Race affects adverse outcomes of deep vein thrombosis, pulmonary embolism, and acute kidney injury in coronavirus disease 2019 hospitalized patients.

OBJECTIVE: The purpose of the present study was to explore the racial disparities in the incidence of deep vein thrombosis (DVT), pulmonary embolism (PE), and acute kidney injury (AKI) in hospitalized patients with coronavirus disease 2019 (COVID-19). METHODS: A retrospective analysis was performed of prospectively collected data of consecutive COVID-19 patients hospitalized from March 11, 2020 to May 27, 2021. The primary outcome measures were the incidence of DVT/PE and mortality. The secondary outcome measures included differences in the length of hospitalization, need for intensive care unit care, readmission, and AKI. Multivariable regression models were used to assess for independent predictors of the primary and secondary outcome measures. RESULTS: The present study included 876 hospitalized patients with COVID-19. The mean age was 64.4 ± 16.2 years, and 355 were women (40.5%). Of the 876 patients, 694 (79.2%) had identified as White, 111 (12.7%) as Black/African American, 48 (5.5%) as Asian, and 23 (2.6%) as other. The overall incidence of DVT/PE was 8.7%. The DVT/PE incidence rates differed across the race groups and was highest for Black/African American patients (n = 18; 16.2%), followed by Asian patients (n = 5; 10.4%), White patients (n = 52; 7.5%), and other (n = 1; 4.4%; P = .03). All but one of the hospitalization outcomes examined demonstrated no differences according to race, including the hospitalization stay (P = .33), need for intensive care unit care (P = .20), readmission rates (P = .52), and hospital all-cause mortality (P = .29). The AKI incidence differed among races, affecting a higher proportion of Black/African American patients (P=.003). On multivariable regression analysis, Black/African American race (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.0-4.0; P = .04) and higher D-dimer levels (OR, 1.1; 95% CI, 1.1-1.2; P < .0001) were predictors of DVT/PE. In addition, Black/African American race (OR, 2.3; 95% CI, 1.4-3.7; P = .001), lower hemoglobin levels (OR, 0.84; 95% CI, 0.8-0.9; P ≤ .0001), male sex (OR, 1.7; 95% CI, 1.2-2.4; P = .005), hypertension (OR, 2.1; 95% CI, 1.4-3.1; P = .0005), and older age (OR, 1.02; 95% CI, 1.006-1.03; P = .003) were predictors of AKI. CONCLUSIONS: In our single-center case series, we found a higher incidence of DVT/PE and AKI among Black/African American patients with COVID-19. Black/African American race and D-dimer levels were independent predictors of DVT/PE, and Black/African American race, hemoglobin, and D-dimer levels were independent predictors of AKI.

Simulation Method for Testing Aerosol Mitigation Strategies: An Observational Study.

BACKGROUND: Frontline health care workers who perform potentially aerosol-generating procedures, such as endotracheal intubations, in patients with coronavirus disease 2019 may be at an increased risk of exposure to severe acute respiratory syndrome coronavirus 2. To continue to care for patients with coronavirus disease 2019, minimizing exposure is paramount. Using simulation, we devised a testing method to evaluate devices that may mitigate the spread of aerosol and droplet-sized particles. METHODS: In this prospective single-center study, participants intubated a manikin 3 times using standard personal protective equipment, once with no barrier device, once with an acrylic box, and once with a modified horizontal drape. The micrometer-sized particle count, generated by a nebulization model, was recorded before and after each intubation. The first-pass intubation rate and time to intubation were recorded. Each operator completed a postsimulation survey about their experience using the barrier devices. RESULTS: Thirty airway proceduralists completed the simulation and survey. There was no significant difference in particle counts (aerosols or droplets) or first-pass intubation, but the horizontal drape was found to significantly increase intubation time (P = 0.01). Most participants preferred the drape over the acrylic box or no barrier device. CONCLUSIONS: The acrylic box and plastic drape did not mitigate particle spread. However, our testing method can be used to test barrier designs using negative pressure or other mitigation strategies for particle spread.

A Multisite Assessment of Inpatient Safety Event Rates During the Coronavirus Disease 2019 Pandemic.

To date, there has been a notable lack of peer-reviewed or publicly available data documenting rates of hospital quality outcomes and patient safety events during the coronavirus disease 2019 pandemic era. The dearth of evidence is perhaps related to the US health care system triaging resources toward patient care and away from reporting and research and also reflects that data used in publicly reported hospital quality rankings and ratings typically lag 2-5 years. At our institution, a learning health system assessment is underway to evaluate how patient safety was affected by the pandemic. Here we share and discuss early findings, noting the limitations of self-reported safety event reporting, and suggest the need for further widespread investigations at other US hospitals. During the 2-year study period from January 1, 2020, through December 31, 2021 across 3 large US academic medical centers at our institution, we documented an overall rate of 25.8 safety events per 1000 inpatient days. The rate of events meeting "harm" criteria was 12.4 per 1000 inpatient days, the rate of nonharm events was 11.1 per 1000 inpatient days, and the fall rate was 2.3 per 1000 inpatient days. This descriptive exploratory analysis suggests that patient safety event rates at our institution did not increase over the course of the pandemic. However, increasing health care worker absences were nonlinearly and strongly associated with patient safety event rates, which raises questions regarding the mechanisms by which patient safety event rates may be affected by staff absences during pandemic peaks.

Association of Neutralizing Antispike Monoclonal Antibody Treatment With Coronavirus Disease 2019 Hospitalization and Assessment of the Monoclonal Antibody Screening Score.

Objective: To test the hypothesis that the Monoclonal Antibody Screening Score performs consistently better in identifying the need for monoclonal antibody infusion throughout each "wave" of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant predominance during the coronavirus disease 2019 (COVID-19) pandemic and that the infusion of contemporary monoclonal antibody treatments is associated with a lower risk of hospitalization. Patients and Methods: In this retrospective cohort study, we evaluated the efficacy of monoclonal antibody treatment compared with that of no monoclonal antibody treatment in symptomatic adults who tested positive for SARS-CoV-2 regardless of their risk factors for disease progression or vaccination status during different periods of SARS-CoV-2 variant predominance. The primary outcome was hospitalization within 28 days after COVID-19 diagnosis. The study was conducted on patients with a diagnosis of COVID-19 from November 19, 2020, through May 12, 2022. Results: Of the included 118,936 eligible patients, hospitalization within 28 days of COVID-19 diagnosis occurred in 2.52% (456/18,090) of patients who received monoclonal antibody treatment and 6.98% (7,037/100,846) of patients who did not. Treatment with monoclonal antibody therapies was associated with a lower risk of hospitalization when using stratified data analytics, propensity scoring, and regression and machine learning models with and without adjustments for putative confounding variables, such as advanced age and coexisting medical conditions (eg, relative risk, 0.15; 95% CI, 0.14-0.17). Conclusion: Among patients with mild to moderate COVID-19, including those who have been vaccinated, monoclonal antibody treatment was associated with a lower risk of hospital admission during each wave of the COVID-19 pandemic.

The Pitfalls of Mining for QuantiFERON Gold in Severely Ill Patients With COVID-19.

Objective: To assess the proportion of indeterminate QuantiFERON-TB Gold Plus (QFT-Plus) results in patients admitted for severe coronavirus disease 2019 (COVID-19) pneumonia and evaluate the factors associated with indeterminate QFT-Plus results. Patients and Methods: Data on COVID-19 admissions at Mayo Clinic in Florida were extracted between October 13, 2020, and September 20, 2021, and data from a prepandemic cohort were extracted between October 13, 2018, and September 20, 2019. A secondary analysis of the COVID-19 cohort was performed using gradient boosting modeling to generate variable importance and SHapley Additive exPlanations plots. Results: Our findings demonstrated more indeterminate QFT-Plus test results in patients hospitalized for severe COVID-19 infection than in patients without COVID-19 (139 of 495, 28.1%). The factors associated with indeterminate QFT-Plus test results included elevated levels of C-reactive protein, ferritin, lactate dehydrogenase and interleukin-6 and included lower levels of leukocyte, lymphocyte, and platelet counts. Conclusion: The patients with severe COVID-19 had a higher likelihood of indeterminate QFT-Plus results, which were associated with elevated levels of inflammatory markers consistent with severe infection. Interferon-gamma release assay screening tests are likely confounded by COVID-19 infection itself, limiting the screening ability for latent tuberculosis infection reactivation. Indeterminate QFT-Plus results may also require follow-up QFT-Plus testing after patient recovery from COVID-19, increasing the cost and complexity of medical decision making and management. Additional risk assessments may be needed in this patient population for screening for latent tuberculosis infection in patients with severe COVID-19.

A systematic review and meta-analysis of racial disparities in deep vein thrombosis and pulmonary embolism events in patients hospitalized with coronavirus disease 2019.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) is associated with an increased risk of venous thromboembolism (VTE). Recent studies have characterized racial disparities in the incidence of VTE. The aim of our study was to present a systematic review and meta-analysis to assess the association between race and VTE in patients hospitalized with COVID-19. METHODS: We performed a systematic literature review to evaluate the number of deep vein thrombosis (DVT) and pulmonary embolism (PE) events reported by racial groups in patients hospitalized with COVID-19. For the qualitative analysis, independent reviewers extracted the data from eligible studies, and we used the Newcastle-Ottawa scale to assess the quality of design and content for accurate interpretation. For the quantitative analysis, we pooled the odds ratios with Der Simonian and Laird random effects models. RESULTS: The qualitative analysis included 11 studies, with 6 included in the meta-analysis. All studies were observational, retrospective cohort studies, except for one retrospective case-control study. Six studies were eligible for the meta-analysis owing to the high interstudy heterogeneity; thus, the variable reports of racial groups reduced the cohort to Black/African American and White patients (n = 9723) in the analysis. The estimated proportion for DVT and PE events for Black/African American and White patients was 0.07 (95% confidence interval, 0.00-0.10) and 0.04 (95% confidence interval, 0.00-0.07), respectively. The P value of .13 suggested nonsignificant differences in the VTE rates between Black/African American and White patients. CONCLUSIONS: In our study, the proportion of DVT and PE events between Black/African American and White patients with COVID-19 were comparable. Future COVID-19 studies should include systematic racial group reporting to identify any disparities in the setting of VTE events.

Low antispike antibody levels correlate with poor outcomes in COVID-19 breakthrough hospitalizations.

BACKGROUND: While COVID-19 immunization programs attempted to reach targeted rates, cases rose significantly since the emergence of the delta variant. This retrospective cohort study describes the correlation between antispike antibodies and outcomes of hospitalized, breakthrough cases during the delta variant surge. METHODS: All patients with positive SARS-CoV-2 polymerase chain reaction hospitalized at Mayo Clinic Florida from 19 June 2021 to 11 November 2021 were considered for analysis. Cases were analyzed by vaccination status. Breakthrough cases were then analyzed by low and high antibody titers against SARS-CoV-2 spike protein, with a cut-off value of ≥132 U/ml. Outcomes included hospital length of stay (LOS), need for intensive care unit (ICU), mechanical ventilation, and mortality. We used 1:1 nearest neighbor propensity score matching without replacement to assess for confounders. RESULTS: Among 627 hospitalized patients with COVID-19, vaccine breakthrough cases were older with more comorbidities compared to unvaccinated. After propensity score matching, the unvaccinated patients had higher mortality (27 [28.4%] vs. 12 [12.6%], p = 0.002) and LOS (7 [1.0-57.0] vs. 5 [1.0-31.0] days, p = 0.011). In breakthrough cases, low-titer patients were more likely to be solid organ transplant recipients (16 [34.0%] vs. 9 [12.3%], p = 0.006), with higher need for ICU care (24 [51.1%] vs. 22 [11.0%], p = 0.034), longer hospital LOS (median 6 vs. 5 days, p = 0.013), and higher mortality (10 [21.3%] vs. 5 [6.8%], p = 0.025) than high-titer patients. CONCLUSIONS: Hospitalized breakthrough cases were more likely to have underlying risk factors than unvaccinated patients. Low-spike antibody titers may serve as an indicator for poor prognosis in breakthrough cases admitted to the hospital.

Multidisciplinary Approach for Lung Transplantation due to COVID-19.

Coronavirus disease 2019 (COVID-19), a novel etiology of end-stage lung disease, has resulted in major disruptions to the process of health care delivery worldwide. These disruptions have led to team-based innovations globally, resulting in a broad range of new processes in cardiopulmonary perioperative management. A key intersection of multidisciplinary teamwork and COVID-19 is found in lung transplantation, in which diverse teams collaborate throughout the perioperative period to achieve optimal outcomes. In this article, we describe the multidisciplinary approach taken by Mayo clinic in Florida to manage patients with COVID-19 presenting for lung transplantation.

V.I.T.A.M. in COVID 19: A Systematic Approach to a Global Pandemic.

INTRODUCTION: In the unprecedented era of COVID-19, ongoing research and evolution of evidence has led to ever-changing guidelines for clinical monitoring and therapeutic options. Formulating treatment protocols requires the understanding and application of the evolving research. OBJECTIVE: The primary objective of this study is to present a systematic evidence-based approach to synthesize the necessary data in order to optimize the management of COVID-19. METHODS: At Mayo Clinic Florida, we developed a multidisciplinary centralized COVID Treatment Review Panel (TRP) of expert pulmonologists, intensivists, infectious disease specialists, anesthesiologists, hematologists, rheumatologists, and hospitalists that in real-time reviews the latest evidence in peer-reviewed journals, the available clinical trials, and help guide the rapid application of therapeutics or interventions to the patient and the bedside provider. RESULTS/CONCLUSIONS: The multi-disciplinary team approach of synthesizing clinical data and coordinating care is effective in responding to rapidly evolving and changing evidence. Systematic data collection and evidence-based treatment algorithms enable physicians to rapidly translate the current literature to clinical practice, and improve care and outcomes of patients.

Quantifying the Importance of COVID-19 Vaccination to Our Future Outlook.

Predictive models have played a critical role in local, national, and international response to the COVID-19 pandemic. In the United States, health care systems and governmental agencies have relied on several models, such as the Institute for Health Metrics and Evaluation, Youyang Gu (YYG), Massachusetts Institute of Technology, and Centers for Disease Control and Prevention ensemble, to predict short- and long-term trends in disease activity. The Mayo Clinic Bayesian SIR model, recently made publicly available, has informed Mayo Clinic practice leadership at all sites across the United States and has been shared with Minnesota governmental leadership to help inform critical decisions during the past year. One key to the accuracy of the Mayo Clinic model is its ability to adapt to the constantly changing dynamics of the pandemic and uncertainties of human behavior, such as changes in the rate of contact among the population over time and by geographic location and now new virus variants. The Mayo Clinic model can also be used to forecast COVID-19 trends in different hypothetical worlds in which no vaccine is available, vaccinations are no longer being accepted from this point forward, and 75% of the population is already vaccinated. Surveys indicate that half of American adults are hesitant to receive a COVID-19 vaccine, and lack of understanding of the benefits of vaccination is an important barrier to use. The focus of this paper is to illustrate the stark contrast between these 3 scenarios and to demonstrate, mathematically, the benefit of high vaccine uptake on the future course of the pandemic.

Oxygen therapy via a noninvasive helmet: A COVID-19 novelty with potential post-pandemic uses.

COVID-19 has placed a significant strain upon healthcare resources at a global level and refractory hypoxemia is the leading cause of death among COVID-19 patients. The management of limited resources such as mechanical ventilators has remained a contentious issue both at an individual and institutional level since the beginning of the pandemic. As a result, the COVID-19 pandemic has presented challenges to critical care practitioners to find innovative ways to provide supplemental oxygen therapy to their patients. We present a single-center experience: a case series of five COVID-19 infected patients managed with a novel approach to provide supplemental oxygen and positive end-expiration pressure (PEEP) via the helmet. Three of the five patients responded to therapy, did not require intubation, and survived to discharge. The other two patients continued to deteriorate clinically, required endotracheal intubation, and subsequently expired during their hospitalization. We extrapolated our accumulated experience with non-invasive oxygen support by helmet in COVID-19 patients to a non-COVID-19 postoperative patient who underwent sinus surgery and developed hypoxemic respiratory failure also resulting in avoidance of endotracheal intubation. We conclude that oxygen therapy via a helmet is a safe, cost-effective technique to prevent intubation in carefully selected patients with infectious and non-infectious causes of hypoxic respiratory failure. Our positive experience with the system warrants further large-scale study and possible technique refinement.

Deployment of an Interdisciplinary Predictive Analytics Task Force to Inform Hospital Operational Decision-Making During the COVID-19 Pandemic.

In March 2020, our institution developed an interdisciplinary predictive analytics task force to provide coronavirus disease 2019 (COVID-19) hospital census forecasting to help clinical leaders understand the potential impacts on hospital operations. As the situation unfolded into a pandemic, our task force provided predictive insights through a structured set of visualizations and key messages that have helped the practice to anticipate and react to changing operational needs and opportunities. The framework shared here for the deployment of a COVID-19 predictive analytics task force could be adapted for effective implementation at other institutions to provide evidence-based messaging for operational decision-making. For hospitals without such a structure, immediate consideration may be warranted in light of the devastating COVID-19 third-wave which has arrived for winter 2020-2021.

Outcomes of COVID-19 With the Mayo Clinic Model of Care and Research.

OBJECTIVE: To report the Mayo Clinic experience with coronavirus disease 2019 (COVID-19) related to patient outcomes. METHODS: We conducted a retrospective chart review of patients with COVID-19 diagnosed between March 1, 2020, and July 31, 2020, at any of the Mayo Clinic sites. We abstracted pertinent comorbid conditions such as age, sex, body mass index, Charlson Comorbidity Index variables, and treatments received. Factors associated with hospitalization and mortality were assessed in univariate and multivariate models. RESULTS: A total of 7891 patients with confirmed COVID-19 infection with research authorization on file received care across the Mayo Clinic sites during the study period. Of these, 7217 patients were adults 18 years or older who were analyzed further. A total of 897 (11.4%) patients required hospitalization, and 354 (4.9%) received care in the intensive care unit (ICU). All hospitalized patients were reviewed by a COVID-19 Treatment Review Panel, and 77.5% (695 of 897) of inpatients received a COVID-19-directed therapy. Overall mortality was 1.2% (94 of 7891), with 7.1% (64 of 897) mortality in hospitalized patients and 11.3% (40 of 354) in patients requiring ICU care. CONCLUSION: Mayo Clinic outcomes of patients with COVID-19 infection in the ICU, hospital, and community compare favorably with those reported nationally. This likely reflects the impact of interprofessional multidisciplinary team evaluation, effective leveraging of clinical trials and available treatments, deployment of remote monitoring tools, and maintenance of adequate operating capacity to not require surge adjustments. These best practices can help guide other health care systems with the continuing response to the COVID-19 pandemic.

Predictors of disease severity and outcome of hospitalized renal transplant recipients with COVID-19 infection: a systematic review of a globally representative sample.

Introduction. COVID-19 presents a special challenge to the kidney transplant population.Methods. A systematic review of articles that examined COVID-19 in kidney transplant recipients was performed. Patients' demographics, clinical, laboratory and radiological presentations, immunosuppression modification, and COVID-19 specific management were abstracted and analyzed. COVID-19 severity was classified into mild, moderate, and severe. Disease outcome was classified by whether the patient was discharged, still hospitalized, or died.Results. 44 articles reporting individual data and 13 articles reporting aggregated data on 149 and 561 kidney transplant recipients respectively with COVID-19 from Asia, Europe and America fulfilled all inclusion and exclusion criteria. Among studies reporting case specific data, 76% of cases had severe disease. Compared to patients with mild/moderate disease, patients with severe disease had higher CRP, LDH, Ferritin, D-dimer and were more likely to have bilateral lung involvement at presentation and longer time since transplantation (P < 0.05 for all). Recipients' age, gender and comorbidities did not impact disease severity. Patients with severe disease had a more aggressive CNI reduction and more antiviral medications utilization. Outcome was reported on 145 cases, of those 34 (23%) died all with severe disease. Longer duration from transplant to disease diagnosis, hypoxia and higher LDH were associated with mortality (P < 0.05). Different immunosuppression reduction strategies, high dose parenteral corticosteroids use and various antiviral combinations did not demonstrate survival advantage. Similar finding was observed for studies reporting aggregated data.Conclusion. COVID-19 in kidney transplant patients is associated with high rate of disease severity and fatality. Higher LDH and longer time since transplantation predicted both disease severity and mortality. None of the COVID-19 specific treatment correlated with, or improved disease outcome in kidney transplant recipients.

Anticoagulation in COVID-19: A Systematic Review, Meta-analysis, and Rapid Guidance From Mayo Clinic.

A higher risk of thrombosis has been described as a prominent feature of coronavirus disease 2019 (COVID-19). This systematic review synthesizes current data on thrombosis risk, prognostic implications, and anticoagulation effects in COVID-19. We included 37 studies from 4070 unique citations. Meta-analysis was performed when feasible. Coagulopathy and thrombotic events were frequent among patients with COVID-19 and further increased in those with more severe forms of the disease. We also present guidance on the prevention and management of thrombosis from a multidisciplinary panel of specialists from Mayo Clinic. The current certainty of evidence is generally very low and continues to evolve.