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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.

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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.

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.


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).

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

This article originally appeared on Clinical Advisor

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Pfizer Seeks Full FDA Approval For COVID-19 Vaccine




Pfizer-BioNTech is seeking the Food and Drug Administration’s approval for its COVID-19 vaccine, with the goal of getting the agency’s green light “in the coming months.” Ben Hasty/MediaNews Group/Reading Eagle via Getty Images hide caption

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Ben Hasty/MediaNews Group/Reading Eagle via Getty Images

Pfizer and its vaccine partner BioNTech have started an application to request the Food and Drug Administration’s approval for its COVID-19 vaccine.

Pfizer is the first coronavirus vaccine maker in the U.S. to request full approval. Like Pfizer, the Moderna and Johnson & Johnson vaccines had been previously cleared for use under the agency’s emergency use authorization — a less rigorous approval method to aid a swifter response to the pandemic.

An FDA approval for a vaccine means the agency has decided that its benefits outweigh the known risks following a review of the manufacturer’s testing results.

If granted, Pfizer’s full stamp of approval would only apply to the vaccine for people who are 16 and older. Meanwhile, the vaccine maker is seeking emergency use authorization for its COVID-19 vaccine to include children between 12 and 15.

“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” Pfizer CEO Albert Bourla said in a press release Friday.

BioNTech’s CEO, Dr. Ugur Sahin, called the submission of the application for FDA approval “an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”

“We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

In that final phase of clinical trials, Pfizer found that its vaccine was 95% effective against COVID-19, the highest efficacy among vaccines authorized for emergency use in the United States.

For the FDA to grant approval, Pfizer-BioNTech will have to comply with a key requirement: providing follow-up data six months after vaccinations.

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CDC Official Who Warned Americans Coronavirus Could Cause ‘Severe’ Disruption Resigns




Dr. Nancy Messonnier joins other officials during an early coronavirus briefing in January 2020: Dr. Robert Redfield (left), then CDC director; Alex Azar (center), then Department of Health and Human Services secretary; and Dr. Anthony Fauci. Patrick Semansky/AP hide caption

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Patrick Semansky/AP

Dr. Nancy Messonnier, the top respiratory disease official at the Centers for Disease Control and Prevention who was among the first to warn the American public about how much the pandemic would change everyday life, is stepping down from the agency.

She made the announcement in an email to staff Friday, as first reported by The Washington Post and confirmed by NPR. Her last day will be May 14.

“My family and I have determined that now is the best time for me to transition to a new phase of my career,” she wrote.

Messonnier had worked for the CDC for more than 25 years, ascending to her role as director of the National Center for Immunization and Respiratory Diseases in 2016. Since late 2019, she had headed the agency’s COVID-19 task force, but she was recently reassigned from that post.

“Dr. Messonnier has been a true hero, and through her career in terms of public health she’s been a steward of public health for the nation. Over this pandemic and through her many-decade career, she’s made significant contributions, and she leaves behind a strong force of leadership and courage in all that she’s done,” CDC chief Dr. Rochelle Walensky said at a Friday briefing of the White House COVID-19 Response Team, declining to comment further.

Messonnier rose to public prominence for her warnings about the coronavirus in early 2020.

At a White House press briefing in late February, when the country had barely more than a dozen reported cases of the virus, Messonnier warned that community spread would be likely and that “disruption to everyday life might be severe.”

“It’s not so much a question of if this will happen anymore, but rather more a question of exactly when this will happen and how many people in this country will have severe illness,” she said.

At the time, her words about the pandemic were among the strongest yet from the Trump administration, which was still publicly downplaying the severity of the situation. Stocks tumbled. The Wall Street Journal later reported that then-President Donald Trump threatened to fire Messonnier shortly afterward.

The next day, Trump announced he was putting the vice president in charge of the government’s response and famously predicted that what were then 15 reported cases “within a couple of days is going to be down to close to zero.”

Messonnier did not appear at any further White House briefings, though she continued to make other public appearances, including briefings at the CDC and an interview with NPR.

In her resignation announcement, Messonnier said she will become the executive director for pandemic and public health systems at the Skoll Foundation, a private organization founded by Jeff Skoll, the first president of eBay. The Skoll Foundation is an NPR sponsor.

NPR health reporter Selena Simmons-Duffin contributed to this report.

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Medicaid and State Financing: Key Indicators to Watch Through Pandemic and Recovery




The health and economic effects of the pandemic have significant implications for Medicaid.  Medicaid, which provides coverage of health and long-term care for low-income residents, is administered by states within broad federal rules and jointly funded by states and the federal government. Medicaid is a counter-cyclical program, meaning that more people become eligible and enroll during economic downturns; at the same time, states may face declines in revenues that make it difficult to fund the state share of funding for the program. As in past economic downturns, the federal government has provided additional financial assistance to states during the current pandemic to help them maintain their Medicaid programs at a time of growing need.  This brief presents the most current data for key indicators to help understand how various economic factors that could affect Medicaid enrollment and spending are changing in light of the pandemic.  An overview of the methods is in the Methods Box at the end of the brief, and a companion brief provides an overview of Medicaid Financing Basics.

What factors could affect Medicaid enrollment?

Medicaid enrollment is typically the primary driver of spending.  Administrative data for Medicaid show that after declines in enrollment from 2017 through 2019, total enrollment nationwide began to grow after February 2020, right before the pandemic began. Between February 2020 and November 2020, enrollment steadily increased to 78.9 million, an increase of 7.7 million, or 10.8%, from actual enrollment in February 2020. These trends in enrollment likely reflect changes in the economy as more people experience income and job loss and become eligible and enroll in Medicaid coverage as well as “maintenance of eligibility” (MOE) provisions in the Families First Coronavirus Response Act (FFCRA) that require states to ensure continuous coverage to current Medicaid enrollees to access a temporary increase in the federal Medicaid match rate.

Key economic indicators that could signal changes to Medicaid enrollment include those showing job and income loss such as the unemployment rate, unemployment insurance claims, and the employment-to-population ratio.  Unemployment rates and unemployment insurance filings capture people who are actively looking for or have recently lost employment, respectively, and may be affected by people who opt to leave the workforce altogether.  Employment-to-population ratios capture what share of the population is working overall.  All measures capture some aspect of income loss, which could make more people eligible for Medicaid. However, Medicaid enrollment changes may lag behind changes in broader economic metrics.  For example, when unemployment rises, increases in Medicaid enrollment may follow, but improvements in unemployment may not immediately translate to slower Medicaid growth. This effect was observed following the end of the Great Recession in 2009 when Medicaid spending and enrollment continued to grow in 2010 and 2011 and is due in part by MOE provisions that prevent states that accept additional federal funding from disenrolling Medicaid beneficiaries.

National data show sharp increases in the average unemployment rate and unemployment claims following the onset of the pandemic in March 2020.  Indicators of employment-to-population ratios also show precipitous declines at the start of the pandemic, unmatched by trends since 2008. While changes in indicators related to employment and jobs have moderated in more recent months, they are still not at pre-pandemic levels. For example, March 2021 saw a national unemployment rate of 6.0% across all states including DC, below the peak of 14.8% in April 2020 but still above 3.5% in February 2020, right before the pandemic.  Similarly, total unemployment claims peaked in May 2020 and have been steadily declining, but total claims in March 2021 were greater than February 2020.  Finally, the employment-to-population ratio dropped to a low of 51.3% in April 2020; the 57.8% ratio in March 2021 is below the February 2020 level of 61.1%.  Unemployment rates and unemployment claims were higher, and the employment-to-population ratios were lower relative to the Great Recession that started in December 2007.

For each employment indicator there was wide variation across states in the average over the most recent 12-month period compared to a year earlier.  Looking at the average for the most recent 12-month period (April 2020 to March 2021) compared to the same period in the prior year, the national unemployment rate increased by 137%; however growth across states varied significantly, from more than a 200% increase in Hawaii, Nevada, Massachusetts, and New Jersey to less than a 50% increase in Mississippi, Nebraska, and Wyoming. All states experienced growth in their average number of unemployment claims and declines in their average employment-to-population ratio when comparing the most recent 12-month average to the year prior. While all states trended in the same direction, Nebraska, South Dakota, and Wyoming were in the top 5 for the smallest changes in their 12-month averages for at least two of the three indicators, and Hawaii, Massachusetts, and Nevada were hardest hit, being in the top 5 with the largest changes in their 12-month averages for at least two of the three indicators.

Employment-related economic consequences are directly related to the proportion of jobs a state has in more impacted sectors. States, like Hawaii and Nevada, which rely heavily on more exposed sectors (restaurants and bars, travel and transportation, entertainment, etc.), have seen larger changes in job-related indicators. On the other hand, states more reliant on less exposed sectors, like agriculture in the Midwestern states, have fared better. The leisure and hospitality industries experienced the highest unemployment rates at the start of the pandemic, but other industries also reliant on in-person work, like mining, are now seeing higher rates of unemployment. Many individuals enrolled in Medicaid even before the pandemic are employed in exposed sectors (such as food and other service industries) and are particularly at risk for income or job loss. Additionally, state issued stay-at-home orders and personal social-distancing behaviors varied across states and also contributed decreased economic activity.

What factors could affect states’ ability to finance Medicaid?

States generally fund their share of Medicaid costs through general revenue collected from residents, businesses, and sales taxes. States must adopt balanced budgets, so during economic downturns when demand for services and programs like Medicaid increases, state revenues typically decline, putting pressure on state budgets.  To provide broad fiscal relief to states and to help support increases in Medicaid enrollment, the Families First Coronavirus Response Act (FFCRA) authorized a 6.2 percentage point increase in the federal match rate (“FMAP”) for states that meet certain “maintenance of eligibility” (MOE) requirements. The additional funds were retroactively available to states beginning January 1, 2020 and continue through the quarter in which the PHE period ends. While the current PHE declaration expires 90 days from April 21, 2021, the Biden Administration has notified states that the PHE will likely remain in place throughout CY 2021 and that states will receive 60 days-notice before the end of the PHE.

Measures of changes in state revenue can provide insight into states’ ability to finance the state share of Medicaid.  State revenues are largely dependent on revenue from personal income taxes, corporate income taxes and sales taxes.  The share of revenue coming from each of these sources varies, and  9 states have no personal income tax at all.  In addition, each type of tax may be affected differently by changes in economic conditions.

While state revenues overall have increased in recent months, the annual change in average monthly revenue for the 12-month period ending February 2021 shows a slight decline in revenue from the prior year.  For the most recent 12-month period (ending February 2021) compared to the prior year, average monthly total revenues are 0.1% lower.  This difference is smaller than that seen for the 12-month period ending June 2020, which saw a 4.5% drop over the prior year.  Overall, throughout the pandemic, states have not experienced revenue declines as large as original projections.

State revenue changes vary across revenue sources, with personal income taxes faring better than sales taxes during the pandemic compared to prior years. Corporate income tax revenues are volatile and can fluctuate considerably from month to month. For the most recent 12-month period (ending February 2021) compared to the prior year, average monthly personal income taxes increased by 3.5%, corporate income taxes grew by 2.4%, and sales taxes fell by 2.6%.  Most states pushed back their April 15th, 2020 income tax filing deadline to July 15th, delaying income tax revenue and affecting the annual averages compared to the prior year.

There is considerable variation across states with regard to changes in revenues. Overall, 18 states experienced a decline in average monthly total tax revenue for the most recent 12-month period compared to the prior year. Changes in overall average monthly tax collections ranged from a decline of 49% in Alaska to growth of 11% in Idaho for the most recent 12-month period (March 2020 to February 2021) compared to the prior year, and there was also variation by revenue source.  Since the pandemic has disproportionately affected low income workers in the service industry, most states experienced smaller declines in personal income tax revenue than expected, especially for states with progressive income tax structures, where people with higher incomes pay a higher share of income tax.  In addition, income tax withholdings on the supplemental federal unemployment benefits may have also sustained state income tax revenues.  States that issued stay-at-home orders saw reduced sales tax revenues, and states that rely heavily on tourism, like Hawaii, Florida, and Nevada, or oil and gas, like Alaska and North Dakota, experienced larger revenue declinesSales tax revenues were bolstered by $600 weekly federal unemployment benefits under the CARES Act that allowed consumers to continue spending and a 2018 Supreme Court decision that authorized states to collect sales tax on online purchases. While sales taxes on groceries have been shown to worsen income and racial inequalities, states that tax groceries saw smaller declines in sales tax revenue during the pandemic.

Looking Ahead

The ongoing health and economic effects of the pandemic will continue to have implications for Medicaid enrollment and financing.  As states adopt budgets for state fiscal year 2022 (which starts July 1 for most states), revenue and spending projections are likely to incorporate potential improvements in revenue tied to COVID-19 vaccination efforts and eased restrictions, the continuation of the temporary fiscal relief and continuous coverage requirements for Medicaid (tied to the duration of the PHE), and new federal stimulus funds that were part of the American Rescue Plan. While revenues and employment indicators are improving, there is a lot of variation across states.  In addition, while indicators are improving on average across states, it is unclear how quickly and how much jobs and revenue in certain sectors of the economy will improve.  As the economy improves, what happens in certain sectors could greatly affect Medicaid as there have been disproportionate effects on low-wage workers who could be eligible for Medicaid.

The data in this analysis draws on a range of sources, including the Bureau of Labor Statistics, Department of Labor, and State and Local Finance Initiative at Urban Institute.  We draw on the most current data available for each specific indicator. For most indicators, we examined both national and state-by-state changes over time. We calculate changes based on a rolling average of the last 12 months compared to the prior year period to avoid major fluctuations using monthly data.

  • We calculate the 12-month average by taking the average of the measure (revenue, unemployment rate, etc.) for the most recent 12-month period and comparing to the same 12-month period the prior year. For example, the percent change calculation for February 2021 compares the average tax revenue from March 2020-February 2021 to the average tax revenue from March 2019-February 2020.
  • Monthly unemployment claims are calculated by combining reported initial and continued unemployment claims for each week, and then aggregating into months using the date in which the filing week ended.
  • For the state level revenue data, state data is removed if there is one revenue outlier that heavily skews the average calculations for that state. When this occurs, a note is added to the figure.
  • All other data is pulled directly from sources and no additional adjustments are made.

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New Study Estimates More Than 900,000 People Have Died Of COVID-19 In U.S.




Medical workers wait to vaccinate people at a pop-up COVID-19 vaccination clinic last month in Hollandale, Miss. Spencer Platt/Getty Images hide caption

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Spencer Platt/Getty Images

A new study estimates that the number of people who have died of COVID-19 in the U.S. is more than 900,000, a number 57% higher than official figures.

Worldwide, the study’s authors say, the COVID-19 death count is nearing 7 million, more than double the reported number of 3.24 million.

The analysis comes from researchers at the University of Washington’s Institute for Health Metrics and Evaluation, who looked at excess mortality from March 2020 through May 3, 2021, compared it with what would be expected in a typical nonpandemic year, then adjusted those figures to account for a handful of other pandemic-related factors.

The final count only estimates deaths “caused directly by the SARS-CoV-2 virus,” according to the study’s authors. SARS-CoV-2 is the virus that causes COVID-19.

Researchers estimated dramatic undercounts in countries such as India, Mexico and Russia, where they said the official death counts are some 400,000 too low in each country. In some countries — including Japan, Egypt and several Central Asian nations — the Institute for Health Metrics and Evaluation’s death toll estimate is more than 10 times higher than reported totals.

“The analysis just shows how challenging it has been during the pandemic to accurately track the deaths — and actually, transmission — of COVID. And by focusing in on the total COVID death rate, I think we bring to light just how much greater the impact of COVID has been already and may be in the future,” said Dr. Christopher Murray, who heads the Institute for Health Metrics and Evaluation.

The group reached its estimates by calculating excess mortality based on a variety of sources, including official death statistics from various countries, as well as academic studies of other locations.

Then, it examined other mortality factors influenced by the pandemic. For example, some of the extra deaths were caused by increased opioid overdoses or deferred health care. On the other hand, the dramatic reduction in flu cases last winter and a modest drop in deaths caused by injury resulted in lower mortality in those categories than usual.

Researchers at UW ultimately concluded that the extra deaths not directly caused by COVID-19 were effectively offset by the other reductions in death rates, leaving them to attribute all of the net excess deaths to the coronavirus.

“When you put all that together, we conclude that the best way, the closest estimate, for the true COVID death is still excess mortality, because some of those things are on the positive side, other factors are on the negative side,” Murray said.

A worker sprays disinfectant inside a temporary quarantine center for COVID-19 patients this week in Hyderabad, India. Researchers estimate more than 400,000 people have died of COVID-19 in India than has been officially reported. Noah Seelam/AFP via Getty Images hide caption

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Noah Seelam/AFP via Getty Images

Experts are in agreement that official reports of COVID-19 deaths undercount the true death toll of the virus. Some countries only report deaths that take place in hospitals, or only when patients are confirmed to have been infected; others have poor health care access altogether.

“We see, for example, that when health systems get hit hard with individuals with COVID, understandably they devote their time to trying to take care of patients,” Murray said.

Because of that, many academics have sought to estimate a true COVID-19 death rate to understand better how the disease spreads.

The revised statistical model used by the Institute for Health Metrics and Evaluation team produced numbers larger than many other analyses, raising some eyebrows in the scientific community.

“I think that the overall message of this (that deaths have been substantially undercounted and in some places more than others) is likely sound, but the absolute numbers are less so for a lot of reasons,” said William Hanage, an epidemiologist at Harvard University, in an email to NPR.

Last month, a group of researchers at Virginia Commonwealth University published a study in the medical journal JAMA that examined excess mortality rates in the U.S. through December.

While that team similarly found the number of excess deaths far exceeded the official COVID-19 death toll, it disagreed that the gap could be blamed entirely on COVID-19 and not other causes.

“Their estimate of excess deaths is enormous and inconsistent with our research and others,” said Dr. Steven Woolf, who led the Virginia Commonwealth team. “There are a lot of assumptions and educated guesses built into their model.”

Other researchers applauded the UW study, calling the researchers’ effort to produce a global model important, especially in identifying countries with small reported outbreaks but larger estimates of a true death toll, which could indicate the virus is spreading more widely than previously thought.

“We need to better understand the impact of COVID across the globe so that countries can understand the trajectory of the pandemic and figure out where to deploy additional resources, like testing supplies and vaccines to stop the spread,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins.

Researchers at UW also released an updated forecast for the COVID-19 death count worldwide, estimating that roughly 2.5 million more people will die of COVID-19 between now and Sept. 1, driven in part by the dramatic surge of cases in India.

In the United States, researchers estimated roughly 44,000 more people will die of COVID-19 by September.

NPR science correspondent Rob Stein contributed to this report.

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