Cardiology News

The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.

Courtesy NIAID-RML

The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.

Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.

More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.

Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.

Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.

The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.

The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.

The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.

The R number needs to be below 1.0 for the spread of the virus to fall.

“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”

A version of this article first appeared on WebMD.com.

The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.

Courtesy NIAID-RML

The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.

Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.

More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.

Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.

Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.

The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.

The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.

The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.

The R number needs to be below 1.0 for the spread of the virus to fall.

“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”

A version of this article first appeared on WebMD.com.

The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.

Courtesy NIAID-RML

The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.

Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.

More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.

Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.

Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.

The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.

The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.

The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.

The R number needs to be below 1.0 for the spread of the virus to fall.

“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”

A version of this article first appeared on WebMD.com.

Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.

Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.

“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.

Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.

“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
 

Equity issues

Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.

To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.

Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.

That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.

Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.

“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”

The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.

Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.

The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.

There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.

The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.

Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.

“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.

In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.

For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.

Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.

Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.

People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.

“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.

A version of this article first appeared on Medscape.com.

Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.

Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.

“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.

Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.

“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
 

Equity issues

Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.

To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.

Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.

That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.

Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.

“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”

The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.

Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.

The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.

There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.

The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.

Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.

“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.

In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.

For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.

Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.

Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.

People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.

“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.

A version of this article first appeared on Medscape.com.

Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.

Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.

“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.

Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.

“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
 

Equity issues

Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.

To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.

Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.

That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.

Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.

“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”

The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.

Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.

The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.

There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.

The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.

Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.

“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.

In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.

For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.

Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.

Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.

People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.

“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.

A version of this article first appeared on Medscape.com.

Patients with heart failure who are infected with SARS-CoV-2 are at high risk for complications, with nearly 1 in 4 dying during hospitalization, according to a large database analysis that included more than 8,000 patients who had heart failure and COVID-19.

Floaria Bicher/iStock/Getty Images Plus

In-hospital mortality was 24.2% for patients who had a history of heart failure and were hospitalized with COVID-19, as compared with 14.2% for individuals without heart failure who were hospitalized with COVID-19.

For perspective, the researchers compared the patients with heart failure and COVID-19 with patients who had a history of heart failure and were hospitalized for an acute worsening episode: the risk for death was about 10-fold higher with COVID-19.

“These patients really face remarkably high risk, and when we compare that to the risk of in-hospital death with something we are a lot more familiar with – acute heart failure – we see that the risk was about 10-fold greater,” said first author Ankeet S. Bhatt, MD, MBA, from Brigham and Women’s Hospital and Harvard Medical School, both in Boston.

In an article published online in JACC Heart Failure on Dec. 28, a group led by Dr. Bhatt and senior author Scott D. Solomon, MD, reported an analysis of administrative data on a total of 2,041,855 incident hospitalizations logged in the Premier Healthcare Database between April 1, 2020, and Sept. 30, 2020.

The Premier Healthcare Database comprises data from more than 1 billion patient encounters, which equates to approximately 1 in every 5 of all inpatient discharges in the United States.

Of 132,312 hospitalizations of patients with a history of heart failure, 23,843 (18.0%) were hospitalized with acute heart failure, 8,383 patients (6.4%) were hospitalized with COVID-19, and 100,068 (75.6%) were hospitalized for other reasons.

Outcomes and resource utilization were compared with 141,895 COVID-19 hospitalizations of patients who did not have heart failure.

Patients were deemed to have a history of heart failure if they were hospitalized at least once for heart failure from Jan. 1, 2019, to March 21, 2020, or had at least two heart failure outpatient visits during that period.

In a comment, Dr. Solomon noted some of the pros and cons of the data used in this study.

“Premier is a huge database, encompassing about one-quarter of all the health care facilities in the United States and one-fifth of all inpatient visits, so for that reason we’re able to look at things that are very difficult to look at in smaller hospital systems, but the data are also limited in that you don’t have as much granular detail as you might in smaller datasets,” said Dr. Solomon.

“One thing to recognize is that our data start at the point of hospital admission, so were looking only at individuals who have crossed the threshold in terms of their illness and been admitted,” he added.

Use of in-hospital resources was significantly greater for patients with heart failure hospitalized for COVID-19, compared with patients hospitalized for acute heart failure or for other reasons. This included “multifold” higher rates of ICU care (29% vs. 15%), mechanical ventilation (17% vs. 6%), and central venous catheter insertion (19% vs. 7%; P < .001 for all).

The proportion of patients who required mechanical ventilation and care in the ICU in the group with COVID-19 but who did not have no heart failure was similar to those who had both conditions.

The greater odds of in-hospital mortality among patients with both heart failure and COVID-19, compared with individuals with heart failure hospitalized for other reasons, was strongest in April, with an adjusted odds ratio of 14.48, compared with subsequent months (adjusted OR for May-September, 10.11; P for interaction < .001).

“We’re obviously not able to say with certainty what was happening in April, but I think that maybe the patients who were most vulnerable to COVID-19 may be more represented in that population, so the patients with comorbidities or who are immunosuppressed or otherwise,” said Dr. Bhatt in an interview.

“The other thing we think is that there may be a learning curve in terms of how to care for patients with acute severe respiratory illness. That includes increased institutional knowledge – like the use of prone ventilation – but also therapies that were subsequently shown to have benefit in randomized clinical trials, such as dexamethasone,” he added.

“These results should remind us to be innovative and thoughtful in our management of patients with heart failure while trying to maintain equity and good health for all,” wrote Nasrien E. Ibrahim, MD, from Massachusetts General Hospital, Boston; Ersilia DeFillipis, MD, Columbia University, New York; and Mitchel Psotka, MD, PhD, Innova Heart and Vascular Institute, Falls Church, Va., in an editorial accompanying the study.

The data emphasize the importance of ensuring equal access to services such as telemedicine, virtual visits, home nursing visits, and remote monitoring, they noted.

“As the COVID-19 pandemic rages on and disproportionately ravages socioeconomically disadvantaged communities, we should focus our efforts on strategies that minimize these inequities,” the editorialists wrote.

Dr. Solomon noted that, although Black and Hispanic patients were overrepresented in the population of heart failure patients hospitalized with COVID-19, once in the hospital, race was not a predictor of in-hospital mortality or the need for mechanical ventilation.

Dr. Bhatt has received speaker fees from Sanofi Pasteur and is supported by a National Institutes of Health/National Heart, Lung, and Blood Institute postdoctoral training grant. Dr. Solomon has received grant support and/or speaking fees from a number of companies and from the NIH/NHLBI. The editorialists disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with heart failure who are infected with SARS-CoV-2 are at high risk for complications, with nearly 1 in 4 dying during hospitalization, according to a large database analysis that included more than 8,000 patients who had heart failure and COVID-19.

Floaria Bicher/iStock/Getty Images Plus

In-hospital mortality was 24.2% for patients who had a history of heart failure and were hospitalized with COVID-19, as compared with 14.2% for individuals without heart failure who were hospitalized with COVID-19.

For perspective, the researchers compared the patients with heart failure and COVID-19 with patients who had a history of heart failure and were hospitalized for an acute worsening episode: the risk for death was about 10-fold higher with COVID-19.

“These patients really face remarkably high risk, and when we compare that to the risk of in-hospital death with something we are a lot more familiar with – acute heart failure – we see that the risk was about 10-fold greater,” said first author Ankeet S. Bhatt, MD, MBA, from Brigham and Women’s Hospital and Harvard Medical School, both in Boston.

In an article published online in JACC Heart Failure on Dec. 28, a group led by Dr. Bhatt and senior author Scott D. Solomon, MD, reported an analysis of administrative data on a total of 2,041,855 incident hospitalizations logged in the Premier Healthcare Database between April 1, 2020, and Sept. 30, 2020.

The Premier Healthcare Database comprises data from more than 1 billion patient encounters, which equates to approximately 1 in every 5 of all inpatient discharges in the United States.

Of 132,312 hospitalizations of patients with a history of heart failure, 23,843 (18.0%) were hospitalized with acute heart failure, 8,383 patients (6.4%) were hospitalized with COVID-19, and 100,068 (75.6%) were hospitalized for other reasons.

Outcomes and resource utilization were compared with 141,895 COVID-19 hospitalizations of patients who did not have heart failure.

Patients were deemed to have a history of heart failure if they were hospitalized at least once for heart failure from Jan. 1, 2019, to March 21, 2020, or had at least two heart failure outpatient visits during that period.

In a comment, Dr. Solomon noted some of the pros and cons of the data used in this study.

“Premier is a huge database, encompassing about one-quarter of all the health care facilities in the United States and one-fifth of all inpatient visits, so for that reason we’re able to look at things that are very difficult to look at in smaller hospital systems, but the data are also limited in that you don’t have as much granular detail as you might in smaller datasets,” said Dr. Solomon.

“One thing to recognize is that our data start at the point of hospital admission, so were looking only at individuals who have crossed the threshold in terms of their illness and been admitted,” he added.

Use of in-hospital resources was significantly greater for patients with heart failure hospitalized for COVID-19, compared with patients hospitalized for acute heart failure or for other reasons. This included “multifold” higher rates of ICU care (29% vs. 15%), mechanical ventilation (17% vs. 6%), and central venous catheter insertion (19% vs. 7%; P < .001 for all).

The proportion of patients who required mechanical ventilation and care in the ICU in the group with COVID-19 but who did not have no heart failure was similar to those who had both conditions.

The greater odds of in-hospital mortality among patients with both heart failure and COVID-19, compared with individuals with heart failure hospitalized for other reasons, was strongest in April, with an adjusted odds ratio of 14.48, compared with subsequent months (adjusted OR for May-September, 10.11; P for interaction < .001).

“We’re obviously not able to say with certainty what was happening in April, but I think that maybe the patients who were most vulnerable to COVID-19 may be more represented in that population, so the patients with comorbidities or who are immunosuppressed or otherwise,” said Dr. Bhatt in an interview.

“The other thing we think is that there may be a learning curve in terms of how to care for patients with acute severe respiratory illness. That includes increased institutional knowledge – like the use of prone ventilation – but also therapies that were subsequently shown to have benefit in randomized clinical trials, such as dexamethasone,” he added.

“These results should remind us to be innovative and thoughtful in our management of patients with heart failure while trying to maintain equity and good health for all,” wrote Nasrien E. Ibrahim, MD, from Massachusetts General Hospital, Boston; Ersilia DeFillipis, MD, Columbia University, New York; and Mitchel Psotka, MD, PhD, Innova Heart and Vascular Institute, Falls Church, Va., in an editorial accompanying the study.

The data emphasize the importance of ensuring equal access to services such as telemedicine, virtual visits, home nursing visits, and remote monitoring, they noted.

“As the COVID-19 pandemic rages on and disproportionately ravages socioeconomically disadvantaged communities, we should focus our efforts on strategies that minimize these inequities,” the editorialists wrote.

Dr. Solomon noted that, although Black and Hispanic patients were overrepresented in the population of heart failure patients hospitalized with COVID-19, once in the hospital, race was not a predictor of in-hospital mortality or the need for mechanical ventilation.

Dr. Bhatt has received speaker fees from Sanofi Pasteur and is supported by a National Institutes of Health/National Heart, Lung, and Blood Institute postdoctoral training grant. Dr. Solomon has received grant support and/or speaking fees from a number of companies and from the NIH/NHLBI. The editorialists disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients with heart failure who are infected with SARS-CoV-2 are at high risk for complications, with nearly 1 in 4 dying during hospitalization, according to a large database analysis that included more than 8,000 patients who had heart failure and COVID-19.

Floaria Bicher/iStock/Getty Images Plus

In-hospital mortality was 24.2% for patients who had a history of heart failure and were hospitalized with COVID-19, as compared with 14.2% for individuals without heart failure who were hospitalized with COVID-19.

For perspective, the researchers compared the patients with heart failure and COVID-19 with patients who had a history of heart failure and were hospitalized for an acute worsening episode: the risk for death was about 10-fold higher with COVID-19.

“These patients really face remarkably high risk, and when we compare that to the risk of in-hospital death with something we are a lot more familiar with – acute heart failure – we see that the risk was about 10-fold greater,” said first author Ankeet S. Bhatt, MD, MBA, from Brigham and Women’s Hospital and Harvard Medical School, both in Boston.

In an article published online in JACC Heart Failure on Dec. 28, a group led by Dr. Bhatt and senior author Scott D. Solomon, MD, reported an analysis of administrative data on a total of 2,041,855 incident hospitalizations logged in the Premier Healthcare Database between April 1, 2020, and Sept. 30, 2020.

The Premier Healthcare Database comprises data from more than 1 billion patient encounters, which equates to approximately 1 in every 5 of all inpatient discharges in the United States.

Of 132,312 hospitalizations of patients with a history of heart failure, 23,843 (18.0%) were hospitalized with acute heart failure, 8,383 patients (6.4%) were hospitalized with COVID-19, and 100,068 (75.6%) were hospitalized for other reasons.

Outcomes and resource utilization were compared with 141,895 COVID-19 hospitalizations of patients who did not have heart failure.

Patients were deemed to have a history of heart failure if they were hospitalized at least once for heart failure from Jan. 1, 2019, to March 21, 2020, or had at least two heart failure outpatient visits during that period.

In a comment, Dr. Solomon noted some of the pros and cons of the data used in this study.

“Premier is a huge database, encompassing about one-quarter of all the health care facilities in the United States and one-fifth of all inpatient visits, so for that reason we’re able to look at things that are very difficult to look at in smaller hospital systems, but the data are also limited in that you don’t have as much granular detail as you might in smaller datasets,” said Dr. Solomon.

“One thing to recognize is that our data start at the point of hospital admission, so were looking only at individuals who have crossed the threshold in terms of their illness and been admitted,” he added.

Use of in-hospital resources was significantly greater for patients with heart failure hospitalized for COVID-19, compared with patients hospitalized for acute heart failure or for other reasons. This included “multifold” higher rates of ICU care (29% vs. 15%), mechanical ventilation (17% vs. 6%), and central venous catheter insertion (19% vs. 7%; P < .001 for all).

The proportion of patients who required mechanical ventilation and care in the ICU in the group with COVID-19 but who did not have no heart failure was similar to those who had both conditions.

The greater odds of in-hospital mortality among patients with both heart failure and COVID-19, compared with individuals with heart failure hospitalized for other reasons, was strongest in April, with an adjusted odds ratio of 14.48, compared with subsequent months (adjusted OR for May-September, 10.11; P for interaction < .001).

“We’re obviously not able to say with certainty what was happening in April, but I think that maybe the patients who were most vulnerable to COVID-19 may be more represented in that population, so the patients with comorbidities or who are immunosuppressed or otherwise,” said Dr. Bhatt in an interview.

“The other thing we think is that there may be a learning curve in terms of how to care for patients with acute severe respiratory illness. That includes increased institutional knowledge – like the use of prone ventilation – but also therapies that were subsequently shown to have benefit in randomized clinical trials, such as dexamethasone,” he added.

“These results should remind us to be innovative and thoughtful in our management of patients with heart failure while trying to maintain equity and good health for all,” wrote Nasrien E. Ibrahim, MD, from Massachusetts General Hospital, Boston; Ersilia DeFillipis, MD, Columbia University, New York; and Mitchel Psotka, MD, PhD, Innova Heart and Vascular Institute, Falls Church, Va., in an editorial accompanying the study.

The data emphasize the importance of ensuring equal access to services such as telemedicine, virtual visits, home nursing visits, and remote monitoring, they noted.

“As the COVID-19 pandemic rages on and disproportionately ravages socioeconomically disadvantaged communities, we should focus our efforts on strategies that minimize these inequities,” the editorialists wrote.

Dr. Solomon noted that, although Black and Hispanic patients were overrepresented in the population of heart failure patients hospitalized with COVID-19, once in the hospital, race was not a predictor of in-hospital mortality or the need for mechanical ventilation.

Dr. Bhatt has received speaker fees from Sanofi Pasteur and is supported by a National Institutes of Health/National Heart, Lung, and Blood Institute postdoctoral training grant. Dr. Solomon has received grant support and/or speaking fees from a number of companies and from the NIH/NHLBI. The editorialists disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Researchers in Madrid may have found a clue to the pathogenesis of ST-segment elevation myocardial infarction (STEMI) in patients with COVID-19; it might also offer a therapeutic target to counter the hypercoagulability seen with COVID-19.

In a case series of five patients with COVID-19 who had an STEMI, neutrophil extracellular traps (NETs) were detected in coronary thrombi of all five patients. The median density was 66%, which is significantly higher than that seen in a historical series of patients with STEMI. In that series, NETs were found in only two-thirds of patients; in that series, the median density was 19%.

In the patients with COVID-19 and STEMI and in the patients reported in the prepandemic historical series from 2015, intracoronary aspirates were obtained during percutaneous coronary intervention using a thrombus aspiration device.

Histologically, findings in the patients from 2015 differed from those of patients with COVID-19. In the patients with COVID, thrombi were composed mostly of fibrin and polymorphonuclear cells. None showed fragments of atherosclerotic plaque or iron deposits indicative of previous episodes of plaque rupture. In contrast, 65% of thrombi from the 2015 series contained plaque fragments.

Ana Blasco, MD, PhD, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, and colleagues report their findings in an article published online Dec. 29 in JAMA Cardiology.

Commenting on the findings in an interview, Irene Lang, MD, from the Medical University of Vienna said, “This is really a very small series, purely observational, and suffering from the problem that acute STEMI is uncommon in COVID-19, but it does serve to demonstrate once more the abundance of NETs in acute myocardial infarction.”

“NETs are very much at the cutting edge of thrombosis research, and NET formation provides yet another link between inflammation and clot formation,” added Peter Libby, MD, from Harvard Medical School and Brigham and Women’s Hospital, Boston.

“Multiple observations have shown thrombosis of arteries large and small, microvessels, and veins in COVID-19. The observations of Blasco et al. add to the growing literature about NETs as contributors to the havoc wrought in multiple organs in advanced COVID-19,” he added in an email exchange with this news organization.

Neither Dr. Lang nor Dr. Libby were involved in this research; both have been actively studying NETs and their contribution to cardiothrombotic disease in recent years.

NETs are newly recognized contributors to venous and arterial thrombosis. These weblike DNA strands are extruded by activated or dying neutrophils and have protein mediators that ensnare pathogens while minimizing damage to the host cell.

First described in 2004, exaggerated NET formation has also been linked to the initiation and accretion of inflammation and thrombosis.

“NETs thus furnish a previously unsuspected link between inflammation, innate immunity, thrombosis, oxidative stress, and cardiovascular diseases,” Dr. Libby and his coauthors wrote in an article on the topic published in Circulation Research earlier this year.

Limiting NET formation or “dissolving” existing NETs could provide a therapeutic avenue not just for patients with COVID-19 but for all patients with thrombotic disease.

“The concept of NETs as a therapeutic target is appealing, in and out of COVID times,” said Dr. Lang.

“I personally believe that the work helps to raise awareness for the potential use of deoxyribonuclease (DNase), an enzyme that acts to clear NETs by dissolving the DNA strands, in the acute treatment of STEMI. Rapid injection of engineered recombinant DNases could potentially wipe away coronary obstructions, ideally before they may cause damage to the myocardium,” she added.

Dr. Blasco and colleagues and Dr. Lang have disclosed no relevant financial relationships. Dr. Libby is an unpaid consultant or member of the advisory board for a number of companies.

A version of this article first appeared on Medscape.com.

Researchers in Madrid may have found a clue to the pathogenesis of ST-segment elevation myocardial infarction (STEMI) in patients with COVID-19; it might also offer a therapeutic target to counter the hypercoagulability seen with COVID-19.

In a case series of five patients with COVID-19 who had an STEMI, neutrophil extracellular traps (NETs) were detected in coronary thrombi of all five patients. The median density was 66%, which is significantly higher than that seen in a historical series of patients with STEMI. In that series, NETs were found in only two-thirds of patients; in that series, the median density was 19%.

In the patients with COVID-19 and STEMI and in the patients reported in the prepandemic historical series from 2015, intracoronary aspirates were obtained during percutaneous coronary intervention using a thrombus aspiration device.

Histologically, findings in the patients from 2015 differed from those of patients with COVID-19. In the patients with COVID, thrombi were composed mostly of fibrin and polymorphonuclear cells. None showed fragments of atherosclerotic plaque or iron deposits indicative of previous episodes of plaque rupture. In contrast, 65% of thrombi from the 2015 series contained plaque fragments.

Ana Blasco, MD, PhD, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, and colleagues report their findings in an article published online Dec. 29 in JAMA Cardiology.

Commenting on the findings in an interview, Irene Lang, MD, from the Medical University of Vienna said, “This is really a very small series, purely observational, and suffering from the problem that acute STEMI is uncommon in COVID-19, but it does serve to demonstrate once more the abundance of NETs in acute myocardial infarction.”

“NETs are very much at the cutting edge of thrombosis research, and NET formation provides yet another link between inflammation and clot formation,” added Peter Libby, MD, from Harvard Medical School and Brigham and Women’s Hospital, Boston.

“Multiple observations have shown thrombosis of arteries large and small, microvessels, and veins in COVID-19. The observations of Blasco et al. add to the growing literature about NETs as contributors to the havoc wrought in multiple organs in advanced COVID-19,” he added in an email exchange with this news organization.

Neither Dr. Lang nor Dr. Libby were involved in this research; both have been actively studying NETs and their contribution to cardiothrombotic disease in recent years.

NETs are newly recognized contributors to venous and arterial thrombosis. These weblike DNA strands are extruded by activated or dying neutrophils and have protein mediators that ensnare pathogens while minimizing damage to the host cell.

First described in 2004, exaggerated NET formation has also been linked to the initiation and accretion of inflammation and thrombosis.

“NETs thus furnish a previously unsuspected link between inflammation, innate immunity, thrombosis, oxidative stress, and cardiovascular diseases,” Dr. Libby and his coauthors wrote in an article on the topic published in Circulation Research earlier this year.

Limiting NET formation or “dissolving” existing NETs could provide a therapeutic avenue not just for patients with COVID-19 but for all patients with thrombotic disease.

“The concept of NETs as a therapeutic target is appealing, in and out of COVID times,” said Dr. Lang.

“I personally believe that the work helps to raise awareness for the potential use of deoxyribonuclease (DNase), an enzyme that acts to clear NETs by dissolving the DNA strands, in the acute treatment of STEMI. Rapid injection of engineered recombinant DNases could potentially wipe away coronary obstructions, ideally before they may cause damage to the myocardium,” she added.

Dr. Blasco and colleagues and Dr. Lang have disclosed no relevant financial relationships. Dr. Libby is an unpaid consultant or member of the advisory board for a number of companies.

A version of this article first appeared on Medscape.com.

Researchers in Madrid may have found a clue to the pathogenesis of ST-segment elevation myocardial infarction (STEMI) in patients with COVID-19; it might also offer a therapeutic target to counter the hypercoagulability seen with COVID-19.

In a case series of five patients with COVID-19 who had an STEMI, neutrophil extracellular traps (NETs) were detected in coronary thrombi of all five patients. The median density was 66%, which is significantly higher than that seen in a historical series of patients with STEMI. In that series, NETs were found in only two-thirds of patients; in that series, the median density was 19%.

In the patients with COVID-19 and STEMI and in the patients reported in the prepandemic historical series from 2015, intracoronary aspirates were obtained during percutaneous coronary intervention using a thrombus aspiration device.

Histologically, findings in the patients from 2015 differed from those of patients with COVID-19. In the patients with COVID, thrombi were composed mostly of fibrin and polymorphonuclear cells. None showed fragments of atherosclerotic plaque or iron deposits indicative of previous episodes of plaque rupture. In contrast, 65% of thrombi from the 2015 series contained plaque fragments.

Ana Blasco, MD, PhD, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, and colleagues report their findings in an article published online Dec. 29 in JAMA Cardiology.

Commenting on the findings in an interview, Irene Lang, MD, from the Medical University of Vienna said, “This is really a very small series, purely observational, and suffering from the problem that acute STEMI is uncommon in COVID-19, but it does serve to demonstrate once more the abundance of NETs in acute myocardial infarction.”

“NETs are very much at the cutting edge of thrombosis research, and NET formation provides yet another link between inflammation and clot formation,” added Peter Libby, MD, from Harvard Medical School and Brigham and Women’s Hospital, Boston.

“Multiple observations have shown thrombosis of arteries large and small, microvessels, and veins in COVID-19. The observations of Blasco et al. add to the growing literature about NETs as contributors to the havoc wrought in multiple organs in advanced COVID-19,” he added in an email exchange with this news organization.

Neither Dr. Lang nor Dr. Libby were involved in this research; both have been actively studying NETs and their contribution to cardiothrombotic disease in recent years.

NETs are newly recognized contributors to venous and arterial thrombosis. These weblike DNA strands are extruded by activated or dying neutrophils and have protein mediators that ensnare pathogens while minimizing damage to the host cell.

First described in 2004, exaggerated NET formation has also been linked to the initiation and accretion of inflammation and thrombosis.

“NETs thus furnish a previously unsuspected link between inflammation, innate immunity, thrombosis, oxidative stress, and cardiovascular diseases,” Dr. Libby and his coauthors wrote in an article on the topic published in Circulation Research earlier this year.

Limiting NET formation or “dissolving” existing NETs could provide a therapeutic avenue not just for patients with COVID-19 but for all patients with thrombotic disease.

“The concept of NETs as a therapeutic target is appealing, in and out of COVID times,” said Dr. Lang.

“I personally believe that the work helps to raise awareness for the potential use of deoxyribonuclease (DNase), an enzyme that acts to clear NETs by dissolving the DNA strands, in the acute treatment of STEMI. Rapid injection of engineered recombinant DNases could potentially wipe away coronary obstructions, ideally before they may cause damage to the myocardium,” she added.

Dr. Blasco and colleagues and Dr. Lang have disclosed no relevant financial relationships. Dr. Libby is an unpaid consultant or member of the advisory board for a number of companies.

A version of this article first appeared on Medscape.com.

Millions of Americans with treatment-resistant hypertension are likely not being tested to determine whether their high blood pressure is driven by primary aldosteronism (PA), despite guidelines that call for such an approach, according to findings from the first reported large-scale, multicenter study of PA testing practices.

Researchers ran a retrospective review of PA testing among 269,010 patients who met the definition as having treatment-resistant hypertension and were managed at any one of 130 Veterans Health Administration (VHA) medical centers from 2000 to 2017.

The results showed that, despite the fact that primary aldosteronism is highly prevalent among patients with treatment-resistant hypertension, only 4,277 (1.6%) underwent assessment for PA during a median of 3.3 years’ follow-up after they first met the defining criteria, Jordana B. Cohen, MD, and her associates reported in a study published in Annals of Internal Medicine on December 28.

“Testing rates also did not change meaningfully over nearly 2 decades ... despite an increasing number of guidelines recommending testing for primary aldosteronism in this population,” including the most recent recommendations from the Endocrine Society, issued in 2016, noted Dr. Cohen, a nephrologist and hypertension researcher at the University of Pennsylvania in Philadelphia, and colleagues.

Most patients in the study (almost 90%) were seen by a primary care practitioner (PCP).

The small percentage of patients seen by a nephrologist or endocrinologist were more than twice as likely to be tested for PA than those seen by a PCP or cardiologist.

Those clinicians who did order a test for PA were much more likely to treat patients with the appropriate medication, a mineralocorticoid receptor antagonist (MRA). In addition, therapy was started sooner, the researchers found.

“Our results corroborate” earlier reports from smaller health systems and suggest that dramatic underuse of PA assessment “is an issue across the US,” Dr. Cohen said in an interview.

The VHA experience “is very representative of what we think goes on across U.S. practice” and contrasts with the VHA’s reputation for “doing a pretty good job managing hypertension” in general, she noted.
 

Missed diagnosis, missed treatment

Dr. Cohen believes a number of factors likely help drive the abysmally low rate of PA testing they observed in the VHA system. She believes rates of PA testing are low elsewhere as well.

First, optimal hypertension management “is often taken for granted” but is challenging in busy primary care practices, so many of patients likely fall through the cracks, she said.

Dr. Cohen cited efforts at her institution, as well as by the VHA system, to better employ electronic health records to flag patients with treatment-resistant hypertension – defined as patients whose systolic or diastolic blood pressure remains at or above 140/90 mm Hg on at least two successive measurements at least a month apart while the patient is undergoing treatment with three conventional antihypertensive drugs – and to guide clinicians to order the right tests and treatments for these patients.

Many care providers mistakenly “see treatment-resistant hypertension as a disease of noncompliance,” although it is much more often the result of a missed diagnosis and inadequate intervention, she explained.
 

Physicians in denial; side effects of MRAs may deter prescribing

A second big cause of low PA testing rates is that doctors make the mistake of thinking a PA test result won’t change how they manage these patients.

The established treatment for most patients with treatment-resistant hypertension as well as PA is adding an MRA, either spironolactone or eplerenone (Inspra).

Many providers cling to the belief that they will start an MRA in these patients without first determining their PA status, says Dr. Cohen, but the data she and her colleagues collected show the opposite.

Overall, about 13% of all patients in the study began treatment with an MRA during follow-up. The likelihood of starting treatment with this drug class was fourfold higher among the patients tested for PA compared with those who were not tested.

PA testing also hastened the start of MRA use by more than a year, compared with untested patients.

“Providers think they prescribe an MRA” to treatment-resistant patients, “but it’s part of their denial. They are not using the evidence-based treatments [spironolactone or eplerenone], perhaps because of concerns about MRA side effects, although those have been pretty well overcome during the past 20 years,” she observed.

Dr. Cohen says gynecomastia is one adverse effect that gives pause to VHA clinicians who see a heavily male patient population. “It’s probably the biggest concern and why PA testing and MRA use is low” in the VHA system, she said.

“You can use a lower dosage of spironolactone, and the incidence is less common with eplerenone,” although using eplerenone does not completely eliminate all gynecomastia cases, she noted.

At the University of Pennsylvania hospitals, men often start on spironolactone first because it retains a significant price advantage, even though eplerenone is now generic, but “if there is a hint of gynecomastia, we quickly switch to eplerenone, which is usually well tolerated,” she explained.

And while eplerenone has a reputation of being less effective than spironolactone, “I’ve prescribed a lot of eplerenone and have had good results,” Dr. Cohen said. “Even if the blood pressure lowering is not as great compared with spironolactone, it still blunts the toxic effects of aldosterone on target organs.”

Hyperkalemia is the other big concern about spironolactone and eplerenone. Both agents cause it at roughly the same rate, although the rate is lower in patients without chronic kidney disease.

A new, nonsteroidal MRA, finerenone, caused substantially less hyperkalemia in a recent phase 3 trial, FIDELIO-DKD, and as a nonsteroidal MRA, it does not cause gynecomastia. Finerenone has promise as a potentially safer option for treating PA and treatment-resistant hypertension, noted Cohen, but so far, no advanced clinical trials have been launched to examine its efficacy for these indications.
 

PA testing allows a surgical option

A third reason to test patients with treatment-resistant hypertension for PA is that jumping straight to MRA treatment denies the patient assessment for a unilateral adrenal adenoma as the cause of excess aldosterone.

When unilateral adenomas exist, patients are candidates for adrenalectomy. Despite the potential advantage this gives patients to eliminate the cause of their PA without the need for additional drug treatment, some clinicians don’t see this as a compelling rationale to test for PA because they have a bias against surgery or have seen too many cases in which surgery failed to produce full hypertension resolution.

“It’s all about setting expectations appropriately” for the impact of this surgery, Dr. Cohen said.

“Adrenalectomy is not a cure; it just gets rid of the source of excess aldosterone.” But in patients with long-standing PA and hypertension, this is often not enough to completely resolve entrenched cardiovascular pathology.
 

PCPs, cardiologists in rural locations least likely to order PA testing

Of the 269,010 patients analyzed by Dr. Cohen and her coauthors, the average age was 65 years; 96% were men; half were obese; and 40% had diabetes. The researchers excluded patients who had already been tested for PA, as well as those who were already receiving treatment with an MRA.

For 88% of the patients, the main physician overseeing care was a PCP. A cardiologist was the main physician for 10%; a nephrologist, for 1%; and an endocrinologist, for fewer than 1%.

The rate of testing for PA varied across the 130 VHA centers that contributed data, ranging from 0% to 6%. The testing data showed that endocrinologists were most likely to order PA testing, doing it 2.48-fold more often than PCPs. Nephrologists were roughly twice as likely to order PA testing than PCPs, and cardiologists ordered testing at about the same rate as PCPs.

Patients managed at VHA centers in rural locations were nearly half as likely to undergo testing as patients managed at nonrural centers. The number of patients with treatment-resistant hypertension seen by a physician or at a center had no significant relationship to PA testing frequency.

The study received no commercial funding. Dr. Cohen has disclosed no relevant financial relationships.

A version of this story first appeared on Medscape.com.

Millions of Americans with treatment-resistant hypertension are likely not being tested to determine whether their high blood pressure is driven by primary aldosteronism (PA), despite guidelines that call for such an approach, according to findings from the first reported large-scale, multicenter study of PA testing practices.

Researchers ran a retrospective review of PA testing among 269,010 patients who met the definition as having treatment-resistant hypertension and were managed at any one of 130 Veterans Health Administration (VHA) medical centers from 2000 to 2017.

The results showed that, despite the fact that primary aldosteronism is highly prevalent among patients with treatment-resistant hypertension, only 4,277 (1.6%) underwent assessment for PA during a median of 3.3 years’ follow-up after they first met the defining criteria, Jordana B. Cohen, MD, and her associates reported in a study published in Annals of Internal Medicine on December 28.

“Testing rates also did not change meaningfully over nearly 2 decades ... despite an increasing number of guidelines recommending testing for primary aldosteronism in this population,” including the most recent recommendations from the Endocrine Society, issued in 2016, noted Dr. Cohen, a nephrologist and hypertension researcher at the University of Pennsylvania in Philadelphia, and colleagues.

Most patients in the study (almost 90%) were seen by a primary care practitioner (PCP).

The small percentage of patients seen by a nephrologist or endocrinologist were more than twice as likely to be tested for PA than those seen by a PCP or cardiologist.

Those clinicians who did order a test for PA were much more likely to treat patients with the appropriate medication, a mineralocorticoid receptor antagonist (MRA). In addition, therapy was started sooner, the researchers found.

“Our results corroborate” earlier reports from smaller health systems and suggest that dramatic underuse of PA assessment “is an issue across the US,” Dr. Cohen said in an interview.

The VHA experience “is very representative of what we think goes on across U.S. practice” and contrasts with the VHA’s reputation for “doing a pretty good job managing hypertension” in general, she noted.
 

Missed diagnosis, missed treatment

Dr. Cohen believes a number of factors likely help drive the abysmally low rate of PA testing they observed in the VHA system. She believes rates of PA testing are low elsewhere as well.

First, optimal hypertension management “is often taken for granted” but is challenging in busy primary care practices, so many of patients likely fall through the cracks, she said.

Dr. Cohen cited efforts at her institution, as well as by the VHA system, to better employ electronic health records to flag patients with treatment-resistant hypertension – defined as patients whose systolic or diastolic blood pressure remains at or above 140/90 mm Hg on at least two successive measurements at least a month apart while the patient is undergoing treatment with three conventional antihypertensive drugs – and to guide clinicians to order the right tests and treatments for these patients.

Many care providers mistakenly “see treatment-resistant hypertension as a disease of noncompliance,” although it is much more often the result of a missed diagnosis and inadequate intervention, she explained.
 

Physicians in denial; side effects of MRAs may deter prescribing

A second big cause of low PA testing rates is that doctors make the mistake of thinking a PA test result won’t change how they manage these patients.

The established treatment for most patients with treatment-resistant hypertension as well as PA is adding an MRA, either spironolactone or eplerenone (Inspra).

Many providers cling to the belief that they will start an MRA in these patients without first determining their PA status, says Dr. Cohen, but the data she and her colleagues collected show the opposite.

Overall, about 13% of all patients in the study began treatment with an MRA during follow-up. The likelihood of starting treatment with this drug class was fourfold higher among the patients tested for PA compared with those who were not tested.

PA testing also hastened the start of MRA use by more than a year, compared with untested patients.

“Providers think they prescribe an MRA” to treatment-resistant patients, “but it’s part of their denial. They are not using the evidence-based treatments [spironolactone or eplerenone], perhaps because of concerns about MRA side effects, although those have been pretty well overcome during the past 20 years,” she observed.

Dr. Cohen says gynecomastia is one adverse effect that gives pause to VHA clinicians who see a heavily male patient population. “It’s probably the biggest concern and why PA testing and MRA use is low” in the VHA system, she said.

“You can use a lower dosage of spironolactone, and the incidence is less common with eplerenone,” although using eplerenone does not completely eliminate all gynecomastia cases, she noted.

At the University of Pennsylvania hospitals, men often start on spironolactone first because it retains a significant price advantage, even though eplerenone is now generic, but “if there is a hint of gynecomastia, we quickly switch to eplerenone, which is usually well tolerated,” she explained.

And while eplerenone has a reputation of being less effective than spironolactone, “I’ve prescribed a lot of eplerenone and have had good results,” Dr. Cohen said. “Even if the blood pressure lowering is not as great compared with spironolactone, it still blunts the toxic effects of aldosterone on target organs.”

Hyperkalemia is the other big concern about spironolactone and eplerenone. Both agents cause it at roughly the same rate, although the rate is lower in patients without chronic kidney disease.

A new, nonsteroidal MRA, finerenone, caused substantially less hyperkalemia in a recent phase 3 trial, FIDELIO-DKD, and as a nonsteroidal MRA, it does not cause gynecomastia. Finerenone has promise as a potentially safer option for treating PA and treatment-resistant hypertension, noted Cohen, but so far, no advanced clinical trials have been launched to examine its efficacy for these indications.
 

PA testing allows a surgical option

A third reason to test patients with treatment-resistant hypertension for PA is that jumping straight to MRA treatment denies the patient assessment for a unilateral adrenal adenoma as the cause of excess aldosterone.

When unilateral adenomas exist, patients are candidates for adrenalectomy. Despite the potential advantage this gives patients to eliminate the cause of their PA without the need for additional drug treatment, some clinicians don’t see this as a compelling rationale to test for PA because they have a bias against surgery or have seen too many cases in which surgery failed to produce full hypertension resolution.

“It’s all about setting expectations appropriately” for the impact of this surgery, Dr. Cohen said.

“Adrenalectomy is not a cure; it just gets rid of the source of excess aldosterone.” But in patients with long-standing PA and hypertension, this is often not enough to completely resolve entrenched cardiovascular pathology.
 

PCPs, cardiologists in rural locations least likely to order PA testing

Of the 269,010 patients analyzed by Dr. Cohen and her coauthors, the average age was 65 years; 96% were men; half were obese; and 40% had diabetes. The researchers excluded patients who had already been tested for PA, as well as those who were already receiving treatment with an MRA.

For 88% of the patients, the main physician overseeing care was a PCP. A cardiologist was the main physician for 10%; a nephrologist, for 1%; and an endocrinologist, for fewer than 1%.

The rate of testing for PA varied across the 130 VHA centers that contributed data, ranging from 0% to 6%. The testing data showed that endocrinologists were most likely to order PA testing, doing it 2.48-fold more often than PCPs. Nephrologists were roughly twice as likely to order PA testing than PCPs, and cardiologists ordered testing at about the same rate as PCPs.

Patients managed at VHA centers in rural locations were nearly half as likely to undergo testing as patients managed at nonrural centers. The number of patients with treatment-resistant hypertension seen by a physician or at a center had no significant relationship to PA testing frequency.

The study received no commercial funding. Dr. Cohen has disclosed no relevant financial relationships.

A version of this story first appeared on Medscape.com.

Millions of Americans with treatment-resistant hypertension are likely not being tested to determine whether their high blood pressure is driven by primary aldosteronism (PA), despite guidelines that call for such an approach, according to findings from the first reported large-scale, multicenter study of PA testing practices.

Researchers ran a retrospective review of PA testing among 269,010 patients who met the definition as having treatment-resistant hypertension and were managed at any one of 130 Veterans Health Administration (VHA) medical centers from 2000 to 2017.

The results showed that, despite the fact that primary aldosteronism is highly prevalent among patients with treatment-resistant hypertension, only 4,277 (1.6%) underwent assessment for PA during a median of 3.3 years’ follow-up after they first met the defining criteria, Jordana B. Cohen, MD, and her associates reported in a study published in Annals of Internal Medicine on December 28.

“Testing rates also did not change meaningfully over nearly 2 decades ... despite an increasing number of guidelines recommending testing for primary aldosteronism in this population,” including the most recent recommendations from the Endocrine Society, issued in 2016, noted Dr. Cohen, a nephrologist and hypertension researcher at the University of Pennsylvania in Philadelphia, and colleagues.

Most patients in the study (almost 90%) were seen by a primary care practitioner (PCP).

The small percentage of patients seen by a nephrologist or endocrinologist were more than twice as likely to be tested for PA than those seen by a PCP or cardiologist.

Those clinicians who did order a test for PA were much more likely to treat patients with the appropriate medication, a mineralocorticoid receptor antagonist (MRA). In addition, therapy was started sooner, the researchers found.

“Our results corroborate” earlier reports from smaller health systems and suggest that dramatic underuse of PA assessment “is an issue across the US,” Dr. Cohen said in an interview.

The VHA experience “is very representative of what we think goes on across U.S. practice” and contrasts with the VHA’s reputation for “doing a pretty good job managing hypertension” in general, she noted.
 

Missed diagnosis, missed treatment

Dr. Cohen believes a number of factors likely help drive the abysmally low rate of PA testing they observed in the VHA system. She believes rates of PA testing are low elsewhere as well.

First, optimal hypertension management “is often taken for granted” but is challenging in busy primary care practices, so many of patients likely fall through the cracks, she said.

Dr. Cohen cited efforts at her institution, as well as by the VHA system, to better employ electronic health records to flag patients with treatment-resistant hypertension – defined as patients whose systolic or diastolic blood pressure remains at or above 140/90 mm Hg on at least two successive measurements at least a month apart while the patient is undergoing treatment with three conventional antihypertensive drugs – and to guide clinicians to order the right tests and treatments for these patients.

Many care providers mistakenly “see treatment-resistant hypertension as a disease of noncompliance,” although it is much more often the result of a missed diagnosis and inadequate intervention, she explained.
 

Physicians in denial; side effects of MRAs may deter prescribing

A second big cause of low PA testing rates is that doctors make the mistake of thinking a PA test result won’t change how they manage these patients.

The established treatment for most patients with treatment-resistant hypertension as well as PA is adding an MRA, either spironolactone or eplerenone (Inspra).

Many providers cling to the belief that they will start an MRA in these patients without first determining their PA status, says Dr. Cohen, but the data she and her colleagues collected show the opposite.

Overall, about 13% of all patients in the study began treatment with an MRA during follow-up. The likelihood of starting treatment with this drug class was fourfold higher among the patients tested for PA compared with those who were not tested.

PA testing also hastened the start of MRA use by more than a year, compared with untested patients.

“Providers think they prescribe an MRA” to treatment-resistant patients, “but it’s part of their denial. They are not using the evidence-based treatments [spironolactone or eplerenone], perhaps because of concerns about MRA side effects, although those have been pretty well overcome during the past 20 years,” she observed.

Dr. Cohen says gynecomastia is one adverse effect that gives pause to VHA clinicians who see a heavily male patient population. “It’s probably the biggest concern and why PA testing and MRA use is low” in the VHA system, she said.

“You can use a lower dosage of spironolactone, and the incidence is less common with eplerenone,” although using eplerenone does not completely eliminate all gynecomastia cases, she noted.

At the University of Pennsylvania hospitals, men often start on spironolactone first because it retains a significant price advantage, even though eplerenone is now generic, but “if there is a hint of gynecomastia, we quickly switch to eplerenone, which is usually well tolerated,” she explained.

And while eplerenone has a reputation of being less effective than spironolactone, “I’ve prescribed a lot of eplerenone and have had good results,” Dr. Cohen said. “Even if the blood pressure lowering is not as great compared with spironolactone, it still blunts the toxic effects of aldosterone on target organs.”

Hyperkalemia is the other big concern about spironolactone and eplerenone. Both agents cause it at roughly the same rate, although the rate is lower in patients without chronic kidney disease.

A new, nonsteroidal MRA, finerenone, caused substantially less hyperkalemia in a recent phase 3 trial, FIDELIO-DKD, and as a nonsteroidal MRA, it does not cause gynecomastia. Finerenone has promise as a potentially safer option for treating PA and treatment-resistant hypertension, noted Cohen, but so far, no advanced clinical trials have been launched to examine its efficacy for these indications.
 

PA testing allows a surgical option

A third reason to test patients with treatment-resistant hypertension for PA is that jumping straight to MRA treatment denies the patient assessment for a unilateral adrenal adenoma as the cause of excess aldosterone.

When unilateral adenomas exist, patients are candidates for adrenalectomy. Despite the potential advantage this gives patients to eliminate the cause of their PA without the need for additional drug treatment, some clinicians don’t see this as a compelling rationale to test for PA because they have a bias against surgery or have seen too many cases in which surgery failed to produce full hypertension resolution.

“It’s all about setting expectations appropriately” for the impact of this surgery, Dr. Cohen said.

“Adrenalectomy is not a cure; it just gets rid of the source of excess aldosterone.” But in patients with long-standing PA and hypertension, this is often not enough to completely resolve entrenched cardiovascular pathology.
 

PCPs, cardiologists in rural locations least likely to order PA testing

Of the 269,010 patients analyzed by Dr. Cohen and her coauthors, the average age was 65 years; 96% were men; half were obese; and 40% had diabetes. The researchers excluded patients who had already been tested for PA, as well as those who were already receiving treatment with an MRA.

For 88% of the patients, the main physician overseeing care was a PCP. A cardiologist was the main physician for 10%; a nephrologist, for 1%; and an endocrinologist, for fewer than 1%.

The rate of testing for PA varied across the 130 VHA centers that contributed data, ranging from 0% to 6%. The testing data showed that endocrinologists were most likely to order PA testing, doing it 2.48-fold more often than PCPs. Nephrologists were roughly twice as likely to order PA testing than PCPs, and cardiologists ordered testing at about the same rate as PCPs.

Patients managed at VHA centers in rural locations were nearly half as likely to undergo testing as patients managed at nonrural centers. The number of patients with treatment-resistant hypertension seen by a physician or at a center had no significant relationship to PA testing frequency.

The study received no commercial funding. Dr. Cohen has disclosed no relevant financial relationships.

A version of this story first appeared on Medscape.com.

The COVID-19 vaccine distribution process in the United States is moving more slowly than anticipated, falling short of Operation Warp Speed’s goal to vaccinate 20 million Americans by the end of the year.

If the current pace of vaccination continues, “it’s going to take years, not months, to vaccinate the American people,” President-elect Joe Biden said during a briefing Dec. 29.

In fact, at the current rate, it would take nearly 10 years to vaccinate enough Americans to bring the pandemic under control, according to NBC News. To reach 80% of the country by late June, 3 million people would need to receive a COVID-19 vaccine each day.

“As I long feared and warned, the effort to distribute and administer the vaccine is not progressing as it should,” Mr. Biden said, reemphasizing his pledge to get 100 million doses to Americans during his first 100 days as president.

So far, 11.4 million doses have been distributed and 2.1 million people have received a vaccine, according to the Centers for Disease Control and Prevention. Most states have administered a fraction of the doses they’ve received, according to data compiled by The New York Times.

Federal officials have said there’s an “expected lag” between delivery of doses, shots going into arms, and the data being reported to the CDC, according to CNN. The Food and Drug Administration must assess each shipment for quality control, which has slowed down distribution, and the CDC data are just now beginning to include the Moderna vaccine, which the FDA authorized for emergency use on Dec. 18.

The 2.1 million number is “an underestimate,” Brett Giroir, MD, the assistant secretary of the U.S. Department of Health & Human Services, told NBC News Dec. 29. At the same time, the U.S. won’t meet the goal of vaccinating 20 million people in the next few days, he said.

Another 30 million doses will go out in January, Dr. Giroir said, followed by 50 million in February.

Some vaccine experts have said they’re not surprised by the speed of vaccine distribution.

“It had to go this way,” Paul Offit, MD, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”

To speed up distribution in 2021, the federal government will need to help states, Mr. Biden said Dec. 29. He plans to use the Defense Authorization Act to ramp up production of vaccine supplies. Even still, the process will take months, he said.

A version of this article first appeared on WebMD.com .

The COVID-19 vaccine distribution process in the United States is moving more slowly than anticipated, falling short of Operation Warp Speed’s goal to vaccinate 20 million Americans by the end of the year.

If the current pace of vaccination continues, “it’s going to take years, not months, to vaccinate the American people,” President-elect Joe Biden said during a briefing Dec. 29.

In fact, at the current rate, it would take nearly 10 years to vaccinate enough Americans to bring the pandemic under control, according to NBC News. To reach 80% of the country by late June, 3 million people would need to receive a COVID-19 vaccine each day.

“As I long feared and warned, the effort to distribute and administer the vaccine is not progressing as it should,” Mr. Biden said, reemphasizing his pledge to get 100 million doses to Americans during his first 100 days as president.

So far, 11.4 million doses have been distributed and 2.1 million people have received a vaccine, according to the Centers for Disease Control and Prevention. Most states have administered a fraction of the doses they’ve received, according to data compiled by The New York Times.

Federal officials have said there’s an “expected lag” between delivery of doses, shots going into arms, and the data being reported to the CDC, according to CNN. The Food and Drug Administration must assess each shipment for quality control, which has slowed down distribution, and the CDC data are just now beginning to include the Moderna vaccine, which the FDA authorized for emergency use on Dec. 18.

The 2.1 million number is “an underestimate,” Brett Giroir, MD, the assistant secretary of the U.S. Department of Health & Human Services, told NBC News Dec. 29. At the same time, the U.S. won’t meet the goal of vaccinating 20 million people in the next few days, he said.

Another 30 million doses will go out in January, Dr. Giroir said, followed by 50 million in February.

Some vaccine experts have said they’re not surprised by the speed of vaccine distribution.

“It had to go this way,” Paul Offit, MD, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”

To speed up distribution in 2021, the federal government will need to help states, Mr. Biden said Dec. 29. He plans to use the Defense Authorization Act to ramp up production of vaccine supplies. Even still, the process will take months, he said.

A version of this article first appeared on WebMD.com .

The COVID-19 vaccine distribution process in the United States is moving more slowly than anticipated, falling short of Operation Warp Speed’s goal to vaccinate 20 million Americans by the end of the year.

If the current pace of vaccination continues, “it’s going to take years, not months, to vaccinate the American people,” President-elect Joe Biden said during a briefing Dec. 29.

In fact, at the current rate, it would take nearly 10 years to vaccinate enough Americans to bring the pandemic under control, according to NBC News. To reach 80% of the country by late June, 3 million people would need to receive a COVID-19 vaccine each day.

“As I long feared and warned, the effort to distribute and administer the vaccine is not progressing as it should,” Mr. Biden said, reemphasizing his pledge to get 100 million doses to Americans during his first 100 days as president.

So far, 11.4 million doses have been distributed and 2.1 million people have received a vaccine, according to the Centers for Disease Control and Prevention. Most states have administered a fraction of the doses they’ve received, according to data compiled by The New York Times.

Federal officials have said there’s an “expected lag” between delivery of doses, shots going into arms, and the data being reported to the CDC, according to CNN. The Food and Drug Administration must assess each shipment for quality control, which has slowed down distribution, and the CDC data are just now beginning to include the Moderna vaccine, which the FDA authorized for emergency use on Dec. 18.

The 2.1 million number is “an underestimate,” Brett Giroir, MD, the assistant secretary of the U.S. Department of Health & Human Services, told NBC News Dec. 29. At the same time, the U.S. won’t meet the goal of vaccinating 20 million people in the next few days, he said.

Another 30 million doses will go out in January, Dr. Giroir said, followed by 50 million in February.

Some vaccine experts have said they’re not surprised by the speed of vaccine distribution.

“It had to go this way,” Paul Offit, MD, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”

To speed up distribution in 2021, the federal government will need to help states, Mr. Biden said Dec. 29. He plans to use the Defense Authorization Act to ramp up production of vaccine supplies. Even still, the process will take months, he said.

A version of this article first appeared on WebMD.com .

A scoring system based on 10 parameters in a complete blood count with differential within 3 days of hospital presentation predict those with COVID-19 who are most likely to progress to critical illness, new evidence shows.

Advantages include prognosis based on a common and inexpensive clinical measure, as well as automatic generation of the score along with CBC results, noted investigators in the observational study conducted throughout 11 European hospitals.

“COVID-19 comes along with specific alterations in circulating blood cells that can be detected by a routine hematology analyzer, especially when that hematology analyzer is also capable to recognize activated immune cells and early circulating blood cells, such as erythroblast and immature granulocytes,” senior author Andre van der Ven, MD, PhD, infectious diseases specialist and professor of international health at Radboud University Medical Center’s Center for Infectious Diseases in Nijmegen, the Netherlands, said in an interview.

Furthermore, Dr. van der Ven said, “these specific changes are also seen in the early course of COVID-19 disease, and more in those that will develop serious disease compared to those with mild disease.”

The study was published online Dec. 21 in the journal eLife.

The study is “almost instinctively correct. It’s basically what clinicians do informally with complete blood count … looking at a combination of results to get the gestalt of what patients are going through,” Samuel Reichberg, MD, PhD, associate medical director of the Northwell Health Core Laboratory in Lake Success, N.Y., said in an interview.

“This is something that begs to be done for COVID-19. I’m surprised no one has done this before,” he added.

Dr. Van der Ven and colleagues created an algorithm based on 1,587 CBC assays from 923 adults. They also validated the scoring system in a second cohort of 217 CBC measurements in 202 people. The findings were concordant – the score accurately predicted the need for critical care within 14 days in 70.5% of the development cohort and 72% of the validation group.

The scoring system was superior to any of the 10 parameters alone. Over 14 days, the majority of those classified as noncritical within the first 3 days remained clinically stable, whereas the “clinical illness” group progressed. Clinical severity peaked on day 6.

Most previous COVID-19 prognosis research was geographically limited, carried a high risk for bias and/or did not validate the findings, Dr. Van der Ven and colleagues noted.
 

Early identification, early intervention

The aim of the score is “to assist with objective risk stratification to support patient management decision-making early on, and thus facilitate timely interventions, such as need for ICU or not, before symptoms of severe illness become clinically overt, with the intention to improve patient outcomes, and not to predict mortality,” the investigators noted.

Dr. Van der Ven and colleagues developed the score based on adults presenting from Feb. 21 to April 6, with outcomes followed until June 9. Median age of the 982 patients was 71 years and approximately two-thirds were men. They used a Sysmex Europe XN-1000 (Hamburg, Germany) hemocytometric analyzer in the study.

Only 7% of this cohort was not admitted to a hospital. Another 74% were admitted to a general ward and the remaining 19% were transferred directly to the ICU.

The scoring system includes parameters for neutrophils, monocytes, red blood cells and immature granulocytes, and when available, reticulocyte and iron bioavailability measures.

The researchers report significant differences over time in the neutrophil-to-lymphocyte ratio between the critical illness and noncritical groups (P < .001), for example. They also found significant differences in hemoglobin levels between cohorts after day 5.

The system generates a score from 0 to 28. Sensitivity for correctly predicting the need for critical care increased from 62% on day 1 to 93% on day 6. 
 

A more objective assessment of risk

The study demonstrated that SARS-CoV-2 infection is characterized by hemocytometric changes over time. These changes, reflected together in the prognostic score, could aid in the early identification of patients whose clinical course is more likely to deteriorate over time.

The findings also support other work that shows men are more likely to present to the hospital with COVID-19, and that older age and presence of comorbidities add to overall risk. “However,” the researchers noted, “not all young patients had a mild course, and not all old patients with comorbidities were critical.”

Therefore, the prognostic score can help identify patients at risk for severe progression outside other risk factors and “support individualized treatment decisions with objective data,” they added.

Dr. Reichberg called the concept of combining CBC parameters into one score “very valuable.” However, he added that incorporating an index into clinical practice “has historically been tricky.”

The results “probably have to be replicated,” Dr. Reichberg said.

He added that it is likely a CBC-based score will be combined with other measures. “I would like to see an index that combines all the tests we do [for COVID-19], including complete blood count.”

Dr. Van der Ven shared the next step in his research. “The algorithm should be installed on the hematology analyzers so the prognostic score will be automatically generated if a full blood count is asked for in a COVID-19 patient,” he said. “So implementation of score is the main focus now.”

Dr. van der Ven disclosed an ad hoc consultancy agreement with Sysmex Europe. Sysmex Europe provided the reagents in the study free of charge; no other funders were involved. Dr. Reichberg has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A scoring system based on 10 parameters in a complete blood count with differential within 3 days of hospital presentation predict those with COVID-19 who are most likely to progress to critical illness, new evidence shows.

Advantages include prognosis based on a common and inexpensive clinical measure, as well as automatic generation of the score along with CBC results, noted investigators in the observational study conducted throughout 11 European hospitals.

“COVID-19 comes along with specific alterations in circulating blood cells that can be detected by a routine hematology analyzer, especially when that hematology analyzer is also capable to recognize activated immune cells and early circulating blood cells, such as erythroblast and immature granulocytes,” senior author Andre van der Ven, MD, PhD, infectious diseases specialist and professor of international health at Radboud University Medical Center’s Center for Infectious Diseases in Nijmegen, the Netherlands, said in an interview.

Furthermore, Dr. van der Ven said, “these specific changes are also seen in the early course of COVID-19 disease, and more in those that will develop serious disease compared to those with mild disease.”

The study was published online Dec. 21 in the journal eLife.

The study is “almost instinctively correct. It’s basically what clinicians do informally with complete blood count … looking at a combination of results to get the gestalt of what patients are going through,” Samuel Reichberg, MD, PhD, associate medical director of the Northwell Health Core Laboratory in Lake Success, N.Y., said in an interview.

“This is something that begs to be done for COVID-19. I’m surprised no one has done this before,” he added.

Dr. Van der Ven and colleagues created an algorithm based on 1,587 CBC assays from 923 adults. They also validated the scoring system in a second cohort of 217 CBC measurements in 202 people. The findings were concordant – the score accurately predicted the need for critical care within 14 days in 70.5% of the development cohort and 72% of the validation group.

The scoring system was superior to any of the 10 parameters alone. Over 14 days, the majority of those classified as noncritical within the first 3 days remained clinically stable, whereas the “clinical illness” group progressed. Clinical severity peaked on day 6.

Most previous COVID-19 prognosis research was geographically limited, carried a high risk for bias and/or did not validate the findings, Dr. Van der Ven and colleagues noted.
 

Early identification, early intervention

The aim of the score is “to assist with objective risk stratification to support patient management decision-making early on, and thus facilitate timely interventions, such as need for ICU or not, before symptoms of severe illness become clinically overt, with the intention to improve patient outcomes, and not to predict mortality,” the investigators noted.

Dr. Van der Ven and colleagues developed the score based on adults presenting from Feb. 21 to April 6, with outcomes followed until June 9. Median age of the 982 patients was 71 years and approximately two-thirds were men. They used a Sysmex Europe XN-1000 (Hamburg, Germany) hemocytometric analyzer in the study.

Only 7% of this cohort was not admitted to a hospital. Another 74% were admitted to a general ward and the remaining 19% were transferred directly to the ICU.

The scoring system includes parameters for neutrophils, monocytes, red blood cells and immature granulocytes, and when available, reticulocyte and iron bioavailability measures.

The researchers report significant differences over time in the neutrophil-to-lymphocyte ratio between the critical illness and noncritical groups (P < .001), for example. They also found significant differences in hemoglobin levels between cohorts after day 5.

The system generates a score from 0 to 28. Sensitivity for correctly predicting the need for critical care increased from 62% on day 1 to 93% on day 6. 
 

A more objective assessment of risk

The study demonstrated that SARS-CoV-2 infection is characterized by hemocytometric changes over time. These changes, reflected together in the prognostic score, could aid in the early identification of patients whose clinical course is more likely to deteriorate over time.

The findings also support other work that shows men are more likely to present to the hospital with COVID-19, and that older age and presence of comorbidities add to overall risk. “However,” the researchers noted, “not all young patients had a mild course, and not all old patients with comorbidities were critical.”

Therefore, the prognostic score can help identify patients at risk for severe progression outside other risk factors and “support individualized treatment decisions with objective data,” they added.

Dr. Reichberg called the concept of combining CBC parameters into one score “very valuable.” However, he added that incorporating an index into clinical practice “has historically been tricky.”

The results “probably have to be replicated,” Dr. Reichberg said.

He added that it is likely a CBC-based score will be combined with other measures. “I would like to see an index that combines all the tests we do [for COVID-19], including complete blood count.”

Dr. Van der Ven shared the next step in his research. “The algorithm should be installed on the hematology analyzers so the prognostic score will be automatically generated if a full blood count is asked for in a COVID-19 patient,” he said. “So implementation of score is the main focus now.”

Dr. van der Ven disclosed an ad hoc consultancy agreement with Sysmex Europe. Sysmex Europe provided the reagents in the study free of charge; no other funders were involved. Dr. Reichberg has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A scoring system based on 10 parameters in a complete blood count with differential within 3 days of hospital presentation predict those with COVID-19 who are most likely to progress to critical illness, new evidence shows.

Advantages include prognosis based on a common and inexpensive clinical measure, as well as automatic generation of the score along with CBC results, noted investigators in the observational study conducted throughout 11 European hospitals.

“COVID-19 comes along with specific alterations in circulating blood cells that can be detected by a routine hematology analyzer, especially when that hematology analyzer is also capable to recognize activated immune cells and early circulating blood cells, such as erythroblast and immature granulocytes,” senior author Andre van der Ven, MD, PhD, infectious diseases specialist and professor of international health at Radboud University Medical Center’s Center for Infectious Diseases in Nijmegen, the Netherlands, said in an interview.

Furthermore, Dr. van der Ven said, “these specific changes are also seen in the early course of COVID-19 disease, and more in those that will develop serious disease compared to those with mild disease.”

The study was published online Dec. 21 in the journal eLife.

The study is “almost instinctively correct. It’s basically what clinicians do informally with complete blood count … looking at a combination of results to get the gestalt of what patients are going through,” Samuel Reichberg, MD, PhD, associate medical director of the Northwell Health Core Laboratory in Lake Success, N.Y., said in an interview.

“This is something that begs to be done for COVID-19. I’m surprised no one has done this before,” he added.

Dr. Van der Ven and colleagues created an algorithm based on 1,587 CBC assays from 923 adults. They also validated the scoring system in a second cohort of 217 CBC measurements in 202 people. The findings were concordant – the score accurately predicted the need for critical care within 14 days in 70.5% of the development cohort and 72% of the validation group.

The scoring system was superior to any of the 10 parameters alone. Over 14 days, the majority of those classified as noncritical within the first 3 days remained clinically stable, whereas the “clinical illness” group progressed. Clinical severity peaked on day 6.

Most previous COVID-19 prognosis research was geographically limited, carried a high risk for bias and/or did not validate the findings, Dr. Van der Ven and colleagues noted.
 

Early identification, early intervention

The aim of the score is “to assist with objective risk stratification to support patient management decision-making early on, and thus facilitate timely interventions, such as need for ICU or not, before symptoms of severe illness become clinically overt, with the intention to improve patient outcomes, and not to predict mortality,” the investigators noted.

Dr. Van der Ven and colleagues developed the score based on adults presenting from Feb. 21 to April 6, with outcomes followed until June 9. Median age of the 982 patients was 71 years and approximately two-thirds were men. They used a Sysmex Europe XN-1000 (Hamburg, Germany) hemocytometric analyzer in the study.

Only 7% of this cohort was not admitted to a hospital. Another 74% were admitted to a general ward and the remaining 19% were transferred directly to the ICU.

The scoring system includes parameters for neutrophils, monocytes, red blood cells and immature granulocytes, and when available, reticulocyte and iron bioavailability measures.

The researchers report significant differences over time in the neutrophil-to-lymphocyte ratio between the critical illness and noncritical groups (P < .001), for example. They also found significant differences in hemoglobin levels between cohorts after day 5.

The system generates a score from 0 to 28. Sensitivity for correctly predicting the need for critical care increased from 62% on day 1 to 93% on day 6. 
 

A more objective assessment of risk

The study demonstrated that SARS-CoV-2 infection is characterized by hemocytometric changes over time. These changes, reflected together in the prognostic score, could aid in the early identification of patients whose clinical course is more likely to deteriorate over time.

The findings also support other work that shows men are more likely to present to the hospital with COVID-19, and that older age and presence of comorbidities add to overall risk. “However,” the researchers noted, “not all young patients had a mild course, and not all old patients with comorbidities were critical.”

Therefore, the prognostic score can help identify patients at risk for severe progression outside other risk factors and “support individualized treatment decisions with objective data,” they added.

Dr. Reichberg called the concept of combining CBC parameters into one score “very valuable.” However, he added that incorporating an index into clinical practice “has historically been tricky.”

The results “probably have to be replicated,” Dr. Reichberg said.

He added that it is likely a CBC-based score will be combined with other measures. “I would like to see an index that combines all the tests we do [for COVID-19], including complete blood count.”

Dr. Van der Ven shared the next step in his research. “The algorithm should be installed on the hematology analyzers so the prognostic score will be automatically generated if a full blood count is asked for in a COVID-19 patient,” he said. “So implementation of score is the main focus now.”

Dr. van der Ven disclosed an ad hoc consultancy agreement with Sysmex Europe. Sysmex Europe provided the reagents in the study free of charge; no other funders were involved. Dr. Reichberg has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. has distributed more than 11.4 million doses of the Pfizer and Moderna COVID-19 vaccines, and more than 2.1 million of those had been given to people as of December 28, according to the CDC.

The CDC’s COVID Data Tracker showed the updated numbers as of 9 a.m. on that day. The distribution total is based on the CDC’s Vaccine Tracking System, and the administered total is based on reports from state and local public health departments, as well as updates from five federal agencies: the Bureau of Prisons, Veterans Administration, Department of Defense, Department of State, and Indian Health Services.

Health care providers report to public health agencies up to 72 hours after the vaccine is given, and public health agencies report to the CDC after that, so there may be a lag in the data. The CDC’s numbers will be updated on Mondays, Wednesdays, and Fridays.

“A large difference between the number of doses distributed and the number of doses administered is expected at this point in the COVID vaccination program due to several factors,” the CDC says.

Delays could occur due to the reporting of doses given, how states and local vaccine sites are managing vaccines, and the pending launch of vaccination through the federal Pharmacy Partnership for Long-Term Care Program.

“Numbers reported on other websites may differ from what is posted on CDC’s website because CDC’s overall numbers are validated through a data submission process with each jurisdiction,” the CDC says.

On Dec. 26, the agency’s tally showed that 9.5 million doses had been distributed and 1.9 million had been given, according to Reuters.

Public health officials and health care workers have begun to voice their concerns about the delay in giving the vaccines.

“We certainly are not at the numbers that we wanted to be at the end of December,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNNDec. 29.

Operation Warp Speed had planned for 20 million people to be vaccinated by the end of the year. Fauci said he hopes that number will be achieved next month.

“I believe that as we get into January, we are going to see an increase in the momentum,” he said.

Shipment delays have affected other priority groups as well. The New York Police Department anticipated a rollout Dec. 29, but it’s now been delayed since the department hasn’t received enough Moderna doses to start giving the shots, according to the New York Daily News.

“We’ve made numerous attempts to get updated information, and when we get further word on its availability, we will immediately keep our members appraised of the new date and the method of distribution,” Paul DiGiacomo, president of the Detectives’ Endowment Association, wrote in a memo to members on Dec. 28.

“Every detective squad has been crushed with [COVID-19],” he told the newspaper. “Within the last couple of weeks, we’ve had at least two detectives hospitalized.”

President-elect Joe Biden will receive a briefing from his COVID-19 advisory team, provide a general update on the pandemic, and describe his own plan for vaccinating people quickly during an address Dec. 29, a transition official told Axios. Biden has pledged to administer 100 million vaccine doses in his first 100 days in office.
 

A version of this article originally appeared on WebMd.

The U.S. has distributed more than 11.4 million doses of the Pfizer and Moderna COVID-19 vaccines, and more than 2.1 million of those had been given to people as of December 28, according to the CDC.

The CDC’s COVID Data Tracker showed the updated numbers as of 9 a.m. on that day. The distribution total is based on the CDC’s Vaccine Tracking System, and the administered total is based on reports from state and local public health departments, as well as updates from five federal agencies: the Bureau of Prisons, Veterans Administration, Department of Defense, Department of State, and Indian Health Services.

Health care providers report to public health agencies up to 72 hours after the vaccine is given, and public health agencies report to the CDC after that, so there may be a lag in the data. The CDC’s numbers will be updated on Mondays, Wednesdays, and Fridays.

“A large difference between the number of doses distributed and the number of doses administered is expected at this point in the COVID vaccination program due to several factors,” the CDC says.

Delays could occur due to the reporting of doses given, how states and local vaccine sites are managing vaccines, and the pending launch of vaccination through the federal Pharmacy Partnership for Long-Term Care Program.

“Numbers reported on other websites may differ from what is posted on CDC’s website because CDC’s overall numbers are validated through a data submission process with each jurisdiction,” the CDC says.

On Dec. 26, the agency’s tally showed that 9.5 million doses had been distributed and 1.9 million had been given, according to Reuters.

Public health officials and health care workers have begun to voice their concerns about the delay in giving the vaccines.

“We certainly are not at the numbers that we wanted to be at the end of December,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNNDec. 29.

Operation Warp Speed had planned for 20 million people to be vaccinated by the end of the year. Fauci said he hopes that number will be achieved next month.

“I believe that as we get into January, we are going to see an increase in the momentum,” he said.

Shipment delays have affected other priority groups as well. The New York Police Department anticipated a rollout Dec. 29, but it’s now been delayed since the department hasn’t received enough Moderna doses to start giving the shots, according to the New York Daily News.

“We’ve made numerous attempts to get updated information, and when we get further word on its availability, we will immediately keep our members appraised of the new date and the method of distribution,” Paul DiGiacomo, president of the Detectives’ Endowment Association, wrote in a memo to members on Dec. 28.

“Every detective squad has been crushed with [COVID-19],” he told the newspaper. “Within the last couple of weeks, we’ve had at least two detectives hospitalized.”

President-elect Joe Biden will receive a briefing from his COVID-19 advisory team, provide a general update on the pandemic, and describe his own plan for vaccinating people quickly during an address Dec. 29, a transition official told Axios. Biden has pledged to administer 100 million vaccine doses in his first 100 days in office.
 

A version of this article originally appeared on WebMd.

The U.S. has distributed more than 11.4 million doses of the Pfizer and Moderna COVID-19 vaccines, and more than 2.1 million of those had been given to people as of December 28, according to the CDC.

The CDC’s COVID Data Tracker showed the updated numbers as of 9 a.m. on that day. The distribution total is based on the CDC’s Vaccine Tracking System, and the administered total is based on reports from state and local public health departments, as well as updates from five federal agencies: the Bureau of Prisons, Veterans Administration, Department of Defense, Department of State, and Indian Health Services.

Health care providers report to public health agencies up to 72 hours after the vaccine is given, and public health agencies report to the CDC after that, so there may be a lag in the data. The CDC’s numbers will be updated on Mondays, Wednesdays, and Fridays.

“A large difference between the number of doses distributed and the number of doses administered is expected at this point in the COVID vaccination program due to several factors,” the CDC says.

Delays could occur due to the reporting of doses given, how states and local vaccine sites are managing vaccines, and the pending launch of vaccination through the federal Pharmacy Partnership for Long-Term Care Program.

“Numbers reported on other websites may differ from what is posted on CDC’s website because CDC’s overall numbers are validated through a data submission process with each jurisdiction,” the CDC says.

On Dec. 26, the agency’s tally showed that 9.5 million doses had been distributed and 1.9 million had been given, according to Reuters.

Public health officials and health care workers have begun to voice their concerns about the delay in giving the vaccines.

“We certainly are not at the numbers that we wanted to be at the end of December,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNNDec. 29.

Operation Warp Speed had planned for 20 million people to be vaccinated by the end of the year. Fauci said he hopes that number will be achieved next month.

“I believe that as we get into January, we are going to see an increase in the momentum,” he said.

Shipment delays have affected other priority groups as well. The New York Police Department anticipated a rollout Dec. 29, but it’s now been delayed since the department hasn’t received enough Moderna doses to start giving the shots, according to the New York Daily News.

“We’ve made numerous attempts to get updated information, and when we get further word on its availability, we will immediately keep our members appraised of the new date and the method of distribution,” Paul DiGiacomo, president of the Detectives’ Endowment Association, wrote in a memo to members on Dec. 28.

“Every detective squad has been crushed with [COVID-19],” he told the newspaper. “Within the last couple of weeks, we’ve had at least two detectives hospitalized.”

President-elect Joe Biden will receive a briefing from his COVID-19 advisory team, provide a general update on the pandemic, and describe his own plan for vaccinating people quickly during an address Dec. 29, a transition official told Axios. Biden has pledged to administer 100 million vaccine doses in his first 100 days in office.
 

A version of this article originally appeared on WebMd.

The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.

scyther5/thinkstock

“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” 

Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.

The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.

People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.

There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.

Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17. 

But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”

Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.

“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”

For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.

scyther5/thinkstock

“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” 

Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.

The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.

People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.

There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.

Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17. 

But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”

Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.

“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”

For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine.

scyther5/thinkstock

“Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19,” the CDC said in the guidance, posted on Dec. 26. “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” 

Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA.

The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barré syndrome (GBS) and Bell’s palsy who are thinking of getting the vaccine.

People with HIV and weakened immune systems “may receive a COVID-19 vaccine. However, they should be aware of the limited safety data,” the CDC said.

There’s no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but “safety data specific to this group are not yet available at this time,” the CDC said.

Cases of Bell’s palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the Food and Drug Administration said Dec. 17. 

But the new CDC guidance said that the FDA “does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s palsy may receive an mRNA COVID-19 vaccine.”

Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body’s immune system attacks nerves just as they leave the spinal cord, the CDC said.

“To date, no cases of GBS have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials,” the CDC guidance said. “With few exceptions, the independent Advisory Committee on Immunization Practices general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.”

For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.

A version of this article first appeared on Medscape.com.

Oxidative stress may account for the “lipid paradox,” a higher incidence of heart disease burden found in nonobese rheumatoid arthritis (RA) patients with lower levels of low-density lipoprotein (LDL). George Karpouzas, MD, an investigator at the Lundquist Institute of Biomedical Innovation, St, Torrance, Calif., discussed this exploratory finding at the virtual annual meeting of the American College of Rheumatology.

A complex dynamic exists between traditional risk factors and cardiovascular (CV) events in RA patients, said Dr. Karpouzas, professor of medicine at the University of California, Los Angeles, and chief of the division of rheumatology, Harbor-UCLA Medical Center. “Lower lipid levels, specifically total cholesterol and to a lesser extent LDL, may be associated with higher risk,” he said. One recent study found that coronary artery calcium (CAC) scores were four times higher in RA patients with lower LDL concentrations (> 70 mg/dL) than those in control groups. “This was especially true in patients who were nonobese, non-Hispanic Whites and never smokers,” said Dr. Karpouzas. Other studies have reported this association between low LDL and increased CVD risk.

These paradoxes led to several questions: Does obesity modify the effect of LDL on cardiovascular disease (CVD) risk in RA and does it moderate the effect of LDL on coronary plaque burden and progression? Do LDL particle composition and oxidation variations underlie the paradoxical association of low LDL with higher coronary atherosclerosis burden in RA? To find answers, Dr. Karpouzas’ team in the Prospective Evaluation of Latent Coronary Atherosclerosis in Rheumatoid Arthritis (PROTECT-RA) trial studied a cohort of 150 established RA patients without symptoms or diagnosis of CV disease.

Dr. Karpouzas presented two oral abstracts that summarized this research during the ACR 2020 session, “RA, diagnosis, manifestations and outcomes: heart of the matter,” which was held virtually.
 

Higher plaque burden seen in nonobese patients

In one part of the study, patients underwent baseline cardiac coronary CT angiography (CTA) over 1 year (2010-2011). Investigators evaluated CAC scores, segment involvement scores (SIS), segment stenosis scores (SSS), and extensive and obstructive disease. Low LDL was defined as < 70 mg/dL, obesity as a waist to height ratio of > 0.58 squared.

Investigators in follow-up work (2017-2018) evaluated for plaque progression, prospectively recording all cardiovascular disease events such as cardiac death, myocardial infarction, unstable angina, stroke, and heart failure hospitalization. Multivariable models assessed the effects of LDL lower than 70 mg/dL, obesity, and their interaction, accounting for factors such as age, sex, statin use, diabetes and hypertension.
 

Four LDL obesity cohorts

Nonobese RA patients with low LDL exhibited the highest plaque burden. “Despite no differences in RA inflammation, patients in this group were more likely to exhibit high levels of LDL oxidation,” Dr. Karpouzas said in an interview. “Nonobese patients with low LDL more likely exhibited new coronary plaque formation as well as increased stenotic severity of prevalent plaque after adjustments for relevant covariates,” he added.

The study’s observational nature exposed it to biases and unmeasured confounding, Dr. Karpouzas emphasized. Because it took place in a single center, the results might not be generalizable to ethnically and racially diverse cohorts. Patients with calcifications, extensive or obstructive coronary plaque at baseline scan received more aggressive treatments, which could have slowed CVD event risk and plaque progression. Investigators cautioned that the results should be seen as “exploratory,” given that CVD event analysis wasn’t applied to the original study design.
 

The oxidation-LDL connection

Another arm of the study examined the oxidation association question. Investigators did a similar analysis of the same patients but also evaluated for cholesterol content, Lp(a) mass, OxLDL levels, IgG and IgM anti-OxLDL and apoB100 immune complexes and proinflammatory cytokines.

RA patients with LDL lower than 70 mg/dL had higher SSS and CAC scores and were more likely to have extensive or obstructive plaque. Statin-naive patients with lower LDL exhibited greater LDL oxidation than higher LDL groups. In addition, those with lower LDL had higher anti-OxLDL and apoB100 than patients with higher LDL.

“Oxidation makes the cholesterol more ‘sticky,’ allowing it to penetrate into the walls of the endothelium, and changes macrophages to foam cells. This malignant process is very powerful and can potentially increase atheroma burden,” study coauthor Matthew Budoff, MD, professor of medicine at UCLA and endowed chair of preventive cardiology at the Lundquist Institute, said in an interview.

Investigators also found an independent association between Lp(a) content and LDL oxidation. This association seemed strong in patients with lower LDL compared to higher LDL groups. In addition, “greater oxidation and immune recognition of oxLDL further associated with higher IL-6 elaboration which may in turn augment atherosclerosis burden in the low LDL group,” said Dr. Karpouzas.

The analysis did not explore alternate mechanisms such as increased cholesterol loading capacity, lower efflux capacity or increased hepatocyte uptake through LDL-R upregulation, a key limitation. Dr. Karpouzas also acknowledged that higher cumulative inflammatory burden incurred before evaluating low LDL patients at baseline may have led to greater coronary plaque burden.

Overall, the study shows that low LDL is not protective in this population, said Dr. Budoff. “Low LDL patients who have atherosclerosis should be treated with statins and other therapies to lower their CV risk.”
 

Larger studies to confirm associations

Attendees of the ACR 2020 session called for additional studies to confirm that LDL oxidation leads to increased coronary atherosclerotic burden in RA patients.

The study provides “mechanistic insight into this important problem for patients with RA,” noted Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine at Harvard Medical School and associate physician at Brigham and Women’s Hospital, Boston.

Some of the patients studied were on lipid-lowering drugs such as statins, though the statistical analysis adjusted for use of these medications, noted Dr. Sparks. “It is possible that excess systemic inflammation alone is responsible for changes in LDL oxidation that may ultimately lead to cardiovascular disease,” he offered.

Future mechanistic and interventional studies related specifically to LDL oxidation “should establish the importance of this pathway in the development of cardiovascular disease in patients with RA,” said Dr. Sparks.

Large studies of patients with different BMI and LDL values followed prospectively for CV events would be ideal, said Joel M. Kremer, MD, president of the Corrona Research Foundation and founder of Corrona, a biopharma data solutions firm. Investigators would need to follow patients for several years. And, such a venture might face some obstacles. “The practical impediments and cost would be substantial. Also, as LDL oxidation may be related to disease activity, there would be ethical and pragmatic issues associated with controlling disease activity in these patients. This would obscure these outcomes of interest,” said Dr. Kremer.

Dr. Karpouzas receives grant and research support from the American Heart Association and Pfizer-Aspire. Dr. Budoff receives grant support from General Electric.

[email protected]

SOURCE: Karpouzas G et al. ACR 2020. Abstract 0485 and Abstract 0486.

Oxidative stress may account for the “lipid paradox,” a higher incidence of heart disease burden found in nonobese rheumatoid arthritis (RA) patients with lower levels of low-density lipoprotein (LDL). George Karpouzas, MD, an investigator at the Lundquist Institute of Biomedical Innovation, St, Torrance, Calif., discussed this exploratory finding at the virtual annual meeting of the American College of Rheumatology.

A complex dynamic exists between traditional risk factors and cardiovascular (CV) events in RA patients, said Dr. Karpouzas, professor of medicine at the University of California, Los Angeles, and chief of the division of rheumatology, Harbor-UCLA Medical Center. “Lower lipid levels, specifically total cholesterol and to a lesser extent LDL, may be associated with higher risk,” he said. One recent study found that coronary artery calcium (CAC) scores were four times higher in RA patients with lower LDL concentrations (> 70 mg/dL) than those in control groups. “This was especially true in patients who were nonobese, non-Hispanic Whites and never smokers,” said Dr. Karpouzas. Other studies have reported this association between low LDL and increased CVD risk.

These paradoxes led to several questions: Does obesity modify the effect of LDL on cardiovascular disease (CVD) risk in RA and does it moderate the effect of LDL on coronary plaque burden and progression? Do LDL particle composition and oxidation variations underlie the paradoxical association of low LDL with higher coronary atherosclerosis burden in RA? To find answers, Dr. Karpouzas’ team in the Prospective Evaluation of Latent Coronary Atherosclerosis in Rheumatoid Arthritis (PROTECT-RA) trial studied a cohort of 150 established RA patients without symptoms or diagnosis of CV disease.

Dr. Karpouzas presented two oral abstracts that summarized this research during the ACR 2020 session, “RA, diagnosis, manifestations and outcomes: heart of the matter,” which was held virtually.
 

Higher plaque burden seen in nonobese patients

In one part of the study, patients underwent baseline cardiac coronary CT angiography (CTA) over 1 year (2010-2011). Investigators evaluated CAC scores, segment involvement scores (SIS), segment stenosis scores (SSS), and extensive and obstructive disease. Low LDL was defined as < 70 mg/dL, obesity as a waist to height ratio of > 0.58 squared.

Investigators in follow-up work (2017-2018) evaluated for plaque progression, prospectively recording all cardiovascular disease events such as cardiac death, myocardial infarction, unstable angina, stroke, and heart failure hospitalization. Multivariable models assessed the effects of LDL lower than 70 mg/dL, obesity, and their interaction, accounting for factors such as age, sex, statin use, diabetes and hypertension.
 

Four LDL obesity cohorts

Nonobese RA patients with low LDL exhibited the highest plaque burden. “Despite no differences in RA inflammation, patients in this group were more likely to exhibit high levels of LDL oxidation,” Dr. Karpouzas said in an interview. “Nonobese patients with low LDL more likely exhibited new coronary plaque formation as well as increased stenotic severity of prevalent plaque after adjustments for relevant covariates,” he added.

The study’s observational nature exposed it to biases and unmeasured confounding, Dr. Karpouzas emphasized. Because it took place in a single center, the results might not be generalizable to ethnically and racially diverse cohorts. Patients with calcifications, extensive or obstructive coronary plaque at baseline scan received more aggressive treatments, which could have slowed CVD event risk and plaque progression. Investigators cautioned that the results should be seen as “exploratory,” given that CVD event analysis wasn’t applied to the original study design.
 

The oxidation-LDL connection

Another arm of the study examined the oxidation association question. Investigators did a similar analysis of the same patients but also evaluated for cholesterol content, Lp(a) mass, OxLDL levels, IgG and IgM anti-OxLDL and apoB100 immune complexes and proinflammatory cytokines.

RA patients with LDL lower than 70 mg/dL had higher SSS and CAC scores and were more likely to have extensive or obstructive plaque. Statin-naive patients with lower LDL exhibited greater LDL oxidation than higher LDL groups. In addition, those with lower LDL had higher anti-OxLDL and apoB100 than patients with higher LDL.

“Oxidation makes the cholesterol more ‘sticky,’ allowing it to penetrate into the walls of the endothelium, and changes macrophages to foam cells. This malignant process is very powerful and can potentially increase atheroma burden,” study coauthor Matthew Budoff, MD, professor of medicine at UCLA and endowed chair of preventive cardiology at the Lundquist Institute, said in an interview.

Investigators also found an independent association between Lp(a) content and LDL oxidation. This association seemed strong in patients with lower LDL compared to higher LDL groups. In addition, “greater oxidation and immune recognition of oxLDL further associated with higher IL-6 elaboration which may in turn augment atherosclerosis burden in the low LDL group,” said Dr. Karpouzas.

The analysis did not explore alternate mechanisms such as increased cholesterol loading capacity, lower efflux capacity or increased hepatocyte uptake through LDL-R upregulation, a key limitation. Dr. Karpouzas also acknowledged that higher cumulative inflammatory burden incurred before evaluating low LDL patients at baseline may have led to greater coronary plaque burden.

Overall, the study shows that low LDL is not protective in this population, said Dr. Budoff. “Low LDL patients who have atherosclerosis should be treated with statins and other therapies to lower their CV risk.”
 

Larger studies to confirm associations

Attendees of the ACR 2020 session called for additional studies to confirm that LDL oxidation leads to increased coronary atherosclerotic burden in RA patients.

The study provides “mechanistic insight into this important problem for patients with RA,” noted Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine at Harvard Medical School and associate physician at Brigham and Women’s Hospital, Boston.

Some of the patients studied were on lipid-lowering drugs such as statins, though the statistical analysis adjusted for use of these medications, noted Dr. Sparks. “It is possible that excess systemic inflammation alone is responsible for changes in LDL oxidation that may ultimately lead to cardiovascular disease,” he offered.

Future mechanistic and interventional studies related specifically to LDL oxidation “should establish the importance of this pathway in the development of cardiovascular disease in patients with RA,” said Dr. Sparks.

Large studies of patients with different BMI and LDL values followed prospectively for CV events would be ideal, said Joel M. Kremer, MD, president of the Corrona Research Foundation and founder of Corrona, a biopharma data solutions firm. Investigators would need to follow patients for several years. And, such a venture might face some obstacles. “The practical impediments and cost would be substantial. Also, as LDL oxidation may be related to disease activity, there would be ethical and pragmatic issues associated with controlling disease activity in these patients. This would obscure these outcomes of interest,” said Dr. Kremer.

Dr. Karpouzas receives grant and research support from the American Heart Association and Pfizer-Aspire. Dr. Budoff receives grant support from General Electric.

[email protected]

SOURCE: Karpouzas G et al. ACR 2020. Abstract 0485 and Abstract 0486.

Oxidative stress may account for the “lipid paradox,” a higher incidence of heart disease burden found in nonobese rheumatoid arthritis (RA) patients with lower levels of low-density lipoprotein (LDL). George Karpouzas, MD, an investigator at the Lundquist Institute of Biomedical Innovation, St, Torrance, Calif., discussed this exploratory finding at the virtual annual meeting of the American College of Rheumatology.

A complex dynamic exists between traditional risk factors and cardiovascular (CV) events in RA patients, said Dr. Karpouzas, professor of medicine at the University of California, Los Angeles, and chief of the division of rheumatology, Harbor-UCLA Medical Center. “Lower lipid levels, specifically total cholesterol and to a lesser extent LDL, may be associated with higher risk,” he said. One recent study found that coronary artery calcium (CAC) scores were four times higher in RA patients with lower LDL concentrations (> 70 mg/dL) than those in control groups. “This was especially true in patients who were nonobese, non-Hispanic Whites and never smokers,” said Dr. Karpouzas. Other studies have reported this association between low LDL and increased CVD risk.

These paradoxes led to several questions: Does obesity modify the effect of LDL on cardiovascular disease (CVD) risk in RA and does it moderate the effect of LDL on coronary plaque burden and progression? Do LDL particle composition and oxidation variations underlie the paradoxical association of low LDL with higher coronary atherosclerosis burden in RA? To find answers, Dr. Karpouzas’ team in the Prospective Evaluation of Latent Coronary Atherosclerosis in Rheumatoid Arthritis (PROTECT-RA) trial studied a cohort of 150 established RA patients without symptoms or diagnosis of CV disease.

Dr. Karpouzas presented two oral abstracts that summarized this research during the ACR 2020 session, “RA, diagnosis, manifestations and outcomes: heart of the matter,” which was held virtually.
 

Higher plaque burden seen in nonobese patients

In one part of the study, patients underwent baseline cardiac coronary CT angiography (CTA) over 1 year (2010-2011). Investigators evaluated CAC scores, segment involvement scores (SIS), segment stenosis scores (SSS), and extensive and obstructive disease. Low LDL was defined as < 70 mg/dL, obesity as a waist to height ratio of > 0.58 squared.

Investigators in follow-up work (2017-2018) evaluated for plaque progression, prospectively recording all cardiovascular disease events such as cardiac death, myocardial infarction, unstable angina, stroke, and heart failure hospitalization. Multivariable models assessed the effects of LDL lower than 70 mg/dL, obesity, and their interaction, accounting for factors such as age, sex, statin use, diabetes and hypertension.
 

Four LDL obesity cohorts

Nonobese RA patients with low LDL exhibited the highest plaque burden. “Despite no differences in RA inflammation, patients in this group were more likely to exhibit high levels of LDL oxidation,” Dr. Karpouzas said in an interview. “Nonobese patients with low LDL more likely exhibited new coronary plaque formation as well as increased stenotic severity of prevalent plaque after adjustments for relevant covariates,” he added.

The study’s observational nature exposed it to biases and unmeasured confounding, Dr. Karpouzas emphasized. Because it took place in a single center, the results might not be generalizable to ethnically and racially diverse cohorts. Patients with calcifications, extensive or obstructive coronary plaque at baseline scan received more aggressive treatments, which could have slowed CVD event risk and plaque progression. Investigators cautioned that the results should be seen as “exploratory,” given that CVD event analysis wasn’t applied to the original study design.
 

The oxidation-LDL connection

Another arm of the study examined the oxidation association question. Investigators did a similar analysis of the same patients but also evaluated for cholesterol content, Lp(a) mass, OxLDL levels, IgG and IgM anti-OxLDL and apoB100 immune complexes and proinflammatory cytokines.

RA patients with LDL lower than 70 mg/dL had higher SSS and CAC scores and were more likely to have extensive or obstructive plaque. Statin-naive patients with lower LDL exhibited greater LDL oxidation than higher LDL groups. In addition, those with lower LDL had higher anti-OxLDL and apoB100 than patients with higher LDL.

“Oxidation makes the cholesterol more ‘sticky,’ allowing it to penetrate into the walls of the endothelium, and changes macrophages to foam cells. This malignant process is very powerful and can potentially increase atheroma burden,” study coauthor Matthew Budoff, MD, professor of medicine at UCLA and endowed chair of preventive cardiology at the Lundquist Institute, said in an interview.

Investigators also found an independent association between Lp(a) content and LDL oxidation. This association seemed strong in patients with lower LDL compared to higher LDL groups. In addition, “greater oxidation and immune recognition of oxLDL further associated with higher IL-6 elaboration which may in turn augment atherosclerosis burden in the low LDL group,” said Dr. Karpouzas.

The analysis did not explore alternate mechanisms such as increased cholesterol loading capacity, lower efflux capacity or increased hepatocyte uptake through LDL-R upregulation, a key limitation. Dr. Karpouzas also acknowledged that higher cumulative inflammatory burden incurred before evaluating low LDL patients at baseline may have led to greater coronary plaque burden.

Overall, the study shows that low LDL is not protective in this population, said Dr. Budoff. “Low LDL patients who have atherosclerosis should be treated with statins and other therapies to lower their CV risk.”
 

Larger studies to confirm associations

Attendees of the ACR 2020 session called for additional studies to confirm that LDL oxidation leads to increased coronary atherosclerotic burden in RA patients.

The study provides “mechanistic insight into this important problem for patients with RA,” noted Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine at Harvard Medical School and associate physician at Brigham and Women’s Hospital, Boston.

Some of the patients studied were on lipid-lowering drugs such as statins, though the statistical analysis adjusted for use of these medications, noted Dr. Sparks. “It is possible that excess systemic inflammation alone is responsible for changes in LDL oxidation that may ultimately lead to cardiovascular disease,” he offered.

Future mechanistic and interventional studies related specifically to LDL oxidation “should establish the importance of this pathway in the development of cardiovascular disease in patients with RA,” said Dr. Sparks.

Large studies of patients with different BMI and LDL values followed prospectively for CV events would be ideal, said Joel M. Kremer, MD, president of the Corrona Research Foundation and founder of Corrona, a biopharma data solutions firm. Investigators would need to follow patients for several years. And, such a venture might face some obstacles. “The practical impediments and cost would be substantial. Also, as LDL oxidation may be related to disease activity, there would be ethical and pragmatic issues associated with controlling disease activity in these patients. This would obscure these outcomes of interest,” said Dr. Kremer.

Dr. Karpouzas receives grant and research support from the American Heart Association and Pfizer-Aspire. Dr. Budoff receives grant support from General Electric.

[email protected]

SOURCE: Karpouzas G et al. ACR 2020. Abstract 0485 and Abstract 0486.