Month: April 2021

Venous Thromboembolism Management in Patients With COVID-19

The severe systemic inflammatory processes and hypercoagulability occurring with COVID-19 illness increase the risk for atherosclerotic plaque disruption and acute myocardial infarction (AMI). Patients with a previous history of coronary disease and/or other significant comorbidities are particularly predisposed to cardiovascular complications with COVID-19 infection.1 In this installment, we will discuss a patient with COVID-19 and venous thromboembolism.

Case Presentation

A 61-year-old woman presents to a rural emergency department with complaints of progressively worsening dyspnea over the past 24 hours and pleuritic chest pain. On initial presentation, the patient is hypoxic with an oxygen saturation of 92% on 5 L/min supplemental oxygen via nasal cannula and exhibits sinus tachycardia (130-140 beats per minute).

The patient’s COVID-19 polymerase chain reaction (PCR) test is positive. Blood work reveals D-dimer is 3 times higher than normal (<0.4 mcg/mL), initial troponin within normal limits (0-0.1 ng/mL), hemoglobin 10.7 g/dL, hematocrit 33.1%, and platelet count 172 ×10/µL.

A massive saddle pulmonary emboli (PE) is present on spiral computed tomography (CT) arteriography with intravenous contrast of the pulmonary arteries. Echocardiogram demonstrates acute cor pulmonale with a right ventricular (RV) to left ventricular (LV) diameter ratio of 1.4. Venous ultrasound reveals a nonocclusive popliteal venous thromboembolism.


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The patient is given full-dose enoxaparin and is transferred to an acute care cardiac specialty hospital for further treatment. Upon arrival at the specialty hospital, she is taken to the catheterization laboratory where a right and left pulmonary angiogram is performed with thrombectomy of the right and left pulmonary arteries.

Significant Medical History

The patient’s medical history includes type 2 diabetes mellitus, hypertension, dyslipidemia, hypothyroidism, and a 60-pack/year history of smoking.

Physical Examination

The patient is a middle-aged woman with obesity who is in acute respiratory distress. She has labored breathing and is tachypneic, with a respiratory rate in the mid-30s. Lung examination reveals mild expiratory wheezing bilaterally; a cardiac summation gallop is noted.

Electrocardiography (ECG) monitoring may indicate findings of cor pulmonale (right-sided heart failure) identified by a new incomplete or complete right bundle branch block, right axis deviation, or right ventricular ischemia with ST-segment depression in right pericardial leads. Monitoring with ECG also helps with evaluating for atrial arrhythmias such as atrial fibrillation commonly seen with PE.1

Spiral CT arteriography of the chest with contrast is ordered to rule out pulmonary embolus, which can be a contributing factor to respiratory symptoms, elevation in biomarkers, and a sequela of COVID-19 infection.3

Ultrasound of the lower extremities (bilaterally) is used to rule out deep vein thrombosis (DVT) in the lower extremities.

Diagnosis

The gold standard for confirmation of a PE is a spiral CT with arteriography. In this case, the test confirmed the presence of a massive saddle pulmonary embolus. Minimally invasive intervention is indicated if the patient is found to have right ventricular strain on echocardiogram (Table 1).

Table 1. Recommended Diagnostic/Laboratory Tests

Coagulation: elevation in PT/INR, D-dimer, platelet count, fibrinogen
Cardiac biomarkers: troponin
Factor V Leiden mutation
Prothrombin gene mutation
Anticardiolipin antibodies (including lupus anticoagulant)
Hyperhomocysteinemia (usually due to folate deficiency)1,2
PT/INR, prothrombin time/international normalized radio

Radionuclide lung scan, commonly known as ventilation-perfusion (VQ) scan, may serve as a diagnostic tool for inpatients who have elevation in renal indices and are not able to undergo contrast studies. A VQ scan with a high clinical suspicion confirms the diagnosis of PE in 40% of cases.1

Echocardiogram is a useful tool for performing risk stratification. The presence of right ventricular wall akinesis or hypokinesis with sparing of the apex has a high specificity for acute PE. Also, in cases of PE, the ratio of the right ventricular end-diastolic area (RVEDA) to left ventricular end-diastolic area (LVEDA) exceeds the upper limit of normal, which is 0.6 mm.1

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Potential Drug Interaction Between Warfarin, COVID-19 Treatment Reported

A probable drug interaction was observed in 2 patients taking warfarin who were initiated on remdesivir and dexamethasone for the treatment of COVID-19, according to a case series recently published in the Journal of Pharmacy Practice.

The patients, a 71-year-old man and a 62 year-old-man, both on long-term warfarin therapy, presented to the emergency department with symptoms of COVID-19. Per the report, each patient’s international normalized ratio (INR) was within their specific goal and both denied any diet, lifestyle, or medication changes prior to admission.

“During admission, both patients experienced a marked elevation in INR within 24 to 48 hours of the initiation of remdesivir with dexamethasone for COVID-19 pneumonia directed therapy,” the authors reported. After several days of modification to their warfarin doses, both patients were stable enough for discharge and were counseled to continue monitoring per the instructions of their outpatient pharmacist.

Although the exact mechanism of action resulting in the interaction between dexamethasone, remdesivir, and warfarin is unknown, the authors concluded that there is potential for interaction based on a calculated Drug Interaction Probability Scale score of 5. “This probable interaction is demonstrated by marked INR elevations within 24 to 48 hours of initiation of the combination in 2 cases with patients with historically stable INR history,” the authors stated.


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Reference

Landayan RP, Saint-Felix S, Williams A. Probable interaction between warfarin and the combination of remdesivir with dexamethasone for coronavirus disease 2019 (COVID-19) treatment: A 2 case report. J. Pharm. Pract. [Published online April 5, 2021]. doi: 10.1177/08971900211008623

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Inflammatory Heart Disease Prevalence in Professional Athletes With Prior COVID-19 Infection

Among professional athletes who have tested positive for coronavirus disease 2019 (COVID-19 infection 0.6% had imaging findings suggestive of inflammatory heart disease that resulted in restriction from participation, according to a screening protocol based on American Heart Association (AHA)/American College of Cardiology (ACC) guidelines, researchers reported in JAMA Cardiology.

In May 2020, a number of major North American professional sports leagues —including Major League Soccer, Major League Baseball, the National Hockey League, the National Football League, and the men’s and women’s National Basketball Association — implemented a conservative return-to-play (RTP) cardiac testing program according to the AHA/ACC recommendations for all athletes who test positive for severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2), the virus that causes COVID-19. In this cross-sectional study, investigators sought to assess the prevalence of detectable inflammatory heart disease in professional athletes with prior SARS-CoV-2 infection in accordance with the current RTP screening recommendations.

The analysis included 789 professional athletes who tested positive for SARS-CoV-2 from May 2020 to October 2020 and underwent RTP cardiac screening. The mean age of the cohort was 25±3 (range, 19-41) years, and 777 (98.5%) were men. Among the athletes, 460 (58.3%) had previous symptomatic COVID-19 illness, and 329 (41.7%) were asymptomatic or paucisymptomatic but had tested positive for SARS-CoV-2.

SARS-CoV-2 positivity was diagnosed by polymerase chain reaction (PCR) assay in 587 (74.4%) athletes and antibody testing in 202 (25.6%) athletes. For athletes who tested positive for SARS-CoV-2 with PCR assay, cardiac screening was performed a mean of 19±17 (range, 3-156) days after the positive SARS-CoV-2 test.


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A total of 30 athletes had initial abnormal screening results and were sent for additional testing. Cardiac magnetic resonance imaging (CMR) was performed in 27 athletes in this group. Downstream testing confirmed diagnosis of inflammatory heart disease in 5 (18.5%) of the 27 athletes (0.6% of the total cohort); 3 athletes had CMR-confirmed myocarditis (0.4% of the total cohort), and 2 athletes had CMR-confirmed pericarditis (0.3% of the total cohort).

The athletes with confirmed inflammatory heart disease were held out from participation in their sport according to the RTP screening recommendations. The remaining 25 (83.3%) athletes who underwent additional testing ultimately did not have findings that suggested acute cardiac injury and returned to play. No clinical cardiac events have occurred in any of the athletes who had cardiac screening and resumed full professional sporting activity, as of late December 2020.

This study has important limitations, according to the researchers. RTP screening examinations were performed in a clinical setting and were usually analyzed and adjudicated by team physicians and cardiologists across the United States and Canada, which may lead to varying determinations of potential cardiac pathology and need for downstream testing. There was also variability in the time between SARS-CoV-2 testing and cardiac screening, and 98.5% of the athletes were men.

“We observed only rare cases of athletes having potential cardiac involvement,” stated the study authors. “This reporting of systematic RTP cardiac screening, while not generalizable to all athletic populations, can provide clinical guidance for other athletic organizations who are preparing and optimizing RTP protocols.”

Disclosures: Some of the authors reported affiliations with sports leagues, associations, and teams. Please see the original reference for a full list of disclosures.

Reference

Martinez MW, Tucker AM, Bloom OJ, et al. Prevalence of inflammatory heart disease among professional athletes with prior COVID-19 infection who received systematic return-to-play cardiac screening. JAMA Cardiol. Published online March 4, 2021. doi: 10.1001/jamacardio.2021.0565

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Vitamin D Supplementation May Lead to Small Risk Reduction for Acute Respiratory Infections

Vitamin D supplementation may safely reduce the overall risk for acute respiratory infection compared with placebo, but the risk reduction is small and the relevance of these findings to coronavirus disease 2019 (COVID-19) is unknown and requires additional investigation. This is according to research published in Lancet Diabetes Endocrinology.

Since the COVID-19 pandemic began, interest in the role of vitamin D in reducing acute respiratory infections has increased. Results of randomized controlled trials, though, have been heterogenous and variable, with some demonstrating protection and others reporting findings that are null. Results of a 2017 meta-analysis indicated the potential protective effect of vitamin D supplementation. Researchers sought to build on those results by conducting a new systematic review and meta-analysis of studies conducted since December 31, 2015.

The primary study outcome was the proportion of patients who had one or more acute respiratory infection (upper, lower, or location unclassified). Secondary outcomes included the proportion of participants who experienced one or more upper or lower respiratory infection, emergency department visit, hospitalization, or both for an acute respiratory infection, death due to acute respiratory infection or respiratory failure, antibiotic use, absence from school or work, serious adverse events, death, and potential adverse reactions to vitamin D.

The analysis included 46 studies representing 75,541 patients. Thirty-five studies compared the effects of vitamin D regimen with placebo, 5 compared higher- and lower-dose vitamin D with placebo groups, and 6 compared the effects of higher dose vitamin D with lower-dose vitamin D regimens.


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Primary outcome data were obtained for 98.1% of 49,419 available participants.

In the 35 studies that measured baseline 25(OH)D concentrations, mean levels ranged from 18.9 to 90.9 nmol/L. Across studies, vitamin D was administered through variable routes, including oral dosing, weekly dosing, bolus dosing once every month to once every 3 months, and combination bolus and daily dosing.

A significantly lower proportion of participants who were taking vitamin D supplements had 1 or more acute respiratory infections compared with those taking placebos (61.3% vs 62.3%; odds ratio [OR], 0.92; 95% CI, 0.86-0.99). The heterogeneity effect for these data was moderate (I2=35.6%).

For secondary comparisons of high vs low dose vitamin D supplementation, no significant differences in the proportion of at least one acute respiratory infection was noted between participant groups (68.2% vs 64.6%; OR, 0.87; 95% CI, 0.73-1.04; I2=0.0%).

In order to investigate the reasons for the heterogeneity of the effect for the primary comparison (vitamin D vs placebo), researchers conducted an analysis stratified by 2 participant level factors (baseline 25(OH)D concentration and age) and 4 trial-level factors (dose, dose frequency, trial duration, and presence or absence of airway disease). Four of these factors—baseline 25(OH)D concentration, dose, dose frequency, and trial duration—were prespecified in study protocols and two—age and presence or absence of airway infections—were exploratory analyses.

Compared with placebo groups, there was no significant effect of vitamin D supplementation on the risk of having 1 or more acute respiratory infection in participants with baseline 25(OH)D concentrations of less than 25 nmol/L, 25 to 49.9 nmol/L, 50 to 74.9 nmol/L, or greater than 75 nmol/L (ORs, 0.81, 1.04, 0.88, 0.76, and 1.00, respectively).

A significant protective effect of vitamin D supplementation was seen on the risk for developing one or more acute respiratory infection compared with placebo, particularly in trials where vitamin D was given daily (OR 0.78) compared with weekly dosing or bolus dosing once a month or once every 3 months (ORs, 0.97 and 0.98).

Significant protective effects were also noted against the risk of having one or more acute respiratory infection vs placebo in trials that were not restricted only to participants with asthma or chronic obstructive pulmonary disease (COPD).

The meta-analysis for secondary outcomes included only the results of placebo-controlled trials. Without considering participant- or trial-level factors, vitamin D supplementation did not demonstrate a significant effect on the proportion of participants who experienced 1 or more upper or lower respiratory infection, used antibiotics to treat an infection, reported absence from school or work, or had been admitted to the hospital, or who went to the emergency department.

Study limitations include the analysis of aggregate trial-level, rather than individual participant-level data due to the need for results in the face of the COVID-19 pandemic, a lack of participant-level data on race, ethnicity, or obesity as potential effect-modifiers, and an inability to account for other factors that might influence the protective effect of supplementation.

“This updated meta-analysis…showed a significant overall protective effect of this intervention compared with a placebo control,” the researchers wrote. “In contrast to findings of our previous meta-analysis of individual participant-level data, we did not see a protective effect…among participants with the lowest baseline 25(OH)D concentrations.”

“The vitamin D dosing regimen of most benefit was daily and used standard doses (400-1000 IU) for up to 12 months. The relevance of these findings to COVID-19 is not known and requires further investigation,” they concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Jolliffe DA, Camargo Jr CA, Sluyter JD, et al. Vitamin D supplementation to prevent acute respiratory infections: A systematic review and meta-analysis of aggregate data from randomized controlled trials. Published online March 30, 2021. Lancet Diabetes Endocrinol. doi: 10.1016/S2213-8587(21)00051-6.

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Patients With Underlying Medical Conditions Now a Priority for COVID-19 Vaccination

In March, the Centers for Disease Control and Prevention (CDC) announced that it would prioritize all patients with diabetes for COVID-19 vaccinations—a decision that was applauded by the American Diabetes Association which sought to reverse a previous guidance that didn’t prioritize all diabetes patients.

“The updated recommendation is a welcome change for the nearly 1.6 million Americans who have type 1 diabetes, many of whom were left behind—even if inadvertently—by the CDC’s previous guidance,” said Tracey D. Brown, the chief executive officer for the American Diabetes Association (ADA). “We know people with diabetes account for nearly 40 percent of all COVID-19 related deaths. Having the CDC acknowledge the serious risk to all people with diabetes from COVID-19 will go a long way toward boosting increasing access to the vaccine for our community at a critical time. It is crucial that remaining states follow suit. The science and the CDC recommendation leave no doubt that all people with diabetes should be prioritized equally.”

As part of the CDC’s phase 1c COVID-19 vaccine rollout that began in March, the CDC recommends that all patients between 16 and 64 years old with underlying medical conditions receive a COVID-19 vaccine. In addition to patients with type 1 or type 2 diabetes, the list includes patients with cancer, chronic kidney disease, chronic lung diseases (including chronic obstructive pulmonary disease, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension), dementia or other neurological conditions, Down syndrome, cardiovascular conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension), HIV infection, patients with immunodeficiency, liver disease, obesity, sickle cell disease or thalassemia, stroke or cerebrovascular disease, among other conditions.

Clinicians should use their judgment and may recommend patients for vaccination even if their underlying medical condition is not included on the list. “Studies have shown that COVID-19 does not affect all population groups equally. The risk of severe COVID-19 increases as the number of underlying medical conditions increases in an individual. Some chronic medical conditions occur more frequently or at a younger age in racial or ethnic minority populations,” the CDC stated in a report published on its website.


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According to a study published in JAMA Network Open by Ning Rosenthal, MD, MPH, PhD, of Premier Applied Sciences, North Carolina, 70.1% of inpatients and 25.1% of outpatients with COVID-19 had at least one comorbidity with the most common being hypertension (30,236 [46.7%]), hyperlipidemia (18,744 [28.9%]), diabetes (18,091 [27.9%]), and chronic pulmonary disease (10,434 [16.1%]). Old age of at least 80 years was found to be the risk factor most often associated with death which applied to 20.3% of inpatients in the Rosenthal et al. study.

Still, pre-existing comorbidities were associated with a higher risk of mortality for patients who were admitted to the hospital for COVID-19 treatment. Rosenthal et al. found that COVID-19 patients with a metastatic solid tumor had a 57% higher risk of inhospital mortality as compared to patients with a history of myocardial infarction (47% increase), patients with cerebrovascular disease (39% increase), congestive heart failure (37% increase), hemiplegia (34% increase), any malignant neoplasm (27% increase), dementia (20% increase), diabetes (20% increase), chronic pulmonary disease (16% increase), and hyperlipidemia (11% increase). The presence of multiple comorbidities was associated with a higher risk of in hospital mortality.

In a review of 235 studies on COVID-19 and its effect on patients with pre-existing comorbidities, the CDC concluded that based on the meta-analysis and systematic reviews included in the CDC review, only nine conditions were found to have a significant association with risk of severe COVID-19 illness. These include cancer, cerebrovascular disease, chronic kidney disease, COPD (chronic obstructive pulmonary disease), diabetes mellitus (type 1 and type 2), cardiovascular conditions (such as heart failure, coronary artery disease, or cardiomyopathies), obesity (BMI ≥30 kg/m2), pregnancy, and a history of smoking or current smokers. Studies that identified other comorbidities said to be a high risk for mortality or severe illness were mostly observational or as a result of case reports.

THE DIABETES PATIENT

Writing in Acta Diabetolgica in February, Qing Cheng of Huazhong University of Science and Technology in Wuhan, China, diabetes patients may be at higher risk of mortality and more severe COVID-19 prognosis possibly because insulin resistance ultimately stimulates the production of pro-inflammatory cytokines, oxidative stress, and adhesion molecules.

“Infection leads to destruction of pancreatic beta cells, decreased pancreatic insulin content, and changes in the host’s ability to respond normally to glucose tolerance tests,” Cheng et al. wrote in the study.

Drs. Rimesh Pal and Sanjay K. Bhadada—two endocrinologist from India—writing in Diabetes & Metabolic Syndrome:  Clinical Review & Reviews, described the physiological disease process between diabetes mellitus and COVID-19 as a “vicious cycle.”

“The two-way interaction between COVID-19 and diabetes mellitus sets up a vicious cycle wherein COVID-19 leads to worsening of dysglycemia and diabetes mellitus, in turn, exacerbates the severity of COVID-19. Thus, it is imperative that people with diabetes mellitus take all necessary precautions and ensure good glycemic control amid the ongoing pandemic,” they wrote.

Pal and Bhadada theorized that “compromised innate immunity, pro-inflammatory cytokine milieu, reduced expression of ACE2 and the use of renin-angiotensin-aldosterone system antagonists in people with diabetes mellitus contribute to poor prognosis in COVID-19. On the contrary, direct β-cell damage, cytokine-induced insulin resistance, hypokalemia and drugs used in the treatment of COVID-19 (like corticosteroids, lopinavir/ritonavir) can contribute to worsening of glucose control in people with diabetes mellitus.”

A panel of physicians writing in The Lancet in April 2020, issued a set of treatment recommendations for diabetes patients with COVID-19. For out-patient care, they recommend stressing to the patient the importance of achieving optimal metabolic control and they caution against prematurely stopping treatments diabetes patients are receiving.

For in-patient care, they recommend monitoring patients for new onset diabetes in patients who are infected with COVID-19.

For diabetes patients receiving in-patient care for COVID-19, routine monitoring should include plasma glucose monitoring, electrolytes, pH, blood ketones, or β-hydroxybutyrate, the panel wrote.

The ultimate goal for treatment should be:

·  Plasma glucose concentration: 4–8 mmol/L (72–144 mg/dL)

·  HbA1c:† less than 53 mmol/mol (7%)

·  CGM/FGM targets

·  TIR (3·9–10 mmol/L): more than 70% (>50% in frail and older people)

·  Hypoglycaemia (<3·9 mmol/L): less than 4% (<1% in frail and older people)

·  Plasma glucose concentration: 4–10 mmol/L (72–180 mg/dL)

For patients with type 2 diabetes and COVID-19, the panel warns against possible negative drug interactions. Patients taking metformin, for example, may experience dehydration and lactic acidosis so it may be necessary to temporarily stop taking the drug. These patients are at high risk of renal injury so renal function should be monitored.

Insulin therapy should not be stopped for patients with COVID-19 and diabetes. They should monitor blood-glucose every 2–4 hours or follow continuous glucose monitoring practices. Medicines should be adjusted, if appropriate, to reach therapeutic goals.

Patients taking sodium-glucose-co-transporter 2 inhibitors canagliflozin, dapagliflozin, and empagliflozin are at risk of dehydration and diabetic ketoacidosis, so they should temporarily stop taking these drugs should these symptoms occur.

Patients taking glucagon-like peptide-1 receptor agonists albiglutide, dulaglutide, exenatide-extended release, liraglutide, lixisenatide, and semaglutide are at risk of dehydration which can lead to a serious illness so they should adhere to strict fluid intake and a routine diet.

Dipeptidyl peptidase-4 inhibitors alogliptin, linagliptin, saxagliptin, and sitagliptin are generally well tolerated and can be continued.

“We do realize that all our recommendations and reflections are based on our expert opinion, awaiting the outcome of randomized clinical trials. Executing clinical trials under challenging circumstances has been proven feasible during the COVID-19 pandemic, and trial networks to provide evidence-based therapies are arising. Investigating subgroups with diabetes and how these relate to COVID-19 outcomes will be important, in particular investigating if some of the various management approaches would be particularly effective in managing diabetes in a COVID-19 context,” Bornstein et al. wrote.

For more information from the American Diabetes Association on COVID-19, visit the ADA’s COVID-19 hub (https://www.diabetes.org/coronavirus-covid-19) for vaccine plans by state.

Disclosures:

n/a

References

1. “American Diabetes Association Applauds CDC Decision to Prioritize All People with Diabetes for the COVID-19 Vaccine,” American Diabetes Association statement issued March 30, 2021 | Arlington, Virginia.

2. “COVID-19, People with Certain Medical Conditions,” Centers for Disease Control and Prevention, March 29, 2021.

3. “Underlying Medical Conditions Associated with High Risk for Severe COVID-19: Information for Healthcare Providers,” Centers for Disease Control and Prevention. Updated March 29, 2021. 

4. Ning Rosentha, MD, MPH, PhD; Zhun Cao, PhD; Jake Gundrum, MS; Jim Sianis, PharmD, MBA; Stella Safo, MD, MPH. “Risk Factors Associated With In-Hospital Mortality in a US National Sample of Patients With COVID-19,” JAMA Open Network. Dec. 10, 2020.  doi:10.1001/jamanetworkopen.2020.29058

5. “Science Brief: Evidence used to update the list of underlying medical conditions that increase a person’s risk of severe illness from COVID-19,” Centers for Disease Control and Prevention. March 29, 2021.

6. Zeng-hong Wu, Yun Tang, and Qing Cheng. “Diabetes increases the mortality of patients with COVID-19: a meta-analysis,” Acta Diabetolgica, a publication of Springer Nature. Received: 23 April 2020 / Accepted: 6 May 2020. Published Feb. 2021. https://doi.org/10.1007/s00592-020-01546-0  

7. Rimesh Pal, Sanjay K Bhadada. “COVID-19 and diabetes mellitus: An unholy interaction of two pandemics,” Diabetes & Metabolic Syndrome:  Clinical Review & Reviews. May 6, 2020. DOI: 10.1016/j.dsx.2020.04.049

8. Stefan R Bornstein, Francesco Rubino, Kamlesh Khunti, et al. “Practical recommendations for the management of diabetes in patients with COVID-19,” The Lancet. Published in print June 2020. Published online April 23, 2020. https://doi.org/10.1016/S2213-8587(20)30152-2  

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COVID-19 Home Collection Antibody Test Gets Emergency Use Authorization

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc), the first antibody test authorized for use with home collected dried blood spot samples.

The Symbiotica COVID-19 Self-Collected Antibody Test System is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The EUA allows for fingerstick dried blood samples to be self-collected at home by an individual 18 years of age and older or collected by an adult from an individual 5 years of age and older. The collected samples are then sent to a Symbiotica, Inc laboratory for analysis. The test is available only by prescription.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. 

The Agency cautioned that the Symbiotica COVID-19 Self-Collected Antibody Test System should not be used to diagnose or exclude acute SARS-CoV-2 infection. It is unknown at this time if the presence of antibodies confers immunity and how long antibodies persist after an infection.


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Reference

Coronavirus (COVID-19) update: FDA issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System. [press release]. Silver Spring, MD: US Food and Drug Administration; April 6, 2021. 

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COVID-19 Vaccination and Imaging Misinterpretation: An Interview With Lacey McIntosh, DO, MPH

The United States is, according to a recent declaration from President Joe Biden, aiming to offer all US adults vaccination against SARS-CoV-2, the virus that causes COVID-19, by May 2021.1 To date, furthermore, more than 30 people per 100 across the country have received at least 1 dose of a currently approved vaccine.2

The vaccination program is likely to improve overall survival in the population of patients with cancer, given the high risk of COVID-19-related mortality in this group. The clinical considerations related to vaccination in this population are, however, not yet established, and some research suggests that oncologists and patients should be aware of the potential manifestations of vaccination on imaging and the consequences this might have on disease assessment, treatment monitoring, and decision-making.

A recent article published in the American Journal of Roentgenology suggests that vaccination can result in axillary, supraclavicular, and/or cervical lymph node enlargement on the side of the injection. Such enlargement may, according to the authors, lead to confounding results and/or even misinterpretation of fluorodeoxyglucose (FDG) positron emission tomographic/computer tomographic (PET/CT) imaging in some cases.

While lymphadenopathy has previously been reported with other vaccines, notably those against seasonal influenza and human papillomavirus, the widespread use of SARS-CoV-2 vaccination necessitates awareness in the clinical community of the potential for confounding findings on imaging, in particular with FDG PET/CT. Clinician awareness of vaccine site and timing can be useful with coordination of imaging to help avoid these manifestations that can, in some cases, interfere with the accuracy of the examinations. Yet given the number of patients with cancer who have received — or are likely to soon receive — vaccination, some scans may not be interpretable, leading to treatment indecision in the face of potentially aggressive disease.


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To this end, Lacey McIntosh, DO, MPH, assistant professor at the University of Massachusetts Medical School in Worcester, and the study’s first author, discussed the implications of this research.

What is the dilemma with performing PET/CT in patients who have been recently vaccinated against COVID-19?

Dr McIntosh: The diagnostic dilemma that we are encountering is that the imaging manifestations of a recent COVID-19 vaccine can mimic cancer, especially on PET/CT. The vaccine causes tracer uptake and sometimes enlargement of lymph nodes of the axilla, supraclavicular region, and neck on the side of administration.

PET/CT is used for a variety of indications in oncology, including lesion characterization, disease staging, monitoring response to treatment, and surveillance for recurrence. Often, treatment decisions and disease status rely heavily on the results of this imaging. These studies can be difficult for physicians to get for their patients, so we want to make sure that when they are done, they are done well and give us the best chance to get the information we need with clear results.

In some cases, a recent vaccine just prior to imaging can potentially result in confusing findings rendering the study not useful and even lead to misinterpretation if information about vaccination is not available to the reading radiologist.

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White House Initiative to Provide COVID-19 Vaccines to Dialysis Clinics Draws Praise

Medical organizations and dialysis companies are commending the Biden administration’s March 25 announcement of a partnership with outpatient dialysis clinics to provide COVID-19 vaccinations to patients receiving in-center dialysis.

“Through this partnership, the Administration will provide vaccines directly to dialysis treatment centers so patients who typically go three times a week for treatment are able to get vaccinated at their place of care,” a statement from the White House reads.

The partnership is part of a $10 billion investment “to expand access to COVID-19 vaccines to the hardest-hit and highest-risk communities across the country.”

Patients on dialysis who contract COVID-19 often have severe health outcomes and have a 50% hospitalization rate and a mortality rate of 20% to 30% from COVID-19, according to the statement.


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The partnership is the result of an unprecedented collaboration between the White House, the Centers for Disease Control and Prevention (CDC), the American Society of Nephrology (ASN), and dialysis organizations across the United States. ASN and the National Kidney Foundation (NKF) as well as dialysis providers Fresenius Medical Care North America (FMCNA), DaVita, and US Renal Care issued statements praising the initiative.

“ASN has been urgently advocating for this decisive action designed to get the vaccine into the arms of one of the most vulnerable groups of people—Americans with kidney failure receiving dialysis—who now will be able to receive the vaccine directly in their dialysis facilities when and where they receive treatment,” ASN President Susan E. Quaggin, MD, said. “Our patients deserve nothing less, and I sincerely thank President Biden, the White House, and the Centers for Disease Control and Prevention for recognizing this reality.”

“Since the start of the pandemic, we have been advocating that kidney patients, especially those on dialysis or living with a transplant, be prioritized,” National Kidney Foundation CEO Kevin Longino said. “The partnership with dialysis clinics announced today will provide meaningful progress towards this goal and will help reduce the risk of increased complications and mortality kidney patients face due to the novel coronavirus, especially in communities of color.”

Rob Kossmann, MD, Chief Medical Officer for FMCNA, noted that most patients with kidney failure who receive treatment in the company’s dialysis centers have hypertension, diabetes, and cardiovascular disease. “These conditions put our patients at much higher risk of severe complications, hospitalization, and death if they contract COVID-19,” Dr Kossmann said. “They also often face transportation and other challenges that make accessing a vaccine on their own very difficult. As our nurses routinely provide other vaccinations and medications in our dialysis centers, this national rollout is an essential step forward.”

“The dialysis provider community came together to advocate for the needs of our patients, said DaVita CEO Javier Rodriguez. “We commend the Biden administration for providing direct access to the COVID-19 vaccine. Dialysis patients are one of the highest risk and most diverse patient populations. Offering patients direct access to the vaccine in a convenient and trusted site of care improves health equity, addresses challenges with third-party sites and reduces hesitancy rates.”

“We’re extremely pleased that the Biden administration has decided to partner with dialysis centers to more efficiently get vaccine to our vulnerable patients and our staff,” said US Renal Care’s Chief Medical Officer Mary Dittrich, MD. “The White House announcement will immediately reduce barriers that have impeded dialysis’ patients access to COVID-19 vaccines. We’re greatly encouraged by the Biden administration’s action, which will save lives.”

“Dialysis providers routinely vaccinate their patients against influenza, pneumonia and hepatitis B, and they are equipped to vaccinate against COVID-19,” the American Kidney Fund, an advocacy group for individuals with kidney disease, said in its statement. “We need to protect our nation’s dialysis patients from this pandemic as soon as possible, and this decision by the Biden-Harris administration will help accomplish that goal.”

The group added, “We applaud the Biden-Harris administration for its commitment to health equity and in prioritizing the distribution of the vaccine to get it immediately to the populations that most need it, including frontline workers and those with kidney failure.”

References

  1. Fact Sheet: Biden Administration announced historic $10 billion investment to expand access to COVID-19 vaccines and build vaccine confidence in hardest-hit and highest-risk communities. March 25, 2021. Press release.
  2. NKF applauds White House initiative to vaccinate dialysis patients in-center nationwide. March 25, 2021. Press release.
  3. Fresenius Medical Care North America applauds White House for national vaccine allocation to dialysis centers. March 25, 2021. Press release.
  4. DaVita statement on government’s nationwide program to vaccinate dialysis patients. March 25, 2021. Press release.

The post White House Initiative to Provide COVID-19 Vaccines to Dialysis Clinics Draws Praise appeared first on Medical Bag.

Review of Barriers to Colorectal Cancer Screening in Hard-to-Reach Populations

The coronavirus disease 2019 (COVID-19) pandemic has changed the way Americans experience every facet of life. Most concerningly, access to preventive health care is more limited than ever before — at a time when it is of paramount importance. A pause in elective procedures, including cancer screening, is leading to sharp declines in important and proven preventive health care assessments.1 These effects may exacerbate existing barriers to care,2 especially for individuals who live in rural areas with limited access to medical resources.3

Logistical hurdles and long-distance travel mean that many patients in rural areas lack access to preventive care, early detection, and treatment.4 This becomes especially problematic when we consider diseases that are managed best with routine screenings and early detection, including colorectal cancer (CRC), which is one of the most preventable and treatable cancers if caught early.5-9 Despite its slow-progressing nature,7,10 CRC is the second deadliest cancer in the United States.11 As the COVID-19 pandemic has evolved, concern that the estimated number of CRC-related deaths could grow over the next decade due to delays in screening brought on by the outbreak has risen.1,12

The Alaska Native people, who represent a medically underserved population in the nation, have the highest CRC incidence (89 per 100,000) and mortality (40 per 100,000) in the US.13 The Alaska Tribal Health System provides medical care to Alaska Native people through community-based clinics and regional hospitals, only 2 of which are connected to the road system. Reaching the other clinics requires travel by small plane, which is highly weather dependent. These factors make access to traditional CRC screening methods including colonoscopy difficult and can cause people to skip screening altogether. Thanks to the collective efforts of providers and public health experts across the state, CRC screening rates in the Alaska Native population have improved substantially; however, they remain lower than national rates.14,15

In 2020, COVID-19 caused a 3-month closure of endoscopy services across the Alaska Tribal Health System. Even as clinics begin to reopen with new safety measures in place, clinic staff are finding that patients are reluctant to come into the hospital for screening for fear of being exposed to the virus.  Amid the ongoing COVID-19 pandemic, efforts to leverage existing screening tools may help providers to accommodate patients from their own homes.


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Pulse Oximetry: Examining Racial Bias in a Valuable But Flawed Tool

In patients requiring supplemental oxygen therapy, the levels administered often depend on an individual’s oxygen saturation as measured by pulse oximetry. However, since this technology was developed in nondiverse populations, racial bias may influence the accuracy of pulse oximeter readings. Accordingly, the use of these devices in determining triage needs and adjustment of oxygen levels could increase the risk of hypoxemia in Black patients compared with non-Black patients.1

In a study recently published in the New England Journal of Medicine, Michael W. Sjoding, MD, assistant professor in the Division of Pulmonary and Critical Care Medicine at the University of Michigan Medical School in Ann Arbor, and colleagues explored this possibility among patients receiving supplemental oxygen across numerous sites.1

Sjoding et al analyzed 10,789 pairs of measures of oxygen saturation by pulse oximetry and arterial oxygen saturation in arterial blood gas from 1333 White patients and 276 Black patients at the University of Michigan Hospital. In addition, they analyzed 37,308 pairs from 7342 White patients and 1050 Black patients in intensive care units (ICUs) in 178 other hospitals.

They detected occult hypoxemia — defined as arterial oxygen saturation of less than 88% despite oxygen saturation of 92% to 96% on pulse oximetry — in 11.7% of Black patients (95% CI, 8.5%-16.0%) compared with 3.6% of White patients (95% CI, 2.7%-4.7%) in an unadjusted analysis of the University of Michigan cohort. Comparable results were found in additional analyses adjusting for age, sex, and cardiovascular risk, and after excluding patients with diabetes or elevated carboxyhemoglobin levels.


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In the multicenter cohort, unadjusted analyses demonstrated occult hypoxemia in 17.0% of Black patients (95% CI, 12.2%-23.3%) and 6.2% of White patients (95% CI, 5.4%-7.1%).1

“Thus, in two large cohorts, Black patients had nearly three times the frequency of occult hypoxemia that was not detected by pulse oximetry as White patients,” wrote Dr Sjoding et al.1 “Given the widespread use of pulse oximetry for medical decision making, these findings have some major implications, especially during the current coronavirus disease 2019 (COVID-19) pandemic.”

Because pulse oximetry determines oxygen levels based on how much light is transmitted through the skin, the darker skin tones among Black patients are likely the reason for the discrepancy noted in the study, Dr Sjoding told us in a recent interview. “Melanin likely changes the relationship between the amount of light transmitted and the oxygen level.”

The observed racial variation in risk highlights the need to consider other clinical and patient-reported data indicative of oxygen levels along with pulse oximetry readings, Dr Sjoding and his coauthors stated. More broadly, these results underscore the need to elucidate and address racial bias associated with medical devices.

While pulse oximeters can provide valuable information, health care professionals should remain aware of the imperfect accuracy of these devices and avoid overreliance on them in clinical decision making. Until the devices are corrected, health care providers need to be aware that a device reading 92% could mean the patient’s true oxygen level is anywhere between 88% and 96% and may be more extreme in some cases, particularly for patients with darker skin,” Dr Sjoding advised.

A relatively simple engineering solution could potentially increase the accuracy of pulse oximeter readings in all patients, but this would require a redesign of these devices. “I think healthcare providers need to take a stand and push for this to make sure it happens,” Dr Sjoding said.

In a letter published in March 2021 in the Lancet Respiratory Medicine, a group of critical care trainees from the United States and the United Kingdom (Hidalgo et al) advocated for prompt reform in this area, noting that the differential inaccuracy of pulse oximeters has been reported on since the 1990s.2 They cited this issue as an “example of systemic racism in health care delivery that has not been addressed despite decades of evidence.”

Although the US Food and Drug Administration (FDA) recently published information about the limitations of pulse oximeters along with relevant recommendations for clinicians and patients, Hidalgo et al deemed these efforts insufficient.2,3, They called on the FDA and other regulatory bodies to conduct a review of these devices and to reserve approval for those with equivalent performance regardless of race.

Additionally, the authors asked that pulmonary and critical care societies push for rigorous testing of pulse oximeters by the regulatory agencies, and also called on “hospitals to commit to only purchasing pulse oximeters that have been shown to work equally well in patients of colour.”2

While a redesign of pulse oximeters to correct the race-based inaccuracies is ultimately needed, a “bedside adjustment may be the least bad approach in the immediate short term until a concrete solution is found,” wrote Philip et al in a letter published in February 2021 in BMJ in response to the findings by Sjoding et al.4 They pointed out that “there is no obvious reason why oximeters should not be calibrated to darker skin and the bedside adjustment made for readings taken from lighter skin.”

References

1. Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial bias in pulse oximetry measurement. N Engl J Med. 2020;383(25):2477-2478. doi:10.1056/NEJMc2029240

2. Hidalgo DC, Olusanya O, Harlan E. Critical care trainees call for pulse oximetry reform. Lancet Respir Med. Published online March 1, 2021. doi:10.1016/S2213-2600(21)00102-8

3. Pulse oximeter accuracy and limitations: FDA safety communication. US Food and Drug Administration. February 19, 2021. Accessed March 31, 2021. https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication

4. Philip KEJ, Tidswell R, McFadyen C. Racial bias in pulse oximetry: more statistical detail may help tackle the problem. BMJ. 2021;372:n298. doi:10.1136/bmj.n298

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