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NETs a possible therapeutic target for COVID-19 thrombosis?

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Thu, 08/26/2021 - 15:53

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.

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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.

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Far too few with treatment-resistant hypertension get hormone test

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Tue, 01/05/2021 - 10:49

 

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.

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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.

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COVID-19 vaccine rollout faces delays

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Thu, 08/26/2021 - 15:53

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 .

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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 .

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Complete blood count scoring can predict COVID-19 severity 

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Thu, 08/26/2021 - 15:53

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.

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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.

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New dietary guidelines omit recommended cuts to sugar, alcohol intake

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Tue, 01/05/2021 - 19:10

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

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Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

  • Follow a healthy dietary pattern at every life stage.
  • Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
  • Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
  • Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

 

 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

  • Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
  • Fruits (especially whole fruit).
  • Grains, at least half of which are whole grain. 
  • Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
  • Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
  • Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

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The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

  • Follow a healthy dietary pattern at every life stage.
  • Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
  • Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
  • Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

 

 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

  • Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
  • Fruits (especially whole fruit).
  • Grains, at least half of which are whole grain. 
  • Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
  • Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
  • Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

  • Follow a healthy dietary pattern at every life stage.
  • Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
  • Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
  • Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

 

 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

  • Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
  • Fruits (especially whole fruit).
  • Grains, at least half of which are whole grain. 
  • Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
  • Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
  • Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

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2.1 Million COVID Vaccine Doses Given in U.S.

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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.

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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.

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CDC issues COVID-19 vaccine guidance for underlying conditions

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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.

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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.

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"Lipid paradox” seen in nonobese RA patients with low LDL

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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.

Dr. George Karpouzas

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.

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

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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.

Dr. George Karpouzas

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.

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.

Dr. George Karpouzas

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.

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

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Scant risk for SARS-CoV-2 from hospital air

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Everywhere they look within hospitals, researchers find RNA from SARS-CoV-2 in the air. But viable viruses typically are found only close to patients, according to a review of published studies.

The finding supports recommendations to use surgical masks in most parts of the hospital, reserving respirators (such as N95 or FFP2) for aerosol-generating procedures on patients’ respiratory tracts, said Gabriel Birgand, PhD, an infectious disease researcher at Imperial College London.

“When the virus is spreading a lot in the community, it’s probably more likely for you to be contaminated in your friends’ areas or in your building than in your work area, where you are well equipped and compliant with all the measures,” he said in an interview. “So it’s pretty good news.”

The systematic review by Dr. Birgand and colleagues was published in JAMA Network Open.

Recommended precautions to protect health care workers from SARS-CoV-2 infections remain controversial. Most authorities believe droplets are the primary route of transmission, which would mean surgical masks may be sufficient protection. But some research has suggested transmission by aerosols as well, making N95 respirators seem necessary. There is even disagreement about the definitions of the words “aerosol” and “droplet.”

To better understand where traces of the virus can be found in the air in hospitals, Dr. Birgand and colleagues analyzed all the studies they could find on the subject in English.

They identified 24 articles with original data. All of the studies used reverse transcription–polymerase chain reaction (PCR) tests to identify SARS-CoV-2 RNA. In five studies, attempts were also made to culture viable viruses. Three studies assessed the particle size relative to RNA concentration or viral titer.

Of 893 air samples across the 24 studies, 52.7% were taken from areas close to patients, 26.5% were taken in clinical areas, 13.7% in staff areas, 4.7% in public areas, and 2.4% in toilets or bathrooms.

Among those studies that quantified RNA, the median interquartile range of concentrations varied from 1.0 x 103 copies/m3 in clinical areas to 9.7 x 103 copies/m3 in toilets or bathrooms.

One study found an RNA concentration of 2.0 x 103 copies for particle sizes >4 mcm and 1.3 x 103 copies/m3 for particle sizes ≤4 mcm, both in patients’ rooms.

Three studies included viral cultures; of those, two resulted in positive cultures, both in a non-ICU setting. In one study, 3 of 39 samples were positive, and in the other, 4 of 4 were positive. Viral cultures in toilets, clinical areas, staff areas, and public areas were negative.

One of these studies assessed viral concentration and found that the median interquartile range was 4.8 tissue culture infectious dose (TCID50)/m3 for particles <1 mcm, 4.27 TCID50/m3 for particles 1-4 mcm, and 1.82 TCID50/m3 for particles >4 mcm.

Although viable viruses weren’t found in staff areas, the presence of viral RNA in places such as dining rooms and meeting rooms raises a concern, Dr. Birgand said.

“All of these staff areas are probably playing an important role in contamination,” he said. “It’s pretty easy to see when you are dining, you are not wearing a face mask, and it’s associated with a strong risk when there is a strong dissemination of the virus in the community.”

Studies on contact tracing among health care workers have also identified meeting rooms and dining rooms as the second most common source of infection after community contact, he said.

In general, the findings of the review correspond to epidemiologic studies, said Angela Rasmussen, PhD, a virologist with the Georgetown University Center for Global Health Science and Security, Washington, who was not involved in the review. “Absent aerosol-generating procedures, health care workers are largely not getting infected when they take droplet precautions.”

One reason may be that patients shed the most infectious viruses a couple of days before and after symptoms begin. By the time they’re hospitalized, they’re less likely to be contagious but may continue to shed viral RNA.

“We don’t really know the basis for the persistence of RNA being produced long after people have been infected and have recovered from the acute infection,” she said, “but it has been observed quite frequently.”

Although the virus cannot remain viable for very long in the air, remnants may still be detected in the form of RNA, Dr. Rasmussen said. In addition, hospitals often do a good job of ventilation.

She pointed out that it can be difficult to cultivate viruses in air samples because of contaminants such as bacteria and fungi. “That’s one of the limitations of a study like this. You’re not really sure if it’s because there’s no viable virus there or because you just aren’t able to collect samples that would allow you to determine that.”

Dr. Birgand and colleagues acknowledged other limitations. The studies they reviewed used different approaches to sampling. Different procedures may have been underway in the rooms being sampled, and factors such as temperature and humidity could have affected the results. In addition, the studies used different cycle thresholds for PCR positivity.

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

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Everywhere they look within hospitals, researchers find RNA from SARS-CoV-2 in the air. But viable viruses typically are found only close to patients, according to a review of published studies.

The finding supports recommendations to use surgical masks in most parts of the hospital, reserving respirators (such as N95 or FFP2) for aerosol-generating procedures on patients’ respiratory tracts, said Gabriel Birgand, PhD, an infectious disease researcher at Imperial College London.

“When the virus is spreading a lot in the community, it’s probably more likely for you to be contaminated in your friends’ areas or in your building than in your work area, where you are well equipped and compliant with all the measures,” he said in an interview. “So it’s pretty good news.”

The systematic review by Dr. Birgand and colleagues was published in JAMA Network Open.

Recommended precautions to protect health care workers from SARS-CoV-2 infections remain controversial. Most authorities believe droplets are the primary route of transmission, which would mean surgical masks may be sufficient protection. But some research has suggested transmission by aerosols as well, making N95 respirators seem necessary. There is even disagreement about the definitions of the words “aerosol” and “droplet.”

To better understand where traces of the virus can be found in the air in hospitals, Dr. Birgand and colleagues analyzed all the studies they could find on the subject in English.

They identified 24 articles with original data. All of the studies used reverse transcription–polymerase chain reaction (PCR) tests to identify SARS-CoV-2 RNA. In five studies, attempts were also made to culture viable viruses. Three studies assessed the particle size relative to RNA concentration or viral titer.

Of 893 air samples across the 24 studies, 52.7% were taken from areas close to patients, 26.5% were taken in clinical areas, 13.7% in staff areas, 4.7% in public areas, and 2.4% in toilets or bathrooms.

Among those studies that quantified RNA, the median interquartile range of concentrations varied from 1.0 x 103 copies/m3 in clinical areas to 9.7 x 103 copies/m3 in toilets or bathrooms.

One study found an RNA concentration of 2.0 x 103 copies for particle sizes >4 mcm and 1.3 x 103 copies/m3 for particle sizes ≤4 mcm, both in patients’ rooms.

Three studies included viral cultures; of those, two resulted in positive cultures, both in a non-ICU setting. In one study, 3 of 39 samples were positive, and in the other, 4 of 4 were positive. Viral cultures in toilets, clinical areas, staff areas, and public areas were negative.

One of these studies assessed viral concentration and found that the median interquartile range was 4.8 tissue culture infectious dose (TCID50)/m3 for particles <1 mcm, 4.27 TCID50/m3 for particles 1-4 mcm, and 1.82 TCID50/m3 for particles >4 mcm.

Although viable viruses weren’t found in staff areas, the presence of viral RNA in places such as dining rooms and meeting rooms raises a concern, Dr. Birgand said.

“All of these staff areas are probably playing an important role in contamination,” he said. “It’s pretty easy to see when you are dining, you are not wearing a face mask, and it’s associated with a strong risk when there is a strong dissemination of the virus in the community.”

Studies on contact tracing among health care workers have also identified meeting rooms and dining rooms as the second most common source of infection after community contact, he said.

In general, the findings of the review correspond to epidemiologic studies, said Angela Rasmussen, PhD, a virologist with the Georgetown University Center for Global Health Science and Security, Washington, who was not involved in the review. “Absent aerosol-generating procedures, health care workers are largely not getting infected when they take droplet precautions.”

One reason may be that patients shed the most infectious viruses a couple of days before and after symptoms begin. By the time they’re hospitalized, they’re less likely to be contagious but may continue to shed viral RNA.

“We don’t really know the basis for the persistence of RNA being produced long after people have been infected and have recovered from the acute infection,” she said, “but it has been observed quite frequently.”

Although the virus cannot remain viable for very long in the air, remnants may still be detected in the form of RNA, Dr. Rasmussen said. In addition, hospitals often do a good job of ventilation.

She pointed out that it can be difficult to cultivate viruses in air samples because of contaminants such as bacteria and fungi. “That’s one of the limitations of a study like this. You’re not really sure if it’s because there’s no viable virus there or because you just aren’t able to collect samples that would allow you to determine that.”

Dr. Birgand and colleagues acknowledged other limitations. The studies they reviewed used different approaches to sampling. Different procedures may have been underway in the rooms being sampled, and factors such as temperature and humidity could have affected the results. In addition, the studies used different cycle thresholds for PCR positivity.

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

Everywhere they look within hospitals, researchers find RNA from SARS-CoV-2 in the air. But viable viruses typically are found only close to patients, according to a review of published studies.

The finding supports recommendations to use surgical masks in most parts of the hospital, reserving respirators (such as N95 or FFP2) for aerosol-generating procedures on patients’ respiratory tracts, said Gabriel Birgand, PhD, an infectious disease researcher at Imperial College London.

“When the virus is spreading a lot in the community, it’s probably more likely for you to be contaminated in your friends’ areas or in your building than in your work area, where you are well equipped and compliant with all the measures,” he said in an interview. “So it’s pretty good news.”

The systematic review by Dr. Birgand and colleagues was published in JAMA Network Open.

Recommended precautions to protect health care workers from SARS-CoV-2 infections remain controversial. Most authorities believe droplets are the primary route of transmission, which would mean surgical masks may be sufficient protection. But some research has suggested transmission by aerosols as well, making N95 respirators seem necessary. There is even disagreement about the definitions of the words “aerosol” and “droplet.”

To better understand where traces of the virus can be found in the air in hospitals, Dr. Birgand and colleagues analyzed all the studies they could find on the subject in English.

They identified 24 articles with original data. All of the studies used reverse transcription–polymerase chain reaction (PCR) tests to identify SARS-CoV-2 RNA. In five studies, attempts were also made to culture viable viruses. Three studies assessed the particle size relative to RNA concentration or viral titer.

Of 893 air samples across the 24 studies, 52.7% were taken from areas close to patients, 26.5% were taken in clinical areas, 13.7% in staff areas, 4.7% in public areas, and 2.4% in toilets or bathrooms.

Among those studies that quantified RNA, the median interquartile range of concentrations varied from 1.0 x 103 copies/m3 in clinical areas to 9.7 x 103 copies/m3 in toilets or bathrooms.

One study found an RNA concentration of 2.0 x 103 copies for particle sizes >4 mcm and 1.3 x 103 copies/m3 for particle sizes ≤4 mcm, both in patients’ rooms.

Three studies included viral cultures; of those, two resulted in positive cultures, both in a non-ICU setting. In one study, 3 of 39 samples were positive, and in the other, 4 of 4 were positive. Viral cultures in toilets, clinical areas, staff areas, and public areas were negative.

One of these studies assessed viral concentration and found that the median interquartile range was 4.8 tissue culture infectious dose (TCID50)/m3 for particles <1 mcm, 4.27 TCID50/m3 for particles 1-4 mcm, and 1.82 TCID50/m3 for particles >4 mcm.

Although viable viruses weren’t found in staff areas, the presence of viral RNA in places such as dining rooms and meeting rooms raises a concern, Dr. Birgand said.

“All of these staff areas are probably playing an important role in contamination,” he said. “It’s pretty easy to see when you are dining, you are not wearing a face mask, and it’s associated with a strong risk when there is a strong dissemination of the virus in the community.”

Studies on contact tracing among health care workers have also identified meeting rooms and dining rooms as the second most common source of infection after community contact, he said.

In general, the findings of the review correspond to epidemiologic studies, said Angela Rasmussen, PhD, a virologist with the Georgetown University Center for Global Health Science and Security, Washington, who was not involved in the review. “Absent aerosol-generating procedures, health care workers are largely not getting infected when they take droplet precautions.”

One reason may be that patients shed the most infectious viruses a couple of days before and after symptoms begin. By the time they’re hospitalized, they’re less likely to be contagious but may continue to shed viral RNA.

“We don’t really know the basis for the persistence of RNA being produced long after people have been infected and have recovered from the acute infection,” she said, “but it has been observed quite frequently.”

Although the virus cannot remain viable for very long in the air, remnants may still be detected in the form of RNA, Dr. Rasmussen said. In addition, hospitals often do a good job of ventilation.

She pointed out that it can be difficult to cultivate viruses in air samples because of contaminants such as bacteria and fungi. “That’s one of the limitations of a study like this. You’re not really sure if it’s because there’s no viable virus there or because you just aren’t able to collect samples that would allow you to determine that.”

Dr. Birgand and colleagues acknowledged other limitations. The studies they reviewed used different approaches to sampling. Different procedures may have been underway in the rooms being sampled, and factors such as temperature and humidity could have affected the results. In addition, the studies used different cycle thresholds for PCR positivity.

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

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New resilience center targets traumatized health care workers

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A physician assistant participating in a virtual workshop began to cry, confessing that she felt overwhelmed with guilt because New Yorkers were hailing her as a frontline hero in the pandemic. That was when Joe Ciavarro knew he was in the right place.

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“She was saying all the things I could not verbalize because I, too, didn’t feel like I deserved all this praise and thousands of people cheering for us every evening when people were losing jobs, didn’t have money for food, and their loved ones were dying without family at their side,” says Mr. Ciavarro, a PA at Mount Sinai Medical Center in New York.

Mr. Ciavarro, who also manages 170 other PAs on two of Mount Sinai’s campuses in Manhattan, has been on the front lines since COVID-19 first hit; he lost a colleague and friend to suicide in September.

The mental anguish from his job prompted him to sign up for the resilience workshop offered by Mount Sinai’s Center for Stress, Resilience, and Personal Growth. The center – the first of its kind in North America – was launched in June to help health care workers like him cope with the intense psychological pressures they were facing. The weekly workshops became a safe place where Mr. Ciavarro and other staff members could share their darkest fears and learn ways to help them deal with their situation.

“It’s been grueling but we learned how to take care of ourselves so we can take care of our patients,” said Mr. Ciavarro. “This has become like a guided group therapy session on ways to manage and develop resilience. And I feel like my emotions are validated, knowing that others feel the same way.”
 

Caring for their own

Medical professionals treating patients with COVID-19 are in similar predicaments, and the psychological fallout is enormous: They’re exhausted by the seemingly never-ending patient load and staffing shortages, and haunted by fears for their own safety and that of their families. Studies in ChinaCanada, and Italy have revealed that a significant number of doctors and nurses in the early days of the pandemic experienced high levels of distress, depression, anxiety, nightmares, and insomnia.

Trauma experts at Mount Sinai believe that, globally, up to 40% of first responders and health care workers – tens of thousands of people – will suffer from PTSD after witnessing the deaths of so many patients who were alone, without family.

Dr. Dennis Charney


But the resilience workshop that Mr. Ciavarro attended offers some hope and is part of a multifaceted program that aims to be a model for other institutions and communities. The Mount Sinai health system already had some programs in place, including centers for 9/11 responders, for spirituality and health, and a wellness program to aid burned-out doctors. But the leadership at Mount Sinai, which includes psychiatrist Dennis Charney, MD, dean of the medical school and a leading expert on PTSD, knew early in the pandemic that emotional and psychological distress would plague health care workers, according to Deborah Marin, MD, director of the new center.

“We decided to quickly put in place a program that we could do virtually, with workshops and apps, that would give access to several services above and beyond what was already going on,” says Dr. Marin, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, who also directs their center for spirituality and health.

The key components include a comprehensive screening tool that helps doctors at the center identify which potential participants are most at risk. Participants build personal inventories that detail the intensity of work-related exposures, personal or family stressors that have arisen because of the pandemic, or any mental health conditions or substance abuse problems that may make staff members more vulnerable.

The weekly workshops led by trained staff are designed to give participants the tools to foster resilience and process their experiences. Online apps provide feedback on their progress and engage them with video and other resources around meditation, relaxation, and resilience techniques.

In addition, all 40,000 members of the Mount Sinai staff are eligible for up to 14 one-on-one sessions with psychologists and psychiatrists who specialize in treating trauma.

“That’s highly unusual – to offer this at no cost to everyone,” said Dr. Marin. “We also have a treatment service that is specifically focused on behavioral health care, so people can learn better coping strategies, and we also have social workers to provide coaching.”

While the center doesn’t have specific numbers on how many nurses, physicians, and other staff have participated in treatment, they have trained over 70 peer leaders for their five workshops that home in on the most important factors of resilience.

Dr. Craig Katz


“We’ve gotten enthusiastic responses from PAs and nurses,” said Craig Katz, MD, an expert in disaster psychiatry at Mount Sinai and a workshop moderator. Physicians have been slower to get on board. “Doctors are a tough nut to crack – it’s largely a culture where they may burn out but don’t want to talk about it. And asking for help is a hard transition for physicians to make.”

How to protect in midst of trauma

In formulating the program’s platform, Mount Sinai experts drew upon their extensive experience aiding 9/11 responders at the World Trade Center (WTC), as well as their system-wide wellness program that aids demoralized and burned-out physicians. While the reach of the pandemic is much broader than 9/11, experts see some commonalities in conditions that emerge after traumatic events, and they also discovered what can help.

Dr. Jonathan DePierro

“We learned from our WTC experience about what are protective factors – what are the social supports that buffer against depression, anxiety, and PTSD,” said Jonathan DePierro, PhD, clinical director of CSRPG and a psychologist at the Mount Sinai WTC Mental Health Program. “We also learned that people who have more prolonged exposures are at greater risk of developing mental health difficulties.”

The program itself reflects these lessons – and that’s why it’s open to all employees, not just medical professionals. Housekeepers, security staffers, even construction workers are also dealing with their lives being in danger. “That wasn’t in their job description,” said Dr. DePierro. “These people tend to have fewer social and economic resources, make less money and have fewer structural supports, which makes them even more vulnerable.”

Dr. Charney’s strategies on building resilience became a bible of sorts for the workshops, according to Dr. Katz, who authored the training curriculum. Sessions deal with how to build up reservoirs of realistic optimism, keep gratitude journals, find spiritual meaning in their lives, maintain physical wellness and create networks of social support. The workshops are meant to help participants create action plans, to reach out for support in their social networks, and keep the focus on the positives.

The goal is to give demoralized health care workers a renewed sense of competence. “The resilience workshop is a launching point to get people to show up and talk,” said Dr. Katz. “And if we do that, we’ve accomplished a lot just getting people in the door.”

The center will also have a research component to identify what works and what doesn’t so their platform can provide a template for other institutions; Dr. Marin said they’ve gotten inquiries about the program from major hospital systems in Michigan and California. They’ll also conduct longitudinal research to determine what lingering problems persist among healthcare workers over time.

Since the center opened its virtual doors, the curriculum has also been altered in response to feedback from the support staff, many of whom live in the community that surrounds Mount Sinai in northern Manhattan, which is largely lower-income Latinx and Black individuals. Workshop materials have been translated into Spanish and now feature people who reflect a more diverse set of experiences.

“Many of our employees and the population we serve identify as non-White so we’ve been doing outreach with a lot of the local unions,” said Dr. Marin. “Our next step is to take what we’re doing and work with local community organizations.”

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

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A physician assistant participating in a virtual workshop began to cry, confessing that she felt overwhelmed with guilt because New Yorkers were hailing her as a frontline hero in the pandemic. That was when Joe Ciavarro knew he was in the right place.

rclassenlayouts/Getty Images

“She was saying all the things I could not verbalize because I, too, didn’t feel like I deserved all this praise and thousands of people cheering for us every evening when people were losing jobs, didn’t have money for food, and their loved ones were dying without family at their side,” says Mr. Ciavarro, a PA at Mount Sinai Medical Center in New York.

Mr. Ciavarro, who also manages 170 other PAs on two of Mount Sinai’s campuses in Manhattan, has been on the front lines since COVID-19 first hit; he lost a colleague and friend to suicide in September.

The mental anguish from his job prompted him to sign up for the resilience workshop offered by Mount Sinai’s Center for Stress, Resilience, and Personal Growth. The center – the first of its kind in North America – was launched in June to help health care workers like him cope with the intense psychological pressures they were facing. The weekly workshops became a safe place where Mr. Ciavarro and other staff members could share their darkest fears and learn ways to help them deal with their situation.

“It’s been grueling but we learned how to take care of ourselves so we can take care of our patients,” said Mr. Ciavarro. “This has become like a guided group therapy session on ways to manage and develop resilience. And I feel like my emotions are validated, knowing that others feel the same way.”
 

Caring for their own

Medical professionals treating patients with COVID-19 are in similar predicaments, and the psychological fallout is enormous: They’re exhausted by the seemingly never-ending patient load and staffing shortages, and haunted by fears for their own safety and that of their families. Studies in ChinaCanada, and Italy have revealed that a significant number of doctors and nurses in the early days of the pandemic experienced high levels of distress, depression, anxiety, nightmares, and insomnia.

Trauma experts at Mount Sinai believe that, globally, up to 40% of first responders and health care workers – tens of thousands of people – will suffer from PTSD after witnessing the deaths of so many patients who were alone, without family.

Dr. Dennis Charney


But the resilience workshop that Mr. Ciavarro attended offers some hope and is part of a multifaceted program that aims to be a model for other institutions and communities. The Mount Sinai health system already had some programs in place, including centers for 9/11 responders, for spirituality and health, and a wellness program to aid burned-out doctors. But the leadership at Mount Sinai, which includes psychiatrist Dennis Charney, MD, dean of the medical school and a leading expert on PTSD, knew early in the pandemic that emotional and psychological distress would plague health care workers, according to Deborah Marin, MD, director of the new center.

“We decided to quickly put in place a program that we could do virtually, with workshops and apps, that would give access to several services above and beyond what was already going on,” says Dr. Marin, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, who also directs their center for spirituality and health.

The key components include a comprehensive screening tool that helps doctors at the center identify which potential participants are most at risk. Participants build personal inventories that detail the intensity of work-related exposures, personal or family stressors that have arisen because of the pandemic, or any mental health conditions or substance abuse problems that may make staff members more vulnerable.

The weekly workshops led by trained staff are designed to give participants the tools to foster resilience and process their experiences. Online apps provide feedback on their progress and engage them with video and other resources around meditation, relaxation, and resilience techniques.

In addition, all 40,000 members of the Mount Sinai staff are eligible for up to 14 one-on-one sessions with psychologists and psychiatrists who specialize in treating trauma.

“That’s highly unusual – to offer this at no cost to everyone,” said Dr. Marin. “We also have a treatment service that is specifically focused on behavioral health care, so people can learn better coping strategies, and we also have social workers to provide coaching.”

While the center doesn’t have specific numbers on how many nurses, physicians, and other staff have participated in treatment, they have trained over 70 peer leaders for their five workshops that home in on the most important factors of resilience.

Dr. Craig Katz


“We’ve gotten enthusiastic responses from PAs and nurses,” said Craig Katz, MD, an expert in disaster psychiatry at Mount Sinai and a workshop moderator. Physicians have been slower to get on board. “Doctors are a tough nut to crack – it’s largely a culture where they may burn out but don’t want to talk about it. And asking for help is a hard transition for physicians to make.”

How to protect in midst of trauma

In formulating the program’s platform, Mount Sinai experts drew upon their extensive experience aiding 9/11 responders at the World Trade Center (WTC), as well as their system-wide wellness program that aids demoralized and burned-out physicians. While the reach of the pandemic is much broader than 9/11, experts see some commonalities in conditions that emerge after traumatic events, and they also discovered what can help.

Dr. Jonathan DePierro

“We learned from our WTC experience about what are protective factors – what are the social supports that buffer against depression, anxiety, and PTSD,” said Jonathan DePierro, PhD, clinical director of CSRPG and a psychologist at the Mount Sinai WTC Mental Health Program. “We also learned that people who have more prolonged exposures are at greater risk of developing mental health difficulties.”

The program itself reflects these lessons – and that’s why it’s open to all employees, not just medical professionals. Housekeepers, security staffers, even construction workers are also dealing with their lives being in danger. “That wasn’t in their job description,” said Dr. DePierro. “These people tend to have fewer social and economic resources, make less money and have fewer structural supports, which makes them even more vulnerable.”

Dr. Charney’s strategies on building resilience became a bible of sorts for the workshops, according to Dr. Katz, who authored the training curriculum. Sessions deal with how to build up reservoirs of realistic optimism, keep gratitude journals, find spiritual meaning in their lives, maintain physical wellness and create networks of social support. The workshops are meant to help participants create action plans, to reach out for support in their social networks, and keep the focus on the positives.

The goal is to give demoralized health care workers a renewed sense of competence. “The resilience workshop is a launching point to get people to show up and talk,” said Dr. Katz. “And if we do that, we’ve accomplished a lot just getting people in the door.”

The center will also have a research component to identify what works and what doesn’t so their platform can provide a template for other institutions; Dr. Marin said they’ve gotten inquiries about the program from major hospital systems in Michigan and California. They’ll also conduct longitudinal research to determine what lingering problems persist among healthcare workers over time.

Since the center opened its virtual doors, the curriculum has also been altered in response to feedback from the support staff, many of whom live in the community that surrounds Mount Sinai in northern Manhattan, which is largely lower-income Latinx and Black individuals. Workshop materials have been translated into Spanish and now feature people who reflect a more diverse set of experiences.

“Many of our employees and the population we serve identify as non-White so we’ve been doing outreach with a lot of the local unions,” said Dr. Marin. “Our next step is to take what we’re doing and work with local community organizations.”

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

A physician assistant participating in a virtual workshop began to cry, confessing that she felt overwhelmed with guilt because New Yorkers were hailing her as a frontline hero in the pandemic. That was when Joe Ciavarro knew he was in the right place.

rclassenlayouts/Getty Images

“She was saying all the things I could not verbalize because I, too, didn’t feel like I deserved all this praise and thousands of people cheering for us every evening when people were losing jobs, didn’t have money for food, and their loved ones were dying without family at their side,” says Mr. Ciavarro, a PA at Mount Sinai Medical Center in New York.

Mr. Ciavarro, who also manages 170 other PAs on two of Mount Sinai’s campuses in Manhattan, has been on the front lines since COVID-19 first hit; he lost a colleague and friend to suicide in September.

The mental anguish from his job prompted him to sign up for the resilience workshop offered by Mount Sinai’s Center for Stress, Resilience, and Personal Growth. The center – the first of its kind in North America – was launched in June to help health care workers like him cope with the intense psychological pressures they were facing. The weekly workshops became a safe place where Mr. Ciavarro and other staff members could share their darkest fears and learn ways to help them deal with their situation.

“It’s been grueling but we learned how to take care of ourselves so we can take care of our patients,” said Mr. Ciavarro. “This has become like a guided group therapy session on ways to manage and develop resilience. And I feel like my emotions are validated, knowing that others feel the same way.”
 

Caring for their own

Medical professionals treating patients with COVID-19 are in similar predicaments, and the psychological fallout is enormous: They’re exhausted by the seemingly never-ending patient load and staffing shortages, and haunted by fears for their own safety and that of their families. Studies in ChinaCanada, and Italy have revealed that a significant number of doctors and nurses in the early days of the pandemic experienced high levels of distress, depression, anxiety, nightmares, and insomnia.

Trauma experts at Mount Sinai believe that, globally, up to 40% of first responders and health care workers – tens of thousands of people – will suffer from PTSD after witnessing the deaths of so many patients who were alone, without family.

Dr. Dennis Charney


But the resilience workshop that Mr. Ciavarro attended offers some hope and is part of a multifaceted program that aims to be a model for other institutions and communities. The Mount Sinai health system already had some programs in place, including centers for 9/11 responders, for spirituality and health, and a wellness program to aid burned-out doctors. But the leadership at Mount Sinai, which includes psychiatrist Dennis Charney, MD, dean of the medical school and a leading expert on PTSD, knew early in the pandemic that emotional and psychological distress would plague health care workers, according to Deborah Marin, MD, director of the new center.

“We decided to quickly put in place a program that we could do virtually, with workshops and apps, that would give access to several services above and beyond what was already going on,” says Dr. Marin, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, who also directs their center for spirituality and health.

The key components include a comprehensive screening tool that helps doctors at the center identify which potential participants are most at risk. Participants build personal inventories that detail the intensity of work-related exposures, personal or family stressors that have arisen because of the pandemic, or any mental health conditions or substance abuse problems that may make staff members more vulnerable.

The weekly workshops led by trained staff are designed to give participants the tools to foster resilience and process their experiences. Online apps provide feedback on their progress and engage them with video and other resources around meditation, relaxation, and resilience techniques.

In addition, all 40,000 members of the Mount Sinai staff are eligible for up to 14 one-on-one sessions with psychologists and psychiatrists who specialize in treating trauma.

“That’s highly unusual – to offer this at no cost to everyone,” said Dr. Marin. “We also have a treatment service that is specifically focused on behavioral health care, so people can learn better coping strategies, and we also have social workers to provide coaching.”

While the center doesn’t have specific numbers on how many nurses, physicians, and other staff have participated in treatment, they have trained over 70 peer leaders for their five workshops that home in on the most important factors of resilience.

Dr. Craig Katz


“We’ve gotten enthusiastic responses from PAs and nurses,” said Craig Katz, MD, an expert in disaster psychiatry at Mount Sinai and a workshop moderator. Physicians have been slower to get on board. “Doctors are a tough nut to crack – it’s largely a culture where they may burn out but don’t want to talk about it. And asking for help is a hard transition for physicians to make.”

How to protect in midst of trauma

In formulating the program’s platform, Mount Sinai experts drew upon their extensive experience aiding 9/11 responders at the World Trade Center (WTC), as well as their system-wide wellness program that aids demoralized and burned-out physicians. While the reach of the pandemic is much broader than 9/11, experts see some commonalities in conditions that emerge after traumatic events, and they also discovered what can help.

Dr. Jonathan DePierro

“We learned from our WTC experience about what are protective factors – what are the social supports that buffer against depression, anxiety, and PTSD,” said Jonathan DePierro, PhD, clinical director of CSRPG and a psychologist at the Mount Sinai WTC Mental Health Program. “We also learned that people who have more prolonged exposures are at greater risk of developing mental health difficulties.”

The program itself reflects these lessons – and that’s why it’s open to all employees, not just medical professionals. Housekeepers, security staffers, even construction workers are also dealing with their lives being in danger. “That wasn’t in their job description,” said Dr. DePierro. “These people tend to have fewer social and economic resources, make less money and have fewer structural supports, which makes them even more vulnerable.”

Dr. Charney’s strategies on building resilience became a bible of sorts for the workshops, according to Dr. Katz, who authored the training curriculum. Sessions deal with how to build up reservoirs of realistic optimism, keep gratitude journals, find spiritual meaning in their lives, maintain physical wellness and create networks of social support. The workshops are meant to help participants create action plans, to reach out for support in their social networks, and keep the focus on the positives.

The goal is to give demoralized health care workers a renewed sense of competence. “The resilience workshop is a launching point to get people to show up and talk,” said Dr. Katz. “And if we do that, we’ve accomplished a lot just getting people in the door.”

The center will also have a research component to identify what works and what doesn’t so their platform can provide a template for other institutions; Dr. Marin said they’ve gotten inquiries about the program from major hospital systems in Michigan and California. They’ll also conduct longitudinal research to determine what lingering problems persist among healthcare workers over time.

Since the center opened its virtual doors, the curriculum has also been altered in response to feedback from the support staff, many of whom live in the community that surrounds Mount Sinai in northern Manhattan, which is largely lower-income Latinx and Black individuals. Workshop materials have been translated into Spanish and now feature people who reflect a more diverse set of experiences.

“Many of our employees and the population we serve identify as non-White so we’ve been doing outreach with a lot of the local unions,” said Dr. Marin. “Our next step is to take what we’re doing and work with local community organizations.”

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

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