The Hospitalist

The greatest relative benefit from omecamtiv mecarbil, a member of the novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.

The findings reinforce the potential for this drug to be helpful in the management of the most advanced stages of heart failure with reduced ejection fraction (HFrEF), reported John R. Teerlink, MD, director of heart failure at San Francisco Veterans Affairs Medical Center, at the annual scientific sessions of the American College of Cardiology.

The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure–related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.

Drilling down on ejection fraction

The new analysis divided participants into quartiles of baseline LVEF and then compared relative outcomes and safety.

In the lowest quartile, defined by a LVEF of 22% or lower, the reduction in risk of events reached 17% (hazard ratio, 0.83; 95% confidence interval, 0.73-0.95) for omecamtiv mecarbil relative to placebo. In the highest, defined by a LVEF of 33% or greater, the benefit fell short of significance (HR 0.99; 95% CI, 0.84-1.16). Across quartiles, LVEF was the “strongest modifier of the treatment effect,” emerging in this analysis as a statistically significant (P = .004) continuous variable.

The comparison by LVEF quartiles also provided an opportunity to show that omecamtiv mecarbil was as safe and well tolerated in those with the most advanced disease as in those less sick. At the lowest levels of LVEF, like the higher levels, omecamtiv mecarbil did not produce any adverse effects on blood pressure, heart rate, potassium homeostasis, or renal function.

In GALACTIC-HF, 8,256 HFrEF patients with LVEF 35% or less were randomized to omecamtiv mecarbil or placebo. The primary composite outcome of hospitalization or urgent visit for heart failure or death from cardiovascular causes was evaluated after a median of 21.8 months on therapy.

When incidence rate per 100 patient years was graphed against the range of LVEF, the relative advantage of omecamtiv mecarbil became visible just below an LVEF of 30%, climbing steadily even to the lowest LVEF, which reached 10%.

Perhaps relevant to the reduction in events, there were also greater relative reductions in NT-proBNP (NT-proB-type natriuretic peptide) for omecamtiv mecarbil at lower relative to higher LVEF. Although omecamtiv mecarbil is not associated with any direct vascular, electrophysiologic, or neurohormonal effects, according to Dr. Teerlink, the indirect effects of selective binding to cardiac myosin has been associated with lower NT-proBNP and other biomarkers of cardiac remodeling in prior clinical studies.

Although Dr. Teerlink acknowledged that relatively few patients in GALACTIC-HF received an angiotensin-receptor neprilysin inhibitor (ARNI) or a sodium glucose cotransporter-2 (SGLT2) inhibitor, he said there is “every reason to believe that omecamtiv mecarbil would be complementary to these therapies.” He said the mechanism of action of omecamtiv mecarbil, which improves systolic function, has no overlap with these drugs.

Importantly, there is a particular need for new treatment options in patients with advanced LVEF, according to Dr. Teerlink, who cited evidence, for example, that “the beneficial effect of [the ARNI] sacubitril valsartan, while still significant, decreases in patients with LVEF less than 35%.”

Overall, based on these results, “we believe that omecamtiv mecarbil represents a novel therapy that holds the promise of improving clinical outcomes in patients with severely reduced ejection fraction, which are the very patients that are most challenging for us to treat,” Dr. Teerlink said.
 

Omecamtiv mecarbil may ‘buy you some time’

Ileana Piña, MD, clinical professor of medicine, Central Michigan University, Mount Pleasant, Mich., agreed. She said that omecamtiv mecarbil, if approved, will be an option for the type of HFrEF patients who are being considered for heart transplant or mechanical-assist devices.

“We are very loath to use inotropes in this population, because we know that ultimately the inotrope is not going to do well,” said Dr. Piña, calling these therapies a “Band-Aid.” Based on the evidence from GALACTIC-HF, she thinks that omecamtiv mecarbil will be more versatile.

“This drug does not increase myocardial oxygen demand as do the inotropes, and it can be given in the outpatient setting if need be, so I see this as a real advance,” Dr. Piña said. Although Dr. Piña acknowledged that omecamtiv mecarbil did not reduce mortality in the GALACTIC-HF trial, “at least it will buy you some time.”

Dr. Teerlink has financial relationships with multiple pharmaceutical companies, including Amgen, Cytogenetics, and Servier, which provided funding for the GALACTIC-HF trial. Dr. Piña reports no potential conflicts of interest.

The greatest relative benefit from omecamtiv mecarbil, a member of the novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.

The findings reinforce the potential for this drug to be helpful in the management of the most advanced stages of heart failure with reduced ejection fraction (HFrEF), reported John R. Teerlink, MD, director of heart failure at San Francisco Veterans Affairs Medical Center, at the annual scientific sessions of the American College of Cardiology.

The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure–related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.

Drilling down on ejection fraction

The new analysis divided participants into quartiles of baseline LVEF and then compared relative outcomes and safety.

In the lowest quartile, defined by a LVEF of 22% or lower, the reduction in risk of events reached 17% (hazard ratio, 0.83; 95% confidence interval, 0.73-0.95) for omecamtiv mecarbil relative to placebo. In the highest, defined by a LVEF of 33% or greater, the benefit fell short of significance (HR 0.99; 95% CI, 0.84-1.16). Across quartiles, LVEF was the “strongest modifier of the treatment effect,” emerging in this analysis as a statistically significant (P = .004) continuous variable.

The comparison by LVEF quartiles also provided an opportunity to show that omecamtiv mecarbil was as safe and well tolerated in those with the most advanced disease as in those less sick. At the lowest levels of LVEF, like the higher levels, omecamtiv mecarbil did not produce any adverse effects on blood pressure, heart rate, potassium homeostasis, or renal function.

In GALACTIC-HF, 8,256 HFrEF patients with LVEF 35% or less were randomized to omecamtiv mecarbil or placebo. The primary composite outcome of hospitalization or urgent visit for heart failure or death from cardiovascular causes was evaluated after a median of 21.8 months on therapy.

When incidence rate per 100 patient years was graphed against the range of LVEF, the relative advantage of omecamtiv mecarbil became visible just below an LVEF of 30%, climbing steadily even to the lowest LVEF, which reached 10%.

Perhaps relevant to the reduction in events, there were also greater relative reductions in NT-proBNP (NT-proB-type natriuretic peptide) for omecamtiv mecarbil at lower relative to higher LVEF. Although omecamtiv mecarbil is not associated with any direct vascular, electrophysiologic, or neurohormonal effects, according to Dr. Teerlink, the indirect effects of selective binding to cardiac myosin has been associated with lower NT-proBNP and other biomarkers of cardiac remodeling in prior clinical studies.

Although Dr. Teerlink acknowledged that relatively few patients in GALACTIC-HF received an angiotensin-receptor neprilysin inhibitor (ARNI) or a sodium glucose cotransporter-2 (SGLT2) inhibitor, he said there is “every reason to believe that omecamtiv mecarbil would be complementary to these therapies.” He said the mechanism of action of omecamtiv mecarbil, which improves systolic function, has no overlap with these drugs.

Importantly, there is a particular need for new treatment options in patients with advanced LVEF, according to Dr. Teerlink, who cited evidence, for example, that “the beneficial effect of [the ARNI] sacubitril valsartan, while still significant, decreases in patients with LVEF less than 35%.”

Overall, based on these results, “we believe that omecamtiv mecarbil represents a novel therapy that holds the promise of improving clinical outcomes in patients with severely reduced ejection fraction, which are the very patients that are most challenging for us to treat,” Dr. Teerlink said.
 

Omecamtiv mecarbil may ‘buy you some time’

Ileana Piña, MD, clinical professor of medicine, Central Michigan University, Mount Pleasant, Mich., agreed. She said that omecamtiv mecarbil, if approved, will be an option for the type of HFrEF patients who are being considered for heart transplant or mechanical-assist devices.

“We are very loath to use inotropes in this population, because we know that ultimately the inotrope is not going to do well,” said Dr. Piña, calling these therapies a “Band-Aid.” Based on the evidence from GALACTIC-HF, she thinks that omecamtiv mecarbil will be more versatile.

“This drug does not increase myocardial oxygen demand as do the inotropes, and it can be given in the outpatient setting if need be, so I see this as a real advance,” Dr. Piña said. Although Dr. Piña acknowledged that omecamtiv mecarbil did not reduce mortality in the GALACTIC-HF trial, “at least it will buy you some time.”

Dr. Teerlink has financial relationships with multiple pharmaceutical companies, including Amgen, Cytogenetics, and Servier, which provided funding for the GALACTIC-HF trial. Dr. Piña reports no potential conflicts of interest.

The greatest relative benefit from omecamtiv mecarbil, a member of the novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.

The findings reinforce the potential for this drug to be helpful in the management of the most advanced stages of heart failure with reduced ejection fraction (HFrEF), reported John R. Teerlink, MD, director of heart failure at San Francisco Veterans Affairs Medical Center, at the annual scientific sessions of the American College of Cardiology.

The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure–related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.

Drilling down on ejection fraction

The new analysis divided participants into quartiles of baseline LVEF and then compared relative outcomes and safety.

In the lowest quartile, defined by a LVEF of 22% or lower, the reduction in risk of events reached 17% (hazard ratio, 0.83; 95% confidence interval, 0.73-0.95) for omecamtiv mecarbil relative to placebo. In the highest, defined by a LVEF of 33% or greater, the benefit fell short of significance (HR 0.99; 95% CI, 0.84-1.16). Across quartiles, LVEF was the “strongest modifier of the treatment effect,” emerging in this analysis as a statistically significant (P = .004) continuous variable.

The comparison by LVEF quartiles also provided an opportunity to show that omecamtiv mecarbil was as safe and well tolerated in those with the most advanced disease as in those less sick. At the lowest levels of LVEF, like the higher levels, omecamtiv mecarbil did not produce any adverse effects on blood pressure, heart rate, potassium homeostasis, or renal function.

In GALACTIC-HF, 8,256 HFrEF patients with LVEF 35% or less were randomized to omecamtiv mecarbil or placebo. The primary composite outcome of hospitalization or urgent visit for heart failure or death from cardiovascular causes was evaluated after a median of 21.8 months on therapy.

When incidence rate per 100 patient years was graphed against the range of LVEF, the relative advantage of omecamtiv mecarbil became visible just below an LVEF of 30%, climbing steadily even to the lowest LVEF, which reached 10%.

Perhaps relevant to the reduction in events, there were also greater relative reductions in NT-proBNP (NT-proB-type natriuretic peptide) for omecamtiv mecarbil at lower relative to higher LVEF. Although omecamtiv mecarbil is not associated with any direct vascular, electrophysiologic, or neurohormonal effects, according to Dr. Teerlink, the indirect effects of selective binding to cardiac myosin has been associated with lower NT-proBNP and other biomarkers of cardiac remodeling in prior clinical studies.

Although Dr. Teerlink acknowledged that relatively few patients in GALACTIC-HF received an angiotensin-receptor neprilysin inhibitor (ARNI) or a sodium glucose cotransporter-2 (SGLT2) inhibitor, he said there is “every reason to believe that omecamtiv mecarbil would be complementary to these therapies.” He said the mechanism of action of omecamtiv mecarbil, which improves systolic function, has no overlap with these drugs.

Importantly, there is a particular need for new treatment options in patients with advanced LVEF, according to Dr. Teerlink, who cited evidence, for example, that “the beneficial effect of [the ARNI] sacubitril valsartan, while still significant, decreases in patients with LVEF less than 35%.”

Overall, based on these results, “we believe that omecamtiv mecarbil represents a novel therapy that holds the promise of improving clinical outcomes in patients with severely reduced ejection fraction, which are the very patients that are most challenging for us to treat,” Dr. Teerlink said.
 

Omecamtiv mecarbil may ‘buy you some time’

Ileana Piña, MD, clinical professor of medicine, Central Michigan University, Mount Pleasant, Mich., agreed. She said that omecamtiv mecarbil, if approved, will be an option for the type of HFrEF patients who are being considered for heart transplant or mechanical-assist devices.

“We are very loath to use inotropes in this population, because we know that ultimately the inotrope is not going to do well,” said Dr. Piña, calling these therapies a “Band-Aid.” Based on the evidence from GALACTIC-HF, she thinks that omecamtiv mecarbil will be more versatile.

“This drug does not increase myocardial oxygen demand as do the inotropes, and it can be given in the outpatient setting if need be, so I see this as a real advance,” Dr. Piña said. Although Dr. Piña acknowledged that omecamtiv mecarbil did not reduce mortality in the GALACTIC-HF trial, “at least it will buy you some time.”

Dr. Teerlink has financial relationships with multiple pharmaceutical companies, including Amgen, Cytogenetics, and Servier, which provided funding for the GALACTIC-HF trial. Dr. Piña reports no potential conflicts of interest.

Approaching the nursing unit, I heard the anxiety in my masked colleagues’ voices. I was starting another rotation on our COVID unit; this week I was trying to develop my emotional awareness in an effort to help with the stress of the job and, just as importantly, take in the moments of positive emotions when they arose. I was making a conscious effort to take in all I saw and felt in the same way I approached my patient examinations: my mind quiet, receptive, and curious.

Seeing my nursing teammates covered with personal protective equipment, I felt a little reverence at the purpose they bring to work. Thinking of our patients, isolated and scared in noisy, ventilated rooms, there was compassion welling up in my chest. Thinking about my role on the team, I felt humbled by the challenges of treating this new disease and meeting the needs of staff and patient.

A few years ago, a period of frustration and disaffectedness had led me to apply my diagnostic eye to myself: I was burning out. Developing a mindfulness practice has transformed my experience at work. Now, the pandemic pushed me to go beyond a few minutes of quieting the mind before work. I was developing my emotional awareness. A growing body of research suggests that emotional awareness helps temper the negative experiences and savor the good. This week on the COVID unit was an opportunity to put this idea to the test.

Across the hall from the desk was Ms. A, 85-year-old woman who always clutched her rosary. My Spanish is not great, but I understood her prayer when I entered the room. She had tested positive for COVID about 7 days before – so had all the people in her multigenerational home. Over the din of the negative-pressure machine, with damp eyes she kept saying she wanted to go home. I felt my body soften and, in my chest, it felt as if my heart moved towards her which is the manifestation of compassion. “I will do my best to get you there soon,” I said in an effort to comfort her.

We often resist strong emotions, especially at work, because they can increase stress in situations where we need to be in control. In high-emotion situations, our brain’s warning centers alert both body and brain. This has helped our ancestors to action over the millennia, but in the hospital, these responses hurt more than help. Our bodies amplifying the emotion, our mind races for solutions and we can feel overwhelmed.

Simply recognizing the emotion and naming it puts the brakes on this process. fMRI data demonstrate that naming the emotions moves the brain activity away from the emotion centers to the appraisal centers in the frontal lobe. Just the perspective to see the emotional process calms it down.

Name it to tame it – this is what those in the field call this act. “This is sadness,” I said to myself as I left Ms. A’s room.

Down the hall was Mr. D; he was an 81-year-old former Vietnamese refugee. He had come in 3 days prior to my coming on service. While he didn’t talk, even with an interpreter, he ate well and had looked comfortable for days on 50% O₂.

Ms. A’s O₂ needs crept up each day as did her anxiety, the plaintive tenor of her prayers and inquiries about going home. I got a priest to visit, not for last rites but just for some support. Over the phone, I updated the family on the prognosis.

A couple of days later, she needed 95% O₂ and with PO₂ was only 70. I told her family it seemed she was losing her battle with the virus. I said we could see how she did on 60% – that’s the max she could get at home with hospice. I called them after 2 hours on 60% to tell them she was up eating and despite slight increased resp rate, she looked okay. “Can you guarantee that she would not make it if she stayed in the hospital? “

My body vibrating with uncertainty – an emotional mix of fear and sadness – I said, “I am sorry, but this is such a new disease, I can’t say that for certain.” On the call, family members voiced different opinions, but in the end, they were unable to give up hope, so we agreed to keep her in hospital.

Down the hall, Mr. D had stopped eating and his sats dropped as did his blood pressure. A nurse exited his room; despite the mask and steamed-up glasses, I could read her body language. “That poor man is dying,” she said. I told her I agreed and called the family with the news and to offer them a chance to visit and to talk about home hospice.

“He has not seen any of us in 10 months,” said his daughter over the phone, “We would love to visit and talk about bringing him home on hospice.” The next morning four of his nine kids showed up with a quart of jook, an Asian rice porridge, for him and pastries for the staff.

They left the room smiling an hour later. “He ate all the jook and he smiled! Yes, let’s work on home with hospice.” That night his blood pressure was better, and we were able to move him to 8 liters oxymizer; the staff was excited by his improvement, too.

The next day Ms. A was less responsive with sats in the 80’s on 100% FiO₂, but she still had this great sense of warmth and dignity about her. When I entered the room, Spanish Catholic hymns were playing, two of her kids stood leaning over the bed and on an iPod, there was a chorus of tears. 20 family members were all crying on a Zoom call. Together this made the most beautiful soundtrack to an end of life I have ever heard. I tried hard not to join the chorus as we talked about turning off the oxygen to help limit her suffering.

We added a bolus of morphine to her drip and removed the oxygen. She looked more beautiful and peaceful without it. Briefly, she closed her eyes then opened them, her breathing calmer. And with the hymns and the chorus of family crying she lived another 20 minutes in the loving presence of her big family.

Leaving the room, I was flooded with “woulda, coulda, shouldas” that accompany work with so much uncertainty and high stakes. “Maybe I should have tried convalescent plasma. Maybe I should have told them she must go home,” and so on my mind went on looking for solutions when there were none. I turned to my body – my chest ached, and I whispered to myself: “This is how sadness feels.”

By thinking about how the emotion feels in the body, we move the mind away from problem solving that can end up leading to unhealthy ruminations. Such thoughts in times of high emotions lead to that pressurized, tightness feeling we get when overwhelmed. Taking in the universal sensations of the emotions is calming and connects us with these deep human experiences in healthy ways. At the same time, the racing and ruminations stop.

Meanwhile, down the hall, Mr. D’s family arrived in great spirits armed with more food for patient and staff. He was to go home later that day with hospice. When they saw him up in the chair without the oxygen, they said: “It is a miracle, Dr. Hass! He is going home on hospice but having beat COVID! We can’t thank you enough!”

“Don’t thank me! He was cured by love and jook! What a lesson for us all. Sometimes there is no better medicine than food from home and love!” With the explosive expansiveness of joy, we shared some “elbow bumps” and took some pictures before he was wheeled home.

Back at the nurse’s station, there were tears. Sometimes life is so full of emotion that it is hard to give it a name – joy? grief? Our bodies almost pulsing, our minds searching for words, it is as if an ancient process is marking a time and place in our souls. “This is what it is to be a human being living with love and creating meaning,” the experience seems to be telling us.

This is awesome work. In fact, awe was what we were feeling then – that sense of wonder we have in the presence of something beautiful or vast that we cannot easily comprehend. Taking in these moments of awe at the power and depth of the human experience is critical to keep us humble, engaged, and emotionally involved.

Cultivating emotional awareness is a simple technique to maintain equanimity as we do the emotionally turbulent work of caring for vulnerable and seriously ill members of our community. It uses the same techniques of attention and diagnosis we use on those we care for. It is a practice that can be seamlessly incorporated into our workday with no time added. Recognizing it, naming it, and feeling it will give us the resilience to handle the challenges this amazing work inevitably brings.

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley–UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

Approaching the nursing unit, I heard the anxiety in my masked colleagues’ voices. I was starting another rotation on our COVID unit; this week I was trying to develop my emotional awareness in an effort to help with the stress of the job and, just as importantly, take in the moments of positive emotions when they arose. I was making a conscious effort to take in all I saw and felt in the same way I approached my patient examinations: my mind quiet, receptive, and curious.

Seeing my nursing teammates covered with personal protective equipment, I felt a little reverence at the purpose they bring to work. Thinking of our patients, isolated and scared in noisy, ventilated rooms, there was compassion welling up in my chest. Thinking about my role on the team, I felt humbled by the challenges of treating this new disease and meeting the needs of staff and patient.

A few years ago, a period of frustration and disaffectedness had led me to apply my diagnostic eye to myself: I was burning out. Developing a mindfulness practice has transformed my experience at work. Now, the pandemic pushed me to go beyond a few minutes of quieting the mind before work. I was developing my emotional awareness. A growing body of research suggests that emotional awareness helps temper the negative experiences and savor the good. This week on the COVID unit was an opportunity to put this idea to the test.

Across the hall from the desk was Ms. A, 85-year-old woman who always clutched her rosary. My Spanish is not great, but I understood her prayer when I entered the room. She had tested positive for COVID about 7 days before – so had all the people in her multigenerational home. Over the din of the negative-pressure machine, with damp eyes she kept saying she wanted to go home. I felt my body soften and, in my chest, it felt as if my heart moved towards her which is the manifestation of compassion. “I will do my best to get you there soon,” I said in an effort to comfort her.

We often resist strong emotions, especially at work, because they can increase stress in situations where we need to be in control. In high-emotion situations, our brain’s warning centers alert both body and brain. This has helped our ancestors to action over the millennia, but in the hospital, these responses hurt more than help. Our bodies amplifying the emotion, our mind races for solutions and we can feel overwhelmed.

Simply recognizing the emotion and naming it puts the brakes on this process. fMRI data demonstrate that naming the emotions moves the brain activity away from the emotion centers to the appraisal centers in the frontal lobe. Just the perspective to see the emotional process calms it down.

Name it to tame it – this is what those in the field call this act. “This is sadness,” I said to myself as I left Ms. A’s room.

Down the hall was Mr. D; he was an 81-year-old former Vietnamese refugee. He had come in 3 days prior to my coming on service. While he didn’t talk, even with an interpreter, he ate well and had looked comfortable for days on 50% O₂.

Ms. A’s O₂ needs crept up each day as did her anxiety, the plaintive tenor of her prayers and inquiries about going home. I got a priest to visit, not for last rites but just for some support. Over the phone, I updated the family on the prognosis.

A couple of days later, she needed 95% O₂ and with PO₂ was only 70. I told her family it seemed she was losing her battle with the virus. I said we could see how she did on 60% – that’s the max she could get at home with hospice. I called them after 2 hours on 60% to tell them she was up eating and despite slight increased resp rate, she looked okay. “Can you guarantee that she would not make it if she stayed in the hospital? “

My body vibrating with uncertainty – an emotional mix of fear and sadness – I said, “I am sorry, but this is such a new disease, I can’t say that for certain.” On the call, family members voiced different opinions, but in the end, they were unable to give up hope, so we agreed to keep her in hospital.

Down the hall, Mr. D had stopped eating and his sats dropped as did his blood pressure. A nurse exited his room; despite the mask and steamed-up glasses, I could read her body language. “That poor man is dying,” she said. I told her I agreed and called the family with the news and to offer them a chance to visit and to talk about home hospice.

“He has not seen any of us in 10 months,” said his daughter over the phone, “We would love to visit and talk about bringing him home on hospice.” The next morning four of his nine kids showed up with a quart of jook, an Asian rice porridge, for him and pastries for the staff.

They left the room smiling an hour later. “He ate all the jook and he smiled! Yes, let’s work on home with hospice.” That night his blood pressure was better, and we were able to move him to 8 liters oxymizer; the staff was excited by his improvement, too.

The next day Ms. A was less responsive with sats in the 80’s on 100% FiO₂, but she still had this great sense of warmth and dignity about her. When I entered the room, Spanish Catholic hymns were playing, two of her kids stood leaning over the bed and on an iPod, there was a chorus of tears. 20 family members were all crying on a Zoom call. Together this made the most beautiful soundtrack to an end of life I have ever heard. I tried hard not to join the chorus as we talked about turning off the oxygen to help limit her suffering.

We added a bolus of morphine to her drip and removed the oxygen. She looked more beautiful and peaceful without it. Briefly, she closed her eyes then opened them, her breathing calmer. And with the hymns and the chorus of family crying she lived another 20 minutes in the loving presence of her big family.

Leaving the room, I was flooded with “woulda, coulda, shouldas” that accompany work with so much uncertainty and high stakes. “Maybe I should have tried convalescent plasma. Maybe I should have told them she must go home,” and so on my mind went on looking for solutions when there were none. I turned to my body – my chest ached, and I whispered to myself: “This is how sadness feels.”

By thinking about how the emotion feels in the body, we move the mind away from problem solving that can end up leading to unhealthy ruminations. Such thoughts in times of high emotions lead to that pressurized, tightness feeling we get when overwhelmed. Taking in the universal sensations of the emotions is calming and connects us with these deep human experiences in healthy ways. At the same time, the racing and ruminations stop.

Meanwhile, down the hall, Mr. D’s family arrived in great spirits armed with more food for patient and staff. He was to go home later that day with hospice. When they saw him up in the chair without the oxygen, they said: “It is a miracle, Dr. Hass! He is going home on hospice but having beat COVID! We can’t thank you enough!”

“Don’t thank me! He was cured by love and jook! What a lesson for us all. Sometimes there is no better medicine than food from home and love!” With the explosive expansiveness of joy, we shared some “elbow bumps” and took some pictures before he was wheeled home.

Back at the nurse’s station, there were tears. Sometimes life is so full of emotion that it is hard to give it a name – joy? grief? Our bodies almost pulsing, our minds searching for words, it is as if an ancient process is marking a time and place in our souls. “This is what it is to be a human being living with love and creating meaning,” the experience seems to be telling us.

This is awesome work. In fact, awe was what we were feeling then – that sense of wonder we have in the presence of something beautiful or vast that we cannot easily comprehend. Taking in these moments of awe at the power and depth of the human experience is critical to keep us humble, engaged, and emotionally involved.

Cultivating emotional awareness is a simple technique to maintain equanimity as we do the emotionally turbulent work of caring for vulnerable and seriously ill members of our community. It uses the same techniques of attention and diagnosis we use on those we care for. It is a practice that can be seamlessly incorporated into our workday with no time added. Recognizing it, naming it, and feeling it will give us the resilience to handle the challenges this amazing work inevitably brings.

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley–UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

Approaching the nursing unit, I heard the anxiety in my masked colleagues’ voices. I was starting another rotation on our COVID unit; this week I was trying to develop my emotional awareness in an effort to help with the stress of the job and, just as importantly, take in the moments of positive emotions when they arose. I was making a conscious effort to take in all I saw and felt in the same way I approached my patient examinations: my mind quiet, receptive, and curious.

Seeing my nursing teammates covered with personal protective equipment, I felt a little reverence at the purpose they bring to work. Thinking of our patients, isolated and scared in noisy, ventilated rooms, there was compassion welling up in my chest. Thinking about my role on the team, I felt humbled by the challenges of treating this new disease and meeting the needs of staff and patient.

A few years ago, a period of frustration and disaffectedness had led me to apply my diagnostic eye to myself: I was burning out. Developing a mindfulness practice has transformed my experience at work. Now, the pandemic pushed me to go beyond a few minutes of quieting the mind before work. I was developing my emotional awareness. A growing body of research suggests that emotional awareness helps temper the negative experiences and savor the good. This week on the COVID unit was an opportunity to put this idea to the test.

Across the hall from the desk was Ms. A, 85-year-old woman who always clutched her rosary. My Spanish is not great, but I understood her prayer when I entered the room. She had tested positive for COVID about 7 days before – so had all the people in her multigenerational home. Over the din of the negative-pressure machine, with damp eyes she kept saying she wanted to go home. I felt my body soften and, in my chest, it felt as if my heart moved towards her which is the manifestation of compassion. “I will do my best to get you there soon,” I said in an effort to comfort her.

We often resist strong emotions, especially at work, because they can increase stress in situations where we need to be in control. In high-emotion situations, our brain’s warning centers alert both body and brain. This has helped our ancestors to action over the millennia, but in the hospital, these responses hurt more than help. Our bodies amplifying the emotion, our mind races for solutions and we can feel overwhelmed.

Simply recognizing the emotion and naming it puts the brakes on this process. fMRI data demonstrate that naming the emotions moves the brain activity away from the emotion centers to the appraisal centers in the frontal lobe. Just the perspective to see the emotional process calms it down.

Name it to tame it – this is what those in the field call this act. “This is sadness,” I said to myself as I left Ms. A’s room.

Down the hall was Mr. D; he was an 81-year-old former Vietnamese refugee. He had come in 3 days prior to my coming on service. While he didn’t talk, even with an interpreter, he ate well and had looked comfortable for days on 50% O₂.

Ms. A’s O₂ needs crept up each day as did her anxiety, the plaintive tenor of her prayers and inquiries about going home. I got a priest to visit, not for last rites but just for some support. Over the phone, I updated the family on the prognosis.

A couple of days later, she needed 95% O₂ and with PO₂ was only 70. I told her family it seemed she was losing her battle with the virus. I said we could see how she did on 60% – that’s the max she could get at home with hospice. I called them after 2 hours on 60% to tell them she was up eating and despite slight increased resp rate, she looked okay. “Can you guarantee that she would not make it if she stayed in the hospital? “

My body vibrating with uncertainty – an emotional mix of fear and sadness – I said, “I am sorry, but this is such a new disease, I can’t say that for certain.” On the call, family members voiced different opinions, but in the end, they were unable to give up hope, so we agreed to keep her in hospital.

Down the hall, Mr. D had stopped eating and his sats dropped as did his blood pressure. A nurse exited his room; despite the mask and steamed-up glasses, I could read her body language. “That poor man is dying,” she said. I told her I agreed and called the family with the news and to offer them a chance to visit and to talk about home hospice.

“He has not seen any of us in 10 months,” said his daughter over the phone, “We would love to visit and talk about bringing him home on hospice.” The next morning four of his nine kids showed up with a quart of jook, an Asian rice porridge, for him and pastries for the staff.

They left the room smiling an hour later. “He ate all the jook and he smiled! Yes, let’s work on home with hospice.” That night his blood pressure was better, and we were able to move him to 8 liters oxymizer; the staff was excited by his improvement, too.

The next day Ms. A was less responsive with sats in the 80’s on 100% FiO₂, but she still had this great sense of warmth and dignity about her. When I entered the room, Spanish Catholic hymns were playing, two of her kids stood leaning over the bed and on an iPod, there was a chorus of tears. 20 family members were all crying on a Zoom call. Together this made the most beautiful soundtrack to an end of life I have ever heard. I tried hard not to join the chorus as we talked about turning off the oxygen to help limit her suffering.

We added a bolus of morphine to her drip and removed the oxygen. She looked more beautiful and peaceful without it. Briefly, she closed her eyes then opened them, her breathing calmer. And with the hymns and the chorus of family crying she lived another 20 minutes in the loving presence of her big family.

Leaving the room, I was flooded with “woulda, coulda, shouldas” that accompany work with so much uncertainty and high stakes. “Maybe I should have tried convalescent plasma. Maybe I should have told them she must go home,” and so on my mind went on looking for solutions when there were none. I turned to my body – my chest ached, and I whispered to myself: “This is how sadness feels.”

By thinking about how the emotion feels in the body, we move the mind away from problem solving that can end up leading to unhealthy ruminations. Such thoughts in times of high emotions lead to that pressurized, tightness feeling we get when overwhelmed. Taking in the universal sensations of the emotions is calming and connects us with these deep human experiences in healthy ways. At the same time, the racing and ruminations stop.

Meanwhile, down the hall, Mr. D’s family arrived in great spirits armed with more food for patient and staff. He was to go home later that day with hospice. When they saw him up in the chair without the oxygen, they said: “It is a miracle, Dr. Hass! He is going home on hospice but having beat COVID! We can’t thank you enough!”

“Don’t thank me! He was cured by love and jook! What a lesson for us all. Sometimes there is no better medicine than food from home and love!” With the explosive expansiveness of joy, we shared some “elbow bumps” and took some pictures before he was wheeled home.

Back at the nurse’s station, there were tears. Sometimes life is so full of emotion that it is hard to give it a name – joy? grief? Our bodies almost pulsing, our minds searching for words, it is as if an ancient process is marking a time and place in our souls. “This is what it is to be a human being living with love and creating meaning,” the experience seems to be telling us.

This is awesome work. In fact, awe was what we were feeling then – that sense of wonder we have in the presence of something beautiful or vast that we cannot easily comprehend. Taking in these moments of awe at the power and depth of the human experience is critical to keep us humble, engaged, and emotionally involved.

Cultivating emotional awareness is a simple technique to maintain equanimity as we do the emotionally turbulent work of caring for vulnerable and seriously ill members of our community. It uses the same techniques of attention and diagnosis we use on those we care for. It is a practice that can be seamlessly incorporated into our workday with no time added. Recognizing it, naming it, and feeling it will give us the resilience to handle the challenges this amazing work inevitably brings.

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley–UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

It’s now official: The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST-WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions. A follow-up report during the annual scientific sessions of the American College of Cardiology fleshed out the evidence and firmed up their landmark conclusion.

The meta-analysis (Abstract 410-08) included 4,500 patients with type 2 diabetes and diagnosed heart failure at entry; its primary endpoint, which was the same in both trials, was the combined incidence of cardiovascular death and the total number of either hospitalization for heart failure or urgent outpatient visits for heart failure.

Compared with placebo, treatment with sotagliflozin for a median of about 15 months dropped this composite endpoint by a relative 33% among the 1,931 who began the study with a left ventricular ejection fraction (LVEF) of at least 50% (HFpEF), by a relative 22% in the 1,758 patients who entered with an LVEF of less than 40% (patients with heart failure with reduced ejection fraction), and by a relative 43% among the 811 patients who began with an LVEF of 40%-49% (patients with heart failure with mid-range ejection fraction). The relative risk reductions were significant for all three subgroups, Deepak L. Bhatt, MD, reported at the meeting.
 

Equally effective ‘across the full range of LVEFs.’

Perhaps as notable and unprecedented was the further finding that the clinical benefits seen with treatment of patients with type 2 diabetes with sotagliflozin was consistent regardless of the ejection fraction they had at entry. Enrolled patients with baseline LVEFs in the range of 25% received a relative benefit from sotagliflozin treatment that was statistically no different from the benefit seen in patients who entered with an LVEF in the neighborhood of 45%, 65%, or at any other level across the LVEF spectrum, a finding that Dr. Bhatt called “remarkable” during a press briefing. “The results show the benefit of sotagliflozin across the full range of LVEFs.”

“We are very excited in the heart failure world by the SGLT2 inhibitors; we’ve been impressed by their reduction in heart failure hospitalizations, but we wonder about the patients with HFpEF, where we haven’t had a blockbuster drug to give,” said Ileana L. Piña, MD, a heart failure specialist and medical officer with the Food and Drug Administration.

The new findings “look like they could pose a regulatory indication [for sotagliflozin] for patients with type 2 diabetes and heart failure across the entire spectrum of heart failure,” said Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart & Vascular institute in Falls Church, Va., and designated discussant for Dr. Bhatt’s report.

A significant on-treatment reduction in CV death

Other new, notable findings from the meta-analysis included the observation that while treatment with sotagliflozin failed to produce a significant reduction in cardiovascular death, compared with placebo, in the intent-to-treat analysis of all patients and of those with heart failure at baseline (it produced nonsignificant point-estimate reductions of 11% compared with placebo for all patients, and of 23% for patients who began the study with heart failure), it did result in a significant 23% relative risk reduction when the researchers focused on patients while they remained adherent to their sotagliflozin regimen (the on-treatment analysis). This 23% relative reduction appeared among all enrolled patients, as well as in the subgroup that started with diagnosed heart failure.

“Given the totality of data from the SGLT2 inhibitors, I think this is a real finding,” Dr. Bhatt said.

Additional analyses also showed that, among women, treatment with sotagliflozin was linked with significant relative reductions in the primary endpoint of roughly 30% compared with placebo among all patients, and also among those with heart failure at baseline. “HFpEF is a problem particularly in older women, and we showed that the benefit was consistent in men and women,” Dr. Bhatt said.

He acknowledged that results are expected soon from two pivotal trials that are examining two different SGLT2 inhibitors, dapagliflozin and empagliflozin, in patients with HFpEF. “I think there will be a class effect for both SGLT2 inhibitors and sotagliflozin for reducing heart failure events in patients with HFpEF, and I predict that the dapagliflozin and empagliflozin trials will have positive results,” Dr. Bhatt said.

Sotagliflozin differs from the SGLT2 inhibitors by also inhibiting SGLT1, an enzyme found in the gastrointestinal system that, when inhibited, results in increased glucose excretion from the gut and a cut in bloodstream levels of postprandial glucose levels. The Food and Drug Administration accepted data from SCORED and SOLOIST-WHF as part of the evidence the agency is now considering for granting a new drug approval to sotagliflozin.

SCORED and SOLOIST-WHF were initially sponsored by Sanofi, and later by Lexicon Pharmaceuticals. Dr. Bhatt’s institution, Brigham and Women’s Hospital, has received funding from Sanofi and Lexicon Pharmaceuticals. He has been a consultant to and received honoraria from K₂P, Level Ex, and MJH Life Sciences; he has been an adviser to Cardax, Cereno Scientific, Myokardia, Novo Nordisk, Phase Bio, and PLx Pharma; and he has received research funding from numerous companies. Dr. Piña has no relevant disclosures. Dr. O’Connor has been a consultant to Arena, Bayer, Bristol-Myers Squibb, Merck, and Windtree, and he has an ownership interest in Biscardia.

[email protected]

It’s now official: The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST-WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions. A follow-up report during the annual scientific sessions of the American College of Cardiology fleshed out the evidence and firmed up their landmark conclusion.

The meta-analysis (Abstract 410-08) included 4,500 patients with type 2 diabetes and diagnosed heart failure at entry; its primary endpoint, which was the same in both trials, was the combined incidence of cardiovascular death and the total number of either hospitalization for heart failure or urgent outpatient visits for heart failure.

Compared with placebo, treatment with sotagliflozin for a median of about 15 months dropped this composite endpoint by a relative 33% among the 1,931 who began the study with a left ventricular ejection fraction (LVEF) of at least 50% (HFpEF), by a relative 22% in the 1,758 patients who entered with an LVEF of less than 40% (patients with heart failure with reduced ejection fraction), and by a relative 43% among the 811 patients who began with an LVEF of 40%-49% (patients with heart failure with mid-range ejection fraction). The relative risk reductions were significant for all three subgroups, Deepak L. Bhatt, MD, reported at the meeting.
 

Equally effective ‘across the full range of LVEFs.’

Perhaps as notable and unprecedented was the further finding that the clinical benefits seen with treatment of patients with type 2 diabetes with sotagliflozin was consistent regardless of the ejection fraction they had at entry. Enrolled patients with baseline LVEFs in the range of 25% received a relative benefit from sotagliflozin treatment that was statistically no different from the benefit seen in patients who entered with an LVEF in the neighborhood of 45%, 65%, or at any other level across the LVEF spectrum, a finding that Dr. Bhatt called “remarkable” during a press briefing. “The results show the benefit of sotagliflozin across the full range of LVEFs.”

“We are very excited in the heart failure world by the SGLT2 inhibitors; we’ve been impressed by their reduction in heart failure hospitalizations, but we wonder about the patients with HFpEF, where we haven’t had a blockbuster drug to give,” said Ileana L. Piña, MD, a heart failure specialist and medical officer with the Food and Drug Administration.

The new findings “look like they could pose a regulatory indication [for sotagliflozin] for patients with type 2 diabetes and heart failure across the entire spectrum of heart failure,” said Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart & Vascular institute in Falls Church, Va., and designated discussant for Dr. Bhatt’s report.

A significant on-treatment reduction in CV death

Other new, notable findings from the meta-analysis included the observation that while treatment with sotagliflozin failed to produce a significant reduction in cardiovascular death, compared with placebo, in the intent-to-treat analysis of all patients and of those with heart failure at baseline (it produced nonsignificant point-estimate reductions of 11% compared with placebo for all patients, and of 23% for patients who began the study with heart failure), it did result in a significant 23% relative risk reduction when the researchers focused on patients while they remained adherent to their sotagliflozin regimen (the on-treatment analysis). This 23% relative reduction appeared among all enrolled patients, as well as in the subgroup that started with diagnosed heart failure.

“Given the totality of data from the SGLT2 inhibitors, I think this is a real finding,” Dr. Bhatt said.

Additional analyses also showed that, among women, treatment with sotagliflozin was linked with significant relative reductions in the primary endpoint of roughly 30% compared with placebo among all patients, and also among those with heart failure at baseline. “HFpEF is a problem particularly in older women, and we showed that the benefit was consistent in men and women,” Dr. Bhatt said.

He acknowledged that results are expected soon from two pivotal trials that are examining two different SGLT2 inhibitors, dapagliflozin and empagliflozin, in patients with HFpEF. “I think there will be a class effect for both SGLT2 inhibitors and sotagliflozin for reducing heart failure events in patients with HFpEF, and I predict that the dapagliflozin and empagliflozin trials will have positive results,” Dr. Bhatt said.

Sotagliflozin differs from the SGLT2 inhibitors by also inhibiting SGLT1, an enzyme found in the gastrointestinal system that, when inhibited, results in increased glucose excretion from the gut and a cut in bloodstream levels of postprandial glucose levels. The Food and Drug Administration accepted data from SCORED and SOLOIST-WHF as part of the evidence the agency is now considering for granting a new drug approval to sotagliflozin.

SCORED and SOLOIST-WHF were initially sponsored by Sanofi, and later by Lexicon Pharmaceuticals. Dr. Bhatt’s institution, Brigham and Women’s Hospital, has received funding from Sanofi and Lexicon Pharmaceuticals. He has been a consultant to and received honoraria from K₂P, Level Ex, and MJH Life Sciences; he has been an adviser to Cardax, Cereno Scientific, Myokardia, Novo Nordisk, Phase Bio, and PLx Pharma; and he has received research funding from numerous companies. Dr. Piña has no relevant disclosures. Dr. O’Connor has been a consultant to Arena, Bayer, Bristol-Myers Squibb, Merck, and Windtree, and he has an ownership interest in Biscardia.

[email protected]

It’s now official: The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST-WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions. A follow-up report during the annual scientific sessions of the American College of Cardiology fleshed out the evidence and firmed up their landmark conclusion.

The meta-analysis (Abstract 410-08) included 4,500 patients with type 2 diabetes and diagnosed heart failure at entry; its primary endpoint, which was the same in both trials, was the combined incidence of cardiovascular death and the total number of either hospitalization for heart failure or urgent outpatient visits for heart failure.

Compared with placebo, treatment with sotagliflozin for a median of about 15 months dropped this composite endpoint by a relative 33% among the 1,931 who began the study with a left ventricular ejection fraction (LVEF) of at least 50% (HFpEF), by a relative 22% in the 1,758 patients who entered with an LVEF of less than 40% (patients with heart failure with reduced ejection fraction), and by a relative 43% among the 811 patients who began with an LVEF of 40%-49% (patients with heart failure with mid-range ejection fraction). The relative risk reductions were significant for all three subgroups, Deepak L. Bhatt, MD, reported at the meeting.
 

Equally effective ‘across the full range of LVEFs.’

Perhaps as notable and unprecedented was the further finding that the clinical benefits seen with treatment of patients with type 2 diabetes with sotagliflozin was consistent regardless of the ejection fraction they had at entry. Enrolled patients with baseline LVEFs in the range of 25% received a relative benefit from sotagliflozin treatment that was statistically no different from the benefit seen in patients who entered with an LVEF in the neighborhood of 45%, 65%, or at any other level across the LVEF spectrum, a finding that Dr. Bhatt called “remarkable” during a press briefing. “The results show the benefit of sotagliflozin across the full range of LVEFs.”

“We are very excited in the heart failure world by the SGLT2 inhibitors; we’ve been impressed by their reduction in heart failure hospitalizations, but we wonder about the patients with HFpEF, where we haven’t had a blockbuster drug to give,” said Ileana L. Piña, MD, a heart failure specialist and medical officer with the Food and Drug Administration.

The new findings “look like they could pose a regulatory indication [for sotagliflozin] for patients with type 2 diabetes and heart failure across the entire spectrum of heart failure,” said Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart & Vascular institute in Falls Church, Va., and designated discussant for Dr. Bhatt’s report.

A significant on-treatment reduction in CV death

Other new, notable findings from the meta-analysis included the observation that while treatment with sotagliflozin failed to produce a significant reduction in cardiovascular death, compared with placebo, in the intent-to-treat analysis of all patients and of those with heart failure at baseline (it produced nonsignificant point-estimate reductions of 11% compared with placebo for all patients, and of 23% for patients who began the study with heart failure), it did result in a significant 23% relative risk reduction when the researchers focused on patients while they remained adherent to their sotagliflozin regimen (the on-treatment analysis). This 23% relative reduction appeared among all enrolled patients, as well as in the subgroup that started with diagnosed heart failure.

“Given the totality of data from the SGLT2 inhibitors, I think this is a real finding,” Dr. Bhatt said.

Additional analyses also showed that, among women, treatment with sotagliflozin was linked with significant relative reductions in the primary endpoint of roughly 30% compared with placebo among all patients, and also among those with heart failure at baseline. “HFpEF is a problem particularly in older women, and we showed that the benefit was consistent in men and women,” Dr. Bhatt said.

He acknowledged that results are expected soon from two pivotal trials that are examining two different SGLT2 inhibitors, dapagliflozin and empagliflozin, in patients with HFpEF. “I think there will be a class effect for both SGLT2 inhibitors and sotagliflozin for reducing heart failure events in patients with HFpEF, and I predict that the dapagliflozin and empagliflozin trials will have positive results,” Dr. Bhatt said.

Sotagliflozin differs from the SGLT2 inhibitors by also inhibiting SGLT1, an enzyme found in the gastrointestinal system that, when inhibited, results in increased glucose excretion from the gut and a cut in bloodstream levels of postprandial glucose levels. The Food and Drug Administration accepted data from SCORED and SOLOIST-WHF as part of the evidence the agency is now considering for granting a new drug approval to sotagliflozin.

SCORED and SOLOIST-WHF were initially sponsored by Sanofi, and later by Lexicon Pharmaceuticals. Dr. Bhatt’s institution, Brigham and Women’s Hospital, has received funding from Sanofi and Lexicon Pharmaceuticals. He has been a consultant to and received honoraria from K₂P, Level Ex, and MJH Life Sciences; he has been an adviser to Cardax, Cereno Scientific, Myokardia, Novo Nordisk, Phase Bio, and PLx Pharma; and he has received research funding from numerous companies. Dr. Piña has no relevant disclosures. Dr. O’Connor has been a consultant to Arena, Bayer, Bristol-Myers Squibb, Merck, and Windtree, and he has an ownership interest in Biscardia.

[email protected]

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

In the wake of the COVID-19 pandemic, a population of patients has arisen with a range of symptoms and complications after surviving the acute phase of illness, according to Mezgebe Berhe, MD, of Baylor University Medical Center, Dallas.

Different terms have been used to describe this condition, including post COVID, long COVID, chronic COVID, and long-haulers, Dr. Berhe said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine. However, the current medical consensus for a definition is post–acute COVID-19 syndrome.

Acute COVID-19 generally lasts for about 4 weeks after the onset of symptoms, and post–acute COVID-19 is generally defined as “persistent symptoms and/or delayed or long-term complications beyond 4 weeks from the onset of symptoms,” he said. The postacute period may be broken into a subacute phase with symptoms and abnormalities present from 4-12 weeks beyond the acute phase, and then a chronic or post–acute COVID-19 syndrome, with symptoms and abnormalities present beyond 12 weeks after the onset of acute COVID-19.

Patients in the subacute or post–COVID-19 phase of illness are polymerase chain reaction negative and may have multiorgan symptomatology, said Dr. Berhe. Physical symptoms include fatigue, decline in quality of life, joint pain, and muscle weakness; reported mental symptoms include anxiety and depression; sleep disturbance; PTSD; cognitive disturbance (described by patients as “brain fog”); and headaches.

Pulmonary symptoms in post–acute COVID-19 patients include dyspnea, cough, and persistent oxygen requirements; patients also have reported palpitations and chest pain. Thromboembolism, chronic kidney disease, and hair loss also have been reported in COVID-19 patients in the postacute period.
 

What studies show

Early reports on postacute consequences of COVID-19 have been reported in published studies from the United States, Europe, and China, and the current treatment recommendations are based on findings from these studies, Dr. Berhe said.

In an observational cohort study from 38 hospitals in Michigan, researchers assessed 60-day outcomes for 1,250 COVID-19 patients who were discharged alive from the hospital. The researchers used medical record abstraction and telephone surveys to assess long-term symptoms. Overall, 6.7% of the patients died and 15.1% required hospital readmission. A total of 488 patients completed the telephone survey. Of these, 32.6% reported persistent symptoms, 18.9% reported new or worsening symptoms, 22.9% reported dyspnea while walking up stairs, 15.4% reported a cough, and 13.1% reported a persistent loss of taste or smell.

Data from multiple countries in Europe have shown similar prevalence of post–acute COVID-19 syndrome, but Dr. Berhe highlighted an Italian study in which 87% of 143 patients discharged from hospitals after acute COVID-19 reported at least one symptom at 60 day. “A decline in quality of life, as measured by the EuroQol visual analog scale, was reported by 44.1% of patients” in the Italian study, Dr. Berhe noted.

In a prospective cohort study conducted in Wuhan, China, researchers conducted a comprehensive in-person evaluation of symptoms in 1,733 COVID-19 patients at 6 months from symptom onset, and found that 76% reported at least one symptom, said Dr. Berhe. “Similar to other studies, muscle weakness and fatigue were the most common symptoms, followed by sleep problems and anxiety/depression. 

Dr. Berhe also cited a literature review published in Clinical Infectious Diseases that addressed COVID-19 in children; in one study of postacute COVID-19, approximately 12% of children had 5 weeks’ prevalence of persistent symptoms, compared with 22% of adults. This finding should remind clinicians that “Children can have devastating persistent symptoms following acute COVID-19 disease,” Dr. Berhe said.

In the post–acute COVID clinic

“Multidisciplinary collaboration is essential to provide integrated outpatient care to survivors of acute COVID-19,” Dr. Berhe said. Such collaboration includes pulmonary and cardiovascular symptom assessment through virtual or in-person follow-up at 4-6 weeks and at 12 weeks after hospital discharge. For those with dyspnea and persistent oxygen requirements at 12 weeks, consider the 6-minute walk test, pulmonary function test, chest x-ray, pulmonary embolism work-up, echocardiogram, and high-resolution CT of the chest as indicated.

With regard to neuropsychiatry, patients should be screened for anxiety, depression, PTSD, sleep disturbance, and cognitive impairment, said Dr. Berhe.

For hematology, “consider extended thromboprophylaxis for high-risk survivors based on shared decision-making,” he said. The incidence of thrombotic events post COVID is less than 5% so you have to be very selective and they should be in the highest-risk category.

COVID-19 patients with acute kidney infections should have a follow-up with a nephrologist soon after hospital discharge, he added.

From a primary care standpoint, early rehabilitation and patient education are important for managing symptoms; also consider recommending patient enrollment in research studies, Dr. Berhe said.

Dr. Berhe has been involved in multiple clinical trials of treating acute COVID-19 patients, but had no financial conflicts to disclose.

In the wake of the COVID-19 pandemic, a population of patients has arisen with a range of symptoms and complications after surviving the acute phase of illness, according to Mezgebe Berhe, MD, of Baylor University Medical Center, Dallas.

Different terms have been used to describe this condition, including post COVID, long COVID, chronic COVID, and long-haulers, Dr. Berhe said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine. However, the current medical consensus for a definition is post–acute COVID-19 syndrome.

Acute COVID-19 generally lasts for about 4 weeks after the onset of symptoms, and post–acute COVID-19 is generally defined as “persistent symptoms and/or delayed or long-term complications beyond 4 weeks from the onset of symptoms,” he said. The postacute period may be broken into a subacute phase with symptoms and abnormalities present from 4-12 weeks beyond the acute phase, and then a chronic or post–acute COVID-19 syndrome, with symptoms and abnormalities present beyond 12 weeks after the onset of acute COVID-19.

Patients in the subacute or post–COVID-19 phase of illness are polymerase chain reaction negative and may have multiorgan symptomatology, said Dr. Berhe. Physical symptoms include fatigue, decline in quality of life, joint pain, and muscle weakness; reported mental symptoms include anxiety and depression; sleep disturbance; PTSD; cognitive disturbance (described by patients as “brain fog”); and headaches.

Pulmonary symptoms in post–acute COVID-19 patients include dyspnea, cough, and persistent oxygen requirements; patients also have reported palpitations and chest pain. Thromboembolism, chronic kidney disease, and hair loss also have been reported in COVID-19 patients in the postacute period.
 

What studies show

Early reports on postacute consequences of COVID-19 have been reported in published studies from the United States, Europe, and China, and the current treatment recommendations are based on findings from these studies, Dr. Berhe said.

In an observational cohort study from 38 hospitals in Michigan, researchers assessed 60-day outcomes for 1,250 COVID-19 patients who were discharged alive from the hospital. The researchers used medical record abstraction and telephone surveys to assess long-term symptoms. Overall, 6.7% of the patients died and 15.1% required hospital readmission. A total of 488 patients completed the telephone survey. Of these, 32.6% reported persistent symptoms, 18.9% reported new or worsening symptoms, 22.9% reported dyspnea while walking up stairs, 15.4% reported a cough, and 13.1% reported a persistent loss of taste or smell.

Data from multiple countries in Europe have shown similar prevalence of post–acute COVID-19 syndrome, but Dr. Berhe highlighted an Italian study in which 87% of 143 patients discharged from hospitals after acute COVID-19 reported at least one symptom at 60 day. “A decline in quality of life, as measured by the EuroQol visual analog scale, was reported by 44.1% of patients” in the Italian study, Dr. Berhe noted.

In a prospective cohort study conducted in Wuhan, China, researchers conducted a comprehensive in-person evaluation of symptoms in 1,733 COVID-19 patients at 6 months from symptom onset, and found that 76% reported at least one symptom, said Dr. Berhe. “Similar to other studies, muscle weakness and fatigue were the most common symptoms, followed by sleep problems and anxiety/depression. 

Dr. Berhe also cited a literature review published in Clinical Infectious Diseases that addressed COVID-19 in children; in one study of postacute COVID-19, approximately 12% of children had 5 weeks’ prevalence of persistent symptoms, compared with 22% of adults. This finding should remind clinicians that “Children can have devastating persistent symptoms following acute COVID-19 disease,” Dr. Berhe said.

In the post–acute COVID clinic

“Multidisciplinary collaboration is essential to provide integrated outpatient care to survivors of acute COVID-19,” Dr. Berhe said. Such collaboration includes pulmonary and cardiovascular symptom assessment through virtual or in-person follow-up at 4-6 weeks and at 12 weeks after hospital discharge. For those with dyspnea and persistent oxygen requirements at 12 weeks, consider the 6-minute walk test, pulmonary function test, chest x-ray, pulmonary embolism work-up, echocardiogram, and high-resolution CT of the chest as indicated.

With regard to neuropsychiatry, patients should be screened for anxiety, depression, PTSD, sleep disturbance, and cognitive impairment, said Dr. Berhe.

For hematology, “consider extended thromboprophylaxis for high-risk survivors based on shared decision-making,” he said. The incidence of thrombotic events post COVID is less than 5% so you have to be very selective and they should be in the highest-risk category.

COVID-19 patients with acute kidney infections should have a follow-up with a nephrologist soon after hospital discharge, he added.

From a primary care standpoint, early rehabilitation and patient education are important for managing symptoms; also consider recommending patient enrollment in research studies, Dr. Berhe said.

Dr. Berhe has been involved in multiple clinical trials of treating acute COVID-19 patients, but had no financial conflicts to disclose.

In the wake of the COVID-19 pandemic, a population of patients has arisen with a range of symptoms and complications after surviving the acute phase of illness, according to Mezgebe Berhe, MD, of Baylor University Medical Center, Dallas.

Different terms have been used to describe this condition, including post COVID, long COVID, chronic COVID, and long-haulers, Dr. Berhe said in a presentation at SHM Converge, the annual conference of the Society of Hospital Medicine. However, the current medical consensus for a definition is post–acute COVID-19 syndrome.

Acute COVID-19 generally lasts for about 4 weeks after the onset of symptoms, and post–acute COVID-19 is generally defined as “persistent symptoms and/or delayed or long-term complications beyond 4 weeks from the onset of symptoms,” he said. The postacute period may be broken into a subacute phase with symptoms and abnormalities present from 4-12 weeks beyond the acute phase, and then a chronic or post–acute COVID-19 syndrome, with symptoms and abnormalities present beyond 12 weeks after the onset of acute COVID-19.

Patients in the subacute or post–COVID-19 phase of illness are polymerase chain reaction negative and may have multiorgan symptomatology, said Dr. Berhe. Physical symptoms include fatigue, decline in quality of life, joint pain, and muscle weakness; reported mental symptoms include anxiety and depression; sleep disturbance; PTSD; cognitive disturbance (described by patients as “brain fog”); and headaches.

Pulmonary symptoms in post–acute COVID-19 patients include dyspnea, cough, and persistent oxygen requirements; patients also have reported palpitations and chest pain. Thromboembolism, chronic kidney disease, and hair loss also have been reported in COVID-19 patients in the postacute period.
 

What studies show

Early reports on postacute consequences of COVID-19 have been reported in published studies from the United States, Europe, and China, and the current treatment recommendations are based on findings from these studies, Dr. Berhe said.

In an observational cohort study from 38 hospitals in Michigan, researchers assessed 60-day outcomes for 1,250 COVID-19 patients who were discharged alive from the hospital. The researchers used medical record abstraction and telephone surveys to assess long-term symptoms. Overall, 6.7% of the patients died and 15.1% required hospital readmission. A total of 488 patients completed the telephone survey. Of these, 32.6% reported persistent symptoms, 18.9% reported new or worsening symptoms, 22.9% reported dyspnea while walking up stairs, 15.4% reported a cough, and 13.1% reported a persistent loss of taste or smell.

Data from multiple countries in Europe have shown similar prevalence of post–acute COVID-19 syndrome, but Dr. Berhe highlighted an Italian study in which 87% of 143 patients discharged from hospitals after acute COVID-19 reported at least one symptom at 60 day. “A decline in quality of life, as measured by the EuroQol visual analog scale, was reported by 44.1% of patients” in the Italian study, Dr. Berhe noted.

In a prospective cohort study conducted in Wuhan, China, researchers conducted a comprehensive in-person evaluation of symptoms in 1,733 COVID-19 patients at 6 months from symptom onset, and found that 76% reported at least one symptom, said Dr. Berhe. “Similar to other studies, muscle weakness and fatigue were the most common symptoms, followed by sleep problems and anxiety/depression. 

Dr. Berhe also cited a literature review published in Clinical Infectious Diseases that addressed COVID-19 in children; in one study of postacute COVID-19, approximately 12% of children had 5 weeks’ prevalence of persistent symptoms, compared with 22% of adults. This finding should remind clinicians that “Children can have devastating persistent symptoms following acute COVID-19 disease,” Dr. Berhe said.

In the post–acute COVID clinic

“Multidisciplinary collaboration is essential to provide integrated outpatient care to survivors of acute COVID-19,” Dr. Berhe said. Such collaboration includes pulmonary and cardiovascular symptom assessment through virtual or in-person follow-up at 4-6 weeks and at 12 weeks after hospital discharge. For those with dyspnea and persistent oxygen requirements at 12 weeks, consider the 6-minute walk test, pulmonary function test, chest x-ray, pulmonary embolism work-up, echocardiogram, and high-resolution CT of the chest as indicated.

With regard to neuropsychiatry, patients should be screened for anxiety, depression, PTSD, sleep disturbance, and cognitive impairment, said Dr. Berhe.

For hematology, “consider extended thromboprophylaxis for high-risk survivors based on shared decision-making,” he said. The incidence of thrombotic events post COVID is less than 5% so you have to be very selective and they should be in the highest-risk category.

COVID-19 patients with acute kidney infections should have a follow-up with a nephrologist soon after hospital discharge, he added.

From a primary care standpoint, early rehabilitation and patient education are important for managing symptoms; also consider recommending patient enrollment in research studies, Dr. Berhe said.

Dr. Berhe has been involved in multiple clinical trials of treating acute COVID-19 patients, but had no financial conflicts to disclose.

Converge 2021 session

High Value Care in Pediatrics – Things We Do for No Reason

Presenter

Ricardo Quinonez, MD, FAAP, FHM

Session summary

Dr. Ricardo Quinonez, associate professor of pediatrics at Baylor College of Medicine and chief of pediatric hospital medicine at Texas Children’s Hospital, both in Houston, presented key topics in pediatric hospital medicine with low-value care management practices which are not supported by recent literature. This session was a continuation of the popular lecture series first presented at the Society of Hospital Medicine annual conference and the “Choosing Wisely: Things We Do for No Reason” article series in the Journal of Hospital Medicine.

Dr. Quinonez began by discussing high flow nasal cannula (HFNC) in bronchiolitis. At first, early observational studies showed a decrease in intubation rate for children placed on HFNC, which resulted in its high utilization. Randomized, controlled trials (RCTs) later showed that early initiation of HFNC did not affect rates of transfer to the ICU, duration of oxygen need, or length of stay.

He then discussed the treatment of symptomatic spontaneous pneumothorax in children, which is often managed by hospital admission, needle aspiration and chest tube placement, and serial chest x-rays. Instead, recent literature supports an ambulatory approach by placing a device with an 8 French catheter with one way Heimlich valve. After placement, a chest x-ray is performed and if the pneumothorax is stable, the patient is discharged with plans for serial chest x-rays as an outpatient. The device is removed after re-expansion of the lung.

Dr. Quinonez then discussed the frequent pediatric complaint of constipation. He stated that abdominal x-rays for evaluation of “stool burden” are not reliable, and x-rays are recommended against in both U.S. and British guidelines. Furthermore, a high-fiber diet is often recommended as a treatment for constipation. However, after review of recent RCTs and cohort studies, no relationship between a low-fiber diet and constipation was seen. Instead, genetics likely plays a large part in causing constipation.

Lastly, Dr. Quinonez discussed electrolyte testing in children with acute gastroenteritis. Electrolyte testing is commonly performed, yet testing patterns vary greatly across children’s hospitals. One quality improvement project found that after decreasing electrolyte testing by more than a third during hospitalizations, no change in readmission rate or renal replacement therapy was reported.
 

Key takeaways

• Early use of high flow nasal cannula in bronchiolitis does not affect rates of transfer to the ICU or length of stay.
• Abdominal x-rays to assess for constipation are not recommended and are not reliable in measuring stool burden.
• A low-fiber diet does not cause constipation.
• Quality improvement projects can help physicians “choose wisely” and decrease things we do for no reason.

Dr. Tantoco is an academic med-peds hospitalist at Northwestern Memorial Hospital and Ann & Robert H. Lurie Children’s Hospital of Chicago. She is an instructor of medicine (hospital medicine) and pediatrics at Northwestern University, Chicago.

Converge 2021 session

High Value Care in Pediatrics – Things We Do for No Reason

Presenter

Ricardo Quinonez, MD, FAAP, FHM

Session summary

Dr. Ricardo Quinonez, associate professor of pediatrics at Baylor College of Medicine and chief of pediatric hospital medicine at Texas Children’s Hospital, both in Houston, presented key topics in pediatric hospital medicine with low-value care management practices which are not supported by recent literature. This session was a continuation of the popular lecture series first presented at the Society of Hospital Medicine annual conference and the “Choosing Wisely: Things We Do for No Reason” article series in the Journal of Hospital Medicine.

Dr. Quinonez began by discussing high flow nasal cannula (HFNC) in bronchiolitis. At first, early observational studies showed a decrease in intubation rate for children placed on HFNC, which resulted in its high utilization. Randomized, controlled trials (RCTs) later showed that early initiation of HFNC did not affect rates of transfer to the ICU, duration of oxygen need, or length of stay.

He then discussed the treatment of symptomatic spontaneous pneumothorax in children, which is often managed by hospital admission, needle aspiration and chest tube placement, and serial chest x-rays. Instead, recent literature supports an ambulatory approach by placing a device with an 8 French catheter with one way Heimlich valve. After placement, a chest x-ray is performed and if the pneumothorax is stable, the patient is discharged with plans for serial chest x-rays as an outpatient. The device is removed after re-expansion of the lung.

Dr. Quinonez then discussed the frequent pediatric complaint of constipation. He stated that abdominal x-rays for evaluation of “stool burden” are not reliable, and x-rays are recommended against in both U.S. and British guidelines. Furthermore, a high-fiber diet is often recommended as a treatment for constipation. However, after review of recent RCTs and cohort studies, no relationship between a low-fiber diet and constipation was seen. Instead, genetics likely plays a large part in causing constipation.

Lastly, Dr. Quinonez discussed electrolyte testing in children with acute gastroenteritis. Electrolyte testing is commonly performed, yet testing patterns vary greatly across children’s hospitals. One quality improvement project found that after decreasing electrolyte testing by more than a third during hospitalizations, no change in readmission rate or renal replacement therapy was reported.
 

Key takeaways

• Early use of high flow nasal cannula in bronchiolitis does not affect rates of transfer to the ICU or length of stay.
• Abdominal x-rays to assess for constipation are not recommended and are not reliable in measuring stool burden.
• A low-fiber diet does not cause constipation.
• Quality improvement projects can help physicians “choose wisely” and decrease things we do for no reason.

Dr. Tantoco is an academic med-peds hospitalist at Northwestern Memorial Hospital and Ann & Robert H. Lurie Children’s Hospital of Chicago. She is an instructor of medicine (hospital medicine) and pediatrics at Northwestern University, Chicago.

Converge 2021 session

High Value Care in Pediatrics – Things We Do for No Reason

Presenter

Ricardo Quinonez, MD, FAAP, FHM

Session summary

Dr. Ricardo Quinonez, associate professor of pediatrics at Baylor College of Medicine and chief of pediatric hospital medicine at Texas Children’s Hospital, both in Houston, presented key topics in pediatric hospital medicine with low-value care management practices which are not supported by recent literature. This session was a continuation of the popular lecture series first presented at the Society of Hospital Medicine annual conference and the “Choosing Wisely: Things We Do for No Reason” article series in the Journal of Hospital Medicine.

Dr. Quinonez began by discussing high flow nasal cannula (HFNC) in bronchiolitis. At first, early observational studies showed a decrease in intubation rate for children placed on HFNC, which resulted in its high utilization. Randomized, controlled trials (RCTs) later showed that early initiation of HFNC did not affect rates of transfer to the ICU, duration of oxygen need, or length of stay.

He then discussed the treatment of symptomatic spontaneous pneumothorax in children, which is often managed by hospital admission, needle aspiration and chest tube placement, and serial chest x-rays. Instead, recent literature supports an ambulatory approach by placing a device with an 8 French catheter with one way Heimlich valve. After placement, a chest x-ray is performed and if the pneumothorax is stable, the patient is discharged with plans for serial chest x-rays as an outpatient. The device is removed after re-expansion of the lung.

Dr. Quinonez then discussed the frequent pediatric complaint of constipation. He stated that abdominal x-rays for evaluation of “stool burden” are not reliable, and x-rays are recommended against in both U.S. and British guidelines. Furthermore, a high-fiber diet is often recommended as a treatment for constipation. However, after review of recent RCTs and cohort studies, no relationship between a low-fiber diet and constipation was seen. Instead, genetics likely plays a large part in causing constipation.

Lastly, Dr. Quinonez discussed electrolyte testing in children with acute gastroenteritis. Electrolyte testing is commonly performed, yet testing patterns vary greatly across children’s hospitals. One quality improvement project found that after decreasing electrolyte testing by more than a third during hospitalizations, no change in readmission rate or renal replacement therapy was reported.
 

Key takeaways

• Early use of high flow nasal cannula in bronchiolitis does not affect rates of transfer to the ICU or length of stay.
• Abdominal x-rays to assess for constipation are not recommended and are not reliable in measuring stool burden.
• A low-fiber diet does not cause constipation.
• Quality improvement projects can help physicians “choose wisely” and decrease things we do for no reason.

Dr. Tantoco is an academic med-peds hospitalist at Northwestern Memorial Hospital and Ann & Robert H. Lurie Children’s Hospital of Chicago. She is an instructor of medicine (hospital medicine) and pediatrics at Northwestern University, Chicago.

Length of hospital stay and the need for intensive care for pediatric COVID-19 patients with multisystem inflammatory syndrome in children was not significantly different for those who presented first as outpatients or emergency patients, based on data from 34 children.

Multisystem inflammatory syndrome in children (MIS-C) can be challenging to diagnose, as the key characteristics of fever, elevated inflammatory markers, and involvement of at least two organ systems often overlap with other illnesses, said Erin B. Treemarcki, DO, of the University of Utah, Salt Lake City, and colleagues.

“Primary care and urgent care providers are often the first point of health care for children with symptoms of MIS-C,” the researchers wrote. In a study (Poster 142) presented at the annual meeting of the Pediatric Academic Societies, held virtually, the researchers conducted a retrospective review of 34 patients younger than 21 years who were hospitalized with MIS-C at a single center between April 2020 and December 2020. The average age of the patients was 7.9 years, 68% were male, 82% were White, and 53% first presented to an outpatient clinic.

Sixteen patients presented to an emergency department and 18 presented to an ambulatory setting. The length of hospitalization ranged from 3 to 16 days with a median of 6 days, and the PICU stay ranged from 1 to 10 days with a median of 2 days.

Overall, the length of hospital stay and rate of PICU admission were not significantly different between the emergency presentation and outpatient presentation groups. Twenty-four patients entered the PICU, 13 at admission and 11 as transfers. However, the median number of days of symptoms prior to admission was significantly higher for outpatient cases (6 days vs. 4 days, P = .03).

One patient was readmitted to the hospital within 30 days for aseptic meningitis, and none of the patients died.

Initial symptoms were not significantly different for outpatient vs. emergency department patients. The most common initial manifestations of MIS-C included fever (100%), gastrointestinal symptoms (85%), and mucocutaneous symptoms (88%). Mucocutaneous symptoms included rash, oral mucosal changes, conjunctivitis, and hand/foot edema. In addition, 65% of the patients met at least 3 criteria for Kawasaki disease, the researchers noted.

The most common elevated labs at presentation regardless of setting were D-dimer (100%), C-reactive protein (97%), ferritin (97%), procalcitonin (97%), and serum IL-6 (94%).

The study findings were limited by the small sample size and focus on data from a single center. However, the results emphasize the varied presentations of MIS-C and the importance that both primary care and urgent care providers know the signs, as they are often the first point of health care for children with MIS-C, the researchers noted.
 

Keep looking for factors that put children at risk

“MIS-C is probably the most serious complication of COVID in children, so we as pediatricians on the front line need to know what it looks like,” Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was surprised by the study finding that children’s length of hospital stay was not affected by presentation setting.

“I would have thought the kids presenting in an outpatient setting would take longer to diagnose, and therefore have a longer hospital stay,” she noted. Instead, the take-home message is that whether the MIS-C diagnosis occurs in the outpatient or emergency setting, the length of stay is the same, and that the most common symptoms are fever, gastrointestinal, mucocutaneous, and cardiac symptoms regardless of initial presentation setting, she said.

More research is needed, and future studies should examine “any potential underlying factors making these particular kids susceptible to MIS-C,” Dr. Kinsella added.

The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts, but serves on the Pediatric News Editorial Advisory Board.

Length of hospital stay and the need for intensive care for pediatric COVID-19 patients with multisystem inflammatory syndrome in children was not significantly different for those who presented first as outpatients or emergency patients, based on data from 34 children.

Multisystem inflammatory syndrome in children (MIS-C) can be challenging to diagnose, as the key characteristics of fever, elevated inflammatory markers, and involvement of at least two organ systems often overlap with other illnesses, said Erin B. Treemarcki, DO, of the University of Utah, Salt Lake City, and colleagues.

“Primary care and urgent care providers are often the first point of health care for children with symptoms of MIS-C,” the researchers wrote. In a study (Poster 142) presented at the annual meeting of the Pediatric Academic Societies, held virtually, the researchers conducted a retrospective review of 34 patients younger than 21 years who were hospitalized with MIS-C at a single center between April 2020 and December 2020. The average age of the patients was 7.9 years, 68% were male, 82% were White, and 53% first presented to an outpatient clinic.

Sixteen patients presented to an emergency department and 18 presented to an ambulatory setting. The length of hospitalization ranged from 3 to 16 days with a median of 6 days, and the PICU stay ranged from 1 to 10 days with a median of 2 days.

Overall, the length of hospital stay and rate of PICU admission were not significantly different between the emergency presentation and outpatient presentation groups. Twenty-four patients entered the PICU, 13 at admission and 11 as transfers. However, the median number of days of symptoms prior to admission was significantly higher for outpatient cases (6 days vs. 4 days, P = .03).

One patient was readmitted to the hospital within 30 days for aseptic meningitis, and none of the patients died.

Initial symptoms were not significantly different for outpatient vs. emergency department patients. The most common initial manifestations of MIS-C included fever (100%), gastrointestinal symptoms (85%), and mucocutaneous symptoms (88%). Mucocutaneous symptoms included rash, oral mucosal changes, conjunctivitis, and hand/foot edema. In addition, 65% of the patients met at least 3 criteria for Kawasaki disease, the researchers noted.

The most common elevated labs at presentation regardless of setting were D-dimer (100%), C-reactive protein (97%), ferritin (97%), procalcitonin (97%), and serum IL-6 (94%).

The study findings were limited by the small sample size and focus on data from a single center. However, the results emphasize the varied presentations of MIS-C and the importance that both primary care and urgent care providers know the signs, as they are often the first point of health care for children with MIS-C, the researchers noted.
 

Keep looking for factors that put children at risk

“MIS-C is probably the most serious complication of COVID in children, so we as pediatricians on the front line need to know what it looks like,” Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was surprised by the study finding that children’s length of hospital stay was not affected by presentation setting.

“I would have thought the kids presenting in an outpatient setting would take longer to diagnose, and therefore have a longer hospital stay,” she noted. Instead, the take-home message is that whether the MIS-C diagnosis occurs in the outpatient or emergency setting, the length of stay is the same, and that the most common symptoms are fever, gastrointestinal, mucocutaneous, and cardiac symptoms regardless of initial presentation setting, she said.

More research is needed, and future studies should examine “any potential underlying factors making these particular kids susceptible to MIS-C,” Dr. Kinsella added.

The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts, but serves on the Pediatric News Editorial Advisory Board.

Length of hospital stay and the need for intensive care for pediatric COVID-19 patients with multisystem inflammatory syndrome in children was not significantly different for those who presented first as outpatients or emergency patients, based on data from 34 children.

Multisystem inflammatory syndrome in children (MIS-C) can be challenging to diagnose, as the key characteristics of fever, elevated inflammatory markers, and involvement of at least two organ systems often overlap with other illnesses, said Erin B. Treemarcki, DO, of the University of Utah, Salt Lake City, and colleagues.

“Primary care and urgent care providers are often the first point of health care for children with symptoms of MIS-C,” the researchers wrote. In a study (Poster 142) presented at the annual meeting of the Pediatric Academic Societies, held virtually, the researchers conducted a retrospective review of 34 patients younger than 21 years who were hospitalized with MIS-C at a single center between April 2020 and December 2020. The average age of the patients was 7.9 years, 68% were male, 82% were White, and 53% first presented to an outpatient clinic.

Sixteen patients presented to an emergency department and 18 presented to an ambulatory setting. The length of hospitalization ranged from 3 to 16 days with a median of 6 days, and the PICU stay ranged from 1 to 10 days with a median of 2 days.

Overall, the length of hospital stay and rate of PICU admission were not significantly different between the emergency presentation and outpatient presentation groups. Twenty-four patients entered the PICU, 13 at admission and 11 as transfers. However, the median number of days of symptoms prior to admission was significantly higher for outpatient cases (6 days vs. 4 days, P = .03).

One patient was readmitted to the hospital within 30 days for aseptic meningitis, and none of the patients died.

Initial symptoms were not significantly different for outpatient vs. emergency department patients. The most common initial manifestations of MIS-C included fever (100%), gastrointestinal symptoms (85%), and mucocutaneous symptoms (88%). Mucocutaneous symptoms included rash, oral mucosal changes, conjunctivitis, and hand/foot edema. In addition, 65% of the patients met at least 3 criteria for Kawasaki disease, the researchers noted.

The most common elevated labs at presentation regardless of setting were D-dimer (100%), C-reactive protein (97%), ferritin (97%), procalcitonin (97%), and serum IL-6 (94%).

The study findings were limited by the small sample size and focus on data from a single center. However, the results emphasize the varied presentations of MIS-C and the importance that both primary care and urgent care providers know the signs, as they are often the first point of health care for children with MIS-C, the researchers noted.
 

Keep looking for factors that put children at risk

“MIS-C is probably the most serious complication of COVID in children, so we as pediatricians on the front line need to know what it looks like,” Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was surprised by the study finding that children’s length of hospital stay was not affected by presentation setting.

“I would have thought the kids presenting in an outpatient setting would take longer to diagnose, and therefore have a longer hospital stay,” she noted. Instead, the take-home message is that whether the MIS-C diagnosis occurs in the outpatient or emergency setting, the length of stay is the same, and that the most common symptoms are fever, gastrointestinal, mucocutaneous, and cardiac symptoms regardless of initial presentation setting, she said.

More research is needed, and future studies should examine “any potential underlying factors making these particular kids susceptible to MIS-C,” Dr. Kinsella added.

The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts, but serves on the Pediatric News Editorial Advisory Board.

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Click here for the wrap-up issue of the SHM Converge Daily News newsletter.

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

A study of COVID-19 outcomes across the United States bolsters reports from China and Europe that indicate that patients with chronic obstructive pulmonary disease (COPD) and SARS-CoV-2 infection have worse outcomes than those of patients with COVID-19 who do not have COPD.

Investigators at the University of Texas Medical Branch at Galveston, Texas, combed through electronic health records from four geographic regions of the United States and identified a cohort of 6,056 patients with COPD among 150,775 patients whose records indicate either a diagnostic code or a positive laboratory test result for COVID-19.

Their findings indicate that patients with both COPD and COVID-19 “have worse outcomes compared to non-COPD COVID-19 patients, including 14-day hospitalization, length of stay, ICU admission, 30-day mortality, and use of mechanical ventilation,” Daniel Puebla Neira, MD, and colleagues from the University of Texas Medical Branch reported in a thematic poster presented during the American Thoracic Society (ATS) 2021 virtual international conference.

A critical care specialist who was not involved in the study said that the results are concerning but not surprising.

“If you already have a lung disease and you develop an additional lung disease on top of that, you don’t have as much reserve and you’re not going to tolerate the acute COVID infection,” said ATS expert Marc Moss, MD, Roger S. Mitchell Professor of Medicine in the division of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The evidence shows that “patients with COPD should be even more cautious, because if they get sick and develop, they could do worse,” he said in an interview.
 

Retrospective analysis

Dr. Neira and colleagues assessed the characteristics and outcomes of patients with COPD who were treated for COVID-19 in the United States from March through August 2020.

Baseline demographics of the patients with and those without COPD were similar except that the mean age was higher among patients with COPD (68.62 vs. 47.08 years).

In addition, a significantly higher proportion of patients with COPD had comorbidities compared with those without COPD. Comorbidities included diabetes, hypertension, asthma, chronic kidney disease, end-stage renal disease, stroke, heart failure, cancer, coronary artery disease, and liver disease (P < .0001 for all comparisons).

Among patients with COPD, percentages were higher with respect to the following parameters: 14-day hospitalization for any cause (28.7% vs. 10.4%), COVID-19-related 14-day hospitalization (28.1% vs. 9.9%), ICU use (26.3% vs. 17.9%), mechanical ventilation use (26.3% vs. 16.1%), and 30-day mortality (13.6% vs. 7.2%; P < .0001 for all comparisons).
 

‘Mechanisms unclear’

“It is unclear what mechanisms drive the association between COPD and mortality in hospitalized patients with COVID-19,” the investigators wrote. “Several biological factors have been proposed, including chronic lung inflammation, oxidative stress, protease-antiprotease imbalance, and increased airway mediators.”

They recommend use of multivariable logistic regression to tease out the effects of covariates among patients with COPD and COVID-19 and call for research into long-term outcomes for these patients, “as survivors of critical illness are increasingly recognized to have cognitive, psychological, and physical consequences.”

Dr. Moss said that in general, the management of patients with COPD and COVID-19 is similar to that for patients with COVID-19 who do not have COPD, although there may be “subtle” differences, such as ventilator settings for patients with COPD.

No source of funding for the study has been disclosed. The investigators and Dr. Moss have disclosed no relevant financial relationships.

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

For patients with COVID-19 admitted to intensive care, giving atorvastatin 20 mg/d did not result in a significant reduction in risk for venous or arterial thrombosis, for treatment with extracorporeal membrane oxygenation (ECMO), or for all-cause mortality, compared with placebo in the INSPIRATION-S study.

However, there was a suggestion of benefit in the subgroup of patients who were treated within 7 days of COVID-19 symptom onset.

The study was presented by Behnood Bikdeli, MD, Brigham and Women’s Hospital, Boston, on May 16 at the annual scientific sessions of the American College of Cardiology.

He explained that COVID-19 is characterized by an exuberant immune response and that there is a potential for thrombotic events because of enhanced endothelial activation and a prothrombotic state.

“In this context, it is interesting to think about statins as potential agents to be studied in COVID-19, because as well as having lipid-lowering actions, they are also thought to have anti-inflammatory and antithrombotic effects,” he said.

In the HARP-2 trial of simvastatin in acute respiratory distress syndrome (ARDS), published a few years ago, the main results were neutral, but in the subgroup of patients with hyperinflammatory ARDS, there was a reduction in mortality with simvastatin in comparison with placebo, Dr. Bikdeli noted.

Moreover, in a series of observational studies of patients with COVID-19, use of statins was associated with a reduction in mortality among hospitalized patients. However, there are limited high-quality data to guide clinical practice, he said.

The INSPIRATION study, conducted in 11 hospitals in Iran, had a two-by-two factorial design to investigate different anticoagulant strategies and the use of atorvastatin for COVID-19 patients in the ICU.

In the anticoagulation part of the trial, which was published in JAMA in March 2020, there was no difference in the primary endpoint of an intermediate dose and standard dose of enoxaparin.

For the statin part of the trial (INSPIRATION-S), 605 patients were randomly assigned to receive atorvastatin 20 mg daily or placebo. Patients who had been taking statins beforehand were excluded. Baseline characteristics were similar for the two groups, with around a quarter of patients taking aspirin and more than 90% taking steroids.

Results showed that atorvastatin was not associated with a significant reduction in the primary outcome – a composite of adjudicated venous or arterial thrombosis, treatment with ECMO, or mortality within 30 days – which occurred in 32.7% of the statin group versus 36.3% of the placebo group (odds ratio, 0.84; P = .35).

Atorvastatin was not associated with any significant differences in any of the individual components of the primary composite endpoint. There was also no significant difference in any of the safety endpoints, which included major bleeding and elevations in liver enzyme levels.

Subgroup analyses were mostly consistent with the main findings, with one exception.

In the subgroup of patients who presented within the first 7 days of COVID-19 symptom onset, there was a hint of a potential protective effect with atorvastatin.

In this group of 171 patients, the primary endpoint occurred in 30.9% of those taking atorvastatin versus 40.3% of those taking placebo (OR, 0.60; P = .055).

“This is an interesting observation, and it is plausible, as these patients may be in a different phase of COVID-19 disease. But we need to be cognizant of the multiplicity of comparisons, and this needs to be further investigated in subsequent studies,” Dr. Bikdeli said.
 

Higher dose in less sick patients a better strategy?

Discussing the study at the ACC presentation, Binita Shah, MD, said the importance of enrolling COVID-19 patients into clinical trials was paramount but that these patients in the ICU may not have been the right population in which to test a statin.

“Maybe for these very sick patients, it is just too late. Trying to rein in the inflammatory cytokine storm and the interaction with thrombosis at this point is very difficult,” Dr. Shah commented.

She suggested that it might be appropriate to try statins in an earlier phase of the disease in order to prevent the inflammatory process, rather than trying to stop it after it had already started.

Dr. Shah also questioned the use of such a low dose of atorvastatin for these patients. “In the cardiovascular literature – at least in ACS [acute coronary syndrome] – high statin doses are used to see short-term benefits. In this very inflammatory milieu, I wonder whether a high-intensity regimen would be more beneficial,” she speculated.

Dr. Bikdeli replied that a low dose of atorvastatin was chosen because early on, several antiviral agents, such as ritonavir, were being used for COVID-19 patients, and these drugs were associated with increases in liver enzyme levels.

“We didn’t want to exacerbate that with high doses of statins,” he said. “But we have now established the safety profile of atorvastatin in these patients, and in retrospect, yes, a higher dose might have been better.”

The INSPIRATION study was funded by the Rajaie Cardiovascular Medical and Research Center, Tehran, Iran. Dr. Bikdeli has disclosed no relevant financial relationships.

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

For patients with COVID-19 admitted to intensive care, giving atorvastatin 20 mg/d did not result in a significant reduction in risk for venous or arterial thrombosis, for treatment with extracorporeal membrane oxygenation (ECMO), or for all-cause mortality, compared with placebo in the INSPIRATION-S study.

However, there was a suggestion of benefit in the subgroup of patients who were treated within 7 days of COVID-19 symptom onset.

The study was presented by Behnood Bikdeli, MD, Brigham and Women’s Hospital, Boston, on May 16 at the annual scientific sessions of the American College of Cardiology.

He explained that COVID-19 is characterized by an exuberant immune response and that there is a potential for thrombotic events because of enhanced endothelial activation and a prothrombotic state.

“In this context, it is interesting to think about statins as potential agents to be studied in COVID-19, because as well as having lipid-lowering actions, they are also thought to have anti-inflammatory and antithrombotic effects,” he said.

In the HARP-2 trial of simvastatin in acute respiratory distress syndrome (ARDS), published a few years ago, the main results were neutral, but in the subgroup of patients with hyperinflammatory ARDS, there was a reduction in mortality with simvastatin in comparison with placebo, Dr. Bikdeli noted.

Moreover, in a series of observational studies of patients with COVID-19, use of statins was associated with a reduction in mortality among hospitalized patients. However, there are limited high-quality data to guide clinical practice, he said.

The INSPIRATION study, conducted in 11 hospitals in Iran, had a two-by-two factorial design to investigate different anticoagulant strategies and the use of atorvastatin for COVID-19 patients in the ICU.

In the anticoagulation part of the trial, which was published in JAMA in March 2020, there was no difference in the primary endpoint of an intermediate dose and standard dose of enoxaparin.

For the statin part of the trial (INSPIRATION-S), 605 patients were randomly assigned to receive atorvastatin 20 mg daily or placebo. Patients who had been taking statins beforehand were excluded. Baseline characteristics were similar for the two groups, with around a quarter of patients taking aspirin and more than 90% taking steroids.

Results showed that atorvastatin was not associated with a significant reduction in the primary outcome – a composite of adjudicated venous or arterial thrombosis, treatment with ECMO, or mortality within 30 days – which occurred in 32.7% of the statin group versus 36.3% of the placebo group (odds ratio, 0.84; P = .35).

Atorvastatin was not associated with any significant differences in any of the individual components of the primary composite endpoint. There was also no significant difference in any of the safety endpoints, which included major bleeding and elevations in liver enzyme levels.

Subgroup analyses were mostly consistent with the main findings, with one exception.

In the subgroup of patients who presented within the first 7 days of COVID-19 symptom onset, there was a hint of a potential protective effect with atorvastatin.

In this group of 171 patients, the primary endpoint occurred in 30.9% of those taking atorvastatin versus 40.3% of those taking placebo (OR, 0.60; P = .055).

“This is an interesting observation, and it is plausible, as these patients may be in a different phase of COVID-19 disease. But we need to be cognizant of the multiplicity of comparisons, and this needs to be further investigated in subsequent studies,” Dr. Bikdeli said.
 

Higher dose in less sick patients a better strategy?

Discussing the study at the ACC presentation, Binita Shah, MD, said the importance of enrolling COVID-19 patients into clinical trials was paramount but that these patients in the ICU may not have been the right population in which to test a statin.

“Maybe for these very sick patients, it is just too late. Trying to rein in the inflammatory cytokine storm and the interaction with thrombosis at this point is very difficult,” Dr. Shah commented.

She suggested that it might be appropriate to try statins in an earlier phase of the disease in order to prevent the inflammatory process, rather than trying to stop it after it had already started.

Dr. Shah also questioned the use of such a low dose of atorvastatin for these patients. “In the cardiovascular literature – at least in ACS [acute coronary syndrome] – high statin doses are used to see short-term benefits. In this very inflammatory milieu, I wonder whether a high-intensity regimen would be more beneficial,” she speculated.

Dr. Bikdeli replied that a low dose of atorvastatin was chosen because early on, several antiviral agents, such as ritonavir, were being used for COVID-19 patients, and these drugs were associated with increases in liver enzyme levels.

“We didn’t want to exacerbate that with high doses of statins,” he said. “But we have now established the safety profile of atorvastatin in these patients, and in retrospect, yes, a higher dose might have been better.”

The INSPIRATION study was funded by the Rajaie Cardiovascular Medical and Research Center, Tehran, Iran. Dr. Bikdeli has disclosed no relevant financial relationships.

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

For patients with COVID-19 admitted to intensive care, giving atorvastatin 20 mg/d did not result in a significant reduction in risk for venous or arterial thrombosis, for treatment with extracorporeal membrane oxygenation (ECMO), or for all-cause mortality, compared with placebo in the INSPIRATION-S study.

However, there was a suggestion of benefit in the subgroup of patients who were treated within 7 days of COVID-19 symptom onset.

The study was presented by Behnood Bikdeli, MD, Brigham and Women’s Hospital, Boston, on May 16 at the annual scientific sessions of the American College of Cardiology.

He explained that COVID-19 is characterized by an exuberant immune response and that there is a potential for thrombotic events because of enhanced endothelial activation and a prothrombotic state.

“In this context, it is interesting to think about statins as potential agents to be studied in COVID-19, because as well as having lipid-lowering actions, they are also thought to have anti-inflammatory and antithrombotic effects,” he said.

In the HARP-2 trial of simvastatin in acute respiratory distress syndrome (ARDS), published a few years ago, the main results were neutral, but in the subgroup of patients with hyperinflammatory ARDS, there was a reduction in mortality with simvastatin in comparison with placebo, Dr. Bikdeli noted.

Moreover, in a series of observational studies of patients with COVID-19, use of statins was associated with a reduction in mortality among hospitalized patients. However, there are limited high-quality data to guide clinical practice, he said.

The INSPIRATION study, conducted in 11 hospitals in Iran, had a two-by-two factorial design to investigate different anticoagulant strategies and the use of atorvastatin for COVID-19 patients in the ICU.

In the anticoagulation part of the trial, which was published in JAMA in March 2020, there was no difference in the primary endpoint of an intermediate dose and standard dose of enoxaparin.

For the statin part of the trial (INSPIRATION-S), 605 patients were randomly assigned to receive atorvastatin 20 mg daily or placebo. Patients who had been taking statins beforehand were excluded. Baseline characteristics were similar for the two groups, with around a quarter of patients taking aspirin and more than 90% taking steroids.

Results showed that atorvastatin was not associated with a significant reduction in the primary outcome – a composite of adjudicated venous or arterial thrombosis, treatment with ECMO, or mortality within 30 days – which occurred in 32.7% of the statin group versus 36.3% of the placebo group (odds ratio, 0.84; P = .35).

Atorvastatin was not associated with any significant differences in any of the individual components of the primary composite endpoint. There was also no significant difference in any of the safety endpoints, which included major bleeding and elevations in liver enzyme levels.

Subgroup analyses were mostly consistent with the main findings, with one exception.

In the subgroup of patients who presented within the first 7 days of COVID-19 symptom onset, there was a hint of a potential protective effect with atorvastatin.

In this group of 171 patients, the primary endpoint occurred in 30.9% of those taking atorvastatin versus 40.3% of those taking placebo (OR, 0.60; P = .055).

“This is an interesting observation, and it is plausible, as these patients may be in a different phase of COVID-19 disease. But we need to be cognizant of the multiplicity of comparisons, and this needs to be further investigated in subsequent studies,” Dr. Bikdeli said.
 

Higher dose in less sick patients a better strategy?

Discussing the study at the ACC presentation, Binita Shah, MD, said the importance of enrolling COVID-19 patients into clinical trials was paramount but that these patients in the ICU may not have been the right population in which to test a statin.

“Maybe for these very sick patients, it is just too late. Trying to rein in the inflammatory cytokine storm and the interaction with thrombosis at this point is very difficult,” Dr. Shah commented.

She suggested that it might be appropriate to try statins in an earlier phase of the disease in order to prevent the inflammatory process, rather than trying to stop it after it had already started.

Dr. Shah also questioned the use of such a low dose of atorvastatin for these patients. “In the cardiovascular literature – at least in ACS [acute coronary syndrome] – high statin doses are used to see short-term benefits. In this very inflammatory milieu, I wonder whether a high-intensity regimen would be more beneficial,” she speculated.

Dr. Bikdeli replied that a low dose of atorvastatin was chosen because early on, several antiviral agents, such as ritonavir, were being used for COVID-19 patients, and these drugs were associated with increases in liver enzyme levels.

“We didn’t want to exacerbate that with high doses of statins,” he said. “But we have now established the safety profile of atorvastatin in these patients, and in retrospect, yes, a higher dose might have been better.”

The INSPIRATION study was funded by the Rajaie Cardiovascular Medical and Research Center, Tehran, Iran. Dr. Bikdeli has disclosed no relevant financial relationships.

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