that died within a year of diagnosis, one in three had documented missed opportunities for earlier HIV diagnosis.

6.
Delineating Health and Health System: Mechanistic Insights into Covid 19 Complications ; : 289-298, 2021.
Article in English | Scopus | ID: covidwho-2326195

ABSTRACT

One of the hallmarks of the global pandemic of coronavirus disease 2019 (COVID-19) is that it targets the immune system by producing inflammatory cytokines. COVID-19 has expedited investigations on numerous therapeutics to fight the disease-causing virus SARS-CoV-2, some without well-established safety or efficacy data. The severity of the disease depends on a number of factors, including genetic background and preexisting conditions. The difference in the genetic makeup makes everyone unique and the understanding of the COVID-19 cure arduous. To dampen these inflammatory markers and to understand the viral disease dynamics, accounting for genetic variability, a combinational three-way approach involving bioinformatics, nutrigenomics, and pharmacogenomics will give answers to many unanswered questions involving patient care. A futuristic approach to prevention and cure calls for continuous research with practice and training provision to the right group, accompanied with the awareness enhancing its utility. © The Author(s), under exclusive licence to Springer Nature Singapore Pte Ltd. 2021.

7.
PLoS Pathog ; 19(5): e1011308, 2023 05.
Article in English | MEDLINE | ID: covidwho-2320731

ABSTRACT

The global spread of the SARS-CoV-2 virus has resulted in emergence of lineages which impact the effectiveness of immunotherapies and vaccines that are based on the early Wuhan isolate. All currently approved vaccines employ the spike protein S, as it is the target for neutralizing antibodies. Here we describe two SARS-CoV-2 isolates with unusually large deletions in the N-terminal domain (NTD) of the spike. Cryo-EM structural analysis shows that the deletions result in complete reshaping of the NTD supersite, an antigenically important region of the NTD. For both spike variants the remodeling of the NTD negatively affects binding of all tested NTD-specific antibodies in and outside of the NTD supersite. For one of the variants, we observed a P9L mediated shift of the signal peptide cleavage site resulting in the loss of a disulfide-bridge; a unique escape mechanism with high antigenic impact. Although the observed deletions and disulfide mutations are rare, similar modifications have become independently established in several other lineages, indicating a possibility to become more dominant in the future. The observed plasticity of the NTD foreshadows its broad potential for immune escape with the continued spread of SARS-CoV-2.


Subject(s)
COVID-19 , Humans , SARS-CoV-2/genetics , Antibodies, Neutralizing , Disulfides , Immunotherapy , Spike Glycoprotein, Coronavirus/genetics , Antibodies, Viral
8.
Movement Disorders Clinical Practice ; 10(Supplement 1):S96, 2023.
Article in English | EMBASE | ID: covidwho-2305006

ABSTRACT

Objective: To describe a case of levo-dopa responsive parkinsonism secondary to combined COVID-19 and Enteric fever in a patient Background: The first link between viruses and parkinsonism comes from the possible relationship between lethargic encephalitis and the Spanish flu of 1918.In addition, other viruses, including West Nile virus, herpes viruses, influenza A virus, and human immunodeficiency virus (HIV), have been associated with parkinsonism Methods: A 31 years old presented with fever ,headache for 5 days followed by altered sensorium. At presentation he had neck rigidity ,was localizing to pain ,not fully oriented and not following verbal command but he had hypoxia and need nasal oxygen support.He had D-Dimer 12506,COVID-19 RTPCR positive and was treated with Remdesivir,ceftriaxone ,dexamethasone after which he had improvement in sensorium.At day 6 of illness he had generalized rigidity,bradykinesia with slow hypophonic speech and was needing support to sit and walk . A provisional diagnosis of infection related parkinsonism was considered and Cerebrospinal fluid study,MRI Brain and spine ,Blood culture were done .His Cerebrospinal fluid study has normal protein , glucose,cells, stains and culture and negative autoimmune and paraneoplastic plane . His urine culture,blood culture was positive for salmonella typhi and serum widal titre was 1:640.MRI Brain and spine does not show any new abnormalities except old trauma sequalae. He was treated with Levo-dopa carbidopa and titrated to a dose of 675 mg/day and had sustained improvement with levo-dopa carbidopa .There are 6 other case of COVID-19 associated parkinsonism in literature .There are also few case of typhoid associated case of parkinsonism described in literature . Our patient had combined infection of both COVID-19 and typhoid associated parkinsonism. Result(s): We report a case of Infection related parkinsonism secondary to combined COVID-19 plus typhoid infection Conclusion(s): Exploring the potential relationship of co-infection SARS-CoV-2 and Salmonella typhi infection with development of parkinsonism is essential because of the epidemiological implications,as well as to gain a better understanding of the pathophysiological aspects of these disorders.

9.
Letters in Applied NanoBioScience ; 11(4):4201-4212, 2022.
Article in English | Scopus | ID: covidwho-2303454

ABSTRACT

Novel coronavirus (COVID-19) recently emerged as a new pandemic disease that affects millions of people worldwide. This disease considers as a potential threat to human society. Researchers are continuously working to identify virus structure, the pathophysiology of the disease, and possible treatment of the disease. Currently, to fight against the coronavirus, two major strategies have been adopted throughout the world;one is to target virus-cell machinery, and the second is to improve patient immunity. In this review, we have described detailed information about the structure and life cycle of the novel coronavirus, current therapy, and future strategies to fight against this pandemic disease. Computational methods are useful for understanding virus structure, disease pathology, and discovering novel anti-COVID agents. These methods can provide fast and efficient solutions to fight against this disease. We also highlighted the potential role of robotic technology and its importance in various clinical aspects. These robotic technologies may also play an important role in fighting COVID-19. © 2021 by the authors.

10.
World Conference on Information Systems for Business Management, ISBM 2022 ; 324:453-460, 2023.
Article in English | Scopus | ID: covidwho-2277878

ABSTRACT

The COVID-19 epidemic demonstrated the importance of technology in the healthcare sector. A lack of ventilators and essential drugs results in a high mortality rate. The most important lesson from the pandemic is that we must use all available resources to alleviate the situation during the pandemic. In this paper, we combine pharmacovigilance and machine learning to predict the effect of an adverse reaction on a patient. We take VAERS data and preprocess it before feeding it to various machine learning algorithms. We assess our model using various parameters. © 2023, The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

11.
5th World Congress on Disaster Management: Volume III ; : 216-226, 2023.
Article in English | Scopus | ID: covidwho-2258988

ABSTRACT

This study is designed to explore the impacts of the COVID pandemic on the socio-economic status of textile workers and to suggest ways for balancing the turnover rate. For the study, a cross-sectional study design and mixed-method approach were employed. The researchers conducted a questionnaire survey of 357 textile workers using convenience sampling and, 5 KIIs, 20 IDIs, and 5 FGDs using purposive sampling. The study area was the Gazipur district of Bangladesh, a hub of the textile industry. Findings from Principle component analysis revealed that 54.38% of the total observed variation can be explained by five components. Working Environment (r = –0.699), Payment System (r = .987), Savings (r = .920), Employee Turnover Rate (r = .769), and Social Status (r = .558) of employees are identified by PCA as the most strongly correlated variables that have significant impacts on the socio-economic condition of textile workers due to Covid 19 pandemic. Finally, through Logistic Regression Analysis, the study has found that Safe Working Environment (OR = 0.203, 95% CI 0.098-0.419), Satisfactory Payment Structure (OR = 2.196, 95% CI 1.354-3.561), and Provident Fund Facilities (OR = 2.908, 95% CI 1.497-5.651) can reduce the turnover rate of textile workers. Additionally, effective labor unions and adequate training facilities can also balance the adverse socio-economic impacts on the textile workers. © 2023 DMICS.

12.
Journal of Pharmaceutical Negative Results ; 13(3):339-354, 2022.
Article in English | EMBASE | ID: covidwho-2281201

ABSTRACT

COVID-19 respiratory viral disease has changed the entire research communities' focus towards Diseases, Health Care, Treatment and related resources decision making and services. Fuzzy approach gives simplification and improvement in processing logic and speed applied to Data analytics and testing of algorithm for different business purposes may be future research domain. Significant COVID-19 analytics can help to classify and prioritize the resources the future consequences to take enhanced self-ruled decisions, to recognise and design pattern in data spread to design strategic policies for medical, health care units and stakeholders.Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

13.
Emerg Infect Dis ; 29(4): 865-868, 2023 04.
Article in English | MEDLINE | ID: covidwho-2261126

ABSTRACT

We sequenced 54 respiratory syncytial virus (RSV) genomes collected during 2021-22 and 2022-23 outbreaks in Washington, USA, to determine the origin of increased RSV cases. Detected RSV strains have been spreading for >10 years, suggesting a role for diminished population immunity from low RSV exposure during the COVID-19 pandemic.


Subject(s)
COVID-19 , Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus, Human , Humans , Respiratory Syncytial Virus Infections/epidemiology , COVID-19/epidemiology , Washington/epidemiology , Pandemics , Respiratory Syncytial Virus, Human/genetics , Disease Outbreaks , Genomics
14.
Resources Policy ; 80, 2023.
Article in English | Web of Science | ID: covidwho-2239164

ABSTRACT

This study evaluates the portfolio diversification potential of different classes of assets-equity, cryptocurrency and precious metals-using total, asymmetric and frequency-based spillover transmission framework. The VARbased generalized variance decomposition method is used to analyse the daily prices of S&P 500, bitcoin, gold, silver and platinum between April 2011 through January 2021. The results of aggregate spillover support bitcoin as a potential diversifier due to its isolation from other sets of assets. The decomposition of overall spillover into downside and upside spillover reveals a higher downside connectedness than the upside, suggesting an asymmetric interdependence amongst these markets. Moreover, the frequency based aggregate spillovers suggest the connectedness is driven mostly by the shorter time-horizons. The study provides important policy implications for market participants with distinct investment objectives.

16.
Pakistan Journal of Medical and Health Sciences ; 16(12):330-333, 2022.
Article in English | EMBASE | ID: covidwho-2234606

ABSTRACT

Background: Empathy is one of the most vital parts of medical ethics that is a prerequisite for good clinical practice, yet the level of empathy of the doctors has not been up to the mark. Objective(s): To measure empathy of healthcare professionals during COVID-19 crisis Material(s) and Method(s): This was a cross Sectional Study done in almost all public and private tertiary care hospitals of Peshawar. The study duration was 6 months (10 September 2021-10 Febuary 2022) after the approval of research proposal. The sampling method was non probability convenient sampling. The inclusion criteria were health professionals involved in the care of the COVID 19 patients like pulmonogists, physicians, trainee doctors, nurses and chest physiotherapists. Exclusion criteria were the doctors from other specialties who were not taking in the management of such patients. Empathy scale was used to collect responses of the participants.The data was analyzed using SPSS latest version Results: Significant association was seen between Consultants, Nurses and PGRs with that they were not interested in patient's personal matters as these are not relevant to medical treatment. i.e. p-value <0.001. Significant association was seen between Consultants, Nurses and PGRs they Viewed things from patient' perspectives might confuse me and make me too distracted to take the right clinical decision (cognitive). I.e. p-value=0. 026 Conclusion(s): The level of empathy did get affected to a colossal extent during the COVID-19 pandemic as reflected by the above results. Copyright © 2022 Lahore Medical And Dental College. All rights reserved.

17.
Results in Engineering ; 17, 2023.
Article in English | Scopus | ID: covidwho-2233715

ABSTRACT

Energy consumption prediction has always remained a concern for researchers because of the rapid growth of the human population and customers joining smart grids network for smart home facilities. Recently, the spread of COVID-19 has dramatically increased energy consumption in the residential sector. Hence, it is essential to produce energy per the residential customers' requirements, improve economic efficiency, and reduce production costs. The previously published papers in the literature have considered the overall energy consumption prediction, making it difficult for production companies to produce energy per customers' future demand. Using the proposed study, production companies can accurately have energy per their customers' needs by forecasting future energy consumption demands. Scientists and researchers are trying to minimize energy consumption by applying different optimization and prediction techniques;hence this study proposed a daily, weekly, and monthly energy consumption prediction model using Temporal Fusion Transformer (TFT). This study relies on a TFT model for energy forecasting, which considers both primary and valuable data sources and batch training techniques. The model's performance has been related to the Long Short-Term Memory (LSTM), LSTM interpretable, and Temporal Convolutional Network (TCN) models. The model's performance has remained better than the other algorithms, with mean squared error (MSE), root mean squared error (RMSE), and mean absolute error (MAE) of 4.09, 2.02, and 1.50. Further, the overall symmetric mean absolute percentage error (sMAPE) of LSTM, LSTM interpretable, TCN, and proposed TFT remained at 29.78%, 31.10%, 36.42%, and 26.46%, respectively. The sMAPE of the TFT has proved that the model has performed better than the other deep learning models. © 2023 The Author(s)

19.
Neurology ; 93(23 Supplement 2):S52-S53, 2022.
Article in English | EMBASE | ID: covidwho-2196693

ABSTRACT

Objective To assess adaptive immunity to SARS-CoV-2 in anti-CD20 treated individuals with mRNA vaccination. Background Anti-CD20 therapies attenuate humoral responses to vaccines. However, their effect on T cell responses is less clear. We examined B and T cell responses following COVID-19 vaccination in patients receiving anti-CD20 therapy for multiple sclerosis (MS) and other autoimmune inflammatory neurologic diseases (AINDs, e.g., autoimmune encephalitis, stiff person syndrome, etc.). Design/Methods MS and AIND patients on anti-CD20 therapies were prospectively enrolled for longitudinal analysis of antibody and T cell responses after a 3rd COVID-19 vaccination. Serum antibodies against the receptorbinding domain of the S1 spike protein (RBD-S1 IgG), neutralizing antibodies, and SARS-CoV-2 CD8 T cell responses, using activationinduced markers (AIM) and INF-gamma release assays (EUROIMMUN, Germany), were measured at various time points including prevaccination, post initial vaccination series, and 4 and 12 weeks after 3rd dose. Results Thirty-four MS and AIND participants are enrolled. Results for these patients (mean age 52 years-old, 79% female, 21 Pfizer, 13 Moderna) demonstrated attenuated RBD IgG antibody responses. However, a robust CD8 T cell response was observed, following a two-dose series, compared to non-immunosuppressed, age-matched vaccinated controls or unvaccinated with severe SARS-CoV-2 infection (p = 0.01). T cell response was sustained long-term (>12 weeks post 3rd dose) in all 11 anti-CD20 patients analyzed thus far. Collections are completed for all participants at 12 weeks and analysis to be completed by 05/15/22. Further analysis includes correlation of the INF- gamma release assay compared to RBD-CD8 T cell response detected by AIM assay. Conclusions Results suggest that patients treated with anti-CD20 therapy generate a robust CD8 T cell response to SARS-CoV-2 mRNA after three doses but remain with attenuated humoral immune responses. Our observational study will provide important data to guide vaccine management in patients on or anticipating anti-CD20 therapy.

20.
Circulation Conference: American Heart Association's ; 146(Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2194370

ABSTRACT

Background: The conduct of clinical trials during COVID-19 created challenges to ensuring access to clinical trials, healthy clinical teams, and patients. Innovative methods such as remote patient follow-up and monitoring visits can lead to successful completion of device trials. Objective(s): The INGEVITY+ Active Fixation Pace/Sense Lead Study examined the safety/ efficacy of the INGEVITY+ Lead in a prospective, non-randomized, multicenter, post-approval study. Method(s): Subjects met indications for a pacing device with INGEVITY+ leads implanted in the RA and RV. The primary safety endpoint was the 3-month lead-related complication-free (LRC-free) rate. The primary efficacy endpoint evaluated the 3-month pacing capture threshold with the secondary efficacy endpoint evaluating the other lead-related electrical parameters. Implanter experience was assessed. Telephone visits with LATITUDE remote transmission of lead measurement data and remote monitoring visits were allowed. Result(s): A total of 201 leads were evaluated in 101 subjects, 46.8% female with a mean age of 73.2 years, at 13 centers in the United States. The study took 6.8 months, with a median follow-up of 3.4 months. The 3-month follow-up was completed by 98% of subjects, of which 36% were remote. A total of 98% of monitoring visits were done remotely. The study met all primary and secondary endpoints. The LRC-free rate through 3-months was 98.5% (lower CL 95.4%). Three leads were repositioned and reimplanted;two were RA dislodgements, and one was a RA perforation and hemothorax requiring thoracentesis. The pacing capture threshold was <= 2V in 98.9% of subjects with a mean of 0.77 V at 0.4-ms pulse width, mean pacing impedance of 712 ohms, and a median P-wave amplitude of 4.3 mV, and median R-wave amplitude of 15.9 mV at 3- months. No helix performance issues were reported. The mean turn count for helix extension was 6.7 and retraction was 7.6. More than 85% of physicians rated the lead as 'very good' or higher on all aspects of lead handling. Conclusion(s): The INGEVITY+ Lead was found to be safe and effective with a very favorable implant experience. This study was entirely conducted successfully during COVID-19 with remote follow-up and monitoring visits, and nearly half of the subjects were females.

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