MDedge Cardiology

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

[email protected]

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

[email protected]

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

[email protected]

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Last spring, when Cliff Willmeng, RN, was working at United Hospital in St. Paul, Minnesota, he’d take off his personal protective equipment (PPE) in the same hallway where children were transported from ambulances to the neighboring Children’s Hospital emergency department. Stretchers would roll across red tape on the floor that designated the area as a “hot zone.” The door from a break room was about 10 feet away.

Willmeng has been a union activist all his life, but he’d never filed a complaint with the Occupational Safety and Health Administration (OSHA) until the COVID-19 pandemic hit.

Concerned about the inadequate space for doffing PPE and other situations in which the spread of SARS-CoV-2 seemed possible, Willmeng and other colleagues filed multiple OSHA complaints with the Minnesota Department of Labor in March and April. Willmeng was also worried about bringing SARS-CoV-2 on his scrubs home to his wife and kids, and he started wearing hospital-supplied scrubs that were meant for doctors and that were washed on site, which was against hospital policy. The hospital fired Willmeng on May 8, citing code of conduct and respectful workplace violations arising from the uniform dispute.

In August, the state agency issued Willmeng’s hospital a $2,100 fine for failure to comply with guidance regarding “respiratory protection” in response to worker complaints over the fact that they were instructed to restaple elastic bands on N95 masks early in the pandemic. In a statement, United Hospital said it contested the citation, and it is in discussions with Minnesota OSHA. “We have and continue to instruct employees not to alter N95 respirators or reuse damaged or soiled N95 respirators,” such as when the straps are broken, the statement says.

Minnesota OSHA has received three times as many emails and phone calls from workers and employers requesting information and assistance during the pandemic, compared with last year, said spokesperson James Honerman. “If Minnesota OSHA is made aware of a workplace safety or health issue, it assesses the situation and determines how best to respond, including conducting a workplace investigation.”

But Willmeng, who has been out of work since he was fired, says that without a receipt or confirmation from OSHA, he has no way of knowing whether there has been any follow-up regarding his complaints. Minnesota OSHA said workers should receive a letter once a case is resolved.

Like Willmeng’s case, none of the more than 10,000 COVID-related complaints the federal OSHA office has received from across the country have resulted in meaningful sanctions. Unions have picketed local OSHA offices and publicized complaints on behalf of their members to protest what they see as a lack of oversight. Legislators have called on US Department of Labor Secretary Eugene Scalia to step up enforcement.

For many health care workers, complaining to OSHA is a last resort after failing to get satisfactory responses from supervisors and appealing to unions for help. But with such minimal oversight from OSHA, some union leaders and legislators say it’s actually more dangerous than not having workplace safety enforcement at all. Lack of directives from the Trump administration has left the agency without the teeth it has cut under previous administrations, and recent changes to the agency’s rules raise questions about whether companies are ever required to report workers’ hospitalizations due to COVID-19.

“It’s so ineffective that it’s more dangerous to workers,” said Kim Cordova, president of United Food and Commercial Workers (UFCW) Local 7, which represents 22,000 health care and other workers in Colorado and Wyoming. “Employers only do what they’re forced to do.” Instead of deterring a multi-billion-dollar company, she said, such low fines signal that a company doesn’t need to worry about COVID-related safety.

“OSHA is doing a lamentably poor job protecting workers during the pandemic,” said James Brudney, JD, a professor at Fordham Law School, in New York, and former chief counsel of the U.S. Senate Subcommittee on Labor. “I’m not alone in saying that the agency has performed so badly.”

Former government officials writing in JAMA were similarly critical: “In the face of the greatest worker health crisis in recent history, OSHA, the lead government agency responsible for worker health and safety, has not fulfilled its responsibilities.”
 

What could have been

There were early signs that the agency wouldn’t be heavy-handed about COVID-19 safety concerns, Brudney said.

The agency could have issued Emergency Temporary Standards, rules it can put in place during pandemics that address specific short-term concerns. These rules could have required employers to take infection-control measures to protect workers, including mask wearing, providing proper PPE, and screening for COVID-19 symptoms. “That’s what the agency is supposed to do. They’re supposed to respond to an emergency with emergency measures,” Brudney said.

But despite legislative pressure and a court case, Secretary of Labor Eugene Scalia has declined to do so, saying that the agency would instead rely on its regular general duty clause, which is always in place to keep workplaces free from hazards that “cause death or serious physical harm.” The agency invoked the general duty clause for COVID-19–related violations for the first time in September to levy modest fines.

In response to a request for an interview, a Department of Labor spokesperson said that preexisting OSHA requirements apply to workers during the pandemic, including providing PPE for workers and assessing sanitation and cleanliness standards. The agency has issued specific guidance to companies on pandemic preparedness, she said, and that it responds to all complaints. Additionally, she cited whistleblower laws that make it illegal for employers to retaliate against employees for making safety and health complaints.

The federal OSHA office received 10,868 COVID-related complaints from Feb. 1 through Oct. 20, citing issues ranging from failure to provide proper PPE to not informing workers about exposures. As of Oct. 22, a total of 2,349 of the complaints involved healthcare workers. This count doesn’t include the untold number of “informal” complaints handled by state OSHA offices.

In a recent JAMA opinion piece, two former government officials agreed that “the federal government has not fully utilized OSHA’s public safety authority” and called the issuing of an Emergency Temporary Standard that would require employers to develop and implement infection control plans “the most important action the federal government could take” to protect workers.

“Employers are more likely to implement these controls if they are mandated by a government agency that has adequate enforcement tools to ensure compliance,” wrote former Assistant Secretary of Labor David Michaels, PhD, MPH, now at the Milken Institute School of Public Health of the George Washington University, Washington, and Gregory Wagner, MD, a former senior adviser at the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, now at the Harvard T.H. Chan School of Public Health, Boston.

They cited the success of a standard that OSHA issued in 1991 in response to the HIV/AIDS crisis. “The bloodborne pathogens standard has contributed to a substantial decline in health care worker risk for bloodborne diseases like HIV and hepatitis B and C,” they wrote. In a new report for the Century Foundation, the pair offered recommendations to the federal government for controlling the spread of the disease by ramping up OSHA’s role.

OSHA did issue a response plan that requires employers to report in regard to employees who experienced workplace exposures to SARS-CoV-2 and who were hospitalized with COVID-19 or died of the disease within certain time frames, but recent changes to these rules make experts question whether companies are in fact required to report hospitalizations.

In its second revision of guidelines, added to its FAQ page on Sept. 30, the agency said that, in order to be reportable, “an in-patient hospitalization due to COVID-19 must occur within 24 hours of an exposure to SARS-CoV-2 at work” and that the employer must report the hospitalization within 24 hours of learning both that the employee has been hospitalized and that the reason for the hospitalization was a work-related case of COVID-19. Previously, the 24-hour hospitalization window started at the time of diagnosis of the disease, rather than the work-related exposure.

The agency subsequently dropped the first citation it had issued for a COVID-related violation, even though the company, a nursing home, had already agreed to pay $3,904 for reporting employee hospitalizations late.

“It’s a step backwards from an important workplace and public health function that OSHA should be doing,” said Wagner, coauthor of the JAMA opinion piece.

Even without issuing Emergency Temporary Standards, critics say OSHA could have acted much earlier. OSHA issued its first COVID-related federal citation, the one against the nursing home that was dropped, in May for events that occurred in mid-April. The second COVID-related federal citation came in July.

The agency could also charge much more substantial fines for the citations it has issued. If a medical facility was cited for a PPE violation, such as the Minnesota hospital where workers were told to restaple the elastic bands on N95s, the agency could have cited the hospital for one violation per employee. Such fines based on multiple violations could add up to the hundreds of thousands to millions of dollars.

“It would send a signal to the highest-risk employers that these are violations that need to be addressed immediately,” Brudney said.

Many of the 22 state OSHA offices appear to be more responsive to COVID-related complaints than the federal agency, creating a system in which health care workers have substantially different rights from one state to the next. The governor of California, for example, recently authorized California’s OSHA division to consider COVID-19 an imminent hazard, to prohibit workers from entering areas where the hazard exists, and to require employers to disclose exposures. The state also recently issued large fines for COVID safety issues: $222,075 to frozen food manufacturer Overhill Farms and $214,080 to employment agency Jobsource North America.

Elsewhere, state laws such as New Jersey’s Conscientious Employee Protection Act give workers the right to refuse to work in unsafe situations, Brudney said. “A lot more action is going on at the state level because so little is being done at the federal level,” he said. “Some of it is governors committed to protecting essential workers and their families.”
 

Unions call for sanctions

Unions are both decrying the lack of enforcement thus far and seeking more oversight going forward.

In August, the National Nurses’ United (NNU) union filed a complaint to implore OSHA to investigate the country’s biggest hospital systems, HCA Healthcare, which operates 184 hospitals and about 2,000 other care sites in 21 states and the United Kingdom. The union describes how, throughout HCA hospitals, there is an environment conducive to the spread of coronavirus. Nurses share space and equipment, such as computers, desks, phones, bathrooms, and break rooms, where staff take off masks to eat and drink. The complaint also describes how there is resistance to testing nurses and a lack of communication about infections among colleagues.

“When they have total disregard for safety, they should be punished to the utmost,” said Markowitz, noting that HCA Healthcare is worth $40 billion. “They can penalize them, but if it’s unsafe conditions for RNs and healthcare workers, we know it’s unsafe for the patients. There needs to be drastic measures to prevent hospital corporations from behaving that way.”

In a statement, HCA spokesman Harlow Sumerford said the company has followed CDC guidance for protecting frontline caregivers. “We’re proud of our response and the significant resources we’ve deployed to help protect our colleagues. Meanwhile, the NNU has chosen to use this pandemic as an opportunity to gain publicity by attacking hospitals across the country,” Sumerford said.

Members of the union recently protested in front of the federal OSHA offices in Denver.

After several months, OSHA finally penalized a meat packing plant where eight workers (six union members) had died of COVID-19 last spring. But the amount – $15,615 – was so low that Cordova worries it will actually have a worse impact than no fine.

“It’s more dangerous to workers because now employers know [they won’t be punished meaningfully],” she said. “During the pandemic, OSHA has been absolutely absent.”

Thus, the recent picketing outside the offices in Denver. But, Cordova noted, it’s unlikely OSHA employees saw them. Their own offices were deemed too risky to stay open during the pandemic. They were vacant.
 

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

Last spring, when Cliff Willmeng, RN, was working at United Hospital in St. Paul, Minnesota, he’d take off his personal protective equipment (PPE) in the same hallway where children were transported from ambulances to the neighboring Children’s Hospital emergency department. Stretchers would roll across red tape on the floor that designated the area as a “hot zone.” The door from a break room was about 10 feet away.

Willmeng has been a union activist all his life, but he’d never filed a complaint with the Occupational Safety and Health Administration (OSHA) until the COVID-19 pandemic hit.

Concerned about the inadequate space for doffing PPE and other situations in which the spread of SARS-CoV-2 seemed possible, Willmeng and other colleagues filed multiple OSHA complaints with the Minnesota Department of Labor in March and April. Willmeng was also worried about bringing SARS-CoV-2 on his scrubs home to his wife and kids, and he started wearing hospital-supplied scrubs that were meant for doctors and that were washed on site, which was against hospital policy. The hospital fired Willmeng on May 8, citing code of conduct and respectful workplace violations arising from the uniform dispute.

In August, the state agency issued Willmeng’s hospital a $2,100 fine for failure to comply with guidance regarding “respiratory protection” in response to worker complaints over the fact that they were instructed to restaple elastic bands on N95 masks early in the pandemic. In a statement, United Hospital said it contested the citation, and it is in discussions with Minnesota OSHA. “We have and continue to instruct employees not to alter N95 respirators or reuse damaged or soiled N95 respirators,” such as when the straps are broken, the statement says.

Minnesota OSHA has received three times as many emails and phone calls from workers and employers requesting information and assistance during the pandemic, compared with last year, said spokesperson James Honerman. “If Minnesota OSHA is made aware of a workplace safety or health issue, it assesses the situation and determines how best to respond, including conducting a workplace investigation.”

But Willmeng, who has been out of work since he was fired, says that without a receipt or confirmation from OSHA, he has no way of knowing whether there has been any follow-up regarding his complaints. Minnesota OSHA said workers should receive a letter once a case is resolved.

Like Willmeng’s case, none of the more than 10,000 COVID-related complaints the federal OSHA office has received from across the country have resulted in meaningful sanctions. Unions have picketed local OSHA offices and publicized complaints on behalf of their members to protest what they see as a lack of oversight. Legislators have called on US Department of Labor Secretary Eugene Scalia to step up enforcement.

For many health care workers, complaining to OSHA is a last resort after failing to get satisfactory responses from supervisors and appealing to unions for help. But with such minimal oversight from OSHA, some union leaders and legislators say it’s actually more dangerous than not having workplace safety enforcement at all. Lack of directives from the Trump administration has left the agency without the teeth it has cut under previous administrations, and recent changes to the agency’s rules raise questions about whether companies are ever required to report workers’ hospitalizations due to COVID-19.

“It’s so ineffective that it’s more dangerous to workers,” said Kim Cordova, president of United Food and Commercial Workers (UFCW) Local 7, which represents 22,000 health care and other workers in Colorado and Wyoming. “Employers only do what they’re forced to do.” Instead of deterring a multi-billion-dollar company, she said, such low fines signal that a company doesn’t need to worry about COVID-related safety.

“OSHA is doing a lamentably poor job protecting workers during the pandemic,” said James Brudney, JD, a professor at Fordham Law School, in New York, and former chief counsel of the U.S. Senate Subcommittee on Labor. “I’m not alone in saying that the agency has performed so badly.”

Former government officials writing in JAMA were similarly critical: “In the face of the greatest worker health crisis in recent history, OSHA, the lead government agency responsible for worker health and safety, has not fulfilled its responsibilities.”
 

What could have been

There were early signs that the agency wouldn’t be heavy-handed about COVID-19 safety concerns, Brudney said.

The agency could have issued Emergency Temporary Standards, rules it can put in place during pandemics that address specific short-term concerns. These rules could have required employers to take infection-control measures to protect workers, including mask wearing, providing proper PPE, and screening for COVID-19 symptoms. “That’s what the agency is supposed to do. They’re supposed to respond to an emergency with emergency measures,” Brudney said.

But despite legislative pressure and a court case, Secretary of Labor Eugene Scalia has declined to do so, saying that the agency would instead rely on its regular general duty clause, which is always in place to keep workplaces free from hazards that “cause death or serious physical harm.” The agency invoked the general duty clause for COVID-19–related violations for the first time in September to levy modest fines.

In response to a request for an interview, a Department of Labor spokesperson said that preexisting OSHA requirements apply to workers during the pandemic, including providing PPE for workers and assessing sanitation and cleanliness standards. The agency has issued specific guidance to companies on pandemic preparedness, she said, and that it responds to all complaints. Additionally, she cited whistleblower laws that make it illegal for employers to retaliate against employees for making safety and health complaints.

The federal OSHA office received 10,868 COVID-related complaints from Feb. 1 through Oct. 20, citing issues ranging from failure to provide proper PPE to not informing workers about exposures. As of Oct. 22, a total of 2,349 of the complaints involved healthcare workers. This count doesn’t include the untold number of “informal” complaints handled by state OSHA offices.

In a recent JAMA opinion piece, two former government officials agreed that “the federal government has not fully utilized OSHA’s public safety authority” and called the issuing of an Emergency Temporary Standard that would require employers to develop and implement infection control plans “the most important action the federal government could take” to protect workers.

“Employers are more likely to implement these controls if they are mandated by a government agency that has adequate enforcement tools to ensure compliance,” wrote former Assistant Secretary of Labor David Michaels, PhD, MPH, now at the Milken Institute School of Public Health of the George Washington University, Washington, and Gregory Wagner, MD, a former senior adviser at the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, now at the Harvard T.H. Chan School of Public Health, Boston.

They cited the success of a standard that OSHA issued in 1991 in response to the HIV/AIDS crisis. “The bloodborne pathogens standard has contributed to a substantial decline in health care worker risk for bloodborne diseases like HIV and hepatitis B and C,” they wrote. In a new report for the Century Foundation, the pair offered recommendations to the federal government for controlling the spread of the disease by ramping up OSHA’s role.

OSHA did issue a response plan that requires employers to report in regard to employees who experienced workplace exposures to SARS-CoV-2 and who were hospitalized with COVID-19 or died of the disease within certain time frames, but recent changes to these rules make experts question whether companies are in fact required to report hospitalizations.

In its second revision of guidelines, added to its FAQ page on Sept. 30, the agency said that, in order to be reportable, “an in-patient hospitalization due to COVID-19 must occur within 24 hours of an exposure to SARS-CoV-2 at work” and that the employer must report the hospitalization within 24 hours of learning both that the employee has been hospitalized and that the reason for the hospitalization was a work-related case of COVID-19. Previously, the 24-hour hospitalization window started at the time of diagnosis of the disease, rather than the work-related exposure.

The agency subsequently dropped the first citation it had issued for a COVID-related violation, even though the company, a nursing home, had already agreed to pay $3,904 for reporting employee hospitalizations late.

“It’s a step backwards from an important workplace and public health function that OSHA should be doing,” said Wagner, coauthor of the JAMA opinion piece.

Even without issuing Emergency Temporary Standards, critics say OSHA could have acted much earlier. OSHA issued its first COVID-related federal citation, the one against the nursing home that was dropped, in May for events that occurred in mid-April. The second COVID-related federal citation came in July.

The agency could also charge much more substantial fines for the citations it has issued. If a medical facility was cited for a PPE violation, such as the Minnesota hospital where workers were told to restaple the elastic bands on N95s, the agency could have cited the hospital for one violation per employee. Such fines based on multiple violations could add up to the hundreds of thousands to millions of dollars.

“It would send a signal to the highest-risk employers that these are violations that need to be addressed immediately,” Brudney said.

Many of the 22 state OSHA offices appear to be more responsive to COVID-related complaints than the federal agency, creating a system in which health care workers have substantially different rights from one state to the next. The governor of California, for example, recently authorized California’s OSHA division to consider COVID-19 an imminent hazard, to prohibit workers from entering areas where the hazard exists, and to require employers to disclose exposures. The state also recently issued large fines for COVID safety issues: $222,075 to frozen food manufacturer Overhill Farms and $214,080 to employment agency Jobsource North America.

Elsewhere, state laws such as New Jersey’s Conscientious Employee Protection Act give workers the right to refuse to work in unsafe situations, Brudney said. “A lot more action is going on at the state level because so little is being done at the federal level,” he said. “Some of it is governors committed to protecting essential workers and their families.”
 

Unions call for sanctions

Unions are both decrying the lack of enforcement thus far and seeking more oversight going forward.

In August, the National Nurses’ United (NNU) union filed a complaint to implore OSHA to investigate the country’s biggest hospital systems, HCA Healthcare, which operates 184 hospitals and about 2,000 other care sites in 21 states and the United Kingdom. The union describes how, throughout HCA hospitals, there is an environment conducive to the spread of coronavirus. Nurses share space and equipment, such as computers, desks, phones, bathrooms, and break rooms, where staff take off masks to eat and drink. The complaint also describes how there is resistance to testing nurses and a lack of communication about infections among colleagues.

“When they have total disregard for safety, they should be punished to the utmost,” said Markowitz, noting that HCA Healthcare is worth $40 billion. “They can penalize them, but if it’s unsafe conditions for RNs and healthcare workers, we know it’s unsafe for the patients. There needs to be drastic measures to prevent hospital corporations from behaving that way.”

In a statement, HCA spokesman Harlow Sumerford said the company has followed CDC guidance for protecting frontline caregivers. “We’re proud of our response and the significant resources we’ve deployed to help protect our colleagues. Meanwhile, the NNU has chosen to use this pandemic as an opportunity to gain publicity by attacking hospitals across the country,” Sumerford said.

Members of the union recently protested in front of the federal OSHA offices in Denver.

After several months, OSHA finally penalized a meat packing plant where eight workers (six union members) had died of COVID-19 last spring. But the amount – $15,615 – was so low that Cordova worries it will actually have a worse impact than no fine.

“It’s more dangerous to workers because now employers know [they won’t be punished meaningfully],” she said. “During the pandemic, OSHA has been absolutely absent.”

Thus, the recent picketing outside the offices in Denver. But, Cordova noted, it’s unlikely OSHA employees saw them. Their own offices were deemed too risky to stay open during the pandemic. They were vacant.
 

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

Last spring, when Cliff Willmeng, RN, was working at United Hospital in St. Paul, Minnesota, he’d take off his personal protective equipment (PPE) in the same hallway where children were transported from ambulances to the neighboring Children’s Hospital emergency department. Stretchers would roll across red tape on the floor that designated the area as a “hot zone.” The door from a break room was about 10 feet away.

Willmeng has been a union activist all his life, but he’d never filed a complaint with the Occupational Safety and Health Administration (OSHA) until the COVID-19 pandemic hit.

Concerned about the inadequate space for doffing PPE and other situations in which the spread of SARS-CoV-2 seemed possible, Willmeng and other colleagues filed multiple OSHA complaints with the Minnesota Department of Labor in March and April. Willmeng was also worried about bringing SARS-CoV-2 on his scrubs home to his wife and kids, and he started wearing hospital-supplied scrubs that were meant for doctors and that were washed on site, which was against hospital policy. The hospital fired Willmeng on May 8, citing code of conduct and respectful workplace violations arising from the uniform dispute.

In August, the state agency issued Willmeng’s hospital a $2,100 fine for failure to comply with guidance regarding “respiratory protection” in response to worker complaints over the fact that they were instructed to restaple elastic bands on N95 masks early in the pandemic. In a statement, United Hospital said it contested the citation, and it is in discussions with Minnesota OSHA. “We have and continue to instruct employees not to alter N95 respirators or reuse damaged or soiled N95 respirators,” such as when the straps are broken, the statement says.

Minnesota OSHA has received three times as many emails and phone calls from workers and employers requesting information and assistance during the pandemic, compared with last year, said spokesperson James Honerman. “If Minnesota OSHA is made aware of a workplace safety or health issue, it assesses the situation and determines how best to respond, including conducting a workplace investigation.”

But Willmeng, who has been out of work since he was fired, says that without a receipt or confirmation from OSHA, he has no way of knowing whether there has been any follow-up regarding his complaints. Minnesota OSHA said workers should receive a letter once a case is resolved.

Like Willmeng’s case, none of the more than 10,000 COVID-related complaints the federal OSHA office has received from across the country have resulted in meaningful sanctions. Unions have picketed local OSHA offices and publicized complaints on behalf of their members to protest what they see as a lack of oversight. Legislators have called on US Department of Labor Secretary Eugene Scalia to step up enforcement.

For many health care workers, complaining to OSHA is a last resort after failing to get satisfactory responses from supervisors and appealing to unions for help. But with such minimal oversight from OSHA, some union leaders and legislators say it’s actually more dangerous than not having workplace safety enforcement at all. Lack of directives from the Trump administration has left the agency without the teeth it has cut under previous administrations, and recent changes to the agency’s rules raise questions about whether companies are ever required to report workers’ hospitalizations due to COVID-19.

“It’s so ineffective that it’s more dangerous to workers,” said Kim Cordova, president of United Food and Commercial Workers (UFCW) Local 7, which represents 22,000 health care and other workers in Colorado and Wyoming. “Employers only do what they’re forced to do.” Instead of deterring a multi-billion-dollar company, she said, such low fines signal that a company doesn’t need to worry about COVID-related safety.

“OSHA is doing a lamentably poor job protecting workers during the pandemic,” said James Brudney, JD, a professor at Fordham Law School, in New York, and former chief counsel of the U.S. Senate Subcommittee on Labor. “I’m not alone in saying that the agency has performed so badly.”

Former government officials writing in JAMA were similarly critical: “In the face of the greatest worker health crisis in recent history, OSHA, the lead government agency responsible for worker health and safety, has not fulfilled its responsibilities.”
 

What could have been

There were early signs that the agency wouldn’t be heavy-handed about COVID-19 safety concerns, Brudney said.

The agency could have issued Emergency Temporary Standards, rules it can put in place during pandemics that address specific short-term concerns. These rules could have required employers to take infection-control measures to protect workers, including mask wearing, providing proper PPE, and screening for COVID-19 symptoms. “That’s what the agency is supposed to do. They’re supposed to respond to an emergency with emergency measures,” Brudney said.

But despite legislative pressure and a court case, Secretary of Labor Eugene Scalia has declined to do so, saying that the agency would instead rely on its regular general duty clause, which is always in place to keep workplaces free from hazards that “cause death or serious physical harm.” The agency invoked the general duty clause for COVID-19–related violations for the first time in September to levy modest fines.

In response to a request for an interview, a Department of Labor spokesperson said that preexisting OSHA requirements apply to workers during the pandemic, including providing PPE for workers and assessing sanitation and cleanliness standards. The agency has issued specific guidance to companies on pandemic preparedness, she said, and that it responds to all complaints. Additionally, she cited whistleblower laws that make it illegal for employers to retaliate against employees for making safety and health complaints.

The federal OSHA office received 10,868 COVID-related complaints from Feb. 1 through Oct. 20, citing issues ranging from failure to provide proper PPE to not informing workers about exposures. As of Oct. 22, a total of 2,349 of the complaints involved healthcare workers. This count doesn’t include the untold number of “informal” complaints handled by state OSHA offices.

In a recent JAMA opinion piece, two former government officials agreed that “the federal government has not fully utilized OSHA’s public safety authority” and called the issuing of an Emergency Temporary Standard that would require employers to develop and implement infection control plans “the most important action the federal government could take” to protect workers.

“Employers are more likely to implement these controls if they are mandated by a government agency that has adequate enforcement tools to ensure compliance,” wrote former Assistant Secretary of Labor David Michaels, PhD, MPH, now at the Milken Institute School of Public Health of the George Washington University, Washington, and Gregory Wagner, MD, a former senior adviser at the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, now at the Harvard T.H. Chan School of Public Health, Boston.

They cited the success of a standard that OSHA issued in 1991 in response to the HIV/AIDS crisis. “The bloodborne pathogens standard has contributed to a substantial decline in health care worker risk for bloodborne diseases like HIV and hepatitis B and C,” they wrote. In a new report for the Century Foundation, the pair offered recommendations to the federal government for controlling the spread of the disease by ramping up OSHA’s role.

OSHA did issue a response plan that requires employers to report in regard to employees who experienced workplace exposures to SARS-CoV-2 and who were hospitalized with COVID-19 or died of the disease within certain time frames, but recent changes to these rules make experts question whether companies are in fact required to report hospitalizations.

In its second revision of guidelines, added to its FAQ page on Sept. 30, the agency said that, in order to be reportable, “an in-patient hospitalization due to COVID-19 must occur within 24 hours of an exposure to SARS-CoV-2 at work” and that the employer must report the hospitalization within 24 hours of learning both that the employee has been hospitalized and that the reason for the hospitalization was a work-related case of COVID-19. Previously, the 24-hour hospitalization window started at the time of diagnosis of the disease, rather than the work-related exposure.

The agency subsequently dropped the first citation it had issued for a COVID-related violation, even though the company, a nursing home, had already agreed to pay $3,904 for reporting employee hospitalizations late.

“It’s a step backwards from an important workplace and public health function that OSHA should be doing,” said Wagner, coauthor of the JAMA opinion piece.

Even without issuing Emergency Temporary Standards, critics say OSHA could have acted much earlier. OSHA issued its first COVID-related federal citation, the one against the nursing home that was dropped, in May for events that occurred in mid-April. The second COVID-related federal citation came in July.

The agency could also charge much more substantial fines for the citations it has issued. If a medical facility was cited for a PPE violation, such as the Minnesota hospital where workers were told to restaple the elastic bands on N95s, the agency could have cited the hospital for one violation per employee. Such fines based on multiple violations could add up to the hundreds of thousands to millions of dollars.

“It would send a signal to the highest-risk employers that these are violations that need to be addressed immediately,” Brudney said.

Many of the 22 state OSHA offices appear to be more responsive to COVID-related complaints than the federal agency, creating a system in which health care workers have substantially different rights from one state to the next. The governor of California, for example, recently authorized California’s OSHA division to consider COVID-19 an imminent hazard, to prohibit workers from entering areas where the hazard exists, and to require employers to disclose exposures. The state also recently issued large fines for COVID safety issues: $222,075 to frozen food manufacturer Overhill Farms and $214,080 to employment agency Jobsource North America.

Elsewhere, state laws such as New Jersey’s Conscientious Employee Protection Act give workers the right to refuse to work in unsafe situations, Brudney said. “A lot more action is going on at the state level because so little is being done at the federal level,” he said. “Some of it is governors committed to protecting essential workers and their families.”
 

Unions call for sanctions

Unions are both decrying the lack of enforcement thus far and seeking more oversight going forward.

In August, the National Nurses’ United (NNU) union filed a complaint to implore OSHA to investigate the country’s biggest hospital systems, HCA Healthcare, which operates 184 hospitals and about 2,000 other care sites in 21 states and the United Kingdom. The union describes how, throughout HCA hospitals, there is an environment conducive to the spread of coronavirus. Nurses share space and equipment, such as computers, desks, phones, bathrooms, and break rooms, where staff take off masks to eat and drink. The complaint also describes how there is resistance to testing nurses and a lack of communication about infections among colleagues.

“When they have total disregard for safety, they should be punished to the utmost,” said Markowitz, noting that HCA Healthcare is worth $40 billion. “They can penalize them, but if it’s unsafe conditions for RNs and healthcare workers, we know it’s unsafe for the patients. There needs to be drastic measures to prevent hospital corporations from behaving that way.”

In a statement, HCA spokesman Harlow Sumerford said the company has followed CDC guidance for protecting frontline caregivers. “We’re proud of our response and the significant resources we’ve deployed to help protect our colleagues. Meanwhile, the NNU has chosen to use this pandemic as an opportunity to gain publicity by attacking hospitals across the country,” Sumerford said.

Members of the union recently protested in front of the federal OSHA offices in Denver.

After several months, OSHA finally penalized a meat packing plant where eight workers (six union members) had died of COVID-19 last spring. But the amount – $15,615 – was so low that Cordova worries it will actually have a worse impact than no fine.

“It’s more dangerous to workers because now employers know [they won’t be punished meaningfully],” she said. “During the pandemic, OSHA has been absolutely absent.”

Thus, the recent picketing outside the offices in Denver. But, Cordova noted, it’s unlikely OSHA employees saw them. Their own offices were deemed too risky to stay open during the pandemic. They were vacant.
 

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

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 cases are surging in rural places across the Mountain States and Midwest, and when it hits health care workers, ready reinforcements aren’t easy to find.

In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.

“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”

In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.

“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”

The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis  by the New York Times.

Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.

Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.

“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”

Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.

Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.

Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.

“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.

This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.

“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”

Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.

Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.

But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.

Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.

“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”

Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.

“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”

Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.

Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.

Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.

“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.

© American Heart Association, Inc.

The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.

These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.

And new approaches do appear to save lives, at least in a hospital setting.

Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.

“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
 

Update adds sixth link to Chains of Survival: Recovery

“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.

Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.

The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
 

New advice on opioid overdoses and bystander training

Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.

In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.

“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.

While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.

According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.

This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.

“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”

The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.

According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.

“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”

Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.

When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.

“It’s always a personal choice,” she said.
 

More for clinicians

For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.

From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.

The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.

SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.

Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.

© American Heart Association, Inc.

The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.

These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.

And new approaches do appear to save lives, at least in a hospital setting.

Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.

“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
 

Update adds sixth link to Chains of Survival: Recovery

“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.

Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.

The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
 

New advice on opioid overdoses and bystander training

Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.

In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.

“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.

While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.

According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.

This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.

“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”

The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.

According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.

“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”

Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.

When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.

“It’s always a personal choice,” she said.
 

More for clinicians

For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.

From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.

The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.

SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.

Highlights of new updated guidelines for cardiopulmonary resuscitation and emergency cardiovascular care from the American Heart Association include management of opioid-related emergencies; discussion of health disparities; and a new emphasis on physical, social, and emotional recovery after resuscitation.

© American Heart Association, Inc.

The AHA is also exploring digital territory to improve CPR outcomes. The guidelines encourage use of mobile phone technology to summon trained laypeople to individuals requiring CPR, and an adaptive learning suite will be available online for personalized CPR instruction, with lessons catered to individual needs and knowledge levels.

These novel approaches reflect an ongoing effort by the AHA to ensure that the guidelines evolve rapidly with science and technology, reported Raina Merchant, MD, chair of the AHA Emergency Cardiovascular Care Committee and associate professor of emergency medicine at the University of Pennsylvania, Philadelphia, and colleagues. In 2015, the committee shifted from 5-year updates to a continuous online review process, citing a need for more immediate implementation of practice-altering data, they wrote in Circulation.

And new approaches do appear to save lives, at least in a hospital setting.

Since 2004, in-hospital cardiac arrest outcomes have been improving, but similar gains have yet to be realized for out-of-hospital cardiac arrest.

“Much of the variation in survival rates is thought to be due to the strength of the Chain of Survival, the [five] critical actions that must occur in rapid succession to maximize the chance of survival from cardiac arrest,” the committee wrote.
 

Update adds sixth link to Chains of Survival: Recovery

“Recovery expectations and survivorship plans that address treatment, surveillance, and rehabilitation need to be provided to cardiac arrest survivors and their caregivers at hospital discharge to address the sequelae of cardiac arrest and optimize transitions of care to independent physical, social, emotional, and role function,” the committee wrote.

Dr. Merchant and colleagues identified three “critically important” recommendations for both cardiac arrest survivors and caregivers during the recovery process: structured psychological assessment; multimodal rehabilitation assessment and treatment; and comprehensive, multidisciplinary discharge planning.

The recovery process is now part of all four Chains of Survival, which are specific to in-hospital and out-of-hospital arrest for adults and children.
 

New advice on opioid overdoses and bystander training

Among instances of out-of-hospital cardiac arrest, the committee noted that opioid overdoses are “sharply on the rise,” leading to new, scenario-specific recommendations. Among them, the committee encouraged lay rescuers and trained responders to activate emergency response systems immediately while awaiting improvements with naloxone and other interventions. They also suggested that, for individuals in known or suspected cardiac arrest, high-quality CPR, including compressions and ventilation, should be prioritized over naloxone administration.

In a broader discussion, the committee identified disparities in CPR training, which could explain lower rates of bystander CPR and poorer outcomes among certain demographics, such as black and Hispanic populations, as well as those with lower socioeconomic status.

“Targeting training efforts should consider barriers such as language, financial considerations, and poor access to information,” the committee wrote.

While low bystander CPR in these areas may be improved through mobile phone technology that alerts trained laypeople to individuals in need, the committee noted that this approach may be impacted by cultural and geographic factors. To date, use of mobile devices to improve bystander intervention rates has been demonstrated through “uniformly positive data,” but never in North America.

According to the guidelines, bystander intervention rates may also be improved through video-based learning, which is as effective as in-person, instructor-led training.

This led the AHA to create an online adaptive learning platform, which the organization describes as a “digital resuscitation portfolio” that connects programs and courses such as the Resuscitation Quality Improvement program and the HeartCode blended learning course.

“It will cover all of the guideline changes,” said Monica Sales, communications manager at the AHA. “It’s really groundbreaking because it’s the first time that we’re able to kind of close that gap between new science and new products.”

The online content also addresses CPR considerations for COVID-19, which were first addressed by interim CPR guidance published by the AHA in April.

According to Alexis Topjian, MD, coauthor of the present guidelines and pediatric critical care medicine physician at Children’s Hospital of Philadelphia, CPR awareness is more important now than ever.

“The major message [of the guidelines] is that high-quality CPR saves lives,” she said. “So push hard, and push fast. You have the power in your hands to make a difference, more so than ever during this pandemic.”

Concerning coronavirus precautions, Dr. Topjian noted that roughly 70% of out-of-hospital CPR events involve people who know each other, so most bystanders have already been exposed to the person in need, thereby reducing the concern of infection.

When asked about performing CPR on strangers, Dr. Topjian remained encouraging, though she noted that decision making may be informed by local coronavirus rates.

“It’s always a personal choice,” she said.
 

More for clinicians

For clinicians, Dr. Topjian highlighted several recommendations, including use of epinephrine as soon as possible during CPR, preferential use of a cuffed endotracheal tube, continuous EEG monitoring during and after cardiac arrest, and rapid intervention for clinical seizures and of nonconvulsive status epilepticus.

From a pediatric perspective, Dr. Topjian pointed out a change in breathing rate for infants and children who are receiving CPR or rescue breathing with a pulse, from 12-20 breaths/min to 20-30 breaths/min. While not a new recommendation, Dr. Topjian also pointed out the lifesaving benefit of early defibrillation among pediatric patients.

The guidelines were funded by the American Heart Association. The investigators disclosed additional relationships with BTG Pharmaceuticals, Zoll Foundation, the National Institutes of Health, and others.

SOURCE: American Heart Association. Circulation. 2020 Oct 20. Suppl 2.

Sugary and artificially sweetened drinks are each associated with an increased risk of developing cardiovascular disease, according to results from a large prospective cohort study.

© Irochka/Fotolia.com

However, the design of that study fails to take into account other sources of dietary sugar, according to one expert.

In a research letter published online Oct. 26 in the Journal of the American College of Cardiology, Eloi Chazelas, a PhD candidate at Sorbonne Paris Nord University in Paris, and colleagues, shared results from nearly 105,000 subjects (79% women, mean age 43 at baseline, median follow up 6.6 years) enrolled in the NutriNet-Santé cohort study.

In this observational study, which began recruiting in 2009, dietary patterns are self-reported by subjects, while health outcomes are validated by investigators.

Mr. Chazelas and his colleagues identified 1,379 first incident cases of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, and angioplasty in the cohort during 2009-2019. Cases that occurred during the first 3 years’ follow up were excluded from the analysis, to avoid potential reverse causality bias.

After adjustment for a wide range of dietary, demographic and health confounders, the investigators found that high consumers of sugary drinks or artificially sweetened drinks saw 20% and 32% higher risk of such events, respectively, compared with people who reported drinking neither beverage type (hazard ratio: 1.20; 95% confidence interval 1.04-1.40, P for trend < .0009 and HR: 1.32; 95% CI, 1.00-1.73, P for trend < .03).

Sugary drinks were defined as containing 5% or more of sugars, including natural fruit juices. The high consumers in the study had a median intake of 185 mL per day of sugary drinks, or 176 mL per day for artificially sweetened drinks. Natural noncaloric sweeteners such as Stevia were included in the artificially sweetened group.

The findings, Mr. Chazelas and colleagues wrote in their analysis, add to evidence that artificially sweetened beverages “might not be a healthy substitute for sugary drinks.” While research has suggested that artificial sweeteners induce glucose intolerance by disturbing gut microbiota, they noted, more and bigger studies are needed to understand the mechanisms by which they might bear on cardiovascular disease risk.

Robert A. Vogel, MD, of the University of Colorado Denver, urged caution in interpreting the researchers’ results. In an interview, Dr. Vogel, a preventive cardiologist, said that it is “notoriously difficult” to evaluate what a food or food group does to the body outside of a carefully controlled trial. What little randomized trial evidence exists comparing the health effects of artificially sweetened and sugary drinks includes a 2012 trial in children that found diet drinks associated with reductions in body fat – if anything a positive indication for heart health.

SOURCE: Chazelas et al. JACC 2020;76(18):2175-80.

Sugary and artificially sweetened drinks are each associated with an increased risk of developing cardiovascular disease, according to results from a large prospective cohort study.

© Irochka/Fotolia.com

However, the design of that study fails to take into account other sources of dietary sugar, according to one expert.

In a research letter published online Oct. 26 in the Journal of the American College of Cardiology, Eloi Chazelas, a PhD candidate at Sorbonne Paris Nord University in Paris, and colleagues, shared results from nearly 105,000 subjects (79% women, mean age 43 at baseline, median follow up 6.6 years) enrolled in the NutriNet-Santé cohort study.

In this observational study, which began recruiting in 2009, dietary patterns are self-reported by subjects, while health outcomes are validated by investigators.

Mr. Chazelas and his colleagues identified 1,379 first incident cases of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, and angioplasty in the cohort during 2009-2019. Cases that occurred during the first 3 years’ follow up were excluded from the analysis, to avoid potential reverse causality bias.

After adjustment for a wide range of dietary, demographic and health confounders, the investigators found that high consumers of sugary drinks or artificially sweetened drinks saw 20% and 32% higher risk of such events, respectively, compared with people who reported drinking neither beverage type (hazard ratio: 1.20; 95% confidence interval 1.04-1.40, P for trend < .0009 and HR: 1.32; 95% CI, 1.00-1.73, P for trend < .03).

Sugary drinks were defined as containing 5% or more of sugars, including natural fruit juices. The high consumers in the study had a median intake of 185 mL per day of sugary drinks, or 176 mL per day for artificially sweetened drinks. Natural noncaloric sweeteners such as Stevia were included in the artificially sweetened group.

The findings, Mr. Chazelas and colleagues wrote in their analysis, add to evidence that artificially sweetened beverages “might not be a healthy substitute for sugary drinks.” While research has suggested that artificial sweeteners induce glucose intolerance by disturbing gut microbiota, they noted, more and bigger studies are needed to understand the mechanisms by which they might bear on cardiovascular disease risk.

Robert A. Vogel, MD, of the University of Colorado Denver, urged caution in interpreting the researchers’ results. In an interview, Dr. Vogel, a preventive cardiologist, said that it is “notoriously difficult” to evaluate what a food or food group does to the body outside of a carefully controlled trial. What little randomized trial evidence exists comparing the health effects of artificially sweetened and sugary drinks includes a 2012 trial in children that found diet drinks associated with reductions in body fat – if anything a positive indication for heart health.

SOURCE: Chazelas et al. JACC 2020;76(18):2175-80.

Sugary and artificially sweetened drinks are each associated with an increased risk of developing cardiovascular disease, according to results from a large prospective cohort study.

© Irochka/Fotolia.com

However, the design of that study fails to take into account other sources of dietary sugar, according to one expert.

In a research letter published online Oct. 26 in the Journal of the American College of Cardiology, Eloi Chazelas, a PhD candidate at Sorbonne Paris Nord University in Paris, and colleagues, shared results from nearly 105,000 subjects (79% women, mean age 43 at baseline, median follow up 6.6 years) enrolled in the NutriNet-Santé cohort study.

In this observational study, which began recruiting in 2009, dietary patterns are self-reported by subjects, while health outcomes are validated by investigators.

Mr. Chazelas and his colleagues identified 1,379 first incident cases of stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, and angioplasty in the cohort during 2009-2019. Cases that occurred during the first 3 years’ follow up were excluded from the analysis, to avoid potential reverse causality bias.

After adjustment for a wide range of dietary, demographic and health confounders, the investigators found that high consumers of sugary drinks or artificially sweetened drinks saw 20% and 32% higher risk of such events, respectively, compared with people who reported drinking neither beverage type (hazard ratio: 1.20; 95% confidence interval 1.04-1.40, P for trend < .0009 and HR: 1.32; 95% CI, 1.00-1.73, P for trend < .03).

Sugary drinks were defined as containing 5% or more of sugars, including natural fruit juices. The high consumers in the study had a median intake of 185 mL per day of sugary drinks, or 176 mL per day for artificially sweetened drinks. Natural noncaloric sweeteners such as Stevia were included in the artificially sweetened group.

The findings, Mr. Chazelas and colleagues wrote in their analysis, add to evidence that artificially sweetened beverages “might not be a healthy substitute for sugary drinks.” While research has suggested that artificial sweeteners induce glucose intolerance by disturbing gut microbiota, they noted, more and bigger studies are needed to understand the mechanisms by which they might bear on cardiovascular disease risk.

Robert A. Vogel, MD, of the University of Colorado Denver, urged caution in interpreting the researchers’ results. In an interview, Dr. Vogel, a preventive cardiologist, said that it is “notoriously difficult” to evaluate what a food or food group does to the body outside of a carefully controlled trial. What little randomized trial evidence exists comparing the health effects of artificially sweetened and sugary drinks includes a 2012 trial in children that found diet drinks associated with reductions in body fat – if anything a positive indication for heart health.

SOURCE: Chazelas et al. JACC 2020;76(18):2175-80.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

COVID-19 has had a huge impact on every aspect of physicians’ medical practice, incomes, and business. Although this will probably not end soon, there are some key tax strategies that can help your financial position if you take some important actions by the end of the year.

Some of the ways in which physicians were hard hit include:

• Physicians who are self-employed are facing increased costs for personal protective equipment, cleaning protocols, and new telehealth infrastructure. Many are also facing staffing shortages as employees fall to part-time work or take time off work to care for family members.
• Even physicians working for large hospitals are not isolated from the financial impact of the virus. A recent survey conducted by Medscape concluded that over 60% of physicians in the United States have experienced a decrease in income since the start of the pandemic.
• Saving and investing have been affected: Physicians may expect to see that companies in which they are invested are cutting dividends. Interest rates (CDs, bonds) are lower, and capital gains distributions are reduced this year. Overall, that makes for a fairly grim financial picture.

While taxable income this year has mostly declined, the applicable tax rates overall are low. However, federal, state, and local budget deficits have been skyrocketing owing to the demands of the pandemic. That means, in all likelihood, there will be tax increases in the coming years to cover spending. However, this year’s financial challenges could lend themselves to a unique tax planning scenario that could potentially benefit physicians as they make long-term plans for their investments.

Given these circumstances, these 12 tips can help you to lessen your tax bite this tax season. Many of these tips entail actions that you need to take before Dec. 31, 2020.
 

1. Coronavirus stimulus rebates

If you have significantly depressed income this year or have lost your job, you may find that you qualify for an Economic Impact Payment, a refundable tax credit on the 2020 tax return. The credit is $1,200 for individuals or $2,400 for joint filers, plus an additional $500 for each qualifying child aged 16 years or younger. You begin to phase out of the credit at an adjusted gross income (AGI) of $75,000 for individuals and $150,000 for joint filers. People who had AGI below these thresholds in 2019 already would have received the credit in advance, but those who now find themselves qualifying will receive the credit when they file their 2020 tax return. No action is needed on your part; your tax preparer will calculate whether you are eligible for the credit when filing your return.

2. Look to accelerate income at lower brackets

With reduced earned income, many physicians will find themselves in significantly lower tax brackets this year. Once you fall below $200,000 for individuals or $250,000 for joint filers, you no longer trigger two additional surcharge taxes. The first is the additional Medicare tax, which is a further 0.9% applied to earned income above those thresholds, on top of ordinary income tax brackets. The second is the Net Investment Income Tax (NIIT), which is an additional 3.8% applied to your investment income on top of capital gains tax brackets.

If you are someone to whom the additional Medicare tax or NIIT no longer applies for 2020, you might consider generating income this year in order to realize the lower tax rates. You could consider selling highly appreciated investments in your taxable portfolio and reinvest the proceeds by repurchasing the same securities, thereby receiving a step-up in cost basis. Remember, when you go to sell securities in retirement, you are only taxed on the gain on the security over your cost basis. By bringing the cost basis up to today’s fair market value, you could be greatly reducing the future tax applied on a sale.

For those with IRA or inherited IRA accounts who also have required minimum distributions (RMDs), you might consider making voluntary withdrawals this year and then reinvesting the proceeds into a savings or taxable account for when you need it. Keep in mind that under the CARES Act, you are no longer required to take RMDs for 2020. However, this action would help avoid being forced to withdraw the amount when you may be at a higher tax bracket. You would need to do this before Dec. 31.
 

3. Build Roth assets strategies

With reduced incomes and lower marginal tax rates applying to the last dollar of income this year, physicians should carefully consider how to take advantage of current tax rates by building Roth assets. There are a few strategies, including switching 401(k) or 457 contributions from pretax to Roth or performing a backdoor Roth IRA contribution. However, neither is as powerful as converting IRA assets to Roth assets because there is no restriction on conversion amount or income cutoffs.

The goal is to convert enough assets to fill up lower applicable marginal tax brackets while avoiding tax surcharges, where possible. Roth IRA conversions can get you in trouble if you don’t know what to expect, so it’s best to work with a financial advisor or tax professional to give you guidance. For example, Roth conversions can trigger some tax surprises, such as the phaseout for the 199A qualified business income deduction, increased taxation on your Social Security benefits, or higher Income-Related Monthly Adjustment Amount surcharges on Medicare Part B and Part D premiums.

Bear in mind that Roth conversions generate taxable income and cannot be undone once completed. However, paying the lower marginal tax rate today may be a big win when RMDs could push physicians into tax brackets as high as or higher than during their working years.
 

4. Coronavirus-related distributions

New this year is a penalty-free way to withdraw qualified retirement plan funds for those who are not yet eligible to make penalty-free withdrawals.

Congress introduced the Coronavirus-Related Distribution under the CARES Act. It allows individuals who have been affected by the pandemic to withdraw up to $100,000 before Dec. 31, 2020, without paying the 10% early withdrawal penalty. If you are considering an early retirement because of the pandemic, it may make sense to take this withdrawal while the option lasts and keep the cash available to help fund the gap before the remainder of your retirement plan assets are available penalty free. Keep in mind that this withdrawal generates taxable ordinary income, even though the early withdrawal penalty does not apply. Taking this withdrawal can boost your taxable income bracket, so calculate carefully before you do this.
 

5. Charitable donations for 2020

There is no shortage of people in need owing to the pandemic. For those who continue to be charitable-minded, a decrease in income may mean you have more opportunity for your regularly recurring charitable donations to decrease your taxes this year. Normally, charitable donations for itemizers are limited to 60% of AGI. However, the CARES Act increased the charitable deduction limit to 100% of AGI for 2020. Even those who claim the standard deduction can take advantage of a new “above-the-line” deduction worth $300 for individuals and $600 for joint filers by making qualified cash donations in 2020. Take special note that the contributions do not apply to donor-advised funds or nonoperating private foundations.

6. Noncash charitable donations

Many physicians are working longer and harder than ever, and for many, that means vacation plans have been placed on hold for the remainder of the year. Don’t let your paid-time-off days go to waste! The IRS now permits leave-based donation programs, which allow employers to make deductible charitable donations for the relief of victims of the COVID-19 pandemic on the basis of the value of the sick, vacation, or personal leave that employees voluntarily forgo. The value of the donation will not be treated as compensation for the employee and will be free of any otherwise applicable Federal Insurance Contributions Act (FICA) taxes, and the employer can deduct the donation as ordinary and necessary business expenses if they meet certain requirements.

7. Claiming 2020 losses on prior tax returns

For self-employed physicians, a wealth of tax planning strategies are available. One of the most significant may be the new provisions under the CARES Act that allow 100% of net operating losses (NOLs) for 3 calendar years of losses – namely 2018, 2019, and 2020 – to be carried back to the prior 5 tax years. Using these NOLs, you may be able to claim a refund for tax returns from prior tax years when there was otherwise a limit on NOLs at 80% of taxable income. If you think this applies to you, it’s wise to meet with your accountant or financial professional to discuss this.

8. Delay payroll taxes where possible

For physicians with employees looking for some cash flow relief, a new payroll tax deferral is available to you this year. Under the CARES Act, employers can delay payment of their 2020 employer payroll tax, namely the 6.2% Social Security tax, with 50% not due until Dec. 31, 2021, and the remainder due Dec. 31, 2022. The deferral will not incur any interest or penalties and is also available to those who are self-employed.

On top of that, a new payroll tax credit was created under the Families First Coronavirus Response Act. Eligible employers can receive this tax credit for the amount of wages they pay to eligible employees who are taking pandemic-related paid family leave or paid sick leave this year. The credit is also available to those who are self-employed. If you think this credit may be applicable to you, it’s worth speaking with your tax preparer about it.
 

9. Increased business property deductions

The nature of many physician business operations has drastically changed this year. For physicians who already have invested in and implemented new telehealth infrastructure, this can create valuable tax deductions to offset their ordinary income. Businesses may take 100% bonus depreciation on the cost of qualified property both acquired and placed in service after Sept. 27, 2017, and before Jan. 1, 2023. In general, during the last quarter of the year, you should look to decelerate business purchases until after Jan. 1, 2021, to get a deduction in 2021 at a higher marginal tax bracket.

10. Switch to cash accounting instead of accrual accounting

With higher expenses and lower profits, some large practice groups may take a second look to see whether they qualify to switch to cash accounting from accrual accounting to defer taxes. This rule change was adopted back in 2017 to allow small-business taxpayers with average annual gross receipts of $25 million or less in the prior 3 years to use the cash method of accounting. Ultimately, this switch should allow practices to owe the IRS money only after invoices were paid.

11. Physicians looking to sell their unprofitable practices

For physicians looking to make a quick exit from their practice in response to the pandemic, there is some tax relief in the event of a sale at a loss. Certain business owners who sell failed businesses will be able to use up to $50,000 of net losses as individuals or $100,000 as joint filers from the sale to offset ordinary income, current or future, under Internal Revenue Code (IRC) Section 1244. Remember that ordinary income tax rates are much higher than capital gains rates, so you could see some tax relief through a sale. The provision covers shareholders of domestic small-business corporations, both C or S corporations, but not partnerships. You would have to sell the business before Dec. 31 to get this deduction in 2020.

12. Physicians looking to sell their profitable practices

Even self-employed physicians who have managed to maintain profitable practices may be looking for early retirement after the exhaustion of the pandemic. If you own stock in a C corporation engaged in an active trade or business that has not had assets of more than $50 million at any time, you can take advantage of the IRC Section 1202 exemption. Section 1202 provides an exclusion from gain from the sale of stock of either $10 million or 10 times the adjusted basis of the stock, owned at least 5 years, in corporations regarded as “qualified small businesses.” This means you may be able to sell your practice at a gain with a handsome tax shield. Again, to get this tax benefit for April’s tax return, you’d have to engage in this activity before year end.

Regardless of whether the pandemic has placed financial constraints on you this year, tax-savvy opportunities are available to capitalize on your reduced income and lower tax rates. It’s always important to keep in mind not just your taxes in any one given year, but your lifetime tax obligations. Financial advisors and tax planners can perform multiyear tax calculations and recommend ways to manage your tax bracket and help lower your overall lifetime tax obligations.
 

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

COVID-19 has had a huge impact on every aspect of physicians’ medical practice, incomes, and business. Although this will probably not end soon, there are some key tax strategies that can help your financial position if you take some important actions by the end of the year.

Some of the ways in which physicians were hard hit include:

• Physicians who are self-employed are facing increased costs for personal protective equipment, cleaning protocols, and new telehealth infrastructure. Many are also facing staffing shortages as employees fall to part-time work or take time off work to care for family members.
• Even physicians working for large hospitals are not isolated from the financial impact of the virus. A recent survey conducted by Medscape concluded that over 60% of physicians in the United States have experienced a decrease in income since the start of the pandemic.
• Saving and investing have been affected: Physicians may expect to see that companies in which they are invested are cutting dividends. Interest rates (CDs, bonds) are lower, and capital gains distributions are reduced this year. Overall, that makes for a fairly grim financial picture.

While taxable income this year has mostly declined, the applicable tax rates overall are low. However, federal, state, and local budget deficits have been skyrocketing owing to the demands of the pandemic. That means, in all likelihood, there will be tax increases in the coming years to cover spending. However, this year’s financial challenges could lend themselves to a unique tax planning scenario that could potentially benefit physicians as they make long-term plans for their investments.

Given these circumstances, these 12 tips can help you to lessen your tax bite this tax season. Many of these tips entail actions that you need to take before Dec. 31, 2020.
 

1. Coronavirus stimulus rebates

If you have significantly depressed income this year or have lost your job, you may find that you qualify for an Economic Impact Payment, a refundable tax credit on the 2020 tax return. The credit is $1,200 for individuals or $2,400 for joint filers, plus an additional $500 for each qualifying child aged 16 years or younger. You begin to phase out of the credit at an adjusted gross income (AGI) of $75,000 for individuals and $150,000 for joint filers. People who had AGI below these thresholds in 2019 already would have received the credit in advance, but those who now find themselves qualifying will receive the credit when they file their 2020 tax return. No action is needed on your part; your tax preparer will calculate whether you are eligible for the credit when filing your return.

2. Look to accelerate income at lower brackets

With reduced earned income, many physicians will find themselves in significantly lower tax brackets this year. Once you fall below $200,000 for individuals or $250,000 for joint filers, you no longer trigger two additional surcharge taxes. The first is the additional Medicare tax, which is a further 0.9% applied to earned income above those thresholds, on top of ordinary income tax brackets. The second is the Net Investment Income Tax (NIIT), which is an additional 3.8% applied to your investment income on top of capital gains tax brackets.

If you are someone to whom the additional Medicare tax or NIIT no longer applies for 2020, you might consider generating income this year in order to realize the lower tax rates. You could consider selling highly appreciated investments in your taxable portfolio and reinvest the proceeds by repurchasing the same securities, thereby receiving a step-up in cost basis. Remember, when you go to sell securities in retirement, you are only taxed on the gain on the security over your cost basis. By bringing the cost basis up to today’s fair market value, you could be greatly reducing the future tax applied on a sale.

For those with IRA or inherited IRA accounts who also have required minimum distributions (RMDs), you might consider making voluntary withdrawals this year and then reinvesting the proceeds into a savings or taxable account for when you need it. Keep in mind that under the CARES Act, you are no longer required to take RMDs for 2020. However, this action would help avoid being forced to withdraw the amount when you may be at a higher tax bracket. You would need to do this before Dec. 31.
 

3. Build Roth assets strategies

With reduced incomes and lower marginal tax rates applying to the last dollar of income this year, physicians should carefully consider how to take advantage of current tax rates by building Roth assets. There are a few strategies, including switching 401(k) or 457 contributions from pretax to Roth or performing a backdoor Roth IRA contribution. However, neither is as powerful as converting IRA assets to Roth assets because there is no restriction on conversion amount or income cutoffs.

The goal is to convert enough assets to fill up lower applicable marginal tax brackets while avoiding tax surcharges, where possible. Roth IRA conversions can get you in trouble if you don’t know what to expect, so it’s best to work with a financial advisor or tax professional to give you guidance. For example, Roth conversions can trigger some tax surprises, such as the phaseout for the 199A qualified business income deduction, increased taxation on your Social Security benefits, or higher Income-Related Monthly Adjustment Amount surcharges on Medicare Part B and Part D premiums.

Bear in mind that Roth conversions generate taxable income and cannot be undone once completed. However, paying the lower marginal tax rate today may be a big win when RMDs could push physicians into tax brackets as high as or higher than during their working years.
 

4. Coronavirus-related distributions

New this year is a penalty-free way to withdraw qualified retirement plan funds for those who are not yet eligible to make penalty-free withdrawals.

Congress introduced the Coronavirus-Related Distribution under the CARES Act. It allows individuals who have been affected by the pandemic to withdraw up to $100,000 before Dec. 31, 2020, without paying the 10% early withdrawal penalty. If you are considering an early retirement because of the pandemic, it may make sense to take this withdrawal while the option lasts and keep the cash available to help fund the gap before the remainder of your retirement plan assets are available penalty free. Keep in mind that this withdrawal generates taxable ordinary income, even though the early withdrawal penalty does not apply. Taking this withdrawal can boost your taxable income bracket, so calculate carefully before you do this.
 

5. Charitable donations for 2020

There is no shortage of people in need owing to the pandemic. For those who continue to be charitable-minded, a decrease in income may mean you have more opportunity for your regularly recurring charitable donations to decrease your taxes this year. Normally, charitable donations for itemizers are limited to 60% of AGI. However, the CARES Act increased the charitable deduction limit to 100% of AGI for 2020. Even those who claim the standard deduction can take advantage of a new “above-the-line” deduction worth $300 for individuals and $600 for joint filers by making qualified cash donations in 2020. Take special note that the contributions do not apply to donor-advised funds or nonoperating private foundations.

6. Noncash charitable donations

Many physicians are working longer and harder than ever, and for many, that means vacation plans have been placed on hold for the remainder of the year. Don’t let your paid-time-off days go to waste! The IRS now permits leave-based donation programs, which allow employers to make deductible charitable donations for the relief of victims of the COVID-19 pandemic on the basis of the value of the sick, vacation, or personal leave that employees voluntarily forgo. The value of the donation will not be treated as compensation for the employee and will be free of any otherwise applicable Federal Insurance Contributions Act (FICA) taxes, and the employer can deduct the donation as ordinary and necessary business expenses if they meet certain requirements.

7. Claiming 2020 losses on prior tax returns

For self-employed physicians, a wealth of tax planning strategies are available. One of the most significant may be the new provisions under the CARES Act that allow 100% of net operating losses (NOLs) for 3 calendar years of losses – namely 2018, 2019, and 2020 – to be carried back to the prior 5 tax years. Using these NOLs, you may be able to claim a refund for tax returns from prior tax years when there was otherwise a limit on NOLs at 80% of taxable income. If you think this applies to you, it’s wise to meet with your accountant or financial professional to discuss this.

8. Delay payroll taxes where possible

For physicians with employees looking for some cash flow relief, a new payroll tax deferral is available to you this year. Under the CARES Act, employers can delay payment of their 2020 employer payroll tax, namely the 6.2% Social Security tax, with 50% not due until Dec. 31, 2021, and the remainder due Dec. 31, 2022. The deferral will not incur any interest or penalties and is also available to those who are self-employed.

On top of that, a new payroll tax credit was created under the Families First Coronavirus Response Act. Eligible employers can receive this tax credit for the amount of wages they pay to eligible employees who are taking pandemic-related paid family leave or paid sick leave this year. The credit is also available to those who are self-employed. If you think this credit may be applicable to you, it’s worth speaking with your tax preparer about it.
 

9. Increased business property deductions

The nature of many physician business operations has drastically changed this year. For physicians who already have invested in and implemented new telehealth infrastructure, this can create valuable tax deductions to offset their ordinary income. Businesses may take 100% bonus depreciation on the cost of qualified property both acquired and placed in service after Sept. 27, 2017, and before Jan. 1, 2023. In general, during the last quarter of the year, you should look to decelerate business purchases until after Jan. 1, 2021, to get a deduction in 2021 at a higher marginal tax bracket.

10. Switch to cash accounting instead of accrual accounting

With higher expenses and lower profits, some large practice groups may take a second look to see whether they qualify to switch to cash accounting from accrual accounting to defer taxes. This rule change was adopted back in 2017 to allow small-business taxpayers with average annual gross receipts of $25 million or less in the prior 3 years to use the cash method of accounting. Ultimately, this switch should allow practices to owe the IRS money only after invoices were paid.

11. Physicians looking to sell their unprofitable practices

For physicians looking to make a quick exit from their practice in response to the pandemic, there is some tax relief in the event of a sale at a loss. Certain business owners who sell failed businesses will be able to use up to $50,000 of net losses as individuals or $100,000 as joint filers from the sale to offset ordinary income, current or future, under Internal Revenue Code (IRC) Section 1244. Remember that ordinary income tax rates are much higher than capital gains rates, so you could see some tax relief through a sale. The provision covers shareholders of domestic small-business corporations, both C or S corporations, but not partnerships. You would have to sell the business before Dec. 31 to get this deduction in 2020.

12. Physicians looking to sell their profitable practices

Even self-employed physicians who have managed to maintain profitable practices may be looking for early retirement after the exhaustion of the pandemic. If you own stock in a C corporation engaged in an active trade or business that has not had assets of more than $50 million at any time, you can take advantage of the IRC Section 1202 exemption. Section 1202 provides an exclusion from gain from the sale of stock of either $10 million or 10 times the adjusted basis of the stock, owned at least 5 years, in corporations regarded as “qualified small businesses.” This means you may be able to sell your practice at a gain with a handsome tax shield. Again, to get this tax benefit for April’s tax return, you’d have to engage in this activity before year end.

Regardless of whether the pandemic has placed financial constraints on you this year, tax-savvy opportunities are available to capitalize on your reduced income and lower tax rates. It’s always important to keep in mind not just your taxes in any one given year, but your lifetime tax obligations. Financial advisors and tax planners can perform multiyear tax calculations and recommend ways to manage your tax bracket and help lower your overall lifetime tax obligations.
 

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

COVID-19 has had a huge impact on every aspect of physicians’ medical practice, incomes, and business. Although this will probably not end soon, there are some key tax strategies that can help your financial position if you take some important actions by the end of the year.

Some of the ways in which physicians were hard hit include:

• Physicians who are self-employed are facing increased costs for personal protective equipment, cleaning protocols, and new telehealth infrastructure. Many are also facing staffing shortages as employees fall to part-time work or take time off work to care for family members.
• Even physicians working for large hospitals are not isolated from the financial impact of the virus. A recent survey conducted by Medscape concluded that over 60% of physicians in the United States have experienced a decrease in income since the start of the pandemic.
• Saving and investing have been affected: Physicians may expect to see that companies in which they are invested are cutting dividends. Interest rates (CDs, bonds) are lower, and capital gains distributions are reduced this year. Overall, that makes for a fairly grim financial picture.

While taxable income this year has mostly declined, the applicable tax rates overall are low. However, federal, state, and local budget deficits have been skyrocketing owing to the demands of the pandemic. That means, in all likelihood, there will be tax increases in the coming years to cover spending. However, this year’s financial challenges could lend themselves to a unique tax planning scenario that could potentially benefit physicians as they make long-term plans for their investments.

Given these circumstances, these 12 tips can help you to lessen your tax bite this tax season. Many of these tips entail actions that you need to take before Dec. 31, 2020.
 

1. Coronavirus stimulus rebates

If you have significantly depressed income this year or have lost your job, you may find that you qualify for an Economic Impact Payment, a refundable tax credit on the 2020 tax return. The credit is $1,200 for individuals or $2,400 for joint filers, plus an additional $500 for each qualifying child aged 16 years or younger. You begin to phase out of the credit at an adjusted gross income (AGI) of $75,000 for individuals and $150,000 for joint filers. People who had AGI below these thresholds in 2019 already would have received the credit in advance, but those who now find themselves qualifying will receive the credit when they file their 2020 tax return. No action is needed on your part; your tax preparer will calculate whether you are eligible for the credit when filing your return.

2. Look to accelerate income at lower brackets

With reduced earned income, many physicians will find themselves in significantly lower tax brackets this year. Once you fall below $200,000 for individuals or $250,000 for joint filers, you no longer trigger two additional surcharge taxes. The first is the additional Medicare tax, which is a further 0.9% applied to earned income above those thresholds, on top of ordinary income tax brackets. The second is the Net Investment Income Tax (NIIT), which is an additional 3.8% applied to your investment income on top of capital gains tax brackets.

If you are someone to whom the additional Medicare tax or NIIT no longer applies for 2020, you might consider generating income this year in order to realize the lower tax rates. You could consider selling highly appreciated investments in your taxable portfolio and reinvest the proceeds by repurchasing the same securities, thereby receiving a step-up in cost basis. Remember, when you go to sell securities in retirement, you are only taxed on the gain on the security over your cost basis. By bringing the cost basis up to today’s fair market value, you could be greatly reducing the future tax applied on a sale.

For those with IRA or inherited IRA accounts who also have required minimum distributions (RMDs), you might consider making voluntary withdrawals this year and then reinvesting the proceeds into a savings or taxable account for when you need it. Keep in mind that under the CARES Act, you are no longer required to take RMDs for 2020. However, this action would help avoid being forced to withdraw the amount when you may be at a higher tax bracket. You would need to do this before Dec. 31.
 

3. Build Roth assets strategies

With reduced incomes and lower marginal tax rates applying to the last dollar of income this year, physicians should carefully consider how to take advantage of current tax rates by building Roth assets. There are a few strategies, including switching 401(k) or 457 contributions from pretax to Roth or performing a backdoor Roth IRA contribution. However, neither is as powerful as converting IRA assets to Roth assets because there is no restriction on conversion amount or income cutoffs.

The goal is to convert enough assets to fill up lower applicable marginal tax brackets while avoiding tax surcharges, where possible. Roth IRA conversions can get you in trouble if you don’t know what to expect, so it’s best to work with a financial advisor or tax professional to give you guidance. For example, Roth conversions can trigger some tax surprises, such as the phaseout for the 199A qualified business income deduction, increased taxation on your Social Security benefits, or higher Income-Related Monthly Adjustment Amount surcharges on Medicare Part B and Part D premiums.

Bear in mind that Roth conversions generate taxable income and cannot be undone once completed. However, paying the lower marginal tax rate today may be a big win when RMDs could push physicians into tax brackets as high as or higher than during their working years.
 

4. Coronavirus-related distributions

New this year is a penalty-free way to withdraw qualified retirement plan funds for those who are not yet eligible to make penalty-free withdrawals.

Congress introduced the Coronavirus-Related Distribution under the CARES Act. It allows individuals who have been affected by the pandemic to withdraw up to $100,000 before Dec. 31, 2020, without paying the 10% early withdrawal penalty. If you are considering an early retirement because of the pandemic, it may make sense to take this withdrawal while the option lasts and keep the cash available to help fund the gap before the remainder of your retirement plan assets are available penalty free. Keep in mind that this withdrawal generates taxable ordinary income, even though the early withdrawal penalty does not apply. Taking this withdrawal can boost your taxable income bracket, so calculate carefully before you do this.
 

5. Charitable donations for 2020

There is no shortage of people in need owing to the pandemic. For those who continue to be charitable-minded, a decrease in income may mean you have more opportunity for your regularly recurring charitable donations to decrease your taxes this year. Normally, charitable donations for itemizers are limited to 60% of AGI. However, the CARES Act increased the charitable deduction limit to 100% of AGI for 2020. Even those who claim the standard deduction can take advantage of a new “above-the-line” deduction worth $300 for individuals and $600 for joint filers by making qualified cash donations in 2020. Take special note that the contributions do not apply to donor-advised funds or nonoperating private foundations.

6. Noncash charitable donations

Many physicians are working longer and harder than ever, and for many, that means vacation plans have been placed on hold for the remainder of the year. Don’t let your paid-time-off days go to waste! The IRS now permits leave-based donation programs, which allow employers to make deductible charitable donations for the relief of victims of the COVID-19 pandemic on the basis of the value of the sick, vacation, or personal leave that employees voluntarily forgo. The value of the donation will not be treated as compensation for the employee and will be free of any otherwise applicable Federal Insurance Contributions Act (FICA) taxes, and the employer can deduct the donation as ordinary and necessary business expenses if they meet certain requirements.

7. Claiming 2020 losses on prior tax returns

For self-employed physicians, a wealth of tax planning strategies are available. One of the most significant may be the new provisions under the CARES Act that allow 100% of net operating losses (NOLs) for 3 calendar years of losses – namely 2018, 2019, and 2020 – to be carried back to the prior 5 tax years. Using these NOLs, you may be able to claim a refund for tax returns from prior tax years when there was otherwise a limit on NOLs at 80% of taxable income. If you think this applies to you, it’s wise to meet with your accountant or financial professional to discuss this.

8. Delay payroll taxes where possible

For physicians with employees looking for some cash flow relief, a new payroll tax deferral is available to you this year. Under the CARES Act, employers can delay payment of their 2020 employer payroll tax, namely the 6.2% Social Security tax, with 50% not due until Dec. 31, 2021, and the remainder due Dec. 31, 2022. The deferral will not incur any interest or penalties and is also available to those who are self-employed.

On top of that, a new payroll tax credit was created under the Families First Coronavirus Response Act. Eligible employers can receive this tax credit for the amount of wages they pay to eligible employees who are taking pandemic-related paid family leave or paid sick leave this year. The credit is also available to those who are self-employed. If you think this credit may be applicable to you, it’s worth speaking with your tax preparer about it.
 

9. Increased business property deductions

The nature of many physician business operations has drastically changed this year. For physicians who already have invested in and implemented new telehealth infrastructure, this can create valuable tax deductions to offset their ordinary income. Businesses may take 100% bonus depreciation on the cost of qualified property both acquired and placed in service after Sept. 27, 2017, and before Jan. 1, 2023. In general, during the last quarter of the year, you should look to decelerate business purchases until after Jan. 1, 2021, to get a deduction in 2021 at a higher marginal tax bracket.

10. Switch to cash accounting instead of accrual accounting

With higher expenses and lower profits, some large practice groups may take a second look to see whether they qualify to switch to cash accounting from accrual accounting to defer taxes. This rule change was adopted back in 2017 to allow small-business taxpayers with average annual gross receipts of $25 million or less in the prior 3 years to use the cash method of accounting. Ultimately, this switch should allow practices to owe the IRS money only after invoices were paid.

11. Physicians looking to sell their unprofitable practices

For physicians looking to make a quick exit from their practice in response to the pandemic, there is some tax relief in the event of a sale at a loss. Certain business owners who sell failed businesses will be able to use up to $50,000 of net losses as individuals or $100,000 as joint filers from the sale to offset ordinary income, current or future, under Internal Revenue Code (IRC) Section 1244. Remember that ordinary income tax rates are much higher than capital gains rates, so you could see some tax relief through a sale. The provision covers shareholders of domestic small-business corporations, both C or S corporations, but not partnerships. You would have to sell the business before Dec. 31 to get this deduction in 2020.

12. Physicians looking to sell their profitable practices

Even self-employed physicians who have managed to maintain profitable practices may be looking for early retirement after the exhaustion of the pandemic. If you own stock in a C corporation engaged in an active trade or business that has not had assets of more than $50 million at any time, you can take advantage of the IRC Section 1202 exemption. Section 1202 provides an exclusion from gain from the sale of stock of either $10 million or 10 times the adjusted basis of the stock, owned at least 5 years, in corporations regarded as “qualified small businesses.” This means you may be able to sell your practice at a gain with a handsome tax shield. Again, to get this tax benefit for April’s tax return, you’d have to engage in this activity before year end.

Regardless of whether the pandemic has placed financial constraints on you this year, tax-savvy opportunities are available to capitalize on your reduced income and lower tax rates. It’s always important to keep in mind not just your taxes in any one given year, but your lifetime tax obligations. Financial advisors and tax planners can perform multiyear tax calculations and recommend ways to manage your tax bracket and help lower your overall lifetime tax obligations.
 

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

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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