Covid-19 Vaccination Impact on Atrial Arrhythmias - Real-World Evidence from the Certitude Registry

Background: The COVID-19 vaccines were developed unprecedentedly and have proven safe and efficacious in reducing transmissibility and severe infection. The impact of mRNA-based COVID-19 vaccines on atrial arrhythmias (AA) incidence is unknown. Objective(s): To analyze the incidence of AA after COVID-19 vaccination in patients with a cardiac implantable electronic device (CIED). Method(s): BIOTRONIK Home Monitoring data and Medicare claims data from CERTITUDE patients implanted with a CIED between 2010-20 were utilized to identify recipients of one or more doses of the COVID-19 vaccine in 2021. Those who had influenza vaccination in 2020 were also identified in the same cohort as a control. From remote monitoring data, the number of atrial high rate events (AHR) and % burden of AA in the three months post-vaccination was compared to the preceding three months using Wilcoxon signed rank test. Kruskal-Wallis test was used for group difference comparisons. New AF diagnosis was determined from ICD-10 diagnosis codes in Medicare claims. Result(s): First and 2nd doses of COVID vaccine (50% Pfizer, 47% Moderna, and 3% J&J) were administered to 7757 and 6579 individuals with a CIED (age 76.2 (+/-9.0) y, 49% males), respectively. In the same cohort, 4723 (61%) individuals received the influenza vaccine. A statistically significant increase in the number of AHR episodes and % burden of AA was noted in the three months post-vaccination compared to the preceding three months after the 1st and 2nd doses of the COVID-19 vaccine (Figure). No such association was noted following influenza vaccination. In subgroup analysis, AHR episodes increased significantly in age groups >70 and men. Post-vaccination increase in AHR episodes was more significant in those without a pre-vaccination history of AHR episodes (mean increase of AHR 6.9+/-88.4, p<0.001) and was non-significant in those with a preceding history of AHR (p=0.8). Among the 764 patients with no AF diagnosis in claims preceding the first COVID-19 vaccine, 87 (11.4%) developed a new AF diagnosis or AHR event in the first three months post-vaccination. Conclusion(s): We report a small but significant increase in the number of CIED-detected atrial arrhythmias following vaccination for COVID-19 but not influenza, specifically in men and age >70 years. Acknowledging the immense public health benefit of COVID-19 vaccines, our results should prompt increased awareness of evaluating for AF in this high-risk group following vaccination. [Formula presented]Copyright © 2023

Ahead of the Curve - Experience from the Uk's First Dedicated Specialist Crm Clinic for Achd Patients

Background: The population of Adults with Congenital Heart Disease (ACHD) is expanding. A significant number will require Cardiac Rhythm Management (CRM) devices. In current UK practice, these patients are routinely seen in non-specialist CRM clinics and little is published regarding best-practice CRM programming and management in the ACHD population. Objective(s): Our objective was to establish a new model of patient-centred/-specific care delivered by specialist CRM physiologists, supported by an EP consultant (with a special interest in ACHD) in a dedicated clinic. We hoped to set new standards of care and patient experience, and improve efficiency and outcomes. Method(s): Data was collected from the electronic record system and CRM device database. A control group of non-ACHD patients was selected at random at our institution over the same period (2018-2022). Result(s): The clinic population n = 468 had a sex ratio of 0.92 (M:F) and mean age of 44 years (range 16 - 86). Mean time since primary implant was 9 years. All device types were represented: loop recorder (52), pacemaker (262), cardioverter defibrillator (116) and cardiac resynchronisation therapy devices (38). The underlying ACHD condition was: simple 46%, moderate 28% and complex 26%. Outcomes of appointments (n = 1,234) are shown vs controls (n = 126) (figure 1). Appointment and patient numbers rose year-on-year (100 to 226 patients, 281 to 367 appointments). There was a lower incidence of 'no review / reprogramming ' in ACHD CRM clinic appointments compared to the non-ACHD population, as well as a higher incidence of programming changes, however the trend over time within the ACHD group showed an increase in 'no review / reprogramming' and a decrease in reviews / reprogramming events. In contrast, non-ACHD patients had an increase in medical reviews and reprogramming required between 2018/19 and 2021/22. This is likely due to the COVID pandemic and deferred time to appointments and review. Conclusion(s): Our data demonstrate that the ACHD CRM population require additional input from the medical and scientist teams when compared to non-ACHD patients, however over time there has been a reduction in major programming/review and a commensurate increase in minor programming/discussion and no review. A reverse trend was observed in the non-ACHD patients pre- and post- COVID. These data support the proposal that specialised clinics provide the optimal management ACHD CRM clinics and should be delivered by dedicated practitioners. [Formula presented]Copyright © 2023

Demonstration of Remote Control of Critical Care Ventilators and the Integrated Clinical Environment

Introduction: The COVID-19 pandemic posed numerous challenges to patient care, including extensive PPE use, patient care in isolation rooms, inadequate numbers of intensivists particularly in rural communities, use of unfamiliar ventilators that would be partially remedied by the ability to remotely control lung ventilation. The goals of the project were to study the intended use, risk management, usability, cybersecurity for remote control of ventilators and demonstrate the use of a single interface for several different ventilators. Method(s): Clinical scenarios were developed including remote control of the ventilator from an antechamber of an isolation room, nursing station within the same ICU, and remote control from across the country. A risk analysis and was performed and a risk management plan established using the AAMI Consensus Report--Emergency Use Guidance for Remote Control of Medical Devices. A cybersecurity plan is in progress. Testing was done at the MDPNP laboratory. We worked with Nihon Kohden OrangeMed NKV-550, Santa Ana, CA, and Thornhill Medical MOVES SLC, Toronto, Canada. Both companies modified their devices to allow remote control by and application operating on DocBox's Apiary platform. Apiary is a commercially available ICE solution, DocBox Inc, Waltham, MA. An expert panel was created to provide guidance on the design of a single common, simple to use graphical user interface (GUI) for both ventilators. Manufacturers' ventilation modes were mapped to ISO 19223 vocabulary, data was logged using ISO/IEEE 11073-10101 terminology using AAMI 2700-2-1, Medical Devices and Medical Systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Requirements for forensic data logging. Result(s): We demonstrated that both ventilators can be controlled and monitored using common user interface within an institution and across the country. Pressure and flow waveforms were available for the NKV-550 ventilator, and usual ventilator measurements were displayed in near-real time. The interface allowed changing FiO2, ventilation mode, respiratory rate, tidal volume, inspiratory pressure, and alarm settings. At times, increased network latency negatively affected the transmission of waveforms. Conclusion(s): We were able to demonstrate remote control of 2 ventilators with a common user interface. Further work needs to be done on cybersecurity, effects of network perturbations, safety of ventilator remote control, usability implications of having a common UI for different devices needs to be investigated.

Quality Management Platform Inspired during Covid-19 Pandemic for Use by Subcontractors in Private Housing Projects

Due to the COVID-19 pandemic in Taiwan, many construction sites must limit the number of people on the jobsite or conduct work independently to avoid the spread of COVID-19. The quality of construction may be in doubt with unclear job handover, especially when workers have COVID-19 infection that should be isolated immediately. On top of that, first-level subcontractor self-inspections are crucial parts of construction process management, and neglecting inspec-tion processes can lead to construction errors and poor quality. To improve current quality inspection methods for private projects, a literature analysis was conducted to identify construction quality management issues that are faced in private housing projects. In-depth interviews with small and medium-sized subcontractors of private housing projects were per-formed to understand the quality management methods that they use in practice. Next, improvement measures for quality management were formulated and a simplified checklist for private project subcontractors, based on the practical feedback obtained, was created. Finally, the AppSheet platform was used to develop an inspection application for construction, and a subcontractor was invited to confirm its feasibility. The paperless design avoids redundant human contact, and the re-sults of this study greatly facilitate construction practice, particularly during the pandemic. The main contribution of this study is its investigation of the procedures that are used by private project subcontractors to inspect their work for quality management;its results can serve as a reference for academics in evaluating construction quality management levels and improving the management of work by subcontractors to promote safety and health.

Therapeutic Plasma Exchange in Adult Patients with COVID-19 and Severe Pneumonia: Single Center Experience of Eighty Patients

Aim: Therapeutic plasma exchange (TPE) is a frequently discussed treatment modality in severe coronavirus disease 2019 (COVID-19) patients. It requires an apheresis device and experienced personnel for the application. In this study, we aimed to reveal the characteristics and clinical outcomes of adult patients with COVID-19 who experienced TPE. Material(s) and Method(s): Adult patients who had undergone TPE in our apheresis unit were retrospectively analyzed and COVID-19-positive cases were included in the study. All the medical information about the cases was obtained from the electronic database and technical details of the procedures were gathered from apheresis unit records. Result(s): A total of 80 patients with a median age of 60 (19-85) years were included in the study. Severe pneumonia was present in 98.8% (n=79) of the cases. More than three-quarters of the patients had lymphopenia, critically elevated C-reactive protein (CRP), and D-dimer, and 41.0% (n=32) had high ferritin. The median length of stay in the intensive care unit was 26 (5-124) days. The mortality rate observed on the 14th and 28th days following the TPE procedure was 51.3% (n=41) and 75.0% (n=60), respectively. High ferritin level, multiple organ failure (MOF), and intubation were parameters found to be associated with mortality in the multivariate analysis. Conclusion(s): The mortality rate observed in patients with COVID-19 who underwent TPE in our study was similar to the cases in the literature without the procedure, while it has been shown that high ferritin levels, intubation, and the presence of MOF increase the risk of mortality.Copyright © 2023, Duzce University Medical School. All rights reserved.

Acute care treatment of COVID-19 pneumonia with acute respiratory failure

Treatment of COVID-19 patients and their extreme numbers represented an unprecedented challenge for the intensive care system in healthcare facilities throughout the Czech Republic, a country particularly affected by the new coronavirus SARS-CoV-2 pandemic. A steep increase in the need for intensive care placed an excess burden on bed and staff capacity. For a severe and critical course of COVID-19, bilateral pneumonia with acute hypoxemic respiratory failure is pathognomonic. In the intensive care setting, COVID-19 therapy is primarily symptomatic, supporting failing respiratory function to gain time needed to restore it and to repair the lungs. The aggressiveness and comprehensiveness of respiratory support depend on the severity of failure, ranging from simple oxygen therapy, to non-invasive support and mechanical ventilation, to extracorporeal support. By contrast, specific COVID-19 therapy is directly targeted against SARS-CoV-2 or modulates the organism's response to the virus. Primary, virus-induced lung injury may be secondarily complicated by coinfection or superinfection, most commonly bacterial, increasing the severity and lethality of the disease. Therefore, anti-infective therapy is crucial for the prognosis and outlook of intensive care COVID-19 patients. Among nosocomial infections com-plicating COVID-19, ventilator-associated pneumonia (developing in mechanically ventilated patients) is particularly important and challenging, and so are issues related to bacterial resistance and rational antibiotic therapy.Copyright © 2021, Trios spol. s.r.o.. All rights reserved.

The effect of etiotropic therapy on the formation of immune disorders in patients with COVID-19

The course of a new coronavirus infection is associated with immune system disorders during the acute stage of the desease. Administration of effective etiotropic drugs contributes to early elimination of the virus. At the same time, risks of post-COVID immune system disorders are minimized. The aim of the study was to investigate features of the immune response formation against the background of etiotropic therapy in patients who underwent COVID-19. Material and methods. An observational retrospective comparative study was conducted. The study involved patients with COVID-19 3 months after treatment with etiotropic drugs (riamilovir or umifenovir). The study involved 87 patients (52 women and 35 men) with varying degrees of COVID-19 severity. In accordance with the study design, participants were divided into 2 groups: the first group - 41 patients (received riamilovir during the acute period of the disease);the second group - 46 patients (received umifenovir in the acute period of the disease). Statistical processing of the results was carried out using the Statistica 8.0 software package. Extensive indicators, median (Me) and interquarter range Q25-Q75 were calculated. Statistical significance between the indicators of independent samples was assessed by Mann-Whitney nonparametric test and Chi-square test. P-values below 0.05 were considered statistically significant. Results and discussion. Analysis of clinical and laboratory data showed that after suffering COVID-19, not all indicators of the immune system in patients who had had COVID-19 recovered to control values. However, it is noted that in patients of the main group, which using riamilovir, compared to the comparison group was less likely to be diagnosed with chronic systemic syndrome, inflammation, dysregulation of the cellular link of immunity in the early post-COVID period.Copyright © Eco-Vector, 2022.

Life Cycle Assessment of Nanofibrous Air Filtering Materials and Respirators

The current spread of COVID-19 pandemics resulted in a surge of a need of respiratory protection devices, including medical facemasks and facepiece respirators. Large amounts of products based on nonwoven filtration material from non-renewable petroleum based plastics (polyethylene) has raised global concerns about excessive environmental impacts of these products. Unfortunately, the replacement of polypropylene nonwoven microfibre based single use masks by the multiple use products did not appear as an effective strategy due to a lower filtration performance, although potentially lower environmental impacts. Nanofibre based filtration devices introduce themselves as potentially more environmentally friendly ones due to a lower overall usage of raw polymer compared to microfibrous ones. We present the LCA modelling of environmental impacts of respiratory protective devices with nanofibrous filter materials and compare those against traditional micro fibrous materials (FFP1 and FFP2 respirator) and medical facemask. Generally, due to a lower mass of nanofibre, these products emerge as a better environmental option, providing similar protection level. © 2022 17th International Conference on Indoor Air Quality and Climate, INDOOR AIR 2022. All rights reserved.

"Cardioxy" - A Novel and Portable Instrumentation Amplifier based and IoT enabled ECG device

During the COVID-19 pandemic the healthcare facilities all over world collapsed due to shortage of essential biomedical devices. ECG devices are one of those crucial instruments required for tracing electrical activities of heart. Due to the high cost of gold standard ECG devices used in the medical industries, the availability of on-demand ECG devices was not accessible to everyone. Thus, the need of portable, low cost, on-demand ECG device was needful at the earliest. In this paper we propose a novel, versatile, 3-lead, IoT enabled, LM324/LM741 operational amplifiers in instrumentation amplifier configuration Electrocardiogram machine that is aimed towards providing accurate information about the electrical activity of our heart in real time. In this attempt, we have come up with an analogue circuit design consisting of multiple operational amplifier IC based fundamental circuit blocks. The prototype is designed in such a way that the output of ECG can be visualised worldwide using IoT. © 2023 IEEE.

Intelligent medicine and beyond

With the developments of medical artificial intelligence (AI), meta-data analysis, intelligence-aided drug design and discovery, surgical robots and image-navigated precision treatments, intelligent medicine (IM) as a new era evolved from ancient medicine and biomedical medicine, has become an emerging topic and important criteria for clinical applications. It is fully characterized by fundamental research-driven, new-generation technique-directed as well as state-of-the-art paradigms for advanced disease diagnosis and therapy leading to an even broader future of modern medicine. As a fundamental subject and also a practice-oriented field, intelligent medicine is highly trans-disciplinary and cross-developed, which has emerged the knowledge of modern medicine, basic sciences and engineering. Basically, intelligent medicine has three domains of intelligent biomaterials, intelligent devices and intelligent techniques. Intelligent biomaterials derive from traditional biomedical materials, and currently are endowed with multiple functionalities for medical uses. For example, micro-/nanorobots, smart responsive biomaterials and digital drugs are representative intelligent biomaterials which have been already commercialized and applied to clinical uses. Intelligent devices, such as surgical robots, rehabilitation robots and medical powered exoskeleton, are an important majority in the family of intelligent medicine. Intelligent biomaterials and intelligent devices are more and more closely integrated with each other especially on the occasions of intelligence acquisition, remote transmission, AI-aided analysis and management. In comparison, intelligent techniques are internalized in the former two domains and are playing a critical role in the development of intelligent medicine. Representative intelligent techniques of telemedicine, image-navigated surgery, virtual/augmented reality and AI-assisted image analysis for early-stage disease assessments have been employed in nowadays clinical operations which to a large extent relieved medical labors. In the past decades, China has been in the leading groups compared to international colleagues in the arena of intelligent medicine, and a series of eminent research has been clinically translated for practical uses in China. For instance, the first 5G-aided remote surgery has been realized in Fujian Province in January 2019, which for the first time validated their applicability for human uses. The surgical robots have found China as the most vigorous market, and more than 10 famous Chinese companies are developing versatile surgical robots for both Chinese people and people all over the world. China also applied AI techniques to new drug developments especially in early 2020 when COVID-19 epidemic roared, and several active molecules and drug motifs have been discovered for early-stage COVID-19 screening and treatments. Based on the significance of intelligent medicine and its rapid developments in both basic research and industrials, this review summarized the comprehensive viewpoints of the Y6 Xiangshan Science Conferences titled with Fundamental Principles and Key Technologies of Intelligent Medicine, and gave an in-depth discussion on main perspectives of future developments of the integration of biomaterial and devices, the integration of bioinformatics and medical hardware, and the synergy of biotechnology and intelligence information. It is expected that this featuring article will further promote intelligent medicine to an even broader community not only for scientists but also for industrials, and in the long run embrace a perspective future for its blooming and rich contributions in China in the coming 5 years.

Use of Novel Oxygenated Right Ventricular Assist Device Hybrid ECLS for Adolescents with Refractory Hypoxemic Respiratory Failure due to Covid-19 Pneumonia

Objective: To describe institutional experience using Oxygenated Right Ventricular Assist Device Oxy-RVAD) Hybrid ECLS for adolescents with respiratory failure due to SARS-CoV-2 pneumonia. Method(s): Between September and December 2021, 44 Covid-19+ patients were admitted to our regional Pediatric Intensive Care Unit (PICU) including 4 adolescents who required Extracorporeal life support (ECLS) due to refractory hypoxemia. Two patients were initially cannulated onto Veno-Venous (VV) ECLS and converted to Oxy-RVAD ECLS due to refractory hypoxemia;the others were cannulated directly onto Oxy-RVAD ECLS. Two patients had observed right ventricular dysfunction (RV) or failure on echocardiography. Cannulations were performed in the cardiac catheterization suite by an interventional cardiologist using percutaneous technique under fluoroscopy. Circuit construction was varied and included the use of a dedicated RVAD cannula or standard cannula used for VA/VV ECLS. All patients were connected to CardiohelpTM systems with built-in centrifugal pumps and oxygenators. Result(s): Two patients were initially placed on VV-ECLS and converted to Oxy-RVAD ECLS days into their course due to severe, refractory hypoxemia with one having improvement in hypoxemia after the conversion. Two patients were cannulated directly to Oxy-RVAD ECLS support. Two patients received renal replacement therapy (RRT) without complications, the others did not have indications for renal support. Two patients underwent tracheostomy on ECMO though none were able to separate from mechanical ventilation. Three patients survived to discharge. No incidents of circuit air or clotting were noted. The patient with the longest ECLS run required one circuit change and was the only patient to develop a superinfection: a successfully-treated fungal infection. All patients were mobilized on ECLS to sitting in a chair;one was able to ambulate. Conclusion(s): Oxy-RVAD hybrid ECLS can be used to effectively support adolescents with severe respiratory disease from conditions associated with RV dysfunction. Pediatric providers can collaborate with adult-focused colleagues to use novel methods to support these patients. RRT can also be used with this circuit. While more experience and data on this modality is needed, Oxy-RVAD ECLS should be considered in patients with severe RV dysfunction and associated refractory hypoxemia.

A Case Series of Kodamaea Ohmeri Infection: The Hidden Threat Unleashed

Intro: Kodamaea ohmeri, previously known as Pichia ohmeri, is an ascomycetous yeast that has emerged as an important cause of fungemia in immunocompromised patients. During the anamorphic stage this organism is also known as Candida guillermondii var. membranaefaciens. Method(s): We report five cases of Kodamaea ohmeri encountered from multicenter in Malaysia. Antifungal agent of choice will be discussed based on literature review. Finding(s): The cases were: (1) a contaminated peritoneal fluid in an adult patient on peritoneal dialysis;(2) a 60-year-old man with infected diabetic foot isolated K. ohmeri from a bone sample. Both cases discharged well without active antifungal fungal therapy. We observed fatality cases involving (3) an old man with underlying gastric adenocarcinoma who complicated with catheter- related bloodstream infection caused by K. ohmeri;(4) a patient with ventilator- associated pneumonia and septicaemic shock secondary to perforated terminal ileum;(5) and a severely ill COVID-19 stage 5b patient who passed away due to systemic fungaemia caused by K. ohmeri. Discussion(s): All three fatal cases received either amphotericin B or caspofungin as active antifungal agent. Literature evidence has shown that 40% of patient met demise despite on active antifungal agent, suggesting that currently no definitive antifungal agent proven to be a superior treatment option for K. ohmeri infection. Removal of indwelling medical device combined with antifungal therapy has favorable clinical outcome. Conclusion(s): Therefore, K. ohmeri infection in severely ill patients should be considered as a critical condition. Potential of alternative antifungal combinations need to be explored for an effective treatment option.Copyright © 2023

A Medical Device Information Data Sheet (MDIDS) to Support the Interoperability of Externally Controllable Infusion Pumps for Tele-Critical Care1

Problem and Motivation. Medical device remote control technologies can enable remote experts to contribute to patient care during tele-critical care during public health emergencies like COVID-19 to address the shortage of local clinical expertise. The benefit of such technologies may be further amplified if one remote-control application can operate multiple interoperable medical devices (e.g. multiple types of ventilators or IV pumps) to support the typical diversity of deployed medical devices in one institution. However, due to the variation in capabilities of different makes/models of the same device type, this unified remote control capability requires the standardization of the data interfaces of similar devices to provide sufficient information about these devices to enable safe remote control. Method(s): Medical Device Interface Data Sheets (MDIDS) [1] can provide a useful tool for documenting current and future device interface requirements and capabilities. We examined several clinical use scenarios where externally controllable infusion pumps are used to support tele-critical care, based on which we generalized an MDIDS for remotely controllable infusion pumps. To validate this generic MDIDS, we cross-checked it with the capabilities of several externally controllable infusion pumps: the NeuroWave Accupump, Eitan Medical Sapphire, and the BD Alaris GH. Result(s): During the development of the generic remotely controllerable infusion pump MDIDS, we were able to identify the common and specific data elements that different infusion pumps need to provide at their data interfaces, considering the great diversity in these devices related to infusion mechanism, infusion programming methods, device alarms and alerts, and system settings. The resulting MDIDS includes over 100 data elements, many of which are essential for safety, including those common across different pump types (e.g., maximum settable infusion rate, occlusion alarm) and those specific to certain pump types (e.g., syringe size for syringe pumps). We developed the generic MDIDS as the theoretical basis and developed an application in our OpenICE open-source interoperability research platform [2] to remotely control the above three infusion pumps either via serial communication (representing controlling the infusion pump at a distance limited by a physical wired connection inside or outside the patient room) or across the Internet using the web extension service of OpenICE (representing situations where remote experts have no physical access to the patient). Conclusion. MDIDS for externally controllable medical devices can provide a solid basis to improve the safety and interoperability of medical device remote control technologies in the tele-critical care context. They can also benefit the research, development, and testing of physiological closed-loop control systems. We applied the MDIDS methodology to infusion pumps and ventilators to support the integration of these devices to the U.S. Army Telemedicine & Advanced Technology Research Center (TATRC) National Emergency Tele-Critical Care System.

Prevalence of impaired upper extremity neural mobility among smart device users during the COVID-19 pandemic.

BACKGROUND: Both the development of various countries and people's health were impacted by the unforeseen global COVID-19 outbreak. Many countries prefer to do their daily business online. Although it was incredibly useful at the time, it still had a problem that was not properly addressed, especially among the student population. OBJECTIVE: The objective of this study was to examine the prevalence of upper extremity neural mobility among students who were using smart devices during the COVID-19 pandemic. METHODS: 458 students who had previously taken home-based online classes during the COVID-19 pandemic and used a smart device for more than six hours were included in this study. The study was conducted in three phases. After being examined in the first two stages of the study, a total of 72 people were chosen for the final phase. Peripheral nerve mobility tests were performed on these 72 subjects. RESULTS: This study observed that 15.72% of smart device users have been affected by forward neck posture and impaired peripheral nerve mobility in the cervical spine. CONCLUSION: The study concludes that forward neck posture is associated with impaired peripheral nerve mobility among smart device users who were in home-based online classes during the COVID-19 pandemic lockdown. Hence, we suggest an appropriate treatment strategy focusing on preventing the forward neck posture through timely analysis and self-care therapies.

Severe COVID-19 Myocarditis in a Young Unvaccinated Patient.

Coronavirus disease 2019 (COVID-19) myocarditis is a rare but serious complication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and has been associated with high-case fatality. For a very long time, since the beginning of the pandemic, there were no definitive guidelines to diagnose and manage this condition, probably secondary to the gaps in understanding the exact pathophysiology of the disease. We present the case of a young, unvaccinated female, with no comorbidities, who had an aggressively progressive COVID-19 myocarditis that was fatal. The patient presented with exertional dyspnea of two days duration and was found to be tachycardic with a heart rate ranging between 130-150 beats per minute. A nasopharyngeal swab for SARS CoV-2 was positive and a bedside echocardiogram showed a low ejection fraction of 20%. Within hours of presenting, she experienced a rapid decompensation requiring intubation. Due to fulminant myocarditis with cardiogenic shock, the patient was planned for cardiac catheterization, Impella placement, and extracorporeal membrane oxygenation (ECMO) support. The cardiac catheterization revealed non-obstructive coronary arteries and the hemodynamics suggested biventricular failure. However, around the time of the cardiac catheterization procedure, she had two events of cardiac arrest with pulseless electrical activity and unfortunately could not be revived after the second arrest despite all resuscitative efforts.

Gait Device Treatment Using Telehealth for Individuals With Stroke During the COVID-19 Pandemic: Nonrandomized Pilot Feasibility Study.

BACKGROUND: During the COVID-19 pandemic, rehabilitation providers and consumers adopted telehealth practices at unprecedented rates. Multiple prepandemic studies demonstrate the feasibility and comparable efficacy between in-clinic and remote treatment for certain impairments caused by stroke, such as upper extremity weakness and impaired motor function. However, less guidance has been available regarding gait assessment and treatment. Despite this limitation, safe and effective gait treatment is fundamental to optimizing health and well-being after stroke and should be considered a treatment priority, including during the COVID-19 pandemic. OBJECTIVE: This study explores the feasibility of using telehealth to deliver gait treatment using a wearable gait device, the iStride device, to stroke survivors during the 2020 pandemic. The gait device is used to treat hemiparetic gait impairments caused by stroke. The device alters the user's gait mechanics and creates a subtle destabilization of the nonparetic limb; therefore, supervision is required during its usage. Before the pandemic, treatment with the gait device had been provided in person to appropriate candidates using a combination of physical therapists and trained personnel. However, upon the emergence of the COVID-19 pandemic, in-person treatment was halted in adherence to pandemic guidelines. This study investigates the feasibility of 2 remote delivery treatment models with the gait device for stroke survivors. METHODS: Participants were recruited during the first half of 2020 after the onset of the pandemic and included 5 individuals with chronic stroke (mean age 72 years; 84 months post stroke). Four participants were previous gait device users who transitioned to the telehealth delivery model to continue their gait treatment remotely. The fifth participant performed all study-related activities, from recruitment through follow-up, remotely. The protocol included virtual training for the at-home care partner, followed by 3 months of remote treatment with the gait device. Participants were instructed to wear gait sensors during all treatment activities. To assess feasibility, we monitored the safety of the remote treatment, compliance with protocol activities, acceptability of the telehealth treatment delivery, and preliminary efficacy of the gait treatment. Functional improvement was measured using the 10-Meter Walk Test, the Timed Up and Go Test, and the 6-Minute Walk Test, and quality of life was assessed using the Stroke-Specific Quality of Life Scale. RESULTS: No serious adverse events occurred, and participants rated high acceptance of the telehealth delivery. Protocol compliance averaged 95% of treatment sessions, 100% of assessments, and 85% of sensor usage during treatment. After 3 months of treatment, the average improvement in each functional outcome exceeded the minimal clinically important difference or minimal detectable change value. CONCLUSIONS: Remote treatment delivery with the gait device appeared feasible with care partner support. Gait treatment using telehealth may be useful to offset negative immobility impacts for those requiring or preferring remote care during the pandemic or otherwise. TRIAL REGISTRATION: ClinicalTrials.gov NCT04434313; https://clinicaltrials.gov/ct2/show/NCT04434313.