Extension of Tablo TrEatmeNt Duration (XTEND) study: successful 24 h prolonged therapy with Tablo in critical patients.

BACKGROUND: The Tablo® Hemodialysis System (Tablo) is an all in one, easy-to-learn device featuring integrated water purification, on demand dialysate production and two-way wireless data transmission and is approved for use in the acute, chronic, and home settings. Prior reports have demonstrated Tablo's ability to achieve clinical goals, seamlessly integrate into hospitals and reduce cost across a wide range of treatment times. Extension of the Tablo cartridge to 24 h allows prolonged therapy and even greater flexibility for prescribers in the acute setting. The objective is to report on the first ever experience with Tablo prolonged therapy between 12 and 24 h in critically ill patients treated at a single-center ICU. METHODS: Nursing staff were trained during a single training session on Tablo prolonged therapy. After a run-in period of five treatments, Tablo data were collected via real-time transmission to a cloud-based, HIPAA compliant platform and reviewed by site staff. Dialysis treatment delivery, clinically significant alarms, and clotting events were recorded. Sub-group analysis between COVID-19 positive and negative patients were reported. RESULTS: One hundred (100) consecutive Tablo prolonged treatments had a median prescribed treatment time of 24 h and a median achieved treatment time of 21.3 h. Median cartridge usage was 1.3 per treatment. The dialysis treatment time was delivered in 91% of treatments, with 6% ending early due to an alarm, and 3% ending due to clotting. Clinically significant alarms occurred at a median rate of 0.5 per treatment hour with a resolution time of 18 s. Median blood pump stoppage time related to these alarms was 2.3 min per treatment. Blood pump stoppage time was higher in the COVID-19 subgroup when compared to the non-COVID-19 subgroup. CONCLUSION: Tablo successfully achieves prescribed treatment time with minimal therapy interruptions from alarms or cartridge changes. This data demonstrates the effectiveness of Tablo in achieving personalization of treatments necessary for unstable patients and enabling successful delivery of extended therapy with minimal clotting. Tablo's prolonged therapy meets the needs of critically patients, including COVID-19 positive patients, requiring renal replacement therapy for greater than 12 h.

Prevention of Venous Thromboembolism in Acutely Ill Medical Patients: A New Era.

Venous thromboembolism (VTE) is the leading preventable cause of death in hospitalized patients and data consistently show that acutely ill medical patients remain at increased risk for VTE-related morbidity and mortality in the post-hospital discharge period. Prescribing extended thromboprophylaxis for up to 45 days following an acute hospitalization in key patient subgroups that include more than one-quarter of hospitalized medically-ill patients represents a paradigm shift in the way hospital-based physicians think about VTE prevention. Advances in the field of primary thromboprophylaxis in acutely-ill medical patients using validated VTE and bleeding risk assessment models have established key patient subgroups at high risk of VTE and low risk of bleeding that may benefit from both in-hospital and extended thromboprophylaxis. The direct oral anticoagulants betrixaban and rivaroxaban are now U.S. Food and Drug Administration-approved for in-hospital and extended thromboprophylaxis in medically ill patients and provide net clinical benefit in these key subgroups. Coronavirus disease-2019 may predispose patients to VTE due to excessive inflammation, platelet activation, endothelial dysfunction, and hemostasis. The optimum preventive strategy for these patients requires further investigation. This article aims to review the latest concepts in predicting and preventing VTE and discuss the new era of extended thromboprophylaxis in hospitalized medically ill patients.

Long-Term Acute Care Hospitals Extend ICU Capacity for COVID-19 Response and Recovery.

The COVID-19 pandemic has presented novel challenges for the entire health-care continuum, requiring transformative changes to hospital and post-acute care, including clinical, administrative, and physical modifications to current standards of operations. Innovative use and adaptation of long-term acute care hospitals (LTACHs) can safely and effectively care for patients during the ongoing COVID-19 pandemic. A framework for the rapid changes, including increasing collaboration with external health-care organizations, creating new methods for enhanced communication, and modifying processes focused on patient safety and clinical outcomes, is described for a network of 94 LTACHs. When managed and modified correctly, LTACHs can play a vital role in managing the national health-care pandemic crisis.

Endotracheal Tube Obstruction Among Patients Mechanically Ventilated for ARDS Due to COVID-19: A Case Series.

BACKGROUND: Patients with COVID-19 and ARDS on prolonged mechanical ventilation are at risk for developing endotracheal tube (ETT) obstruction that has not been previously described in patients with ARDS due to other causes. The purpose of this report is to describe a case series of patients with COVID-19 and ARDS in which ETT occlusion resulted in significant clinical consequences and to define the pathology of the obstructing material. METHODS: Incidents of ETT occlusion during mechanical ventilation of COVID-19 patients were reported by clinicians and retrospective chart review was conducted. Statistical analysis was performed comparing event rates between COVID-19 and non-COVID 19 patients on mechanical ventilation over the predefined period. Specimens were collected and submitted for pathological examination. FINDINGS: Eleven COVID-19 patients experienced endotracheal tube occlusion over a period of 2 months. Average age was 69 (14.3, range 33-85) years. Mean APACHE III score was 73.6 (17.3). All patients had AKI and cytokine storm. Nine exhibited biomarkers for hypercoagulability. Average days on mechanical ventilation before intervention for ETT occlusion was 14 (5.18) days (range of 9 to 23 days). Five patients were discharged from the ICU, and 4 expired. Average documented airway resistance on admission was 14.2 (3.0) cm H2O/L/sec. Airway resistance before tube exchange was 28.1 (8.0) cm H2O /L/sec. No similar events of endotracheal tube occlusion were identified in non-COVID patients on mechanical ventilation during the same time period. Microscopically, the material consisted of mucin admixed with necrotic cell debris, variable numbers of degenerated inflammatory cells, oral contaminants and red blood cells. INTERPRETATION: Patients with COVID-19 and ARDS on prolonged mechanical ventilation are at risk for developing ETT obstruction due to deposition of a thick, tenacious material within the tube that consists primarily of mucin and cellular debris. Clinicians should be aware of this dangerous but treatable complication.

Selecting appropriate endpoints for assessing treatment effects in comparative clinical studies for COVID-19.

To evaluate the efficacy and safety of a new treatment for COVID-19 vs. standard care, certain key endpoints are related to the duration of a specific event, such as hospitalization, ICU stay, or receipt of supplemental oxygen. However, since patients may die in the hospital during study follow-up, using, for example, the duration of hospitalization to assess treatment efficacy can be misleading. If the treatment tends to prolong patients' survival compared with standard care, patients in the new treatment group may spend more time in hospital. This can lead to a "survival bias" issue, where a treatment that is effective for preventing death appears to prolong an undesirable outcome. On the other hand, by using hospital-free survival time as the endpoint, we can circumvent the survival bias issue. In this article, we use reconstructed data from a recent, large clinical trial for COVID-19 to illustrate the advantages of this approach. For the analysis of ICU stay or oxygen usage, where the initiating event is potentially an outcome of treatment, standard survival analysis techniques may not be appropriate. We also discuss issues with analyzing the durations of such events.

Anti-inflammatory therapies for pericardial diseases in the COVID-19 pandemic: safety and potentiality.

: The COVID-19 pandemic is challenging our cardiovascular care of patients with heart diseases. In the setting of pericardial diseases, there are two possible different scenarios to consider: the patient being treated for pericarditis who subsequently becomes infected with SARS-CoV-2, and the patient with COVID-19 who develops pericarditis or pericardial effusion. In both conditions, clinicians may be doubtful regarding the safety of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, colchicine, and biological agents, such as anti-IL1 agents (e.g. anakinra), that are the mainstay of therapy for pericarditis.For NSAIDs, there is no clear scientific evidence linking ibuprofen and other NSAIDs to worsening of COVID-19; however, it seems prudent to continue them, if necessary to control pericarditis, and on the other hand, to prefer paracetamol for fever and systemic symptoms related to COVID-19. Treatments with corticosteroids, colchicine, and anakinra appear well tolerated in the context of COVID-19 infection and are currently actively evaluated as potential therapeutic options for COVID infection at different stages of the disease. On this basis, currently most treatments for pericarditis do not appear contraindicated also in the presence of possible COVID-19 infection and should not be discontinued, and some (corticosteroids, colchicine, and anakinra) can be considered to treat both conditions.