Journal of Clinical Outcomes Management

Lung cancer patients should be prioritized for COVID-19 testing, according to an editorial published in Annals of Oncology.

In fact, treatment recommendations should call for baseline COVID-19 testing for all patients with lung cancer, Antonio Passaro, MD, PhD, of the European Institute of Oncology in Milan, Italy, and colleagues argued in the editorial.

“While all types of malignancies seem to be associated with high COVID-19 prevalence, morbidity, and mortality, lung cancer represents a specific scenario of cumulative risk factors for COVID-19 complications,” the authors wrote.

“[Lung cancer patients] are at a uniquely escalated risk of complications from COVID-19 due to the common features of smoking history, respiratory and cardiac disease, advanced age, and often predisposing risks from treatment, such as lung surgery and immunosuppressive chemotherapy,” said Howard (Jack) West, MD, of City of Hope Comprehensive Cancer Center in Duarte, Calif., who was not involved in the editorial.

“They also routinely experience a cough as well as chest imaging that may overlap between their underlying lung cancer, possible side effects of treatment, and potential COVID-19, leading to troubling ambiguity that can only be addressed by proactive and widespread testing of patients with lung cancer at the earliest opportunity and as a very high priority,” Dr. West added.

Dr. Passaro and colleagues’ editorial outlined these and other issues that suggest a need to prioritize testing in lung cancer patients.

Disease characteristics, treatment, and imaging

Lung cancer patients may have “defective pulmonary architecture,” such as mechanical obstruction from a tumor or previous lung surgery, that predisposes them to infection and can increase the risk of cytokine release. This is a concern because massive cytokine release during SARS-CoV-2 infection “has been postulated to be the major step in leading to the development of ARDS [acute respiratory distress syndrome],” Dr. Passaro and colleagues wrote.

The authors also argued that similar clinical symptoms among lung cancer patients and those with COVID-19 – such as cough, fever, and dyspnea – underscore the need for an accurate screening model to allow for early COVID-19 detection and potentially improve outcomes.

Similarly, lung cancer patients and COVID-19 patients may have overlapping findings on imaging. The radiologic effects of some common treatments for lung cancer can lead to the same kind of ground glass opacities and other findings seen in COVID-19 patients. Therefore, the authors predict an increase in “COVID-19-suspicious imaging, even in the absence of new symptoms” in the coming weeks.

Another issue to consider is the frequent use of corticosteroids in cancer patients. Corticosteroids may be harmful when used for COVID-19–related acute respiratory distress syndrome and could mask early symptoms of infection. Therefore, routine COVID-19 testing in patients receiving steroids may be warranted, according to Dr. Passaro and colleagues.

In addition, immunosuppression associated with cancer treatment “may impose specific consideration on the schedule and dose of cytotoxic chemotherapy for lung cancer patients in epidemic areas,” the authors wrote.

Increasing awareness: A registry and guidelines

“In the era of COVID-19, the optimal management of patients with lung cancer remains unknown, and the oncology community should have increased awareness to prevent the emergence of an increase in cancer-related and infectious mortality,” Dr. Passaro and colleagues wrote.

To that end, a novel global registry (TERAVOLT) has been launched and is collecting data worldwide with an aim of developing a tailored risk assessment strategy for lung cancer patients. The authors noted that developing international consensus with respect to COVID-19 testing in lung cancer is essential for achieving that goal.

The European Society for Medical Oncology recently released guidelines for treating lung cancer patients during the COVID-19 pandemic, but those guidelines do not include recommendations on COVID-19 testing.

“Baseline SARS-CoV-2 testing for all patients affected by lung cancer should be recommended,” Dr. Passaro and colleagues wrote. “In addition, for those patients with a negative swab test and new ground glass opacities detected on CT scan, with or without new respiratory symptoms, bronchoscopy should be considered to increase testing sensitivity.”

This work was partially supported by the Italian Ministry of Health. The authors reported having no relevant conflicts of interest. Dr. West is a regular correspondent for Medscape, which is owned by the same parent company as MDedge.

[email protected]

SOURCE: Passaro A et al. Annals of Oncology. doi: 10.1016/j.annonc.2020.04.002.

Lung cancer patients should be prioritized for COVID-19 testing, according to an editorial published in Annals of Oncology.

In fact, treatment recommendations should call for baseline COVID-19 testing for all patients with lung cancer, Antonio Passaro, MD, PhD, of the European Institute of Oncology in Milan, Italy, and colleagues argued in the editorial.

“While all types of malignancies seem to be associated with high COVID-19 prevalence, morbidity, and mortality, lung cancer represents a specific scenario of cumulative risk factors for COVID-19 complications,” the authors wrote.

“[Lung cancer patients] are at a uniquely escalated risk of complications from COVID-19 due to the common features of smoking history, respiratory and cardiac disease, advanced age, and often predisposing risks from treatment, such as lung surgery and immunosuppressive chemotherapy,” said Howard (Jack) West, MD, of City of Hope Comprehensive Cancer Center in Duarte, Calif., who was not involved in the editorial.

“They also routinely experience a cough as well as chest imaging that may overlap between their underlying lung cancer, possible side effects of treatment, and potential COVID-19, leading to troubling ambiguity that can only be addressed by proactive and widespread testing of patients with lung cancer at the earliest opportunity and as a very high priority,” Dr. West added.

Dr. Passaro and colleagues’ editorial outlined these and other issues that suggest a need to prioritize testing in lung cancer patients.

Disease characteristics, treatment, and imaging

Lung cancer patients may have “defective pulmonary architecture,” such as mechanical obstruction from a tumor or previous lung surgery, that predisposes them to infection and can increase the risk of cytokine release. This is a concern because massive cytokine release during SARS-CoV-2 infection “has been postulated to be the major step in leading to the development of ARDS [acute respiratory distress syndrome],” Dr. Passaro and colleagues wrote.

The authors also argued that similar clinical symptoms among lung cancer patients and those with COVID-19 – such as cough, fever, and dyspnea – underscore the need for an accurate screening model to allow for early COVID-19 detection and potentially improve outcomes.

Similarly, lung cancer patients and COVID-19 patients may have overlapping findings on imaging. The radiologic effects of some common treatments for lung cancer can lead to the same kind of ground glass opacities and other findings seen in COVID-19 patients. Therefore, the authors predict an increase in “COVID-19-suspicious imaging, even in the absence of new symptoms” in the coming weeks.

Another issue to consider is the frequent use of corticosteroids in cancer patients. Corticosteroids may be harmful when used for COVID-19–related acute respiratory distress syndrome and could mask early symptoms of infection. Therefore, routine COVID-19 testing in patients receiving steroids may be warranted, according to Dr. Passaro and colleagues.

In addition, immunosuppression associated with cancer treatment “may impose specific consideration on the schedule and dose of cytotoxic chemotherapy for lung cancer patients in epidemic areas,” the authors wrote.

Increasing awareness: A registry and guidelines

“In the era of COVID-19, the optimal management of patients with lung cancer remains unknown, and the oncology community should have increased awareness to prevent the emergence of an increase in cancer-related and infectious mortality,” Dr. Passaro and colleagues wrote.

To that end, a novel global registry (TERAVOLT) has been launched and is collecting data worldwide with an aim of developing a tailored risk assessment strategy for lung cancer patients. The authors noted that developing international consensus with respect to COVID-19 testing in lung cancer is essential for achieving that goal.

The European Society for Medical Oncology recently released guidelines for treating lung cancer patients during the COVID-19 pandemic, but those guidelines do not include recommendations on COVID-19 testing.

“Baseline SARS-CoV-2 testing for all patients affected by lung cancer should be recommended,” Dr. Passaro and colleagues wrote. “In addition, for those patients with a negative swab test and new ground glass opacities detected on CT scan, with or without new respiratory symptoms, bronchoscopy should be considered to increase testing sensitivity.”

This work was partially supported by the Italian Ministry of Health. The authors reported having no relevant conflicts of interest. Dr. West is a regular correspondent for Medscape, which is owned by the same parent company as MDedge.

[email protected]

SOURCE: Passaro A et al. Annals of Oncology. doi: 10.1016/j.annonc.2020.04.002.

Lung cancer patients should be prioritized for COVID-19 testing, according to an editorial published in Annals of Oncology.

In fact, treatment recommendations should call for baseline COVID-19 testing for all patients with lung cancer, Antonio Passaro, MD, PhD, of the European Institute of Oncology in Milan, Italy, and colleagues argued in the editorial.

“While all types of malignancies seem to be associated with high COVID-19 prevalence, morbidity, and mortality, lung cancer represents a specific scenario of cumulative risk factors for COVID-19 complications,” the authors wrote.

“[Lung cancer patients] are at a uniquely escalated risk of complications from COVID-19 due to the common features of smoking history, respiratory and cardiac disease, advanced age, and often predisposing risks from treatment, such as lung surgery and immunosuppressive chemotherapy,” said Howard (Jack) West, MD, of City of Hope Comprehensive Cancer Center in Duarte, Calif., who was not involved in the editorial.

“They also routinely experience a cough as well as chest imaging that may overlap between their underlying lung cancer, possible side effects of treatment, and potential COVID-19, leading to troubling ambiguity that can only be addressed by proactive and widespread testing of patients with lung cancer at the earliest opportunity and as a very high priority,” Dr. West added.

Dr. Passaro and colleagues’ editorial outlined these and other issues that suggest a need to prioritize testing in lung cancer patients.

Disease characteristics, treatment, and imaging

Lung cancer patients may have “defective pulmonary architecture,” such as mechanical obstruction from a tumor or previous lung surgery, that predisposes them to infection and can increase the risk of cytokine release. This is a concern because massive cytokine release during SARS-CoV-2 infection “has been postulated to be the major step in leading to the development of ARDS [acute respiratory distress syndrome],” Dr. Passaro and colleagues wrote.

The authors also argued that similar clinical symptoms among lung cancer patients and those with COVID-19 – such as cough, fever, and dyspnea – underscore the need for an accurate screening model to allow for early COVID-19 detection and potentially improve outcomes.

Similarly, lung cancer patients and COVID-19 patients may have overlapping findings on imaging. The radiologic effects of some common treatments for lung cancer can lead to the same kind of ground glass opacities and other findings seen in COVID-19 patients. Therefore, the authors predict an increase in “COVID-19-suspicious imaging, even in the absence of new symptoms” in the coming weeks.

Another issue to consider is the frequent use of corticosteroids in cancer patients. Corticosteroids may be harmful when used for COVID-19–related acute respiratory distress syndrome and could mask early symptoms of infection. Therefore, routine COVID-19 testing in patients receiving steroids may be warranted, according to Dr. Passaro and colleagues.

In addition, immunosuppression associated with cancer treatment “may impose specific consideration on the schedule and dose of cytotoxic chemotherapy for lung cancer patients in epidemic areas,” the authors wrote.

Increasing awareness: A registry and guidelines

“In the era of COVID-19, the optimal management of patients with lung cancer remains unknown, and the oncology community should have increased awareness to prevent the emergence of an increase in cancer-related and infectious mortality,” Dr. Passaro and colleagues wrote.

To that end, a novel global registry (TERAVOLT) has been launched and is collecting data worldwide with an aim of developing a tailored risk assessment strategy for lung cancer patients. The authors noted that developing international consensus with respect to COVID-19 testing in lung cancer is essential for achieving that goal.

The European Society for Medical Oncology recently released guidelines for treating lung cancer patients during the COVID-19 pandemic, but those guidelines do not include recommendations on COVID-19 testing.

“Baseline SARS-CoV-2 testing for all patients affected by lung cancer should be recommended,” Dr. Passaro and colleagues wrote. “In addition, for those patients with a negative swab test and new ground glass opacities detected on CT scan, with or without new respiratory symptoms, bronchoscopy should be considered to increase testing sensitivity.”

This work was partially supported by the Italian Ministry of Health. The authors reported having no relevant conflicts of interest. Dr. West is a regular correspondent for Medscape, which is owned by the same parent company as MDedge.

[email protected]

SOURCE: Passaro A et al. Annals of Oncology. doi: 10.1016/j.annonc.2020.04.002.

In early March, 35 residents in the Life Care Center in Kirkland, Washington, died due to complications associated with COVID-19. And that facility thus became the first example of how extremely vulnerable nursing home residents are to COVID-19. Since then, around the US, thousands of nursing home residents have died from complications of the virus. US Department of Veterans Affairs (VA) nursing homes, while rated high in VA health inspection reports, have not been exempt.

As of April 21, the VA had confirmed > 5,500 coronavirus cases in 50 states, the District of Columbia, and Puerto Rico. More than 350 veterans have died of COVID-19, according to VA data. The VA calculates its rates by health care system or VA medical center and does not provide separate data for the community living centers (CLCs).

The VA initiated an isolation strategy on March 10 that suspended most new admissions and barred outsiders from all of its 134 nursing homes. The only exception to the rule was when a patient was expected to die soon. The VA has taken other precautions as well, including extra screening and directing patients to use telehealth where possible.

State-run long-term care facilities for veterans have been hard hit across the country. At the Soldiers’ Home in Holyoke, Massachusetts, which is run by the state of Massachusetts, 5 of 11 veterans who died recently tested positive for COVID-19. At the 4 state-run nursing homes in Alabama, as of April 14, 45 people were confirmed positive and 2 residents had died. The largest outbreak was in the Bill Nichols State Veterans Home in Alexander City. Alabama State Rep. Ed Oliver and Commissioner Kent Davis, of the Alabama Department of Veterans Affairs (ADVA), are looking into how the outbreak started and whether it could have been prevented. “We have reports of lack of hand sanitizers, and those are the things we’re looking at right now,” Rep. Oliver said. The ADVA says residents who test positive are isolated for treatment, and infected employees are prohibited from entering the homes.

States have deployed National Guard troops to facilities following large scale outbreaks and multiple deaths. Pennsylvania deployed 30 National Guard troops to its Southeastern Veterans Center facility in Spring City after at least 10 veterans had died and at least 19 health care workers had tested positive for the virus. The facility is 1 of 6 extended-care facilities run by the Pennsylvania Department of Military and Veterans Affairs. In New Jersey, 40 National Guard troops, 25 New Jersey Department of Health nurses, and 90 VA nurses were deployed to 2 of its veterans facilities amid worsening outbreaks. At the Paramus facility, 155 residents had tested positive and 39 had died, and at the home in Edison, 86 veterans had tested positive and 25 died; 6 more died at a third state facility.

However, reporting remains inconsistent across many states and facilities. Only on April 19 did the Centers for Medicare and Medicaid Services (CMS) order nursing home facilities to inform residents and families about COVID-19 cases inside. This followed similar orders in New Jersey, New York, California, Washington, and other states.

“Nursing homes have been ground zero for COVID-19,” said CMS Administrator Seema Verma in a written statement. “Nursing home reporting to the [Centers for Disease Control and Prevention] is a critical component of the go-forward national COVID-19 surveillance system and to efforts to reopen America.”

In early March, 35 residents in the Life Care Center in Kirkland, Washington, died due to complications associated with COVID-19. And that facility thus became the first example of how extremely vulnerable nursing home residents are to COVID-19. Since then, around the US, thousands of nursing home residents have died from complications of the virus. US Department of Veterans Affairs (VA) nursing homes, while rated high in VA health inspection reports, have not been exempt.

As of April 21, the VA had confirmed > 5,500 coronavirus cases in 50 states, the District of Columbia, and Puerto Rico. More than 350 veterans have died of COVID-19, according to VA data. The VA calculates its rates by health care system or VA medical center and does not provide separate data for the community living centers (CLCs).

The VA initiated an isolation strategy on March 10 that suspended most new admissions and barred outsiders from all of its 134 nursing homes. The only exception to the rule was when a patient was expected to die soon. The VA has taken other precautions as well, including extra screening and directing patients to use telehealth where possible.

State-run long-term care facilities for veterans have been hard hit across the country. At the Soldiers’ Home in Holyoke, Massachusetts, which is run by the state of Massachusetts, 5 of 11 veterans who died recently tested positive for COVID-19. At the 4 state-run nursing homes in Alabama, as of April 14, 45 people were confirmed positive and 2 residents had died. The largest outbreak was in the Bill Nichols State Veterans Home in Alexander City. Alabama State Rep. Ed Oliver and Commissioner Kent Davis, of the Alabama Department of Veterans Affairs (ADVA), are looking into how the outbreak started and whether it could have been prevented. “We have reports of lack of hand sanitizers, and those are the things we’re looking at right now,” Rep. Oliver said. The ADVA says residents who test positive are isolated for treatment, and infected employees are prohibited from entering the homes.

States have deployed National Guard troops to facilities following large scale outbreaks and multiple deaths. Pennsylvania deployed 30 National Guard troops to its Southeastern Veterans Center facility in Spring City after at least 10 veterans had died and at least 19 health care workers had tested positive for the virus. The facility is 1 of 6 extended-care facilities run by the Pennsylvania Department of Military and Veterans Affairs. In New Jersey, 40 National Guard troops, 25 New Jersey Department of Health nurses, and 90 VA nurses were deployed to 2 of its veterans facilities amid worsening outbreaks. At the Paramus facility, 155 residents had tested positive and 39 had died, and at the home in Edison, 86 veterans had tested positive and 25 died; 6 more died at a third state facility.

However, reporting remains inconsistent across many states and facilities. Only on April 19 did the Centers for Medicare and Medicaid Services (CMS) order nursing home facilities to inform residents and families about COVID-19 cases inside. This followed similar orders in New Jersey, New York, California, Washington, and other states.

“Nursing homes have been ground zero for COVID-19,” said CMS Administrator Seema Verma in a written statement. “Nursing home reporting to the [Centers for Disease Control and Prevention] is a critical component of the go-forward national COVID-19 surveillance system and to efforts to reopen America.”

In early March, 35 residents in the Life Care Center in Kirkland, Washington, died due to complications associated with COVID-19. And that facility thus became the first example of how extremely vulnerable nursing home residents are to COVID-19. Since then, around the US, thousands of nursing home residents have died from complications of the virus. US Department of Veterans Affairs (VA) nursing homes, while rated high in VA health inspection reports, have not been exempt.

As of April 21, the VA had confirmed > 5,500 coronavirus cases in 50 states, the District of Columbia, and Puerto Rico. More than 350 veterans have died of COVID-19, according to VA data. The VA calculates its rates by health care system or VA medical center and does not provide separate data for the community living centers (CLCs).

The VA initiated an isolation strategy on March 10 that suspended most new admissions and barred outsiders from all of its 134 nursing homes. The only exception to the rule was when a patient was expected to die soon. The VA has taken other precautions as well, including extra screening and directing patients to use telehealth where possible.

State-run long-term care facilities for veterans have been hard hit across the country. At the Soldiers’ Home in Holyoke, Massachusetts, which is run by the state of Massachusetts, 5 of 11 veterans who died recently tested positive for COVID-19. At the 4 state-run nursing homes in Alabama, as of April 14, 45 people were confirmed positive and 2 residents had died. The largest outbreak was in the Bill Nichols State Veterans Home in Alexander City. Alabama State Rep. Ed Oliver and Commissioner Kent Davis, of the Alabama Department of Veterans Affairs (ADVA), are looking into how the outbreak started and whether it could have been prevented. “We have reports of lack of hand sanitizers, and those are the things we’re looking at right now,” Rep. Oliver said. The ADVA says residents who test positive are isolated for treatment, and infected employees are prohibited from entering the homes.

States have deployed National Guard troops to facilities following large scale outbreaks and multiple deaths. Pennsylvania deployed 30 National Guard troops to its Southeastern Veterans Center facility in Spring City after at least 10 veterans had died and at least 19 health care workers had tested positive for the virus. The facility is 1 of 6 extended-care facilities run by the Pennsylvania Department of Military and Veterans Affairs. In New Jersey, 40 National Guard troops, 25 New Jersey Department of Health nurses, and 90 VA nurses were deployed to 2 of its veterans facilities amid worsening outbreaks. At the Paramus facility, 155 residents had tested positive and 39 had died, and at the home in Edison, 86 veterans had tested positive and 25 died; 6 more died at a third state facility.

However, reporting remains inconsistent across many states and facilities. Only on April 19 did the Centers for Medicare and Medicaid Services (CMS) order nursing home facilities to inform residents and families about COVID-19 cases inside. This followed similar orders in New Jersey, New York, California, Washington, and other states.

“Nursing homes have been ground zero for COVID-19,” said CMS Administrator Seema Verma in a written statement. “Nursing home reporting to the [Centers for Disease Control and Prevention] is a critical component of the go-forward national COVID-19 surveillance system and to efforts to reopen America.”

For Luanne Freer, MD, an expert in high-altitude pulmonary edema (HAPE) and founder and director of Everest ER, a nonprofit seasonal clinic at the Mt. Everest base camp in Nepal (elevation, 17,600 ft), a sudden flurry of messages and questions she received about a possible COVID-19/HAPE link was startling.

Courtesy Rowie Ververis

“That’s why it kind of poked me in the eye,” she said, referencing her extensive experience treating HAPE, which she described as a pressure-related phenomenon. “My goodness, they are so completely different.”

Dr. Freer, an emergency physician, reached out to several pulmonary intensivists with experience treating both HAPE and COVID-19 to gauge their reactions, and within 36 hours, they had drafted their response. In the commentary, published in High Altitude Medicine & Biology, the clinicians note that the comparison between HAPE and COVID-19 is potentially risky.

“As a group of physicians who have in some cases cared for patients with COVID-19 and in all cases cared for patients with HAPE and studied its pathophysiology and management, we feel it important to correct this misconception, as continued amplification of this message could have adverse effects on management of these patients,” they wrote.

The suggestion that COVID-19 lung injury sometimes looks more like HAPE than like acute respiratory distress syndrome (ARDS) appeared in a journal review article in late March and was put forth by medical professionals on social media where it gained traction in recent weeks and was amplified in multiple media outlets, including this one.

“With COVID, we don’t understand everything that’s going on, but we know for sure it’s an inflammatory process – not a pressure-related problem,” Dr. Freer said. “I thought ... this could be so dangerous to load the medicines that we use when we’re treating HAPE onto patients with COVID-19.”

The pathophysiological mechanisms in HAPE are different than those in other respiratory syndromes, including those associated with COVID-19, said Andrew M. Luks, MD, of the UW Medicine, Seattle, and the first author on the commentary.

“HAPE is a noncardiogenic form of pulmonary edema, as are ARDS due to bacteria or viral pneumonia, re-expansion pulmonary edema, immersion pulmonary edema, negative pressure pulmonary edema, and neurogenic pulmonary edema,” Dr. Luks, Dr. Freer, and colleagues wrote in the commentary, explaining that all of these entities cause varying degrees of hypoxemia and diffuse bilateral opacities on chest imaging. “Importantly, in all of these cases, edema accumulates in the interstitial and alveolar spaces of the lung as a result of imbalance in Starling forces.”

A difference between these entities, however, is “the mechanism by which that imbalance develops,” they noted.

The excessive and uneven hypoxic pulmonary vasoconstriction that leads to a marked increase in pulmonary artery pressure, subsequent lung overperfusion, increased pulmonary capillary hydrostatic pressure, and leakage of fluid from the vascular space into the alveolar space as seen in HAPE, is a “fundamentally different phenomenon than what is seen in COVID-19-related ARDS, which involves viral-mediated inflammatory responses as the primary pathophysiological mechanism,” they added.

The authors described several other differences between the conditions, ultimately noting that “understanding the distinction between the pathophysiological mechanisms of these entities is critical for patient management.”

In HAPE, supplemental oxygen alone may be sufficient; in COVID-19, it may improve hypoxemia but won’t resolve the underlying inflammation or injury, they explained, adding that “only good supportive care including mechanical ventilation, quite often for long periods of time, allows some patients to survive until their disease resolves.”

Further, HAPE can be prevented or treated with pulmonary vasodilators such a nifedipine or sildenafil, which decrease pulmonary artery pressure and, as a result lower pulmonary capillary hydrostatic pressure, they said.

Use of such medications for COVID-19 might decrease pulmonary artery pressure and improve right ventricular function in COVID-19, but “by releasing hypoxic pulmonary vasoconstriction and increasing perfusion to nonventilated regions of the lung, they could also worsen ventilation-perfusion mismatch” and thereby worsen hypoxemia, they explained, adding that the treatments can also cause or worsen hypotension.

Efforts to share observations and experience are important in medicine, but sometimes, as in this circumstance, “they get out there, spread around – like a brushfire almost – and get [unwarranted] face validity,” Dr. Luks said, noting that in response to information circulating about COVID-19 and HAPE, he has already heard medical professionals floating the idea of treating COVID-19 with treatments used for HAPE.

It’s true that some COVID-19 lung injury cases are behaving differently than typical ARDS, he said, adding that presentation can vary.

“But trying to equate HAPE and COVID-19 is just wrong,” he said. “HAPE and COVID-19 may share several features ...but those are features that are shared by a lot of different forms of respiratory failure.”

In a recent video interview, WebMD’s chief medical officer John Whyte, MD, spoke with a New York City physician trained in critical care and emergency medicine, Cameron Kyle-Sidell, MD, who raised the need to consider different respiratory protocols for COVID-19, noting that standard protocols were falling short in many cases.

“What we’re seeing ... is something unusual, it’s something that we are not used to,” Dr. Kyle-Sidell of Maimonides Medical Center said in that interview, stressing that the presentation differed from that seen in typical ARDS. “The patterns I was seeing did not make sense.”

Like others, he noted that COVID-19 patients were presenting with illness that clinically looked more like HAPE, but that the pathophysiology is not necessary similar to HAPE.

At around the same time, Luciano Gattinoni, MD, of the Medical University of Göttingen in Germany and colleagues, published a letter to the editor in the American Journal of Respiratory and Critical Care Medicine stressing that the ARDS presentation in COVID-19 patients is atypical and requires a patient physiology–driven treatment approach, rather than a standard protocol–driven approach. Dr. Gattinoni and colleagues suggested that instead of high positive end-expiratory pressure (PEEP), physicians should consider the lowest possible PEEP and gentle ventilation.

Dr. Luks agreed that “some patients with COVID-19 do not have the same physiologic derangements that we see in a lot of other people with ARDS.”

“[Dr. Gattinoni] is making the point that we need to treat these people differently ... and I think that’s a valid point, and honestly, that’s a point that applied even before COVID-19,” he said. “Most of the things that we see in clinical practice – there’s a lot of heterogeneity between patients, and you have to be prepared to tailor your therapy in light of the differences that you’re picking up from your observations at the bedside and other data that you’re getting on the patient.”

The main concern Dr. Luks and his coauthors wanted to convey, they said, is making sure that the anecdotal experiences and observations of clinicians struggling to find answers don’t spiral out of control without proper vetting, thereby leading to patient harm.

“In this challenging time, we must identify the best means to care for these critically ill patients. That approach should be grounded in sound pulmonary physiology, clinical experience and, when available, evidence from clinical studies,” they concluded.

Dr. Luks and Dr. Freer reported having no financial disclosures.

[email protected]

For Luanne Freer, MD, an expert in high-altitude pulmonary edema (HAPE) and founder and director of Everest ER, a nonprofit seasonal clinic at the Mt. Everest base camp in Nepal (elevation, 17,600 ft), a sudden flurry of messages and questions she received about a possible COVID-19/HAPE link was startling.

Courtesy Rowie Ververis

“That’s why it kind of poked me in the eye,” she said, referencing her extensive experience treating HAPE, which she described as a pressure-related phenomenon. “My goodness, they are so completely different.”

Dr. Freer, an emergency physician, reached out to several pulmonary intensivists with experience treating both HAPE and COVID-19 to gauge their reactions, and within 36 hours, they had drafted their response. In the commentary, published in High Altitude Medicine & Biology, the clinicians note that the comparison between HAPE and COVID-19 is potentially risky.

“As a group of physicians who have in some cases cared for patients with COVID-19 and in all cases cared for patients with HAPE and studied its pathophysiology and management, we feel it important to correct this misconception, as continued amplification of this message could have adverse effects on management of these patients,” they wrote.

The suggestion that COVID-19 lung injury sometimes looks more like HAPE than like acute respiratory distress syndrome (ARDS) appeared in a journal review article in late March and was put forth by medical professionals on social media where it gained traction in recent weeks and was amplified in multiple media outlets, including this one.

“With COVID, we don’t understand everything that’s going on, but we know for sure it’s an inflammatory process – not a pressure-related problem,” Dr. Freer said. “I thought ... this could be so dangerous to load the medicines that we use when we’re treating HAPE onto patients with COVID-19.”

The pathophysiological mechanisms in HAPE are different than those in other respiratory syndromes, including those associated with COVID-19, said Andrew M. Luks, MD, of the UW Medicine, Seattle, and the first author on the commentary.

“HAPE is a noncardiogenic form of pulmonary edema, as are ARDS due to bacteria or viral pneumonia, re-expansion pulmonary edema, immersion pulmonary edema, negative pressure pulmonary edema, and neurogenic pulmonary edema,” Dr. Luks, Dr. Freer, and colleagues wrote in the commentary, explaining that all of these entities cause varying degrees of hypoxemia and diffuse bilateral opacities on chest imaging. “Importantly, in all of these cases, edema accumulates in the interstitial and alveolar spaces of the lung as a result of imbalance in Starling forces.”

A difference between these entities, however, is “the mechanism by which that imbalance develops,” they noted.

The excessive and uneven hypoxic pulmonary vasoconstriction that leads to a marked increase in pulmonary artery pressure, subsequent lung overperfusion, increased pulmonary capillary hydrostatic pressure, and leakage of fluid from the vascular space into the alveolar space as seen in HAPE, is a “fundamentally different phenomenon than what is seen in COVID-19-related ARDS, which involves viral-mediated inflammatory responses as the primary pathophysiological mechanism,” they added.

The authors described several other differences between the conditions, ultimately noting that “understanding the distinction between the pathophysiological mechanisms of these entities is critical for patient management.”

In HAPE, supplemental oxygen alone may be sufficient; in COVID-19, it may improve hypoxemia but won’t resolve the underlying inflammation or injury, they explained, adding that “only good supportive care including mechanical ventilation, quite often for long periods of time, allows some patients to survive until their disease resolves.”

Further, HAPE can be prevented or treated with pulmonary vasodilators such a nifedipine or sildenafil, which decrease pulmonary artery pressure and, as a result lower pulmonary capillary hydrostatic pressure, they said.

Use of such medications for COVID-19 might decrease pulmonary artery pressure and improve right ventricular function in COVID-19, but “by releasing hypoxic pulmonary vasoconstriction and increasing perfusion to nonventilated regions of the lung, they could also worsen ventilation-perfusion mismatch” and thereby worsen hypoxemia, they explained, adding that the treatments can also cause or worsen hypotension.

Efforts to share observations and experience are important in medicine, but sometimes, as in this circumstance, “they get out there, spread around – like a brushfire almost – and get [unwarranted] face validity,” Dr. Luks said, noting that in response to information circulating about COVID-19 and HAPE, he has already heard medical professionals floating the idea of treating COVID-19 with treatments used for HAPE.

It’s true that some COVID-19 lung injury cases are behaving differently than typical ARDS, he said, adding that presentation can vary.

“But trying to equate HAPE and COVID-19 is just wrong,” he said. “HAPE and COVID-19 may share several features ...but those are features that are shared by a lot of different forms of respiratory failure.”

In a recent video interview, WebMD’s chief medical officer John Whyte, MD, spoke with a New York City physician trained in critical care and emergency medicine, Cameron Kyle-Sidell, MD, who raised the need to consider different respiratory protocols for COVID-19, noting that standard protocols were falling short in many cases.

“What we’re seeing ... is something unusual, it’s something that we are not used to,” Dr. Kyle-Sidell of Maimonides Medical Center said in that interview, stressing that the presentation differed from that seen in typical ARDS. “The patterns I was seeing did not make sense.”

Like others, he noted that COVID-19 patients were presenting with illness that clinically looked more like HAPE, but that the pathophysiology is not necessary similar to HAPE.

At around the same time, Luciano Gattinoni, MD, of the Medical University of Göttingen in Germany and colleagues, published a letter to the editor in the American Journal of Respiratory and Critical Care Medicine stressing that the ARDS presentation in COVID-19 patients is atypical and requires a patient physiology–driven treatment approach, rather than a standard protocol–driven approach. Dr. Gattinoni and colleagues suggested that instead of high positive end-expiratory pressure (PEEP), physicians should consider the lowest possible PEEP and gentle ventilation.

Dr. Luks agreed that “some patients with COVID-19 do not have the same physiologic derangements that we see in a lot of other people with ARDS.”

“[Dr. Gattinoni] is making the point that we need to treat these people differently ... and I think that’s a valid point, and honestly, that’s a point that applied even before COVID-19,” he said. “Most of the things that we see in clinical practice – there’s a lot of heterogeneity between patients, and you have to be prepared to tailor your therapy in light of the differences that you’re picking up from your observations at the bedside and other data that you’re getting on the patient.”

The main concern Dr. Luks and his coauthors wanted to convey, they said, is making sure that the anecdotal experiences and observations of clinicians struggling to find answers don’t spiral out of control without proper vetting, thereby leading to patient harm.

“In this challenging time, we must identify the best means to care for these critically ill patients. That approach should be grounded in sound pulmonary physiology, clinical experience and, when available, evidence from clinical studies,” they concluded.

Dr. Luks and Dr. Freer reported having no financial disclosures.

[email protected]

For Luanne Freer, MD, an expert in high-altitude pulmonary edema (HAPE) and founder and director of Everest ER, a nonprofit seasonal clinic at the Mt. Everest base camp in Nepal (elevation, 17,600 ft), a sudden flurry of messages and questions she received about a possible COVID-19/HAPE link was startling.

Courtesy Rowie Ververis

“That’s why it kind of poked me in the eye,” she said, referencing her extensive experience treating HAPE, which she described as a pressure-related phenomenon. “My goodness, they are so completely different.”

Dr. Freer, an emergency physician, reached out to several pulmonary intensivists with experience treating both HAPE and COVID-19 to gauge their reactions, and within 36 hours, they had drafted their response. In the commentary, published in High Altitude Medicine & Biology, the clinicians note that the comparison between HAPE and COVID-19 is potentially risky.

“As a group of physicians who have in some cases cared for patients with COVID-19 and in all cases cared for patients with HAPE and studied its pathophysiology and management, we feel it important to correct this misconception, as continued amplification of this message could have adverse effects on management of these patients,” they wrote.

The suggestion that COVID-19 lung injury sometimes looks more like HAPE than like acute respiratory distress syndrome (ARDS) appeared in a journal review article in late March and was put forth by medical professionals on social media where it gained traction in recent weeks and was amplified in multiple media outlets, including this one.

“With COVID, we don’t understand everything that’s going on, but we know for sure it’s an inflammatory process – not a pressure-related problem,” Dr. Freer said. “I thought ... this could be so dangerous to load the medicines that we use when we’re treating HAPE onto patients with COVID-19.”

The pathophysiological mechanisms in HAPE are different than those in other respiratory syndromes, including those associated with COVID-19, said Andrew M. Luks, MD, of the UW Medicine, Seattle, and the first author on the commentary.

“HAPE is a noncardiogenic form of pulmonary edema, as are ARDS due to bacteria or viral pneumonia, re-expansion pulmonary edema, immersion pulmonary edema, negative pressure pulmonary edema, and neurogenic pulmonary edema,” Dr. Luks, Dr. Freer, and colleagues wrote in the commentary, explaining that all of these entities cause varying degrees of hypoxemia and diffuse bilateral opacities on chest imaging. “Importantly, in all of these cases, edema accumulates in the interstitial and alveolar spaces of the lung as a result of imbalance in Starling forces.”

A difference between these entities, however, is “the mechanism by which that imbalance develops,” they noted.

The excessive and uneven hypoxic pulmonary vasoconstriction that leads to a marked increase in pulmonary artery pressure, subsequent lung overperfusion, increased pulmonary capillary hydrostatic pressure, and leakage of fluid from the vascular space into the alveolar space as seen in HAPE, is a “fundamentally different phenomenon than what is seen in COVID-19-related ARDS, which involves viral-mediated inflammatory responses as the primary pathophysiological mechanism,” they added.

The authors described several other differences between the conditions, ultimately noting that “understanding the distinction between the pathophysiological mechanisms of these entities is critical for patient management.”

In HAPE, supplemental oxygen alone may be sufficient; in COVID-19, it may improve hypoxemia but won’t resolve the underlying inflammation or injury, they explained, adding that “only good supportive care including mechanical ventilation, quite often for long periods of time, allows some patients to survive until their disease resolves.”

Further, HAPE can be prevented or treated with pulmonary vasodilators such a nifedipine or sildenafil, which decrease pulmonary artery pressure and, as a result lower pulmonary capillary hydrostatic pressure, they said.

Use of such medications for COVID-19 might decrease pulmonary artery pressure and improve right ventricular function in COVID-19, but “by releasing hypoxic pulmonary vasoconstriction and increasing perfusion to nonventilated regions of the lung, they could also worsen ventilation-perfusion mismatch” and thereby worsen hypoxemia, they explained, adding that the treatments can also cause or worsen hypotension.

Efforts to share observations and experience are important in medicine, but sometimes, as in this circumstance, “they get out there, spread around – like a brushfire almost – and get [unwarranted] face validity,” Dr. Luks said, noting that in response to information circulating about COVID-19 and HAPE, he has already heard medical professionals floating the idea of treating COVID-19 with treatments used for HAPE.

It’s true that some COVID-19 lung injury cases are behaving differently than typical ARDS, he said, adding that presentation can vary.

“But trying to equate HAPE and COVID-19 is just wrong,” he said. “HAPE and COVID-19 may share several features ...but those are features that are shared by a lot of different forms of respiratory failure.”

In a recent video interview, WebMD’s chief medical officer John Whyte, MD, spoke with a New York City physician trained in critical care and emergency medicine, Cameron Kyle-Sidell, MD, who raised the need to consider different respiratory protocols for COVID-19, noting that standard protocols were falling short in many cases.

“What we’re seeing ... is something unusual, it’s something that we are not used to,” Dr. Kyle-Sidell of Maimonides Medical Center said in that interview, stressing that the presentation differed from that seen in typical ARDS. “The patterns I was seeing did not make sense.”

Like others, he noted that COVID-19 patients were presenting with illness that clinically looked more like HAPE, but that the pathophysiology is not necessary similar to HAPE.

At around the same time, Luciano Gattinoni, MD, of the Medical University of Göttingen in Germany and colleagues, published a letter to the editor in the American Journal of Respiratory and Critical Care Medicine stressing that the ARDS presentation in COVID-19 patients is atypical and requires a patient physiology–driven treatment approach, rather than a standard protocol–driven approach. Dr. Gattinoni and colleagues suggested that instead of high positive end-expiratory pressure (PEEP), physicians should consider the lowest possible PEEP and gentle ventilation.

Dr. Luks agreed that “some patients with COVID-19 do not have the same physiologic derangements that we see in a lot of other people with ARDS.”

“[Dr. Gattinoni] is making the point that we need to treat these people differently ... and I think that’s a valid point, and honestly, that’s a point that applied even before COVID-19,” he said. “Most of the things that we see in clinical practice – there’s a lot of heterogeneity between patients, and you have to be prepared to tailor your therapy in light of the differences that you’re picking up from your observations at the bedside and other data that you’re getting on the patient.”

The main concern Dr. Luks and his coauthors wanted to convey, they said, is making sure that the anecdotal experiences and observations of clinicians struggling to find answers don’t spiral out of control without proper vetting, thereby leading to patient harm.

“In this challenging time, we must identify the best means to care for these critically ill patients. That approach should be grounded in sound pulmonary physiology, clinical experience and, when available, evidence from clinical studies,” they concluded.

Dr. Luks and Dr. Freer reported having no financial disclosures.

[email protected]

The American Society of Echocardiography (ASE) has issued a statement on protecting patients and echocardiography service providers during the COVID-19 pandemic.

Given the risk for cardiovascular complications associated with COVID-19, echocardiographic services will likely be needed for patients with suspected or confirmed COVID-19, meaning echo providers will be exposed to SARS-CoV-2, write the statement authors, led by James N. Kirkpatrick, MD, director of the echocardiography laboratory at University of Washington Medical Center in Seattle.

The statement was published online April 6 in the Journal of the American College of Cardiology.

The authors say the statement is intended to help guide the practice of echocardiography in this “challenging time.” It was developed with input from a variety of echocardiography providers and institutions who have experience with the COVID-19, or have been “actively and thoughtfully preparing for it.”

Who, When, Where, and How

The statement covers triaging and decision pathways for handling requests for echocardiography, as well as indications and recommended procedures, in cases of suspected or confirmed COVID-19.

Among the recommendations:

• Only perform transthoracic echocardiograms (TTE), stress echocardiograms, and transesophageal echocardiograms (TEE) if they are expected to provide clinical benefit. Appropriate-use criteria represent the first decision point as to whether an echocardiographic test should be performed.
• Determine which studies are “elective” and reschedule them, performing all others. Identify “nonelective” (urgent/emergent) indications and defer all others.
• Determine the clinical benefit of echocardiography for symptomatic patients whose SARS-CoV-2 status is unknown.
• Cautiously consider the benefit of a TEE examination weighed against the risk for exposure of healthcare personnel to aerosolization in a patient with suspected or confirmed COVID-19.
• Postpone or cancel TEEs if an alternative imaging modality can provide the necessary information.
• Note that treadmill or bicycle stress echo tests in patients with COVID-19 may lead to exposure because of deep breathing and/or coughing during exercise. These tests should generally be deferred or converted to a pharmacologic stress echo.
   

   

The ASE statement also provides advice on safe imaging protocol and adequate personal protection measures.

“In addition to limiting the number of echocardiography practitioners involved in scanning, consideration should be given to limiting the exposure of staff who may be particularly susceptible to severe complications of COVID-19,” the ASE advises.

Staff who are older than 60 years, who have chronic conditions, are immunocompromised or are pregnant may wish to avoid contact with patients suspected or confirmed to have COVID-19.

It’s also important to realize the risk for transmission in reading rooms. “Keyboards, monitors, mice, chairs, phones, desktops, and door knobs should be frequently cleaned, and ventilation provided wherever possible,” the ASE advises. When the echo lab reading room is located in a high-traffic area, remote review of images or via webinar might be advisable, they suggest.

Summing up, Kirkland and colleagues say providing echocardiographic service “remains crucial in this difficult time of the SARS-CoV-2 outbreak. Working together, we can continue to provide high-quality care while minimizing risk to ourselves, our patients, and the public at large. Carefully considering ‘Whom to Image’, ‘Where to Image’ and ‘How to Image’ has the potential to reduce the risks of transmission.”

The authors note that the statements and recommendations are primarily based on expert opinion rather than on scientifically verified data and are subject to change as the COVID-19 outbreak continues to evolve and new data emerges.
 

This article first appeared on Medscape.com.

The American Society of Echocardiography (ASE) has issued a statement on protecting patients and echocardiography service providers during the COVID-19 pandemic.

Given the risk for cardiovascular complications associated with COVID-19, echocardiographic services will likely be needed for patients with suspected or confirmed COVID-19, meaning echo providers will be exposed to SARS-CoV-2, write the statement authors, led by James N. Kirkpatrick, MD, director of the echocardiography laboratory at University of Washington Medical Center in Seattle.

The statement was published online April 6 in the Journal of the American College of Cardiology.

The authors say the statement is intended to help guide the practice of echocardiography in this “challenging time.” It was developed with input from a variety of echocardiography providers and institutions who have experience with the COVID-19, or have been “actively and thoughtfully preparing for it.”

Who, When, Where, and How

The statement covers triaging and decision pathways for handling requests for echocardiography, as well as indications and recommended procedures, in cases of suspected or confirmed COVID-19.

Among the recommendations:

• Only perform transthoracic echocardiograms (TTE), stress echocardiograms, and transesophageal echocardiograms (TEE) if they are expected to provide clinical benefit. Appropriate-use criteria represent the first decision point as to whether an echocardiographic test should be performed.
• Determine which studies are “elective” and reschedule them, performing all others. Identify “nonelective” (urgent/emergent) indications and defer all others.
• Determine the clinical benefit of echocardiography for symptomatic patients whose SARS-CoV-2 status is unknown.
• Cautiously consider the benefit of a TEE examination weighed against the risk for exposure of healthcare personnel to aerosolization in a patient with suspected or confirmed COVID-19.
• Postpone or cancel TEEs if an alternative imaging modality can provide the necessary information.
• Note that treadmill or bicycle stress echo tests in patients with COVID-19 may lead to exposure because of deep breathing and/or coughing during exercise. These tests should generally be deferred or converted to a pharmacologic stress echo.
   

   

The ASE statement also provides advice on safe imaging protocol and adequate personal protection measures.

“In addition to limiting the number of echocardiography practitioners involved in scanning, consideration should be given to limiting the exposure of staff who may be particularly susceptible to severe complications of COVID-19,” the ASE advises.

Staff who are older than 60 years, who have chronic conditions, are immunocompromised or are pregnant may wish to avoid contact with patients suspected or confirmed to have COVID-19.

It’s also important to realize the risk for transmission in reading rooms. “Keyboards, monitors, mice, chairs, phones, desktops, and door knobs should be frequently cleaned, and ventilation provided wherever possible,” the ASE advises. When the echo lab reading room is located in a high-traffic area, remote review of images or via webinar might be advisable, they suggest.

Summing up, Kirkland and colleagues say providing echocardiographic service “remains crucial in this difficult time of the SARS-CoV-2 outbreak. Working together, we can continue to provide high-quality care while minimizing risk to ourselves, our patients, and the public at large. Carefully considering ‘Whom to Image’, ‘Where to Image’ and ‘How to Image’ has the potential to reduce the risks of transmission.”

The authors note that the statements and recommendations are primarily based on expert opinion rather than on scientifically verified data and are subject to change as the COVID-19 outbreak continues to evolve and new data emerges.
 

This article first appeared on Medscape.com.

The American Society of Echocardiography (ASE) has issued a statement on protecting patients and echocardiography service providers during the COVID-19 pandemic.

Given the risk for cardiovascular complications associated with COVID-19, echocardiographic services will likely be needed for patients with suspected or confirmed COVID-19, meaning echo providers will be exposed to SARS-CoV-2, write the statement authors, led by James N. Kirkpatrick, MD, director of the echocardiography laboratory at University of Washington Medical Center in Seattle.

The statement was published online April 6 in the Journal of the American College of Cardiology.

The authors say the statement is intended to help guide the practice of echocardiography in this “challenging time.” It was developed with input from a variety of echocardiography providers and institutions who have experience with the COVID-19, or have been “actively and thoughtfully preparing for it.”

Who, When, Where, and How

The statement covers triaging and decision pathways for handling requests for echocardiography, as well as indications and recommended procedures, in cases of suspected or confirmed COVID-19.

Among the recommendations:

• Only perform transthoracic echocardiograms (TTE), stress echocardiograms, and transesophageal echocardiograms (TEE) if they are expected to provide clinical benefit. Appropriate-use criteria represent the first decision point as to whether an echocardiographic test should be performed.
• Determine which studies are “elective” and reschedule them, performing all others. Identify “nonelective” (urgent/emergent) indications and defer all others.
• Determine the clinical benefit of echocardiography for symptomatic patients whose SARS-CoV-2 status is unknown.
• Cautiously consider the benefit of a TEE examination weighed against the risk for exposure of healthcare personnel to aerosolization in a patient with suspected or confirmed COVID-19.
• Postpone or cancel TEEs if an alternative imaging modality can provide the necessary information.
• Note that treadmill or bicycle stress echo tests in patients with COVID-19 may lead to exposure because of deep breathing and/or coughing during exercise. These tests should generally be deferred or converted to a pharmacologic stress echo.
   

   

The ASE statement also provides advice on safe imaging protocol and adequate personal protection measures.

“In addition to limiting the number of echocardiography practitioners involved in scanning, consideration should be given to limiting the exposure of staff who may be particularly susceptible to severe complications of COVID-19,” the ASE advises.

Staff who are older than 60 years, who have chronic conditions, are immunocompromised or are pregnant may wish to avoid contact with patients suspected or confirmed to have COVID-19.

It’s also important to realize the risk for transmission in reading rooms. “Keyboards, monitors, mice, chairs, phones, desktops, and door knobs should be frequently cleaned, and ventilation provided wherever possible,” the ASE advises. When the echo lab reading room is located in a high-traffic area, remote review of images or via webinar might be advisable, they suggest.

Summing up, Kirkland and colleagues say providing echocardiographic service “remains crucial in this difficult time of the SARS-CoV-2 outbreak. Working together, we can continue to provide high-quality care while minimizing risk to ourselves, our patients, and the public at large. Carefully considering ‘Whom to Image’, ‘Where to Image’ and ‘How to Image’ has the potential to reduce the risks of transmission.”

The authors note that the statements and recommendations are primarily based on expert opinion rather than on scientifically verified data and are subject to change as the COVID-19 outbreak continues to evolve and new data emerges.
 

This article first appeared on Medscape.com.

Family physician Frank Maselli, MD, saw approximately 30 patients a day in his office in the Bronx before COVID-19. But New York City has become a hot spot for the virus that has claimed the lives of the lives of more than 40,000 people nationwide.

Now Maselli and the other 10 physicians in the practice each treat only eight or nine patients a day via telemedicine. He spends most of his time on the phone answering patients’ questions about COVID-19 symptoms and potential exposure. Although he tries to bill for telemedicine and phone calls, he says many commercial payers reject the claims because their processing systems aren’t updated to reflect new coverage policies. He has enough cash in reserve to cover two payrolls, but he knows he needs a backup plan if patient volumes continue to decrease indefinitely.

“Our doctors will take a pay cut before we let people go,” says Maselli. “So far we’re OK because we’re getting paid for things we did two months ago before all of this happened.”

Ninety-seven percent of medical practices have experienced a negative financial impact directly or indirectly related to the COVID-19 pandemic, according to new data from the Medical Group Management Association (MGMA). On average, practices report a 60% decrease in patient volume and a 55% decrease in revenue since the beginning of the public health emergency.
 

Four options for financial assistance

However, there are ways to offset revenue loss and remain financially viable during the economic uncertainty of the COVID-19 pandemic. Options include the US Small Business Administration’s (SBA) Paycheck Protection Program; the SBA’s Emergency Economic Injury Disaster Loan (EIDL); Medicare’s advanced payment program; and an SBA Coronavirus Economic Stabilization Act (CESA) loan. These are in addition to several other strategies aimed at reducing costs and improving revenue.

1. Maselli, for example, applied for the Paycheck Protection Program, a short-term loan that helps small businesses (i.e., for physician offices, those with an annual revenue of under $12 million) keep staff employed during the COVID-19 crisis. The loan covers a variety of costs, including payroll, rent, utilities, mortgage interest, and interest on any other debt obligations incurred before February 15 of this year.

“We have no idea if this is coming and when, but it would be a big help,” he adds.

(As of press time, the Paycheck Protection Program had stopped accepting applications, having reached the limit of its $349 billion budget. Congress must now agree on legislation to add additional funding to assist small businesses.)

Practices can take out a loan of up to 2.5 times the average monthly payroll (excluding payroll for those making more than $100,000 annually) with a cap of $10 million. For example, if the average monthly payroll is $10,000 – and no employees earn more than $100,000 annually – the maximum loan amount is $25,000.

Practices approved for this loan can expect to receive the funds from their SBA-approved lender within 10 calendar days of the date of loan approval. Although it’s technically a loan, the good news is that it doesn’t need to be repaid if the practice complies with all of the loan requirements – particularly these two: The practice uses at least 75% of the loan specifically for payroll, and the practice keeps employees on the payroll (or rehire, when necessary) for 8 weeks after the loan origination date.

Forgiveness is reduced if full-time headcount declines, or if salaries and wages decrease. If a practice does need to repay all or a portion of the loan, it must do so within 2 years at an interest rate of 1%, and payments are deferred for 6 months.

Andrew D. McDonald, FACHE, practice leader of health care consulting at LBMC Healthcare, says it behooves practices to apply for this loan because it’s essentially free money during a time when revenue may be at an all-time low. “While the devil is in the details, on the surface, the paycheck protection funds appear to be a no-brainer. However, each practice will need to confirm with their lender that it’s a solid decision.”

One challenge with this loan is that some banks weren’t necessarily ready to accept applications on April 3, and many continue to lag behind in processing these applications.

2. A second option is the SBA’s EIDL, a low-interest, long-term loan (capped at 3.75% for small businesses) that practices with 500 or fewer employees can use to pay fixed debts, payrolls, accounts payable, and other bills that could have been paid had the disaster not occurred. Borrowers can ask for up to $2 million, and the maximum term of this loan is 30 years, though the overall process for obtaining these loans will depend on the lender.

Practices have until December 16 to apply for this loan. They can also apply for an expedited disbursement (i.e., an Economic Injury Disaster Advance) of up to $10,000 that’s paid within 3 days of the request.

3. A third option is Medicare’s COVID-19 advanced payment program. Under this program, eligible physicians are those who:

• Billed Medicare for claims within 180 days prior to the date of the request
• Are financially solvent (i.e., aren’t in bankruptcy)
• Are free from any active medical review or program integrity investigations
• Are in good standing with Medicare (i.e., don’t have an outstanding delinquent Medicare overpayment)

If physicians meet this criteria, they can ask their Medicare Administrative Contractor (MAC) to provide an advanced payment of up to 100% of the Medicare payment amount based on a 3-month lookback period.

Once requested, MACs will issue payment within 7 calendar days from the date of the request. Repayment will occur in the form of automatic recoupments beginning 120 days after the advanced payment is received. Medicare has already approved more than 21,000 requests totaling more than $51 billion. CMS has provided a fact sheet to learn more about how to request an accelerated payment.

“The key is that you need to repay this, so you want to set a reasonable goal,” says Sarah Hostetter, senior consultant at Advisory Board, a health care research & data consulting firm. She says practices should consider what they’ll realistically be able to repay within 120 days.

4. A fourth option – specifically for mid-size practices – is a CESA loan, the details of which have yet to be announced, that will enable practices to access funds with an annualized rate no greater than 2% and with no principal or interest due for at least 6 months. The CARES Act, signed into law 3 weeks ago, provides $454 billion for this program.
 

Selecting the right option for your practice

Which singular option – or combination of options – is best for your practice? McDonald says to ask these questions:

• How well are patient volumes holding up?
• How well are physicians pivoting to telehealth?
• What is the overall economic loss?
• What are the available liquid assets, and how long can the practice maintain its financial viability over the next couple of months and beyond?

Cheryl Mongillo, MBA, administrative director of two independent family practices in Delaware, applied for both the Paycheck Protection Program and Medicare advanced payments because she’s worried about being able to pay staff while also covering costs related to personal protective equipment, medical waste, and cleaning, all of which have tripled since the pandemic began. One of the practices includes one physician and four nurse practitioners. The other includes five physicians and three nurse practitioners. In total, both practices employ 35 additional staff.

“I want our staff to know how much we care about them. My hope is that after this is over, our business will pick back up pretty quickly,” she adds. “However, until I can get the business back, I needed something to keep us afloat.”

Others are being more cautious. Crystal Bruning, practice manager at an Ob/Gyn clinic in Orlando, Florida, says her practice applied for the Paycheck Protection Program but is waiting another month or so before deciding whether it will also take advantage of Medicare advanced payments.

The practice is still trying to assess the true financial impact of its 30% reduction in patient volume. Bruning says the advanced payments wouldn’t amount to much anyway because only 10% of the practice’s patients have Medicare.
 

Making tough financial decisions while awaiting assistance

Kansas-based family physician Jennifer Bacani McKenney, MD, says she hasn’t paid herself a salary in weeks because of the revenue loss her practice has incurred.

“I want to make sure we can pay [all 12] employees,” she says. “In my family, we have two incomes, and we’re pretty good at saving money. However, I know not every physician can afford to do this.”

Although McKenney’s practice has seen a 75% reduction in patient volume, staff continue to provide virtual visits – including Zoom-based nursing home visits – phone visits, and in-person visits for acute illnesses. They also provide curbside immunizations. Still, long-term revenue loss is a concern. “I have a threshold in mind based on what we have in reserves,” she says. “If we hit that point, we would need to talk about a loan or Medicare advanced payments.”

Arkansas-based family physician Lonnie S. Robinson, MD, says he immediately applied for the Paycheck Protection Program after it was announced. “We also made sure we had a line of credit with our local bank during the very first discussions about what the pandemic would mean for our revenue streams,” he says.

However, because he’s in a rural area of the state, he continues to struggle with telemedicine due to broadband and connectivity challenges. Cash flow is another challenge because a lot of insurance companies are waiving copayments.

“I didn’t realize the amount of money we collect immediately from the patient,” he says. “This was a substantial revenue stream, and it was immediate revenue – not revenue waiting on a claim to be paid.”

Illinois-based family physician Deborah L. Winiger, MD, says she also applied for the Paycheck Protection Program but in the meantime had to reduce staff hours by a third because her patient volume dropped by more than half. She will also encourage staff to pursue temporary positions at a local hospital if the federal funds don’t materialize.

Kelly Shackleton, practice manager at a New York-based internal medicine practice, says she laid off 7 of her 16 staff members (including lab technicians, licensed practical nurses, billers, a referral specialist, and a file clerk) due to a 70% decrease in patient volume.

“I didn’t lay them all off at once,” she says. “I kept them until things were all caught up in each department. I plan to get them all back when the time is right, but I want to be sure to keep the practice afloat so they have a place to return to.” If the Paycheck Protection Program for which she applied comes through, then she will rehire them. She also applied for Medicare advanced payments and increased the practice’s line of credit.
 

Bill properly – and for everything you are still doing

Accurate and complete coding is critical during this time of financial instability, says Maselli. “I keep telling doctors to bill for everything they do,” he says. This includes phone calls between patients and physicians or other qualified healthcare providers (CPT codes 99441-99443). Note that these are time-based codes, requiring a minimum of five minutes of medical discussion.

Remote physiologic monitoring (including monitoring a patient’s oxygen saturation levels using pulse oximetry), virtual check-ins, and online digital evaluation and management services are also covered by Medicare and some commercial payers.

Other good news is that the Centers for Medicare & Medicaid Services added more than 80 additional services that providers can furnish using telehealth, including new patient office visits, home visits, prolonged office visits, smoking and tobacco cessation counseling, annual depression and alcohol screenings, advanced care planning, and much more.

Mongillo, the family practice administrator in Delaware, agrees that physicians need to bill for as many services as possible. At one of the family medicine practices she manages, physicians perform wellness visits, when appropriate, if patients are already coming into the office for another ailment.

Also look for ways to cut costs. For example, Mongillo was able to renegotiate the practice’s telemedicine contract after she received several proposals from other vendors offering three months of complimentary service. Shackleton discontinued provider dictation services to save money.

Physicians need to take a hard look at what’s going on to help them sustain their business through times of uncertainty, says Advisory Board’s Hostetter. “Now is the time to evaluate options and figure out what’s right for your practice,” she adds.

This article first appeared on Medscape.com.

Family physician Frank Maselli, MD, saw approximately 30 patients a day in his office in the Bronx before COVID-19. But New York City has become a hot spot for the virus that has claimed the lives of the lives of more than 40,000 people nationwide.

Now Maselli and the other 10 physicians in the practice each treat only eight or nine patients a day via telemedicine. He spends most of his time on the phone answering patients’ questions about COVID-19 symptoms and potential exposure. Although he tries to bill for telemedicine and phone calls, he says many commercial payers reject the claims because their processing systems aren’t updated to reflect new coverage policies. He has enough cash in reserve to cover two payrolls, but he knows he needs a backup plan if patient volumes continue to decrease indefinitely.

“Our doctors will take a pay cut before we let people go,” says Maselli. “So far we’re OK because we’re getting paid for things we did two months ago before all of this happened.”

Ninety-seven percent of medical practices have experienced a negative financial impact directly or indirectly related to the COVID-19 pandemic, according to new data from the Medical Group Management Association (MGMA). On average, practices report a 60% decrease in patient volume and a 55% decrease in revenue since the beginning of the public health emergency.
 

Four options for financial assistance

However, there are ways to offset revenue loss and remain financially viable during the economic uncertainty of the COVID-19 pandemic. Options include the US Small Business Administration’s (SBA) Paycheck Protection Program; the SBA’s Emergency Economic Injury Disaster Loan (EIDL); Medicare’s advanced payment program; and an SBA Coronavirus Economic Stabilization Act (CESA) loan. These are in addition to several other strategies aimed at reducing costs and improving revenue.

1. Maselli, for example, applied for the Paycheck Protection Program, a short-term loan that helps small businesses (i.e., for physician offices, those with an annual revenue of under $12 million) keep staff employed during the COVID-19 crisis. The loan covers a variety of costs, including payroll, rent, utilities, mortgage interest, and interest on any other debt obligations incurred before February 15 of this year.

“We have no idea if this is coming and when, but it would be a big help,” he adds.

(As of press time, the Paycheck Protection Program had stopped accepting applications, having reached the limit of its $349 billion budget. Congress must now agree on legislation to add additional funding to assist small businesses.)

Practices can take out a loan of up to 2.5 times the average monthly payroll (excluding payroll for those making more than $100,000 annually) with a cap of $10 million. For example, if the average monthly payroll is $10,000 – and no employees earn more than $100,000 annually – the maximum loan amount is $25,000.

Practices approved for this loan can expect to receive the funds from their SBA-approved lender within 10 calendar days of the date of loan approval. Although it’s technically a loan, the good news is that it doesn’t need to be repaid if the practice complies with all of the loan requirements – particularly these two: The practice uses at least 75% of the loan specifically for payroll, and the practice keeps employees on the payroll (or rehire, when necessary) for 8 weeks after the loan origination date.

Forgiveness is reduced if full-time headcount declines, or if salaries and wages decrease. If a practice does need to repay all or a portion of the loan, it must do so within 2 years at an interest rate of 1%, and payments are deferred for 6 months.

Andrew D. McDonald, FACHE, practice leader of health care consulting at LBMC Healthcare, says it behooves practices to apply for this loan because it’s essentially free money during a time when revenue may be at an all-time low. “While the devil is in the details, on the surface, the paycheck protection funds appear to be a no-brainer. However, each practice will need to confirm with their lender that it’s a solid decision.”

One challenge with this loan is that some banks weren’t necessarily ready to accept applications on April 3, and many continue to lag behind in processing these applications.

2. A second option is the SBA’s EIDL, a low-interest, long-term loan (capped at 3.75% for small businesses) that practices with 500 or fewer employees can use to pay fixed debts, payrolls, accounts payable, and other bills that could have been paid had the disaster not occurred. Borrowers can ask for up to $2 million, and the maximum term of this loan is 30 years, though the overall process for obtaining these loans will depend on the lender.

Practices have until December 16 to apply for this loan. They can also apply for an expedited disbursement (i.e., an Economic Injury Disaster Advance) of up to $10,000 that’s paid within 3 days of the request.

3. A third option is Medicare’s COVID-19 advanced payment program. Under this program, eligible physicians are those who:

• Billed Medicare for claims within 180 days prior to the date of the request
• Are financially solvent (i.e., aren’t in bankruptcy)
• Are free from any active medical review or program integrity investigations
• Are in good standing with Medicare (i.e., don’t have an outstanding delinquent Medicare overpayment)

If physicians meet this criteria, they can ask their Medicare Administrative Contractor (MAC) to provide an advanced payment of up to 100% of the Medicare payment amount based on a 3-month lookback period.

Once requested, MACs will issue payment within 7 calendar days from the date of the request. Repayment will occur in the form of automatic recoupments beginning 120 days after the advanced payment is received. Medicare has already approved more than 21,000 requests totaling more than $51 billion. CMS has provided a fact sheet to learn more about how to request an accelerated payment.

“The key is that you need to repay this, so you want to set a reasonable goal,” says Sarah Hostetter, senior consultant at Advisory Board, a health care research & data consulting firm. She says practices should consider what they’ll realistically be able to repay within 120 days.

4. A fourth option – specifically for mid-size practices – is a CESA loan, the details of which have yet to be announced, that will enable practices to access funds with an annualized rate no greater than 2% and with no principal or interest due for at least 6 months. The CARES Act, signed into law 3 weeks ago, provides $454 billion for this program.
 

Selecting the right option for your practice

Which singular option – or combination of options – is best for your practice? McDonald says to ask these questions:

• How well are patient volumes holding up?
• How well are physicians pivoting to telehealth?
• What is the overall economic loss?
• What are the available liquid assets, and how long can the practice maintain its financial viability over the next couple of months and beyond?

Cheryl Mongillo, MBA, administrative director of two independent family practices in Delaware, applied for both the Paycheck Protection Program and Medicare advanced payments because she’s worried about being able to pay staff while also covering costs related to personal protective equipment, medical waste, and cleaning, all of which have tripled since the pandemic began. One of the practices includes one physician and four nurse practitioners. The other includes five physicians and three nurse practitioners. In total, both practices employ 35 additional staff.

“I want our staff to know how much we care about them. My hope is that after this is over, our business will pick back up pretty quickly,” she adds. “However, until I can get the business back, I needed something to keep us afloat.”

Others are being more cautious. Crystal Bruning, practice manager at an Ob/Gyn clinic in Orlando, Florida, says her practice applied for the Paycheck Protection Program but is waiting another month or so before deciding whether it will also take advantage of Medicare advanced payments.

The practice is still trying to assess the true financial impact of its 30% reduction in patient volume. Bruning says the advanced payments wouldn’t amount to much anyway because only 10% of the practice’s patients have Medicare.
 

Making tough financial decisions while awaiting assistance

Kansas-based family physician Jennifer Bacani McKenney, MD, says she hasn’t paid herself a salary in weeks because of the revenue loss her practice has incurred.

“I want to make sure we can pay [all 12] employees,” she says. “In my family, we have two incomes, and we’re pretty good at saving money. However, I know not every physician can afford to do this.”

Although McKenney’s practice has seen a 75% reduction in patient volume, staff continue to provide virtual visits – including Zoom-based nursing home visits – phone visits, and in-person visits for acute illnesses. They also provide curbside immunizations. Still, long-term revenue loss is a concern. “I have a threshold in mind based on what we have in reserves,” she says. “If we hit that point, we would need to talk about a loan or Medicare advanced payments.”

Arkansas-based family physician Lonnie S. Robinson, MD, says he immediately applied for the Paycheck Protection Program after it was announced. “We also made sure we had a line of credit with our local bank during the very first discussions about what the pandemic would mean for our revenue streams,” he says.

However, because he’s in a rural area of the state, he continues to struggle with telemedicine due to broadband and connectivity challenges. Cash flow is another challenge because a lot of insurance companies are waiving copayments.

“I didn’t realize the amount of money we collect immediately from the patient,” he says. “This was a substantial revenue stream, and it was immediate revenue – not revenue waiting on a claim to be paid.”

Illinois-based family physician Deborah L. Winiger, MD, says she also applied for the Paycheck Protection Program but in the meantime had to reduce staff hours by a third because her patient volume dropped by more than half. She will also encourage staff to pursue temporary positions at a local hospital if the federal funds don’t materialize.

Kelly Shackleton, practice manager at a New York-based internal medicine practice, says she laid off 7 of her 16 staff members (including lab technicians, licensed practical nurses, billers, a referral specialist, and a file clerk) due to a 70% decrease in patient volume.

“I didn’t lay them all off at once,” she says. “I kept them until things were all caught up in each department. I plan to get them all back when the time is right, but I want to be sure to keep the practice afloat so they have a place to return to.” If the Paycheck Protection Program for which she applied comes through, then she will rehire them. She also applied for Medicare advanced payments and increased the practice’s line of credit.
 

Bill properly – and for everything you are still doing

Accurate and complete coding is critical during this time of financial instability, says Maselli. “I keep telling doctors to bill for everything they do,” he says. This includes phone calls between patients and physicians or other qualified healthcare providers (CPT codes 99441-99443). Note that these are time-based codes, requiring a minimum of five minutes of medical discussion.

Remote physiologic monitoring (including monitoring a patient’s oxygen saturation levels using pulse oximetry), virtual check-ins, and online digital evaluation and management services are also covered by Medicare and some commercial payers.

Other good news is that the Centers for Medicare & Medicaid Services added more than 80 additional services that providers can furnish using telehealth, including new patient office visits, home visits, prolonged office visits, smoking and tobacco cessation counseling, annual depression and alcohol screenings, advanced care planning, and much more.

Mongillo, the family practice administrator in Delaware, agrees that physicians need to bill for as many services as possible. At one of the family medicine practices she manages, physicians perform wellness visits, when appropriate, if patients are already coming into the office for another ailment.

Also look for ways to cut costs. For example, Mongillo was able to renegotiate the practice’s telemedicine contract after she received several proposals from other vendors offering three months of complimentary service. Shackleton discontinued provider dictation services to save money.

Physicians need to take a hard look at what’s going on to help them sustain their business through times of uncertainty, says Advisory Board’s Hostetter. “Now is the time to evaluate options and figure out what’s right for your practice,” she adds.

This article first appeared on Medscape.com.

Family physician Frank Maselli, MD, saw approximately 30 patients a day in his office in the Bronx before COVID-19. But New York City has become a hot spot for the virus that has claimed the lives of the lives of more than 40,000 people nationwide.

Now Maselli and the other 10 physicians in the practice each treat only eight or nine patients a day via telemedicine. He spends most of his time on the phone answering patients’ questions about COVID-19 symptoms and potential exposure. Although he tries to bill for telemedicine and phone calls, he says many commercial payers reject the claims because their processing systems aren’t updated to reflect new coverage policies. He has enough cash in reserve to cover two payrolls, but he knows he needs a backup plan if patient volumes continue to decrease indefinitely.

“Our doctors will take a pay cut before we let people go,” says Maselli. “So far we’re OK because we’re getting paid for things we did two months ago before all of this happened.”

Ninety-seven percent of medical practices have experienced a negative financial impact directly or indirectly related to the COVID-19 pandemic, according to new data from the Medical Group Management Association (MGMA). On average, practices report a 60% decrease in patient volume and a 55% decrease in revenue since the beginning of the public health emergency.
 

Four options for financial assistance

However, there are ways to offset revenue loss and remain financially viable during the economic uncertainty of the COVID-19 pandemic. Options include the US Small Business Administration’s (SBA) Paycheck Protection Program; the SBA’s Emergency Economic Injury Disaster Loan (EIDL); Medicare’s advanced payment program; and an SBA Coronavirus Economic Stabilization Act (CESA) loan. These are in addition to several other strategies aimed at reducing costs and improving revenue.

1. Maselli, for example, applied for the Paycheck Protection Program, a short-term loan that helps small businesses (i.e., for physician offices, those with an annual revenue of under $12 million) keep staff employed during the COVID-19 crisis. The loan covers a variety of costs, including payroll, rent, utilities, mortgage interest, and interest on any other debt obligations incurred before February 15 of this year.

“We have no idea if this is coming and when, but it would be a big help,” he adds.

(As of press time, the Paycheck Protection Program had stopped accepting applications, having reached the limit of its $349 billion budget. Congress must now agree on legislation to add additional funding to assist small businesses.)

Practices can take out a loan of up to 2.5 times the average monthly payroll (excluding payroll for those making more than $100,000 annually) with a cap of $10 million. For example, if the average monthly payroll is $10,000 – and no employees earn more than $100,000 annually – the maximum loan amount is $25,000.

Practices approved for this loan can expect to receive the funds from their SBA-approved lender within 10 calendar days of the date of loan approval. Although it’s technically a loan, the good news is that it doesn’t need to be repaid if the practice complies with all of the loan requirements – particularly these two: The practice uses at least 75% of the loan specifically for payroll, and the practice keeps employees on the payroll (or rehire, when necessary) for 8 weeks after the loan origination date.

Forgiveness is reduced if full-time headcount declines, or if salaries and wages decrease. If a practice does need to repay all or a portion of the loan, it must do so within 2 years at an interest rate of 1%, and payments are deferred for 6 months.

Andrew D. McDonald, FACHE, practice leader of health care consulting at LBMC Healthcare, says it behooves practices to apply for this loan because it’s essentially free money during a time when revenue may be at an all-time low. “While the devil is in the details, on the surface, the paycheck protection funds appear to be a no-brainer. However, each practice will need to confirm with their lender that it’s a solid decision.”

One challenge with this loan is that some banks weren’t necessarily ready to accept applications on April 3, and many continue to lag behind in processing these applications.

2. A second option is the SBA’s EIDL, a low-interest, long-term loan (capped at 3.75% for small businesses) that practices with 500 or fewer employees can use to pay fixed debts, payrolls, accounts payable, and other bills that could have been paid had the disaster not occurred. Borrowers can ask for up to $2 million, and the maximum term of this loan is 30 years, though the overall process for obtaining these loans will depend on the lender.

Practices have until December 16 to apply for this loan. They can also apply for an expedited disbursement (i.e., an Economic Injury Disaster Advance) of up to $10,000 that’s paid within 3 days of the request.

3. A third option is Medicare’s COVID-19 advanced payment program. Under this program, eligible physicians are those who:

• Billed Medicare for claims within 180 days prior to the date of the request
• Are financially solvent (i.e., aren’t in bankruptcy)
• Are free from any active medical review or program integrity investigations
• Are in good standing with Medicare (i.e., don’t have an outstanding delinquent Medicare overpayment)

If physicians meet this criteria, they can ask their Medicare Administrative Contractor (MAC) to provide an advanced payment of up to 100% of the Medicare payment amount based on a 3-month lookback period.

Once requested, MACs will issue payment within 7 calendar days from the date of the request. Repayment will occur in the form of automatic recoupments beginning 120 days after the advanced payment is received. Medicare has already approved more than 21,000 requests totaling more than $51 billion. CMS has provided a fact sheet to learn more about how to request an accelerated payment.

“The key is that you need to repay this, so you want to set a reasonable goal,” says Sarah Hostetter, senior consultant at Advisory Board, a health care research & data consulting firm. She says practices should consider what they’ll realistically be able to repay within 120 days.

4. A fourth option – specifically for mid-size practices – is a CESA loan, the details of which have yet to be announced, that will enable practices to access funds with an annualized rate no greater than 2% and with no principal or interest due for at least 6 months. The CARES Act, signed into law 3 weeks ago, provides $454 billion for this program.
 

Selecting the right option for your practice

Which singular option – or combination of options – is best for your practice? McDonald says to ask these questions:

• How well are patient volumes holding up?
• How well are physicians pivoting to telehealth?
• What is the overall economic loss?
• What are the available liquid assets, and how long can the practice maintain its financial viability over the next couple of months and beyond?

Cheryl Mongillo, MBA, administrative director of two independent family practices in Delaware, applied for both the Paycheck Protection Program and Medicare advanced payments because she’s worried about being able to pay staff while also covering costs related to personal protective equipment, medical waste, and cleaning, all of which have tripled since the pandemic began. One of the practices includes one physician and four nurse practitioners. The other includes five physicians and three nurse practitioners. In total, both practices employ 35 additional staff.

“I want our staff to know how much we care about them. My hope is that after this is over, our business will pick back up pretty quickly,” she adds. “However, until I can get the business back, I needed something to keep us afloat.”

Others are being more cautious. Crystal Bruning, practice manager at an Ob/Gyn clinic in Orlando, Florida, says her practice applied for the Paycheck Protection Program but is waiting another month or so before deciding whether it will also take advantage of Medicare advanced payments.

The practice is still trying to assess the true financial impact of its 30% reduction in patient volume. Bruning says the advanced payments wouldn’t amount to much anyway because only 10% of the practice’s patients have Medicare.
 

Making tough financial decisions while awaiting assistance

Kansas-based family physician Jennifer Bacani McKenney, MD, says she hasn’t paid herself a salary in weeks because of the revenue loss her practice has incurred.

“I want to make sure we can pay [all 12] employees,” she says. “In my family, we have two incomes, and we’re pretty good at saving money. However, I know not every physician can afford to do this.”

Although McKenney’s practice has seen a 75% reduction in patient volume, staff continue to provide virtual visits – including Zoom-based nursing home visits – phone visits, and in-person visits for acute illnesses. They also provide curbside immunizations. Still, long-term revenue loss is a concern. “I have a threshold in mind based on what we have in reserves,” she says. “If we hit that point, we would need to talk about a loan or Medicare advanced payments.”

Arkansas-based family physician Lonnie S. Robinson, MD, says he immediately applied for the Paycheck Protection Program after it was announced. “We also made sure we had a line of credit with our local bank during the very first discussions about what the pandemic would mean for our revenue streams,” he says.

However, because he’s in a rural area of the state, he continues to struggle with telemedicine due to broadband and connectivity challenges. Cash flow is another challenge because a lot of insurance companies are waiving copayments.

“I didn’t realize the amount of money we collect immediately from the patient,” he says. “This was a substantial revenue stream, and it was immediate revenue – not revenue waiting on a claim to be paid.”

Illinois-based family physician Deborah L. Winiger, MD, says she also applied for the Paycheck Protection Program but in the meantime had to reduce staff hours by a third because her patient volume dropped by more than half. She will also encourage staff to pursue temporary positions at a local hospital if the federal funds don’t materialize.

Kelly Shackleton, practice manager at a New York-based internal medicine practice, says she laid off 7 of her 16 staff members (including lab technicians, licensed practical nurses, billers, a referral specialist, and a file clerk) due to a 70% decrease in patient volume.

“I didn’t lay them all off at once,” she says. “I kept them until things were all caught up in each department. I plan to get them all back when the time is right, but I want to be sure to keep the practice afloat so they have a place to return to.” If the Paycheck Protection Program for which she applied comes through, then she will rehire them. She also applied for Medicare advanced payments and increased the practice’s line of credit.
 

Bill properly – and for everything you are still doing

Accurate and complete coding is critical during this time of financial instability, says Maselli. “I keep telling doctors to bill for everything they do,” he says. This includes phone calls between patients and physicians or other qualified healthcare providers (CPT codes 99441-99443). Note that these are time-based codes, requiring a minimum of five minutes of medical discussion.

Remote physiologic monitoring (including monitoring a patient’s oxygen saturation levels using pulse oximetry), virtual check-ins, and online digital evaluation and management services are also covered by Medicare and some commercial payers.

Other good news is that the Centers for Medicare & Medicaid Services added more than 80 additional services that providers can furnish using telehealth, including new patient office visits, home visits, prolonged office visits, smoking and tobacco cessation counseling, annual depression and alcohol screenings, advanced care planning, and much more.

Mongillo, the family practice administrator in Delaware, agrees that physicians need to bill for as many services as possible. At one of the family medicine practices she manages, physicians perform wellness visits, when appropriate, if patients are already coming into the office for another ailment.

Also look for ways to cut costs. For example, Mongillo was able to renegotiate the practice’s telemedicine contract after she received several proposals from other vendors offering three months of complimentary service. Shackleton discontinued provider dictation services to save money.

Physicians need to take a hard look at what’s going on to help them sustain their business through times of uncertainty, says Advisory Board’s Hostetter. “Now is the time to evaluate options and figure out what’s right for your practice,” she adds.

This article first appeared on Medscape.com.

As a department chief managing during this crisis, everyone greets me sympathetically: “This must be so stressful for you! Are you doing OK?” “Um, I’m great,” I answer contritely. Yes, this is hard, yet I feel fine. But why? Shouldn’t I be fretting the damage done by the COVID cyclone? Our operations are smashed and our staff scrambled, my family and friends are out of work; these are difficult times. But a harmful effect on my health or yours is not inevitable. There are things we can do to inoculate ourselves.

karandaev/iStock/Getty Images

No doubt, exercise (if you can find weights!), eating well, sleeping, and meditating help, but they are secondary. None of these protect much if you still believe stress is killing you. You must first reframe what is happening. Health psychologist Kelly McGonigal, PhD, from Stanford (Calif.) University, is a world expert on this topic. If you’ve not seen her TED talk about stress, then watch it now. She teaches how stress is indeed harmful to your health – but only if you believe it to be so. Many studies have borne this out. One showed that people who reported high stress in the previous year were 43% more likely to die than those who did not. But that risk held only when they believed stress was harmful to them. Those who did not think that stress was harmful not only fared better but also had the lowest likelihood of death, lower even than those who reported little stress! So it wasn’t the stress that mattered, it was the physiologic response to it. And that you can control.

Changing your beliefs is no easy feat. There is work to be done, Dr. McGonigal would argue. You must not only reframe our stress as healthful, but also act in ways to make this true. This is easier for us as physicians. First, we understand better than most that difficulty is a normal part of life. We have countless stories of hardship, tragedy, pain and suffering from the work we do. The pandemic may be extraordinary in breadth, but not in depth. We’ve seen worse happen to patients. Second, we have firsthand experience that suffering ends and often leads to strength and resilience. Even in our own lives, it was by traveling through the extraordinary stress of medical school and residency that we arrived here. That trying period in your life forged the strength, courage, which serves you today. It also made you more compassionate. Here lies the biggest take-away for COVID survival.

Cortisol increases when we are under duress. So does oxytocin. The former gets most of the press, the latter is more interesting. That oxytocin release during stress conferred survival benefits to us as a species: When a threat arrived, we not only ran, but also grabbed the kids, too! Oxytocin is the “tend and befriend” compliment to cortisol’s “fight or flight.” Focusing on this priming to strengthen social ties, listen, spend (Zoom) time together, and provide emotional support is key to our recovery. Even small acts of giving for our staff, friends, family, and strangers can significantly shift consequences of this stress from harmful to beneficial.

Last year, my uncle died in a tragic accident. My aunt, who is alone, is now also isolated. She’s lost her partner, her guardian, and she is afraid. Rather than succumb to the stress, she imagined something she could do to wrest some control. Last week, she filled her minivan with pink and yellow tulips bunched in bouquets and tied with handwritten notes of encouragement. She then drove up and down the streets in her North Attleboro, Mass., neighborhood and left the flowers on doorsteps until her van was empty. She did so to share with them the bit of joy that spring brings, she says, and to encourage people to stay inside!

This is a difficult time for us, and yet even more difficult for others. Perhaps the best we can do is to find ways to bring a bit of joy or comfort to others.


“In some ways suffering ceases to be suffering at the moment it finds a meaning, such as the meaning of a sacrifice.” – Viktor Frankl

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. He had no relevant disclosures. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

As a department chief managing during this crisis, everyone greets me sympathetically: “This must be so stressful for you! Are you doing OK?” “Um, I’m great,” I answer contritely. Yes, this is hard, yet I feel fine. But why? Shouldn’t I be fretting the damage done by the COVID cyclone? Our operations are smashed and our staff scrambled, my family and friends are out of work; these are difficult times. But a harmful effect on my health or yours is not inevitable. There are things we can do to inoculate ourselves.

karandaev/iStock/Getty Images

No doubt, exercise (if you can find weights!), eating well, sleeping, and meditating help, but they are secondary. None of these protect much if you still believe stress is killing you. You must first reframe what is happening. Health psychologist Kelly McGonigal, PhD, from Stanford (Calif.) University, is a world expert on this topic. If you’ve not seen her TED talk about stress, then watch it now. She teaches how stress is indeed harmful to your health – but only if you believe it to be so. Many studies have borne this out. One showed that people who reported high stress in the previous year were 43% more likely to die than those who did not. But that risk held only when they believed stress was harmful to them. Those who did not think that stress was harmful not only fared better but also had the lowest likelihood of death, lower even than those who reported little stress! So it wasn’t the stress that mattered, it was the physiologic response to it. And that you can control.

Changing your beliefs is no easy feat. There is work to be done, Dr. McGonigal would argue. You must not only reframe our stress as healthful, but also act in ways to make this true. This is easier for us as physicians. First, we understand better than most that difficulty is a normal part of life. We have countless stories of hardship, tragedy, pain and suffering from the work we do. The pandemic may be extraordinary in breadth, but not in depth. We’ve seen worse happen to patients. Second, we have firsthand experience that suffering ends and often leads to strength and resilience. Even in our own lives, it was by traveling through the extraordinary stress of medical school and residency that we arrived here. That trying period in your life forged the strength, courage, which serves you today. It also made you more compassionate. Here lies the biggest take-away for COVID survival.

Cortisol increases when we are under duress. So does oxytocin. The former gets most of the press, the latter is more interesting. That oxytocin release during stress conferred survival benefits to us as a species: When a threat arrived, we not only ran, but also grabbed the kids, too! Oxytocin is the “tend and befriend” compliment to cortisol’s “fight or flight.” Focusing on this priming to strengthen social ties, listen, spend (Zoom) time together, and provide emotional support is key to our recovery. Even small acts of giving for our staff, friends, family, and strangers can significantly shift consequences of this stress from harmful to beneficial.

Last year, my uncle died in a tragic accident. My aunt, who is alone, is now also isolated. She’s lost her partner, her guardian, and she is afraid. Rather than succumb to the stress, she imagined something she could do to wrest some control. Last week, she filled her minivan with pink and yellow tulips bunched in bouquets and tied with handwritten notes of encouragement. She then drove up and down the streets in her North Attleboro, Mass., neighborhood and left the flowers on doorsteps until her van was empty. She did so to share with them the bit of joy that spring brings, she says, and to encourage people to stay inside!

This is a difficult time for us, and yet even more difficult for others. Perhaps the best we can do is to find ways to bring a bit of joy or comfort to others.


“In some ways suffering ceases to be suffering at the moment it finds a meaning, such as the meaning of a sacrifice.” – Viktor Frankl

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. He had no relevant disclosures. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

As a department chief managing during this crisis, everyone greets me sympathetically: “This must be so stressful for you! Are you doing OK?” “Um, I’m great,” I answer contritely. Yes, this is hard, yet I feel fine. But why? Shouldn’t I be fretting the damage done by the COVID cyclone? Our operations are smashed and our staff scrambled, my family and friends are out of work; these are difficult times. But a harmful effect on my health or yours is not inevitable. There are things we can do to inoculate ourselves.

karandaev/iStock/Getty Images

No doubt, exercise (if you can find weights!), eating well, sleeping, and meditating help, but they are secondary. None of these protect much if you still believe stress is killing you. You must first reframe what is happening. Health psychologist Kelly McGonigal, PhD, from Stanford (Calif.) University, is a world expert on this topic. If you’ve not seen her TED talk about stress, then watch it now. She teaches how stress is indeed harmful to your health – but only if you believe it to be so. Many studies have borne this out. One showed that people who reported high stress in the previous year were 43% more likely to die than those who did not. But that risk held only when they believed stress was harmful to them. Those who did not think that stress was harmful not only fared better but also had the lowest likelihood of death, lower even than those who reported little stress! So it wasn’t the stress that mattered, it was the physiologic response to it. And that you can control.

Changing your beliefs is no easy feat. There is work to be done, Dr. McGonigal would argue. You must not only reframe our stress as healthful, but also act in ways to make this true. This is easier for us as physicians. First, we understand better than most that difficulty is a normal part of life. We have countless stories of hardship, tragedy, pain and suffering from the work we do. The pandemic may be extraordinary in breadth, but not in depth. We’ve seen worse happen to patients. Second, we have firsthand experience that suffering ends and often leads to strength and resilience. Even in our own lives, it was by traveling through the extraordinary stress of medical school and residency that we arrived here. That trying period in your life forged the strength, courage, which serves you today. It also made you more compassionate. Here lies the biggest take-away for COVID survival.

Cortisol increases when we are under duress. So does oxytocin. The former gets most of the press, the latter is more interesting. That oxytocin release during stress conferred survival benefits to us as a species: When a threat arrived, we not only ran, but also grabbed the kids, too! Oxytocin is the “tend and befriend” compliment to cortisol’s “fight or flight.” Focusing on this priming to strengthen social ties, listen, spend (Zoom) time together, and provide emotional support is key to our recovery. Even small acts of giving for our staff, friends, family, and strangers can significantly shift consequences of this stress from harmful to beneficial.

Last year, my uncle died in a tragic accident. My aunt, who is alone, is now also isolated. She’s lost her partner, her guardian, and she is afraid. Rather than succumb to the stress, she imagined something she could do to wrest some control. Last week, she filled her minivan with pink and yellow tulips bunched in bouquets and tied with handwritten notes of encouragement. She then drove up and down the streets in her North Attleboro, Mass., neighborhood and left the flowers on doorsteps until her van was empty. She did so to share with them the bit of joy that spring brings, she says, and to encourage people to stay inside!

This is a difficult time for us, and yet even more difficult for others. Perhaps the best we can do is to find ways to bring a bit of joy or comfort to others.


“In some ways suffering ceases to be suffering at the moment it finds a meaning, such as the meaning of a sacrifice.” – Viktor Frankl

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. He had no relevant disclosures. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

The Food and Drug Administration has authorized the first diagnostic test with a home collection option for COVID-19, a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.

The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.

“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.

[email protected]

The Food and Drug Administration has authorized the first diagnostic test with a home collection option for COVID-19, a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.

The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.

“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.

[email protected]

The Food and Drug Administration has authorized the first diagnostic test with a home collection option for COVID-19, a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.

The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.

“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.

[email protected]

Patients with a mild traumatic brain injury (mTBI) who are exposed to blue light experience less depression and fewer cognitive and other concussion-related symptoms than those exposed to a placebo light, a new study has found. Exposure to blue light in the morning through a special device may be a “critical factor” in resetting the circadian rhythm and helping people who have suffered a concussion, author William D. “Scott” Killgore, MD, professor of psychiatry, psychology, and medical imaging, the University of Arizona College of Medicine, Tucson, told Medscape Medical News.

“This is very new, so I wouldn’t say it’s the treatment of choice, but we should start looking at using this system as a nonpharmacologic way to perhaps help patients recover faster from a concussion,” he said.

The findings were released March 2 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.

About half of patients with a concussion experience sleep problems, including problems falling asleep, staying asleep, and waking up in the middle of the night, said Dr. Killgore.

Poor sleep interrupts the brain’s repair mechanism. “Sleep is important for cleaning out the neurotoxins that build up in your brain during the day. Sleep also helps build oligodendrocyte precursor cells that provide insulation around nerve cells,” he said.
 

Master clock

Blue light stimulates receptors in the back of the retina that respond only to this wavelength of light, said Dr. Killgore. “It specifically projects to an area in the hypothalamus – essentially the brain’s master clock – that regulates your sleep-wake schedules. So exposure to that bright light essentially resets your circadian rhythm.”

That master clock involves regulating the brain’s production of melatonin. Morning exposure to blue light shifts that production to facilitate sleep at the appropriate time.

The ideal time to be exposed to blue light is from about 8:00 to 11:00 AM. “Timing is critical,” said Dr. Killgore. “If you get light at the wrong time, it will reset your circadian rhythm in the wrong direction.”

Previous research has shown that exposure to blue light leads to improved sleep, which is widely believed to lead to improved mood.

A separate study conducted by Dr. Killgore and colleagues that involved another group of mTBI patients was recently published in Neurobiology of Disease. That study showed that the participants who received blue light experienced a shift in circadian timing of about an hour. “They were going to sleep an hour earlier and waking up an hour earlier,” said Dr. Killgore.

The blue light also appeared to change brain structure and brain function, among other things, he said.

The current study included 35 patients who had suffered an mTBI within the previous 18 months. Most injuries were sports related and occurred while playing football or soccer or riding a bike.

Participants were randomly assigned to use a device fitted with a blue LED light (peak wavelength, 469 nm) or one fitted with an amber-colored LED light. They were instructed to use the device every morning for 30 minutes within 2 hours of waking.

The blue-light group comprised five men and 12 women (mean age, 25.5 years). The amber-light group comprised eight men and 10 women (mean age, 26.3 years).

Researchers told participants only that the study was exploring various aspects of light. “Subjects didn’t know if they were getting a control or active device,” said Dr. Killgore.

Researchers used the Beck Depression Inventory (BDI) to evaluate depression symptoms and the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ). This 16-item questionnaire assesses symptoms in the acute stage as well as those that are more chronic.

After 6 weeks, the blue-light group had lower scores on the BDI compared to the amber-light group (P = .005).

“We found that in the amber-light group, there was essentially no change in terms of depression,” said Dr. Killgore. “But those who got the blue light showed a significant reduction in depressive symptoms, about a 22% decline overall relative to baseline, so a nice drop in overall depression.”

Changes in BDI scores were significantly positively associated with changes in the total chronic symptom score (P = .002) in the blue-light group but not the amber-light group. “Those who got blue light showed a significant reduction in the number of symptoms associated with concussion whereas those who got the amber light stayed the same,” said Dr. Killgore.

There were similar findings for somatic symptoms, such as headache and pain (P = .031), and for cognitive symptoms (P = .014) in the blue-light group.

“These subjects were having fewer problems remembering and paying attention, so their concentration seemed to be improving, at least subjectively,” commented Dr. Killgore.

There was no significant benefit from the blue light for emotional symptoms. “There was a decline, but it wasn’t statistically significant, even though there was a decline in depression,” said Dr. Killgore.

This, he explained, could be due to the small sample size and the greater sensitivity of the BDI for emotional symptoms relative to the RPCSQ. “The BDI has 21 items that are all focused on aspects of depression, whereas the RPCSQ only asks one item for depression and one item for irritability/anger.”

Less daytime sleepiness

The researchers also found a significant improvement in daytime sleepiness. “Subjects were much less sleepy by the end of the study if they got blue light than if they got amber light,” said Dr. Killgore.

Participants wore an actigraphy device that took sleep measurements. Early results indicate that blue-light recipients were getting more sleep by the end of the study.

Researchers are now analyzing additional data to see whether the improvements in depression and post-concussion symptoms are linked to improved sleep. They also gathered data from brain imaging that will be analyzed at a later date.

Dr. Killgore and his colleagues aim to determine what distinguishes people who respond to blue-light therapy from those who don’t. “We want to know what it is that would allow some people to be more responsive than others, so we’re going to be exploring skin color, eye color, genetic factors, and other factors,” he said.

They’re also conducting a study of blue-light therapy in patients with posttraumatic stress disorder, 90% of whom have sleep problems.

“This is quite fascinating,” said Dr. Killgore. “It looks like if you get blue light after your treatment, the treatment sticks better than if you didn’t get the blue light. We think that sleep is probably playing an important role in that.”

Several light devices are available, ranging in price from about $100 to $200.

Commenting on the research, concussion expert Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, Port St. Lucie, said the study is interesting from a number of perspectives.

For one thing, it shows that blue-light therapy “provides an inexpensive and minimally invasive way to treat concussion,” he said.

Dr. Conidi said he would recommend blue-light therapy for concussion patients. “I could see neurology practices offering the device to patients as an in-office treatment or to take home for a small fee. I think athletes would be quite receptive to this, as they’re always looking for nonpharmacological ways to treat concussion.”

Dr. Conidi noted that the new results are consistent with other studies that show that decreased depression and improved sleep help with somatic symptoms.

From a research perspective, the study provides a “stepping stone” for larger trials, said Dr. Conidi. He would like to see more studies of acute concussion, such as studies as to whether the therapy shortens the duration of symptoms.

“I would also like to see controlled studies on headache and vestibular symptoms, which are the two most common,” he said.

The study was funded by the US Department of Defense. Killgore and Conidi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with a mild traumatic brain injury (mTBI) who are exposed to blue light experience less depression and fewer cognitive and other concussion-related symptoms than those exposed to a placebo light, a new study has found. Exposure to blue light in the morning through a special device may be a “critical factor” in resetting the circadian rhythm and helping people who have suffered a concussion, author William D. “Scott” Killgore, MD, professor of psychiatry, psychology, and medical imaging, the University of Arizona College of Medicine, Tucson, told Medscape Medical News.

“This is very new, so I wouldn’t say it’s the treatment of choice, but we should start looking at using this system as a nonpharmacologic way to perhaps help patients recover faster from a concussion,” he said.

The findings were released March 2 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.

About half of patients with a concussion experience sleep problems, including problems falling asleep, staying asleep, and waking up in the middle of the night, said Dr. Killgore.

Poor sleep interrupts the brain’s repair mechanism. “Sleep is important for cleaning out the neurotoxins that build up in your brain during the day. Sleep also helps build oligodendrocyte precursor cells that provide insulation around nerve cells,” he said.
 

Master clock

Blue light stimulates receptors in the back of the retina that respond only to this wavelength of light, said Dr. Killgore. “It specifically projects to an area in the hypothalamus – essentially the brain’s master clock – that regulates your sleep-wake schedules. So exposure to that bright light essentially resets your circadian rhythm.”

That master clock involves regulating the brain’s production of melatonin. Morning exposure to blue light shifts that production to facilitate sleep at the appropriate time.

The ideal time to be exposed to blue light is from about 8:00 to 11:00 AM. “Timing is critical,” said Dr. Killgore. “If you get light at the wrong time, it will reset your circadian rhythm in the wrong direction.”

Previous research has shown that exposure to blue light leads to improved sleep, which is widely believed to lead to improved mood.

A separate study conducted by Dr. Killgore and colleagues that involved another group of mTBI patients was recently published in Neurobiology of Disease. That study showed that the participants who received blue light experienced a shift in circadian timing of about an hour. “They were going to sleep an hour earlier and waking up an hour earlier,” said Dr. Killgore.

The blue light also appeared to change brain structure and brain function, among other things, he said.

The current study included 35 patients who had suffered an mTBI within the previous 18 months. Most injuries were sports related and occurred while playing football or soccer or riding a bike.

Participants were randomly assigned to use a device fitted with a blue LED light (peak wavelength, 469 nm) or one fitted with an amber-colored LED light. They were instructed to use the device every morning for 30 minutes within 2 hours of waking.

The blue-light group comprised five men and 12 women (mean age, 25.5 years). The amber-light group comprised eight men and 10 women (mean age, 26.3 years).

Researchers told participants only that the study was exploring various aspects of light. “Subjects didn’t know if they were getting a control or active device,” said Dr. Killgore.

Researchers used the Beck Depression Inventory (BDI) to evaluate depression symptoms and the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ). This 16-item questionnaire assesses symptoms in the acute stage as well as those that are more chronic.

After 6 weeks, the blue-light group had lower scores on the BDI compared to the amber-light group (P = .005).

“We found that in the amber-light group, there was essentially no change in terms of depression,” said Dr. Killgore. “But those who got the blue light showed a significant reduction in depressive symptoms, about a 22% decline overall relative to baseline, so a nice drop in overall depression.”

Changes in BDI scores were significantly positively associated with changes in the total chronic symptom score (P = .002) in the blue-light group but not the amber-light group. “Those who got blue light showed a significant reduction in the number of symptoms associated with concussion whereas those who got the amber light stayed the same,” said Dr. Killgore.

There were similar findings for somatic symptoms, such as headache and pain (P = .031), and for cognitive symptoms (P = .014) in the blue-light group.

“These subjects were having fewer problems remembering and paying attention, so their concentration seemed to be improving, at least subjectively,” commented Dr. Killgore.

There was no significant benefit from the blue light for emotional symptoms. “There was a decline, but it wasn’t statistically significant, even though there was a decline in depression,” said Dr. Killgore.

This, he explained, could be due to the small sample size and the greater sensitivity of the BDI for emotional symptoms relative to the RPCSQ. “The BDI has 21 items that are all focused on aspects of depression, whereas the RPCSQ only asks one item for depression and one item for irritability/anger.”

Less daytime sleepiness

The researchers also found a significant improvement in daytime sleepiness. “Subjects were much less sleepy by the end of the study if they got blue light than if they got amber light,” said Dr. Killgore.

Participants wore an actigraphy device that took sleep measurements. Early results indicate that blue-light recipients were getting more sleep by the end of the study.

Researchers are now analyzing additional data to see whether the improvements in depression and post-concussion symptoms are linked to improved sleep. They also gathered data from brain imaging that will be analyzed at a later date.

Dr. Killgore and his colleagues aim to determine what distinguishes people who respond to blue-light therapy from those who don’t. “We want to know what it is that would allow some people to be more responsive than others, so we’re going to be exploring skin color, eye color, genetic factors, and other factors,” he said.

They’re also conducting a study of blue-light therapy in patients with posttraumatic stress disorder, 90% of whom have sleep problems.

“This is quite fascinating,” said Dr. Killgore. “It looks like if you get blue light after your treatment, the treatment sticks better than if you didn’t get the blue light. We think that sleep is probably playing an important role in that.”

Several light devices are available, ranging in price from about $100 to $200.

Commenting on the research, concussion expert Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, Port St. Lucie, said the study is interesting from a number of perspectives.

For one thing, it shows that blue-light therapy “provides an inexpensive and minimally invasive way to treat concussion,” he said.

Dr. Conidi said he would recommend blue-light therapy for concussion patients. “I could see neurology practices offering the device to patients as an in-office treatment or to take home for a small fee. I think athletes would be quite receptive to this, as they’re always looking for nonpharmacological ways to treat concussion.”

Dr. Conidi noted that the new results are consistent with other studies that show that decreased depression and improved sleep help with somatic symptoms.

From a research perspective, the study provides a “stepping stone” for larger trials, said Dr. Conidi. He would like to see more studies of acute concussion, such as studies as to whether the therapy shortens the duration of symptoms.

“I would also like to see controlled studies on headache and vestibular symptoms, which are the two most common,” he said.

The study was funded by the US Department of Defense. Killgore and Conidi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with a mild traumatic brain injury (mTBI) who are exposed to blue light experience less depression and fewer cognitive and other concussion-related symptoms than those exposed to a placebo light, a new study has found. Exposure to blue light in the morning through a special device may be a “critical factor” in resetting the circadian rhythm and helping people who have suffered a concussion, author William D. “Scott” Killgore, MD, professor of psychiatry, psychology, and medical imaging, the University of Arizona College of Medicine, Tucson, told Medscape Medical News.

“This is very new, so I wouldn’t say it’s the treatment of choice, but we should start looking at using this system as a nonpharmacologic way to perhaps help patients recover faster from a concussion,” he said.

The findings were released March 2 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.

About half of patients with a concussion experience sleep problems, including problems falling asleep, staying asleep, and waking up in the middle of the night, said Dr. Killgore.

Poor sleep interrupts the brain’s repair mechanism. “Sleep is important for cleaning out the neurotoxins that build up in your brain during the day. Sleep also helps build oligodendrocyte precursor cells that provide insulation around nerve cells,” he said.
 

Master clock

Blue light stimulates receptors in the back of the retina that respond only to this wavelength of light, said Dr. Killgore. “It specifically projects to an area in the hypothalamus – essentially the brain’s master clock – that regulates your sleep-wake schedules. So exposure to that bright light essentially resets your circadian rhythm.”

That master clock involves regulating the brain’s production of melatonin. Morning exposure to blue light shifts that production to facilitate sleep at the appropriate time.

The ideal time to be exposed to blue light is from about 8:00 to 11:00 AM. “Timing is critical,” said Dr. Killgore. “If you get light at the wrong time, it will reset your circadian rhythm in the wrong direction.”

Previous research has shown that exposure to blue light leads to improved sleep, which is widely believed to lead to improved mood.

A separate study conducted by Dr. Killgore and colleagues that involved another group of mTBI patients was recently published in Neurobiology of Disease. That study showed that the participants who received blue light experienced a shift in circadian timing of about an hour. “They were going to sleep an hour earlier and waking up an hour earlier,” said Dr. Killgore.

The blue light also appeared to change brain structure and brain function, among other things, he said.

The current study included 35 patients who had suffered an mTBI within the previous 18 months. Most injuries were sports related and occurred while playing football or soccer or riding a bike.

Participants were randomly assigned to use a device fitted with a blue LED light (peak wavelength, 469 nm) or one fitted with an amber-colored LED light. They were instructed to use the device every morning for 30 minutes within 2 hours of waking.

The blue-light group comprised five men and 12 women (mean age, 25.5 years). The amber-light group comprised eight men and 10 women (mean age, 26.3 years).

Researchers told participants only that the study was exploring various aspects of light. “Subjects didn’t know if they were getting a control or active device,” said Dr. Killgore.

Researchers used the Beck Depression Inventory (BDI) to evaluate depression symptoms and the Rivermead Post-Concussion Symptom Questionnaire (RPCSQ). This 16-item questionnaire assesses symptoms in the acute stage as well as those that are more chronic.

After 6 weeks, the blue-light group had lower scores on the BDI compared to the amber-light group (P = .005).

“We found that in the amber-light group, there was essentially no change in terms of depression,” said Dr. Killgore. “But those who got the blue light showed a significant reduction in depressive symptoms, about a 22% decline overall relative to baseline, so a nice drop in overall depression.”

Changes in BDI scores were significantly positively associated with changes in the total chronic symptom score (P = .002) in the blue-light group but not the amber-light group. “Those who got blue light showed a significant reduction in the number of symptoms associated with concussion whereas those who got the amber light stayed the same,” said Dr. Killgore.

There were similar findings for somatic symptoms, such as headache and pain (P = .031), and for cognitive symptoms (P = .014) in the blue-light group.

“These subjects were having fewer problems remembering and paying attention, so their concentration seemed to be improving, at least subjectively,” commented Dr. Killgore.

There was no significant benefit from the blue light for emotional symptoms. “There was a decline, but it wasn’t statistically significant, even though there was a decline in depression,” said Dr. Killgore.

This, he explained, could be due to the small sample size and the greater sensitivity of the BDI for emotional symptoms relative to the RPCSQ. “The BDI has 21 items that are all focused on aspects of depression, whereas the RPCSQ only asks one item for depression and one item for irritability/anger.”

Less daytime sleepiness

The researchers also found a significant improvement in daytime sleepiness. “Subjects were much less sleepy by the end of the study if they got blue light than if they got amber light,” said Dr. Killgore.

Participants wore an actigraphy device that took sleep measurements. Early results indicate that blue-light recipients were getting more sleep by the end of the study.

Researchers are now analyzing additional data to see whether the improvements in depression and post-concussion symptoms are linked to improved sleep. They also gathered data from brain imaging that will be analyzed at a later date.

Dr. Killgore and his colleagues aim to determine what distinguishes people who respond to blue-light therapy from those who don’t. “We want to know what it is that would allow some people to be more responsive than others, so we’re going to be exploring skin color, eye color, genetic factors, and other factors,” he said.

They’re also conducting a study of blue-light therapy in patients with posttraumatic stress disorder, 90% of whom have sleep problems.

“This is quite fascinating,” said Dr. Killgore. “It looks like if you get blue light after your treatment, the treatment sticks better than if you didn’t get the blue light. We think that sleep is probably playing an important role in that.”

Several light devices are available, ranging in price from about $100 to $200.

Commenting on the research, concussion expert Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, Port St. Lucie, said the study is interesting from a number of perspectives.

For one thing, it shows that blue-light therapy “provides an inexpensive and minimally invasive way to treat concussion,” he said.

Dr. Conidi said he would recommend blue-light therapy for concussion patients. “I could see neurology practices offering the device to patients as an in-office treatment or to take home for a small fee. I think athletes would be quite receptive to this, as they’re always looking for nonpharmacological ways to treat concussion.”

Dr. Conidi noted that the new results are consistent with other studies that show that decreased depression and improved sleep help with somatic symptoms.

From a research perspective, the study provides a “stepping stone” for larger trials, said Dr. Conidi. He would like to see more studies of acute concussion, such as studies as to whether the therapy shortens the duration of symptoms.

“I would also like to see controlled studies on headache and vestibular symptoms, which are the two most common,” he said.

The study was funded by the US Department of Defense. Killgore and Conidi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Post hoc analyses of recent large, clinical outcomes studies of PCSK9 inhibitors have revealed two tantalizing and unexpected potential benefits from these drugs: an ability to substantially reduce the incidence or severity of venous thromboembolism and aortic stenosis.

The evidence also suggests that these effects are linked to the ability of these drugs to reduce blood levels of Lp(a) lipoprotein by roughly a quarter, currently the biggest known effect on Lp(a) levels of any approved medication.

One study ran post hoc analyses of venous thromboembolism (VTE) events in the FOURIER pivotal trial of evolocumab (Repatha), with more than 27,500 randomized patients (N Engl J Med. 2017 May 4; 376[18]:1713-22), and in the ODYSSEY OUTCOMES pivotal trial of alirocumab (Praluent), with nearly 19,000 randomized patients (N Engl J Med. 2018 Nov 29;379[22]:2097-2107). The analyses showed that, with evolocumab treatment, the incidence of VTE events fell by a statistically significant 29%, compared with patients on placebo, while in ODYSSEY OUTCOMES patients treated with alirocumab had a 33% cut in VTE events, compared with placebo-treated patients, a difference that just missed statistical significance (Circulation. 2020 Mar 29. doi: 10.1161/CIRCULATIONAHA.120.046524) in analyses that were not prespecified before these trials started, Nicholas A. Marston, MD, said in a presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

A combined analysis of 46,488 patients from both studies showed a 31% cut in VTE events with PCSK9 inhibitor treatment, a highly significant finding using VTE endpoints that were not specifically tallied nor adjudicated but collected as part of the serious adverse event reporting in the two pivotal trials, said Dr. Marston, a cardiologist at Brigham and Women’s Hospital in Boston. This is the first report of a statistically significant link between treatment with PCSK9-inhibiting agents and a reduction in VTE, he added. Researchers from the ODYSSEY OUTCOMES trial had reported a VTE analysis in 2019, and while data from that trial on its own showed a nominal 33% lower VTE rate with alirocumab treatment, it just missed statistical significance.

The VTE effect took about a year on treatment to start to manifest. During the first 12 months of FOURIER, the rate of VTE events among patients in the two treatment arms was virtually identical. But starting during months 13-18 on treatment, the event curves in the two arms began to increasingly diverge, and overall during the period from month 13 to the end of the study treatment with evolocumab was linked with a statistically significant 46% reduction in VTE events, compared with patients who received placebo. The results Dr. Marston reported were also published online (Circulation. 2020 Mar 29. doi: 10.1161/CIRCULATIONAHA.120.046397).

The suggestion that this association may be linked to the impact of PCSK9 inhibitors on Lp(a) came from an additional analysis that Dr. Marston presented, which looked at the link between evolocumab use and a change in VTE event rates, compared with placebo, depending on baseline lipoprotein levels. Evolocumab treatment was associated with a roughly similar, modest, and not statistically significant reduction in VTE events, compared with placebo regardless of whether patients had baseline levels of LDL cholesterol below the median or at or above the median. In contrast, when a similar analysis divided patients based on whether their Lp(a) level at baseline was below, or at or above, the median the results showed no discernible effect of evolocumab treatment, compared with on VTE events in patients with lower baseline Lp(a), but in those with higher levels treatment with evolocumab linked with a 48% cut in VTE events, compared with placebo, a statistically significant difference.

In FOURIER, treatment with evolocumab lowered baseline Lp(a) levels by a median of 27%, compared with placebo, among the 25,096 enrolled patients who had their baseline levels measured. As previously reported, prespecified analysis of FOURIER data also showed that the impact of evolocumab, compared with placebo, on the combined rate of coronary heart disease death, MI, or need for urgent coronary revascularization was enhanced among patients with elevated baseline Lp(a) and moderated in those who entered with lower levels. Among patients who entered FOURIER with Lp(a) levels at or below the median treatment with evolocumab cut the primary endpoint by 7%, compared with placebo, a difference that was not statistically significant. Among patients who began the study with Lp(a) levels above the median, evolocumab treatment cut the primary endpoint by 23%, compared with placebo, a statistically significant effect (Circulation. 2019 Mar 19;139[12]:1483-92).

The aortic stenosis connection

A second study reported in the online scientific sessions (Abstract 914-08) used only FOURIER data, and showed that patients treated with evolocumab had a roughly similar response pattern in their incidence of aortic stenosis (AS) events as they did for VTE events.

During the first year of the study, the incidence of AS events was virtually identical among patients treated with evolocumab and those who received placebo. But after the first 12 months and through the study’s end, patients on evolocumab showed a statistically significant 52% relative reduction in AS events, compared with control patients, said Brian A. Bergmark, MD. For the entire study duration, treatment with evolocumab linked with a 34% relative reduction in AS events, compared with placebo, a difference that did not reach statistical significance, added Dr. Bergmark, an interventional cardiologist also at Brigham and Women’s Hospital. The observed halving in total AS events that linked with evolocumab treatment after the first year of the study included a similar-magnitude reduction specifically in the incidence of aortic valve replacement procedures in the evolocumab-treated patients.

Further analysis of both total AS events and aortic valve replacements in FOURIER patients showed that they occurred at a significantly elevated rate in patients who entered the study with higher baseline Lp(a) levels in a multivariate analysis, but a similar analysis showed no significant association between the incidence of these AS-related events and baseline levels of LDL cholesterol, he said.

The AS analysis carried the same important limitations as the VTE analysis: It ran on a post hoc basis and focused on events that were relatively uncommon and not adjudicated, Dr. Bergmark cautioned. Nonetheless, other investigators saw important potential implications from both the VTE and AS observations, with the huge caveat that they need replication in prospective studies designed to specifically address the validity of these findings.
 

What it could mean

These observed associations between PCSK9 inhibitor treatment and apparent reductions in the rate of both VTE and AS events “represent a tremendous clinical breakthrough,” commented Michelle L. O’Donoghue, MD, a cardiologist at Brigham and Women’s Hospital who is a FOURIER coinvestigator and has led some of the Lp(a) analyses run from that study.

Bruce Jancin/MDedge News

“To date, we have not identified any therapies that slow progression of AS. Other classes of lipid-lowering therapies, such as statins, have been tested and not demonstrated a significant effect,” Dr. O’Donoghue said in an interview.

“For AS, the results are very intriguing. If confirmed, it could be groundbreaking. AS is the most common valve disease in the developed world, and no medical therapy exists. The potential is immense,” commented George Thanassoulis, MD, director of preventive and genomic cardiology at McGill University, Montreal. “Having a medical treatment that could slow AS progression would completely change the disease. It’s conceivable to slow the disease enough that patients may never require valve replacement.” But an interview he cautioned that, “although the results are exciting, the analysis has many limitations. What we need is a dedicated, randomized trial for AS. I hope this stimulates that.”

“For VTE, it’s an interesting finding, but I don’t think it will have clinical utility because we have good treatment for VTE,” added Dr. Thanassoulis, but others saw more opportunity from what could be a new way to reduce VTE risk.

“Given that many patients have difficulty with the bleeding risk from anticoagulants, this option [a PCSK9 inhibitor] may be quite welcome for preventing VTE,” commented Gregory Piazza, MD, a cardiologist and VTE specialist at Brigham and Women’s Hospital who was not involved in any of the PCSK9 inhibitor studies.

“At this time we would not suggest that PCSK9 inhibitors replace an anticoagulant for patients with an established clot or at high risk for a recurrent clot, but if patients have an indication for a PCSK9 inhibitor, the further reduction in venous clot can be viewed as an additional benefit of this therapy,” said Dr. O’Donoghue.
 

How it might work

A possible mechanism underlying a VTE effect is unclear. Results from the JUPITER trial more than a decade ago had shown a significant association between treatment with 20 mg/day of rosuvastatin and a cut in VTE episodes, compared with placebo, in a prespecified, secondary analysis of the trial with nearly 18,000 patients selected for having a relatively high level of high-sensitivity C-reactive protein (N Engl J Med. 2009 Apr 30;360[18]:1851-61). But a meta-analysis of 29 controlled statin trials that used a variety of statin types and dosages (and included the JUPITER results) failed to confirm a statistically significant change in VTE rates from statins, though they produced a small, nominal reduction (PLoS Med. 2012 Sep 18. doi: 10.1371/journal.pmed.1001310).

Lp(a) “has long been linked to thrombosis, in particular arterial thrombosis,” so the link observed in the PCSK9 inhibitor trials “is not surprising,” said Dr. Piazza. Dr. O’Donoghue agreed that prior evidence had “suggested a prothrombotic role for Lp(a).”

Dr. Thanassoulis was more skeptical of a Lp(a) connection to VTE. “There has always been controversy regarding the prothrombotic effects of Lp(a) and whether it’s clinically relevant,” he said. “The genetic data, from Mendelian randomization studies, is not consistent” with a Lp(a) and VTE link.

The association of AS and Lp(a) may be stronger. “Our team showed that people with genetic variants that predispose to high Lp(a) have a much higher incidence of AS,” Dr. Thanassoulis noted. “We and others have also demonstrated that both Lp(a) and LDL are likely causal mediators of aortic valve calcification and stenosis.”

Dr. O’Donoghue also cited observational genetic data that linked elevated Lp(a) with AS. “Mendelian randomization studies have demonstrated that Lp(a) is a causal contributer to AS, and evolocumab reduced Lp(a) by 25%-30%, raising the possibility that Lp(a) lowering with these drugs may be the mechanism,” she said.
 

The future of Lp(a) lowering

This last point from Dr. O’Donoghue, that PCSK9 inhibitors cut Lp(a) levels by about 25%-30%, means that they are the most potent Lp(a)-lowering agents currently available, but it also leaves lots of room for other agents to do even better in cutting Lp(a).

“There are now drugs in development that block production of the Lp(a) protein and dramatically reduce its concentration, by about 80%,” Dr. O’Donoghue noted. “It will be of interest to study whether these novel therapies, now in phase 2 and phase 3 studies, have any effect on the risk for VTE and AS.”

“Several drugs in development, including antisense RNA and RNA-interfering molecules, are much more potent and lower Lp(a) by 80%-90%. Because of this potency they can completely normalize Lp(a) in most patients. For Lp(a) lowering, the future is in these new molecules. Randomized trials have started, and we will hopefully have some results in about 5 years,” said Dr. Thanassoulis.

Until then, the prospect of possibly soon documenting benefits from PCSK9 inhibitors beyond their impact on cutting LDL cholesterol raises some hope to get more bang for the considerable buck these drugs cost. But Dr. Thanassoulis was skeptical it would move the cost-benefit ratio much. “VTE and AS are relatively rare, compared with atherosclerotic cardiovascular events, and therefore the added value at the population level would be small,” he predicted. But if treatment with a drug could help patients avoid surgical or percutaneous valve interventions “that could be really interesting from a cost-benefit perspective.”

FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). ODYSSEY OUTCOMES was funded by Sanofi and Regeneron, the companies that developed and market alirocumab (Praluent). Dr. Marston had no disclosures. Dr. Bergmark has been a consultant to Daiichi Sankyo, Janssen, Quark, and Servier and has received research funding from Abbott Vascular, AstraZeneca, and MedImmune. Dr. O’Donoghue has been a consultant to and has received research funding from Amgen; has been a consultant to Janssen and Novartis; and has received research funding from AstraZeneca, Eisai, GlaxoSmithKline, Janssen, Medimmune, Merck, and The Medicines Company. Dr. Thanassoulis has been an adviser to and speaker for Amgen; an adviser to Ionis and Sanofi/Regeneron; a speaker on behalf of Boehringer Ingelheim, Sanofi, and Servier; and has received research funding from Ionis and Servier. Dr. Piazza has been a consultant to Optum, Pfizer, and Thrombolex and he has received research funding from Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Ekos, Janssen, and Portola.

[email protected]

Post hoc analyses of recent large, clinical outcomes studies of PCSK9 inhibitors have revealed two tantalizing and unexpected potential benefits from these drugs: an ability to substantially reduce the incidence or severity of venous thromboembolism and aortic stenosis.

The evidence also suggests that these effects are linked to the ability of these drugs to reduce blood levels of Lp(a) lipoprotein by roughly a quarter, currently the biggest known effect on Lp(a) levels of any approved medication.

One study ran post hoc analyses of venous thromboembolism (VTE) events in the FOURIER pivotal trial of evolocumab (Repatha), with more than 27,500 randomized patients (N Engl J Med. 2017 May 4; 376[18]:1713-22), and in the ODYSSEY OUTCOMES pivotal trial of alirocumab (Praluent), with nearly 19,000 randomized patients (N Engl J Med. 2018 Nov 29;379[22]:2097-2107). The analyses showed that, with evolocumab treatment, the incidence of VTE events fell by a statistically significant 29%, compared with patients on placebo, while in ODYSSEY OUTCOMES patients treated with alirocumab had a 33% cut in VTE events, compared with placebo-treated patients, a difference that just missed statistical significance (Circulation. 2020 Mar 29. doi: 10.1161/CIRCULATIONAHA.120.046524) in analyses that were not prespecified before these trials started, Nicholas A. Marston, MD, said in a presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

A combined analysis of 46,488 patients from both studies showed a 31% cut in VTE events with PCSK9 inhibitor treatment, a highly significant finding using VTE endpoints that were not specifically tallied nor adjudicated but collected as part of the serious adverse event reporting in the two pivotal trials, said Dr. Marston, a cardiologist at Brigham and Women’s Hospital in Boston. This is the first report of a statistically significant link between treatment with PCSK9-inhibiting agents and a reduction in VTE, he added. Researchers from the ODYSSEY OUTCOMES trial had reported a VTE analysis in 2019, and while data from that trial on its own showed a nominal 33% lower VTE rate with alirocumab treatment, it just missed statistical significance.

The VTE effect took about a year on treatment to start to manifest. During the first 12 months of FOURIER, the rate of VTE events among patients in the two treatment arms was virtually identical. But starting during months 13-18 on treatment, the event curves in the two arms began to increasingly diverge, and overall during the period from month 13 to the end of the study treatment with evolocumab was linked with a statistically significant 46% reduction in VTE events, compared with patients who received placebo. The results Dr. Marston reported were also published online (Circulation. 2020 Mar 29. doi: 10.1161/CIRCULATIONAHA.120.046397).

The suggestion that this association may be linked to the impact of PCSK9 inhibitors on Lp(a) came from an additional analysis that Dr. Marston presented, which looked at the link between evolocumab use and a change in VTE event rates, compared with placebo, depending on baseline lipoprotein levels. Evolocumab treatment was associated with a roughly similar, modest, and not statistically significant reduction in VTE events, compared with placebo regardless of whether patients had baseline levels of LDL cholesterol below the median or at or above the median. In contrast, when a similar analysis divided patients based on whether their Lp(a) level at baseline was below, or at or above, the median the results showed no discernible effect of evolocumab treatment, compared with on VTE events in patients with lower baseline Lp(a), but in those with higher levels treatment with evolocumab linked with a 48% cut in VTE events, compared with placebo, a statistically significant difference.

In FOURIER, treatment with evolocumab lowered baseline Lp(a) levels by a median of 27%, compared with placebo, among the 25,096 enrolled patients who had their baseline levels measured. As previously reported, prespecified analysis of FOURIER data also showed that the impact of evolocumab, compared with placebo, on the combined rate of coronary heart disease death, MI, or need for urgent coronary revascularization was enhanced among patients with elevated baseline Lp(a) and moderated in those who entered with lower levels. Among patients who entered FOURIER with Lp(a) levels at or below the median treatment with evolocumab cut the primary endpoint by 7%, compared with placebo, a difference that was not statistically significant. Among patients who began the study with Lp(a) levels above the median, evolocumab treatment cut the primary endpoint by 23%, compared with placebo, a statistically significant effect (Circulation. 2019 Mar 19;139[12]:1483-92).

The aortic stenosis connection

A second study reported in the online scientific sessions (Abstract 914-08) used only FOURIER data, and showed that patients treated with evolocumab had a roughly similar response pattern in their incidence of aortic stenosis (AS) events as they did for VTE events.

During the first year of the study, the incidence of AS events was virtually identical among patients treated with evolocumab and those who received placebo. But after the first 12 months and through the study’s end, patients on evolocumab showed a statistically significant 52% relative reduction in AS events, compared with control patients, said Brian A. Bergmark, MD. For the entire study duration, treatment with evolocumab linked with a 34% relative reduction in AS events, compared with placebo, a difference that did not reach statistical significance, added Dr. Bergmark, an interventional cardiologist also at Brigham and Women’s Hospital. The observed halving in total AS events that linked with evolocumab treatment after the first year of the study included a similar-magnitude reduction specifically in the incidence of aortic valve replacement procedures in the evolocumab-treated patients.

Further analysis of both total AS events and aortic valve replacements in FOURIER patients showed that they occurred at a significantly elevated rate in patients who entered the study with higher baseline Lp(a) levels in a multivariate analysis, but a similar analysis showed no significant association between the incidence of these AS-related events and baseline levels of LDL cholesterol, he said.

The AS analysis carried the same important limitations as the VTE analysis: It ran on a post hoc basis and focused on events that were relatively uncommon and not adjudicated, Dr. Bergmark cautioned. Nonetheless, other investigators saw important potential implications from both the VTE and AS observations, with the huge caveat that they need replication in prospective studies designed to specifically address the validity of these findings.
 

What it could mean

These observed associations between PCSK9 inhibitor treatment and apparent reductions in the rate of both VTE and AS events “represent a tremendous clinical breakthrough,” commented Michelle L. O’Donoghue, MD, a cardiologist at Brigham and Women’s Hospital who is a FOURIER coinvestigator and has led some of the Lp(a) analyses run from that study.

Bruce Jancin/MDedge News

“To date, we have not identified any therapies that slow progression of AS. Other classes of lipid-lowering therapies, such as statins, have been tested and not demonstrated a significant effect,” Dr. O’Donoghue said in an interview.

“For AS, the results are very intriguing. If confirmed, it could be groundbreaking. AS is the most common valve disease in the developed world, and no medical therapy exists. The potential is immense,” commented George Thanassoulis, MD, director of preventive and genomic cardiology at McGill University, Montreal. “Having a medical treatment that could slow AS progression would completely change the disease. It’s conceivable to slow the disease enough that patients may never require valve replacement.” But an interview he cautioned that, “although the results are exciting, the analysis has many limitations. What we need is a dedicated, randomized trial for AS. I hope this stimulates that.”

“For VTE, it’s an interesting finding, but I don’t think it will have clinical utility because we have good treatment for VTE,” added Dr. Thanassoulis, but others saw more opportunity from what could be a new way to reduce VTE risk.

“Given that many patients have difficulty with the bleeding risk from anticoagulants, this option [a PCSK9 inhibitor] may be quite welcome for preventing VTE,” commented Gregory Piazza, MD, a cardiologist and VTE specialist at Brigham and Women’s Hospital who was not involved in any of the PCSK9 inhibitor studies.

“At this time we would not suggest that PCSK9 inhibitors replace an anticoagulant for patients with an established clot or at high risk for a recurrent clot, but if patients have an indication for a PCSK9 inhibitor, the further reduction in venous clot can be viewed as an additional benefit of this therapy,” said Dr. O’Donoghue.
 

How it might work

A possible mechanism underlying a VTE effect is unclear. Results from the JUPITER trial more than a decade ago had shown a significant association between treatment with 20 mg/day of rosuvastatin and a cut in VTE episodes, compared with placebo, in a prespecified, secondary analysis of the trial with nearly 18,000 patients selected for having a relatively high level of high-sensitivity C-reactive protein (N Engl J Med. 2009 Apr 30;360[18]:1851-61). But a meta-analysis of 29 controlled statin trials that used a variety of statin types and dosages (and included the JUPITER results) failed to confirm a statistically significant change in VTE rates from statins, though they produced a small, nominal reduction (PLoS Med. 2012 Sep 18. doi: 10.1371/journal.pmed.1001310).

Lp(a) “has long been linked to thrombosis, in particular arterial thrombosis,” so the link observed in the PCSK9 inhibitor trials “is not surprising,” said Dr. Piazza. Dr. O’Donoghue agreed that prior evidence had “suggested a prothrombotic role for Lp(a).”

Dr. Thanassoulis was more skeptical of a Lp(a) connection to VTE. “There has always been controversy regarding the prothrombotic effects of Lp(a) and whether it’s clinically relevant,” he said. “The genetic data, from Mendelian randomization studies, is not consistent” with a Lp(a) and VTE link.

The association of AS and Lp(a) may be stronger. “Our team showed that people with genetic variants that predispose to high Lp(a) have a much higher incidence of AS,” Dr. Thanassoulis noted. “We and others have also demonstrated that both Lp(a) and LDL are likely causal mediators of aortic valve calcification and stenosis.”

Dr. O’Donoghue also cited observational genetic data that linked elevated Lp(a) with AS. “Mendelian randomization studies have demonstrated that Lp(a) is a causal contributer to AS, and evolocumab reduced Lp(a) by 25%-30%, raising the possibility that Lp(a) lowering with these drugs may be the mechanism,” she said.
 

The future of Lp(a) lowering

This last point from Dr. O’Donoghue, that PCSK9 inhibitors cut Lp(a) levels by about 25%-30%, means that they are the most potent Lp(a)-lowering agents currently available, but it also leaves lots of room for other agents to do even better in cutting Lp(a).

“There are now drugs in development that block production of the Lp(a) protein and dramatically reduce its concentration, by about 80%,” Dr. O’Donoghue noted. “It will be of interest to study whether these novel therapies, now in phase 2 and phase 3 studies, have any effect on the risk for VTE and AS.”

“Several drugs in development, including antisense RNA and RNA-interfering molecules, are much more potent and lower Lp(a) by 80%-90%. Because of this potency they can completely normalize Lp(a) in most patients. For Lp(a) lowering, the future is in these new molecules. Randomized trials have started, and we will hopefully have some results in about 5 years,” said Dr. Thanassoulis.

Until then, the prospect of possibly soon documenting benefits from PCSK9 inhibitors beyond their impact on cutting LDL cholesterol raises some hope to get more bang for the considerable buck these drugs cost. But Dr. Thanassoulis was skeptical it would move the cost-benefit ratio much. “VTE and AS are relatively rare, compared with atherosclerotic cardiovascular events, and therefore the added value at the population level would be small,” he predicted. But if treatment with a drug could help patients avoid surgical or percutaneous valve interventions “that could be really interesting from a cost-benefit perspective.”

FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). ODYSSEY OUTCOMES was funded by Sanofi and Regeneron, the companies that developed and market alirocumab (Praluent). Dr. Marston had no disclosures. Dr. Bergmark has been a consultant to Daiichi Sankyo, Janssen, Quark, and Servier and has received research funding from Abbott Vascular, AstraZeneca, and MedImmune. Dr. O’Donoghue has been a consultant to and has received research funding from Amgen; has been a consultant to Janssen and Novartis; and has received research funding from AstraZeneca, Eisai, GlaxoSmithKline, Janssen, Medimmune, Merck, and The Medicines Company. Dr. Thanassoulis has been an adviser to and speaker for Amgen; an adviser to Ionis and Sanofi/Regeneron; a speaker on behalf of Boehringer Ingelheim, Sanofi, and Servier; and has received research funding from Ionis and Servier. Dr. Piazza has been a consultant to Optum, Pfizer, and Thrombolex and he has received research funding from Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Ekos, Janssen, and Portola.

[email protected]

Post hoc analyses of recent large, clinical outcomes studies of PCSK9 inhibitors have revealed two tantalizing and unexpected potential benefits from these drugs: an ability to substantially reduce the incidence or severity of venous thromboembolism and aortic stenosis.

The evidence also suggests that these effects are linked to the ability of these drugs to reduce blood levels of Lp(a) lipoprotein by roughly a quarter, currently the biggest known effect on Lp(a) levels of any approved medication.

One study ran post hoc analyses of venous thromboembolism (VTE) events in the FOURIER pivotal trial of evolocumab (Repatha), with more than 27,500 randomized patients (N Engl J Med. 2017 May 4; 376[18]:1713-22), and in the ODYSSEY OUTCOMES pivotal trial of alirocumab (Praluent), with nearly 19,000 randomized patients (N Engl J Med. 2018 Nov 29;379[22]:2097-2107). The analyses showed that, with evolocumab treatment, the incidence of VTE events fell by a statistically significant 29%, compared with patients on placebo, while in ODYSSEY OUTCOMES patients treated with alirocumab had a 33% cut in VTE events, compared with placebo-treated patients, a difference that just missed statistical significance (Circulation. 2020 Mar 29. doi: 10.1161/CIRCULATIONAHA.120.046524) in analyses that were not prespecified before these trials started, Nicholas A. Marston, MD, said in a presentation of his research during the joint scientific sessions of the American College of Cardiology and the World Heart Federation, which was presented online this year. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.

A combined analysis of 46,488 patients from both studies showed a 31% cut in VTE events with PCSK9 inhibitor treatment, a highly significant finding using VTE endpoints that were not specifically tallied nor adjudicated but collected as part of the serious adverse event reporting in the two pivotal trials, said Dr. Marston, a cardiologist at Brigham and Women’s Hospital in Boston. This is the first report of a statistically significant link between treatment with PCSK9-inhibiting agents and a reduction in VTE, he added. Researchers from the ODYSSEY OUTCOMES trial had reported a VTE analysis in 2019, and while data from that trial on its own showed a nominal 33% lower VTE rate with alirocumab treatment, it just missed statistical significance.

The VTE effect took about a year on treatment to start to manifest. During the first 12 months of FOURIER, the rate of VTE events among patients in the two treatment arms was virtually identical. But starting during months 13-18 on treatment, the event curves in the two arms began to increasingly diverge, and overall during the period from month 13 to the end of the study treatment with evolocumab was linked with a statistically significant 46% reduction in VTE events, compared with patients who received placebo. The results Dr. Marston reported were also published online (Circulation. 2020 Mar 29. doi: 10.1161/CIRCULATIONAHA.120.046397).

The suggestion that this association may be linked to the impact of PCSK9 inhibitors on Lp(a) came from an additional analysis that Dr. Marston presented, which looked at the link between evolocumab use and a change in VTE event rates, compared with placebo, depending on baseline lipoprotein levels. Evolocumab treatment was associated with a roughly similar, modest, and not statistically significant reduction in VTE events, compared with placebo regardless of whether patients had baseline levels of LDL cholesterol below the median or at or above the median. In contrast, when a similar analysis divided patients based on whether their Lp(a) level at baseline was below, or at or above, the median the results showed no discernible effect of evolocumab treatment, compared with on VTE events in patients with lower baseline Lp(a), but in those with higher levels treatment with evolocumab linked with a 48% cut in VTE events, compared with placebo, a statistically significant difference.

In FOURIER, treatment with evolocumab lowered baseline Lp(a) levels by a median of 27%, compared with placebo, among the 25,096 enrolled patients who had their baseline levels measured. As previously reported, prespecified analysis of FOURIER data also showed that the impact of evolocumab, compared with placebo, on the combined rate of coronary heart disease death, MI, or need for urgent coronary revascularization was enhanced among patients with elevated baseline Lp(a) and moderated in those who entered with lower levels. Among patients who entered FOURIER with Lp(a) levels at or below the median treatment with evolocumab cut the primary endpoint by 7%, compared with placebo, a difference that was not statistically significant. Among patients who began the study with Lp(a) levels above the median, evolocumab treatment cut the primary endpoint by 23%, compared with placebo, a statistically significant effect (Circulation. 2019 Mar 19;139[12]:1483-92).

The aortic stenosis connection

A second study reported in the online scientific sessions (Abstract 914-08) used only FOURIER data, and showed that patients treated with evolocumab had a roughly similar response pattern in their incidence of aortic stenosis (AS) events as they did for VTE events.

During the first year of the study, the incidence of AS events was virtually identical among patients treated with evolocumab and those who received placebo. But after the first 12 months and through the study’s end, patients on evolocumab showed a statistically significant 52% relative reduction in AS events, compared with control patients, said Brian A. Bergmark, MD. For the entire study duration, treatment with evolocumab linked with a 34% relative reduction in AS events, compared with placebo, a difference that did not reach statistical significance, added Dr. Bergmark, an interventional cardiologist also at Brigham and Women’s Hospital. The observed halving in total AS events that linked with evolocumab treatment after the first year of the study included a similar-magnitude reduction specifically in the incidence of aortic valve replacement procedures in the evolocumab-treated patients.

Further analysis of both total AS events and aortic valve replacements in FOURIER patients showed that they occurred at a significantly elevated rate in patients who entered the study with higher baseline Lp(a) levels in a multivariate analysis, but a similar analysis showed no significant association between the incidence of these AS-related events and baseline levels of LDL cholesterol, he said.

The AS analysis carried the same important limitations as the VTE analysis: It ran on a post hoc basis and focused on events that were relatively uncommon and not adjudicated, Dr. Bergmark cautioned. Nonetheless, other investigators saw important potential implications from both the VTE and AS observations, with the huge caveat that they need replication in prospective studies designed to specifically address the validity of these findings.
 

What it could mean

These observed associations between PCSK9 inhibitor treatment and apparent reductions in the rate of both VTE and AS events “represent a tremendous clinical breakthrough,” commented Michelle L. O’Donoghue, MD, a cardiologist at Brigham and Women’s Hospital who is a FOURIER coinvestigator and has led some of the Lp(a) analyses run from that study.

Bruce Jancin/MDedge News

“To date, we have not identified any therapies that slow progression of AS. Other classes of lipid-lowering therapies, such as statins, have been tested and not demonstrated a significant effect,” Dr. O’Donoghue said in an interview.

“For AS, the results are very intriguing. If confirmed, it could be groundbreaking. AS is the most common valve disease in the developed world, and no medical therapy exists. The potential is immense,” commented George Thanassoulis, MD, director of preventive and genomic cardiology at McGill University, Montreal. “Having a medical treatment that could slow AS progression would completely change the disease. It’s conceivable to slow the disease enough that patients may never require valve replacement.” But an interview he cautioned that, “although the results are exciting, the analysis has many limitations. What we need is a dedicated, randomized trial for AS. I hope this stimulates that.”

“For VTE, it’s an interesting finding, but I don’t think it will have clinical utility because we have good treatment for VTE,” added Dr. Thanassoulis, but others saw more opportunity from what could be a new way to reduce VTE risk.

“Given that many patients have difficulty with the bleeding risk from anticoagulants, this option [a PCSK9 inhibitor] may be quite welcome for preventing VTE,” commented Gregory Piazza, MD, a cardiologist and VTE specialist at Brigham and Women’s Hospital who was not involved in any of the PCSK9 inhibitor studies.

“At this time we would not suggest that PCSK9 inhibitors replace an anticoagulant for patients with an established clot or at high risk for a recurrent clot, but if patients have an indication for a PCSK9 inhibitor, the further reduction in venous clot can be viewed as an additional benefit of this therapy,” said Dr. O’Donoghue.
 

How it might work

A possible mechanism underlying a VTE effect is unclear. Results from the JUPITER trial more than a decade ago had shown a significant association between treatment with 20 mg/day of rosuvastatin and a cut in VTE episodes, compared with placebo, in a prespecified, secondary analysis of the trial with nearly 18,000 patients selected for having a relatively high level of high-sensitivity C-reactive protein (N Engl J Med. 2009 Apr 30;360[18]:1851-61). But a meta-analysis of 29 controlled statin trials that used a variety of statin types and dosages (and included the JUPITER results) failed to confirm a statistically significant change in VTE rates from statins, though they produced a small, nominal reduction (PLoS Med. 2012 Sep 18. doi: 10.1371/journal.pmed.1001310).

Lp(a) “has long been linked to thrombosis, in particular arterial thrombosis,” so the link observed in the PCSK9 inhibitor trials “is not surprising,” said Dr. Piazza. Dr. O’Donoghue agreed that prior evidence had “suggested a prothrombotic role for Lp(a).”

Dr. Thanassoulis was more skeptical of a Lp(a) connection to VTE. “There has always been controversy regarding the prothrombotic effects of Lp(a) and whether it’s clinically relevant,” he said. “The genetic data, from Mendelian randomization studies, is not consistent” with a Lp(a) and VTE link.

The association of AS and Lp(a) may be stronger. “Our team showed that people with genetic variants that predispose to high Lp(a) have a much higher incidence of AS,” Dr. Thanassoulis noted. “We and others have also demonstrated that both Lp(a) and LDL are likely causal mediators of aortic valve calcification and stenosis.”

Dr. O’Donoghue also cited observational genetic data that linked elevated Lp(a) with AS. “Mendelian randomization studies have demonstrated that Lp(a) is a causal contributer to AS, and evolocumab reduced Lp(a) by 25%-30%, raising the possibility that Lp(a) lowering with these drugs may be the mechanism,” she said.
 

The future of Lp(a) lowering

This last point from Dr. O’Donoghue, that PCSK9 inhibitors cut Lp(a) levels by about 25%-30%, means that they are the most potent Lp(a)-lowering agents currently available, but it also leaves lots of room for other agents to do even better in cutting Lp(a).

“There are now drugs in development that block production of the Lp(a) protein and dramatically reduce its concentration, by about 80%,” Dr. O’Donoghue noted. “It will be of interest to study whether these novel therapies, now in phase 2 and phase 3 studies, have any effect on the risk for VTE and AS.”

“Several drugs in development, including antisense RNA and RNA-interfering molecules, are much more potent and lower Lp(a) by 80%-90%. Because of this potency they can completely normalize Lp(a) in most patients. For Lp(a) lowering, the future is in these new molecules. Randomized trials have started, and we will hopefully have some results in about 5 years,” said Dr. Thanassoulis.

Until then, the prospect of possibly soon documenting benefits from PCSK9 inhibitors beyond their impact on cutting LDL cholesterol raises some hope to get more bang for the considerable buck these drugs cost. But Dr. Thanassoulis was skeptical it would move the cost-benefit ratio much. “VTE and AS are relatively rare, compared with atherosclerotic cardiovascular events, and therefore the added value at the population level would be small,” he predicted. But if treatment with a drug could help patients avoid surgical or percutaneous valve interventions “that could be really interesting from a cost-benefit perspective.”

FOURIER was funded by Amgen, the company that markets evolocumab (Repatha). ODYSSEY OUTCOMES was funded by Sanofi and Regeneron, the companies that developed and market alirocumab (Praluent). Dr. Marston had no disclosures. Dr. Bergmark has been a consultant to Daiichi Sankyo, Janssen, Quark, and Servier and has received research funding from Abbott Vascular, AstraZeneca, and MedImmune. Dr. O’Donoghue has been a consultant to and has received research funding from Amgen; has been a consultant to Janssen and Novartis; and has received research funding from AstraZeneca, Eisai, GlaxoSmithKline, Janssen, Medimmune, Merck, and The Medicines Company. Dr. Thanassoulis has been an adviser to and speaker for Amgen; an adviser to Ionis and Sanofi/Regeneron; a speaker on behalf of Boehringer Ingelheim, Sanofi, and Servier; and has received research funding from Ionis and Servier. Dr. Piazza has been a consultant to Optum, Pfizer, and Thrombolex and he has received research funding from Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Ekos, Janssen, and Portola.

[email protected]

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.

The American Heart Association (AHA) and seven other medical societies have issued interim guidance to inform treatment of victims of cardiac arrest with suspected or confirmed COVID-19, focusing on reducing provider exposure, and prioritizing oxygenation and ventilation strategies, goals of care, and appropriateness of resuscitation.

“We were very specific in calling this ‘interim guidance’ based on expert opinion because things are evolving so quickly and we are learning more and more every day as more and more patients with COVID-19 are taken care of,” corresponding author Comilla Sasson, MD, PhD, vice president, Emergency Cardiovascular Care (ECC) Science and Innovation, American Heart Association, told theheart.org | Medscape Cardiology.

“We wanted this to be a starting point for providing the clinical guidance that everyone is looking for and, as we collect more data, the guidance will change, as it has for CDC [Centers for Disease Control and Prevention] and WHO [World Health Organization],” she said.

“The guidance sought to balance the provision of timely, high-quality resuscitation to patients while simultaneously protecting rescuers,” she added.

The guidance was published online April 9 in Circulation. The AHA produced the guidelines in collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, the Society of Critical Care Anesthesiologists, and the American Society of Anesthesiologists, with support from the American Association of Critical Care Nurses and National EMS Physicians.
 

Respiratory Etiologies

“We think of cardiac arrest in adults, especially as related to cardiac etiologies, but we are now thinking of it in COVID-19 more as hypoxemia or respiratory failure, which can predispose patients to cardiac arrest,” Sasson explained.

Healthcare workers are the “highest-risk profession” for contracting the COVID-19, with resuscitations carrying “added risk” for several reasons, the authors note.

Administering CPR involves performing numerous aerosol-generating procedures that can cause viral particles to remain suspended in the air and be inhaled by those nearby, with a half-life of approximately 1 hour, they point out.

Moreover, resuscitation efforts “require numerous providers to work in close proximity to one another and the patient,” and the high-stress emergent nature of these events may result in lapses in infection-control procedures.

The guidance is designed “to protect not only the patient but also the provider and involves strategies regarding oxygenation and ventilation that differ from what we’ve done in the past since we have a strong feeling that this is a different disease process that may require different approaches than what we’ve dealt with in the past,” Sasson commented.

Reducing Provider Exposure

Providers should don PPE to protect both themselves and their colleagues from unnecessary exposure, the authors advise, noting that recommendations for PPE standards may “vary considerably,” so health or emergency medical services (EMS) standards should be taken into account.

Moreover, it is important to allow only the most essential providers into the room or on the scene. In keeping with reducing the number of rescuers, the authors recommend replacing manual chest compressions with mechanical CPR devices for patients who meet height and weight criteria in settings with “protocols and expertise in place for their use.”

COVID-19 status should be communicated to any new providers prior to their arrival on the scene, the authors stress.
 

Oxygenation and Ventilation Strategies

“Reducing risk of aerosolization during the process of intubation is key,” Sasson emphasized.

For this reason, a high-efficiency particulate air HEPA filter (if available) should be attached to any manual or mechanical ventilation device, specifically in the path of exhaled gas, before any breaths are administered.

Moreover, it is important to intubate early with a cuffed tube and connect to a mechanical ventilator, if possible. The intubator should be engaged with the “highest chance of first-pass success,” and chest compression should be paused to intubate.

To further increase the chance of a successful first intubation, use of video laryngoscopy (if available) is helpful.

Additional guidance includes:

• Using a bag-mask device (or T-piece in neonates) with a HEPA filter and a tight seal prior to intubation
• Considering passive oxygenation with non-rebreathing face mask as an alternative to bag-mask device for short duration (in adults)
• Considering supraglottic airway if intubation is delayed
• Minimizing closed circuit disconnections.

Resuscitation Considerations

“One big take-home point of the guidance is to consider resuscitation appropriateness, starting with goals of care when the patient comes to us, and continuing or stopping resuscitation when needed, based on the discussion with the family as well as local protocol,” Sasson said.

A variety of factors need to be taken into account, including age, comorbidities, and illness severity to determine the appropriateness of resuscitation, and “the likelihood of success” must be balanced “against the risk to rescuers and patients from whom resources are being diverted,” the authors state.

An Array of Scenarios

“We divided bystander CPR into adults vs pediatrics and into those who are living with a person who is in cardiac arrest – because they have already been exposed [to COVID-19] – vs those who are not living with the patient,” Sasson reported. “We also addressed the role of lay bystanders.”

For lay rescuers:

• Household members should perform at least hands-only CPR, if willing and able to do so
• Use of a face mark or cloth covering of the mouth and nose of the rescuer and/or patient may reduce the risk of transmission to a nonhousehold member
• In children, lay rescuers should perform chest compressions and “consider mouth-to-mouth resuscitation,” especially if they are household members.
• If available, an automated external defibrillator should be used to assess and treat victims of out-of-hospital cardiac arrest (OHCA).

The authors offer additional guidance for in-hospital cardiac arrest (IHCA), including addressing advanced care directives, closing the door when possible to prevent airborne contamination of adjacent space, and considering leaving the patient on a mechanical ventilator with HEPA filter.

They additionally address the special needs of neonates, recommending the presence of a “skilled attendant prepared to resuscitate, irrespective of COVID-19 status,” and stressing the importance of PPE since the mother may be a “potential source of aerosolization for the neonatal team.” Additional measures include avoidance of routine airway suctioning and the use of endotracheal medications.

Critically ill pregnant women with COVID-19 are more vulnerable to acute decompensation because of the cardiopulmonary physiological changes associated with pregnancy, the authors note. Preparation for a potential perimortem delivery should take place after 4 minutes of resuscitation and be initiated early in the resuscitation algorithm so as to allow specialized obstetrical and neonatal teams with PPE to convene.

“We will be continually updating this guidance and we are encouraging people to ask questions,” Sasson summarized.

She noted that a hospital-based COVID-19 registry is being formed to collect “clinically relevant data” that will inform and update the current guidance.

Sasson reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
 

This article first appeared on Medscape.com.