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FDA approves in-home breast cancer treatment
Advantageous for infusion centers?
The Food and Drug Administration approved a combination of pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche) that is administered subcutaneously – rather than intravenously – for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete, according to the FDA.
Administration takes approximately 8 minutes for the initial loading dose and approximately 5 minutes for maintenance doses, according to a Genentech press statement. This compares favorably with the 150 minutes needed for the combined loading dose of intravenous pertuzumab and trastuzumab, and the 60-150 minutes for intravenous maintenance infusions, the company said.
“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an outpatient option for patients to receive trastuzumab and pertuzumab,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in an agency press release.
“The fixed-dose combination of trastuzumab and pertuzumab offers a simpler, faster, and easier treatment experience for patients with HER2-positive breast cancer,” said Antoinette Tan, MD, MHSc, chief of breast medical oncology at Levine Cancer Institute, Charlotte, N.C., in the company statement.
Dr. Tan also said that home administration “can be advantageous for patients and infusion centers.”
However, in April, the Community Oncology Alliance strenuously objected to this type of treatment in a patient’s home, as reported by Medscape Medical News.
The group, which represents U.S. community-based practices, said it “fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns.”
The FDA’s approval was based on the results of the pivotal phase 3 FeDeriCa trial, a noninferiority study in patients with HER2-positive early breast cancer, which demonstrated that the new product had comparable efficacy and safety as intravenous pertuzumab and intravenous trastuzumab.
In terms of efficacy, the subcutaneous product demonstrated noninferior plasma levels of pertuzumab, which was the primary endpoint, when compared with IV administration of pertuzumab.
Safety was comparable between the two approaches, with no new safety signals using the subcutaneous delivery method, including no “meaningful difference” in cardiac toxicity, according to Genentech. However, there were more administration-related reactions with the new product. The most common adverse events in both groups were alopecia, nausea, diarrhea, and anemia.
The new product uses a drug delivery technology (Enhanze, Halozyme Therapeutics) that employs a proprietary enzyme that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to facilitate the dispersion and absorption of injected therapeutic drugs, according to Genentech.
In May, at the European Society for Medical Oncology Breast Cancer Virtual Meeting 2020, investigators of the phase 2 PHranceSCa study reported that “more than 80%” of patients preferred subcutaneous to intravenous administration of pertuzumab and trastuzumab.
This article first appeared on Medscape.com.
Advantageous for infusion centers?
Advantageous for infusion centers?
The Food and Drug Administration approved a combination of pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche) that is administered subcutaneously – rather than intravenously – for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete, according to the FDA.
Administration takes approximately 8 minutes for the initial loading dose and approximately 5 minutes for maintenance doses, according to a Genentech press statement. This compares favorably with the 150 minutes needed for the combined loading dose of intravenous pertuzumab and trastuzumab, and the 60-150 minutes for intravenous maintenance infusions, the company said.
“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an outpatient option for patients to receive trastuzumab and pertuzumab,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in an agency press release.
“The fixed-dose combination of trastuzumab and pertuzumab offers a simpler, faster, and easier treatment experience for patients with HER2-positive breast cancer,” said Antoinette Tan, MD, MHSc, chief of breast medical oncology at Levine Cancer Institute, Charlotte, N.C., in the company statement.
Dr. Tan also said that home administration “can be advantageous for patients and infusion centers.”
However, in April, the Community Oncology Alliance strenuously objected to this type of treatment in a patient’s home, as reported by Medscape Medical News.
The group, which represents U.S. community-based practices, said it “fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns.”
The FDA’s approval was based on the results of the pivotal phase 3 FeDeriCa trial, a noninferiority study in patients with HER2-positive early breast cancer, which demonstrated that the new product had comparable efficacy and safety as intravenous pertuzumab and intravenous trastuzumab.
In terms of efficacy, the subcutaneous product demonstrated noninferior plasma levels of pertuzumab, which was the primary endpoint, when compared with IV administration of pertuzumab.
Safety was comparable between the two approaches, with no new safety signals using the subcutaneous delivery method, including no “meaningful difference” in cardiac toxicity, according to Genentech. However, there were more administration-related reactions with the new product. The most common adverse events in both groups were alopecia, nausea, diarrhea, and anemia.
The new product uses a drug delivery technology (Enhanze, Halozyme Therapeutics) that employs a proprietary enzyme that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to facilitate the dispersion and absorption of injected therapeutic drugs, according to Genentech.
In May, at the European Society for Medical Oncology Breast Cancer Virtual Meeting 2020, investigators of the phase 2 PHranceSCa study reported that “more than 80%” of patients preferred subcutaneous to intravenous administration of pertuzumab and trastuzumab.
This article first appeared on Medscape.com.
The Food and Drug Administration approved a combination of pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche) that is administered subcutaneously – rather than intravenously – for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete, according to the FDA.
Administration takes approximately 8 minutes for the initial loading dose and approximately 5 minutes for maintenance doses, according to a Genentech press statement. This compares favorably with the 150 minutes needed for the combined loading dose of intravenous pertuzumab and trastuzumab, and the 60-150 minutes for intravenous maintenance infusions, the company said.
“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an outpatient option for patients to receive trastuzumab and pertuzumab,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in an agency press release.
“The fixed-dose combination of trastuzumab and pertuzumab offers a simpler, faster, and easier treatment experience for patients with HER2-positive breast cancer,” said Antoinette Tan, MD, MHSc, chief of breast medical oncology at Levine Cancer Institute, Charlotte, N.C., in the company statement.
Dr. Tan also said that home administration “can be advantageous for patients and infusion centers.”
However, in April, the Community Oncology Alliance strenuously objected to this type of treatment in a patient’s home, as reported by Medscape Medical News.
The group, which represents U.S. community-based practices, said it “fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns.”
The FDA’s approval was based on the results of the pivotal phase 3 FeDeriCa trial, a noninferiority study in patients with HER2-positive early breast cancer, which demonstrated that the new product had comparable efficacy and safety as intravenous pertuzumab and intravenous trastuzumab.
In terms of efficacy, the subcutaneous product demonstrated noninferior plasma levels of pertuzumab, which was the primary endpoint, when compared with IV administration of pertuzumab.
Safety was comparable between the two approaches, with no new safety signals using the subcutaneous delivery method, including no “meaningful difference” in cardiac toxicity, according to Genentech. However, there were more administration-related reactions with the new product. The most common adverse events in both groups were alopecia, nausea, diarrhea, and anemia.
The new product uses a drug delivery technology (Enhanze, Halozyme Therapeutics) that employs a proprietary enzyme that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to facilitate the dispersion and absorption of injected therapeutic drugs, according to Genentech.
In May, at the European Society for Medical Oncology Breast Cancer Virtual Meeting 2020, investigators of the phase 2 PHranceSCa study reported that “more than 80%” of patients preferred subcutaneous to intravenous administration of pertuzumab and trastuzumab.
This article first appeared on Medscape.com.
Skin patterns of COVID-19 vary widely
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
FROM AAD 20
How racism contributes to the effects of SARS-CoV-2
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
Endothelial injury may play a major role in COVID-19–associated coagulopathy
A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).
A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.
George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.
Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.5-7
For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.
The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.
Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).
There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
Results and interpretation
Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.
Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).
Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.
Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).
Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.
The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
Influence on therapy
Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.
These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.
The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.
Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
Challenges and unanswered questions
Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.
Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.
Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.
It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.
The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.
Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.
The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.
Dr. Goshua disclosed no conflicts of interest.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.
References
1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.
2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028
3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024
4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869
5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.
6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134
7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.
A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).
A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.
George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.
Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.5-7
For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.
The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.
Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).
There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
Results and interpretation
Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.
Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).
Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.
Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).
Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.
The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
Influence on therapy
Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.
These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.
The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.
Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
Challenges and unanswered questions
Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.
Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.
Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.
It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.
The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.
Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.
The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.
Dr. Goshua disclosed no conflicts of interest.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.
References
1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.
2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028
3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024
4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869
5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.
6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134
7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.
A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).
A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.
George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.
Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.5-7
For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.
The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.
Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).
There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
Results and interpretation
Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.
Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).
Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.
Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).
Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.
The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
Influence on therapy
Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.
These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.
The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.
Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
Challenges and unanswered questions
Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.
Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.
Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.
It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.
The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.
Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.
The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.
Dr. Goshua disclosed no conflicts of interest.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.
References
1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.
2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028
3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024
4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869
5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.
6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134
7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.
FROM EHA CONGRESS
ACIP plans priority groups in advance of COVID-19 vaccine
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
Treatments linked to death in COVID patients with thoracic cancers
Prior treatment with steroids, anticoagulants, chemotherapy alone, or chemotherapy plus immunotherapy were all associated with an increased risk of death, but prior treatment with tyrosine kinase inhibitors or immunotherapy alone were not.
At the same time, there were no COVID-19–directed treatments that seemed to affect the risk of death.
“When we look at therapies administered to treat COVID-19 … including anticoagulation, antibiotics, antivirals, hydroxychloroquine, we found that no particular therapy was associated with increased chance of recovery from COVID-19,” said Leora Horn, MD, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.
Dr. Horn presented these findings as part of the American Society of Clinical Oncology virtual scientific program.
About TERAVOLT
The TERAVOLT registry is the brainchild of Marina Garassino, MD, of the National Cancer Institute of Milan. On March 15, Dr. Garassino emailed colleagues around the world with the idea of starting the registry. Within 5 days, the final protocol was approved, and the first patient was entered onto TERAVOLT.
In creating a registry, Dr. Garassino and colleagues wanted to “determine the demographic factors, comorbidities, cancer characteristics, and therapies that place patients with thoracic malignancies who develop COVID-19 most at risk for hospitalization and death,” Dr. Horn said.
Other goals of the registry are “to understand the clinical course of patients with thoracic malignancies who are infected by SARS-CoV-2, to provide practitioners with real-time data on therapeutic strategies that may impact survival, [and] to evaluate the long-term impact on cancer outcomes related to care adjustments and delays in patients with thoracic malignancies,” she added.
Dr. Garassino presented the first analysis of TERAVOLT data at the AACR virtual meeting I in April. Results were recently published in The Lancet Oncology as well. That analysis included 200 patients, 98% of whom were from Europe, and the median follow-up was 15 days.
Baseline characteristics and outcomes
Dr. Horn’s updated analysis included 400 patients with a median follow-up of 33 days from COVID-19 diagnosis. The data encompassed patients from North and South America, Europe, Africa, Asia, and Australia.
Of the 400 patients, 169 had recovered, 141 had died, and 118 were still in the hospital at the time of analysis. In all, 334 patients (78.3%) required a hospital admission, and 33 (8.3%) were admitted to the ICU. The median length of hospitalization was 10 days.
Across the three outcome groups (recovered, died, ongoing), the median age was 67-70 years. Most patients had non–small cell lung cancer (74.5%-81.9%), and most had stage IV disease (61.4%-76.8%).
A majority of patients were male (63.3%-70.2%), and most were current or former smokers (77.5%-86.9%). The median body mass index was 24-25 kg/m2, and 35%-46.4% of patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0.
Most patients (82.2%-90.7%) had COVID-19 diagnosed via real-time polymerase chain reaction, although some patients were diagnosed via clinical findings alone (3.1%-5%).
“[R]egardless of outcome, the most common presenting symptom was fever, cough, or dyspnea,” Dr. Horn noted.
As for complications of COVID-19, 71% of patients who died had pneumonitis/pneumonia, 49.6% had acute respiratory distress syndrome, 14.9% had multiorgan failure, 12.1% had sepsis, and 5.7% had coagulopathy.
Among recovered patients, 59% had pneumonitis/pneumonia, 4.1% had acute respiratory distress syndrome, 3% had coagulopathy, 0.6% had sepsis, and none had multiorgan failure.
Patients who recovered were more likely to have no comorbidities at baseline, and 31.2% of patients who died had at least one comorbidity. The most frequent comorbidities were hypertension, chronic obstructive pulmonary disease, vascular disease, diabetes, and renal insufficiencies.
Prior treatments and COVID therapy
Among patients who died, 33.4% were on ACE inhibitors or angiotensin II receptor blockers, 27% were on anticoagulants, and 23.4% were on steroids (the equivalent of at least 10 mg of prednisone per day) at the time of COVID-19 diagnosis.
Among recovered patients, 20.7% were on ACE inhibitors or angiotensin II receptor blockers, 18.3% were on anticoagulants, and 14.2% were on steroids at the time of COVID-19 diagnosis.
“When we look at cancer therapy in the last 3 months, we can see that, regardless of outcome, the majority of patients had either not been treated or were on first-line therapy at the time of their COVID-19 diagnosis,” Dr. Horn noted.
Among patients who died, 46.8% had received chemotherapy, 22% had received immunotherapy, 12.8% had received targeted therapy, and 9.2% had received radiotherapy.
Among recovered patients, 33.7% had received chemotherapy, 26.6% had received immunotherapy, 19.5% had received targeted therapy, and 14.2% had received radiotherapy.
COVID-19–directed treatments included anticoagulation, antibiotics, antivirals, antifungals, steroids, interleukin-6 inhibitors, and hydroxychloroquine. Use of these therapies was similar among patients who recovered and patients who died.
Factors associated with death
In all, 79.4% of deaths were attributed to COVID-19, 10.6% were attributed to cancer, 8.5% were attributed to cancer and COVID-19, and 1.4% of deaths had an unknown cause.
In a univariate analysis, baseline characteristics associated with an increased risk of death were age of 65 years or older (P = .0033), one or more comorbidity (P = .0351), and ECOG performance status of 1 (P < .0001). Therapies associated with an increased risk of death in a univariate analysis included steroids (P = .0186), anticoagulation (P = .0562), and either chemotherapy alone or chemotherapy plus immunotherapy (P = .0256).
In a multivariate analysis, age over 65 years (P = .018), ECOG performance status of 1 (P < .001), prior use of steroids (P = .052), and receipt of chemotherapy alone or in combination with immunotherapy (P = .025) were all associated with an increased risk of death.
“There is no impact of gender [sex], body mass index, smoking status, stage, or type of cancer on risk of death,” Dr. Horn said. “Therapy administered to treat COVID-19 is not significantly associated with outcome.”
“The impact of COVID-19 infection on cancer management and outcomes must be evaluated,” she added. “Data collection is ongoing, with additional analysis and studies planned to look at patient and provider perception of COVID-19 and the impact it has had on cancer care.”
Strengths and limitations
There are several limitations to findings from the TERAVOLT registry, according to invited discussant Giuseppe Curigliano, MD, PhD, of the University of Milan.
He said the results are limited by the differences in triage decisions between European and other centers, the fact that most patients in TERAVOLT were hospitalized, the high proportion of patients with stage IV non–small cell lung cancer, and methods of data collection and analysis.
“There is no real-time data capture, no auditing, no standardized outcome definitions, and CRFs [case report forms] had a lot of limitations,” Dr. Curigliano said. “We have multiple biases, including selection bias, recall bias, confounding by indication, and changes in practice or disease evolution.”
Dr. Curigliano noted, however, that TERAVOLT is the largest real-world dataset of patients with COVID-19 and thoracic malignancies.
Furthermore, results from TERAVOLT correspond to results from the CCC-19 registry. Data from both registries suggest that older age, the presence of comorbidities, higher ECOG performances status, and chemotherapy alone or in combination with other therapies are associated with increased mortality among patients with cancer and COVID-19.
The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer. Dr. Horn disclosed relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, and other pharmaceutical companies. Dr. Curigliano disclosed relationships with AstraZeneca, Boehringer Ingelheim, Ellipses Pharma, and other pharmaceutical companies.
SOURCE: Horn L et al. ASCO 2020, Abstract LBA111.
Prior treatment with steroids, anticoagulants, chemotherapy alone, or chemotherapy plus immunotherapy were all associated with an increased risk of death, but prior treatment with tyrosine kinase inhibitors or immunotherapy alone were not.
At the same time, there were no COVID-19–directed treatments that seemed to affect the risk of death.
“When we look at therapies administered to treat COVID-19 … including anticoagulation, antibiotics, antivirals, hydroxychloroquine, we found that no particular therapy was associated with increased chance of recovery from COVID-19,” said Leora Horn, MD, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.
Dr. Horn presented these findings as part of the American Society of Clinical Oncology virtual scientific program.
About TERAVOLT
The TERAVOLT registry is the brainchild of Marina Garassino, MD, of the National Cancer Institute of Milan. On March 15, Dr. Garassino emailed colleagues around the world with the idea of starting the registry. Within 5 days, the final protocol was approved, and the first patient was entered onto TERAVOLT.
In creating a registry, Dr. Garassino and colleagues wanted to “determine the demographic factors, comorbidities, cancer characteristics, and therapies that place patients with thoracic malignancies who develop COVID-19 most at risk for hospitalization and death,” Dr. Horn said.
Other goals of the registry are “to understand the clinical course of patients with thoracic malignancies who are infected by SARS-CoV-2, to provide practitioners with real-time data on therapeutic strategies that may impact survival, [and] to evaluate the long-term impact on cancer outcomes related to care adjustments and delays in patients with thoracic malignancies,” she added.
Dr. Garassino presented the first analysis of TERAVOLT data at the AACR virtual meeting I in April. Results were recently published in The Lancet Oncology as well. That analysis included 200 patients, 98% of whom were from Europe, and the median follow-up was 15 days.
Baseline characteristics and outcomes
Dr. Horn’s updated analysis included 400 patients with a median follow-up of 33 days from COVID-19 diagnosis. The data encompassed patients from North and South America, Europe, Africa, Asia, and Australia.
Of the 400 patients, 169 had recovered, 141 had died, and 118 were still in the hospital at the time of analysis. In all, 334 patients (78.3%) required a hospital admission, and 33 (8.3%) were admitted to the ICU. The median length of hospitalization was 10 days.
Across the three outcome groups (recovered, died, ongoing), the median age was 67-70 years. Most patients had non–small cell lung cancer (74.5%-81.9%), and most had stage IV disease (61.4%-76.8%).
A majority of patients were male (63.3%-70.2%), and most were current or former smokers (77.5%-86.9%). The median body mass index was 24-25 kg/m2, and 35%-46.4% of patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0.
Most patients (82.2%-90.7%) had COVID-19 diagnosed via real-time polymerase chain reaction, although some patients were diagnosed via clinical findings alone (3.1%-5%).
“[R]egardless of outcome, the most common presenting symptom was fever, cough, or dyspnea,” Dr. Horn noted.
As for complications of COVID-19, 71% of patients who died had pneumonitis/pneumonia, 49.6% had acute respiratory distress syndrome, 14.9% had multiorgan failure, 12.1% had sepsis, and 5.7% had coagulopathy.
Among recovered patients, 59% had pneumonitis/pneumonia, 4.1% had acute respiratory distress syndrome, 3% had coagulopathy, 0.6% had sepsis, and none had multiorgan failure.
Patients who recovered were more likely to have no comorbidities at baseline, and 31.2% of patients who died had at least one comorbidity. The most frequent comorbidities were hypertension, chronic obstructive pulmonary disease, vascular disease, diabetes, and renal insufficiencies.
Prior treatments and COVID therapy
Among patients who died, 33.4% were on ACE inhibitors or angiotensin II receptor blockers, 27% were on anticoagulants, and 23.4% were on steroids (the equivalent of at least 10 mg of prednisone per day) at the time of COVID-19 diagnosis.
Among recovered patients, 20.7% were on ACE inhibitors or angiotensin II receptor blockers, 18.3% were on anticoagulants, and 14.2% were on steroids at the time of COVID-19 diagnosis.
“When we look at cancer therapy in the last 3 months, we can see that, regardless of outcome, the majority of patients had either not been treated or were on first-line therapy at the time of their COVID-19 diagnosis,” Dr. Horn noted.
Among patients who died, 46.8% had received chemotherapy, 22% had received immunotherapy, 12.8% had received targeted therapy, and 9.2% had received radiotherapy.
Among recovered patients, 33.7% had received chemotherapy, 26.6% had received immunotherapy, 19.5% had received targeted therapy, and 14.2% had received radiotherapy.
COVID-19–directed treatments included anticoagulation, antibiotics, antivirals, antifungals, steroids, interleukin-6 inhibitors, and hydroxychloroquine. Use of these therapies was similar among patients who recovered and patients who died.
Factors associated with death
In all, 79.4% of deaths were attributed to COVID-19, 10.6% were attributed to cancer, 8.5% were attributed to cancer and COVID-19, and 1.4% of deaths had an unknown cause.
In a univariate analysis, baseline characteristics associated with an increased risk of death were age of 65 years or older (P = .0033), one or more comorbidity (P = .0351), and ECOG performance status of 1 (P < .0001). Therapies associated with an increased risk of death in a univariate analysis included steroids (P = .0186), anticoagulation (P = .0562), and either chemotherapy alone or chemotherapy plus immunotherapy (P = .0256).
In a multivariate analysis, age over 65 years (P = .018), ECOG performance status of 1 (P < .001), prior use of steroids (P = .052), and receipt of chemotherapy alone or in combination with immunotherapy (P = .025) were all associated with an increased risk of death.
“There is no impact of gender [sex], body mass index, smoking status, stage, or type of cancer on risk of death,” Dr. Horn said. “Therapy administered to treat COVID-19 is not significantly associated with outcome.”
“The impact of COVID-19 infection on cancer management and outcomes must be evaluated,” she added. “Data collection is ongoing, with additional analysis and studies planned to look at patient and provider perception of COVID-19 and the impact it has had on cancer care.”
Strengths and limitations
There are several limitations to findings from the TERAVOLT registry, according to invited discussant Giuseppe Curigliano, MD, PhD, of the University of Milan.
He said the results are limited by the differences in triage decisions between European and other centers, the fact that most patients in TERAVOLT were hospitalized, the high proportion of patients with stage IV non–small cell lung cancer, and methods of data collection and analysis.
“There is no real-time data capture, no auditing, no standardized outcome definitions, and CRFs [case report forms] had a lot of limitations,” Dr. Curigliano said. “We have multiple biases, including selection bias, recall bias, confounding by indication, and changes in practice or disease evolution.”
Dr. Curigliano noted, however, that TERAVOLT is the largest real-world dataset of patients with COVID-19 and thoracic malignancies.
Furthermore, results from TERAVOLT correspond to results from the CCC-19 registry. Data from both registries suggest that older age, the presence of comorbidities, higher ECOG performances status, and chemotherapy alone or in combination with other therapies are associated with increased mortality among patients with cancer and COVID-19.
The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer. Dr. Horn disclosed relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, and other pharmaceutical companies. Dr. Curigliano disclosed relationships with AstraZeneca, Boehringer Ingelheim, Ellipses Pharma, and other pharmaceutical companies.
SOURCE: Horn L et al. ASCO 2020, Abstract LBA111.
Prior treatment with steroids, anticoagulants, chemotherapy alone, or chemotherapy plus immunotherapy were all associated with an increased risk of death, but prior treatment with tyrosine kinase inhibitors or immunotherapy alone were not.
At the same time, there were no COVID-19–directed treatments that seemed to affect the risk of death.
“When we look at therapies administered to treat COVID-19 … including anticoagulation, antibiotics, antivirals, hydroxychloroquine, we found that no particular therapy was associated with increased chance of recovery from COVID-19,” said Leora Horn, MD, of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.
Dr. Horn presented these findings as part of the American Society of Clinical Oncology virtual scientific program.
About TERAVOLT
The TERAVOLT registry is the brainchild of Marina Garassino, MD, of the National Cancer Institute of Milan. On March 15, Dr. Garassino emailed colleagues around the world with the idea of starting the registry. Within 5 days, the final protocol was approved, and the first patient was entered onto TERAVOLT.
In creating a registry, Dr. Garassino and colleagues wanted to “determine the demographic factors, comorbidities, cancer characteristics, and therapies that place patients with thoracic malignancies who develop COVID-19 most at risk for hospitalization and death,” Dr. Horn said.
Other goals of the registry are “to understand the clinical course of patients with thoracic malignancies who are infected by SARS-CoV-2, to provide practitioners with real-time data on therapeutic strategies that may impact survival, [and] to evaluate the long-term impact on cancer outcomes related to care adjustments and delays in patients with thoracic malignancies,” she added.
Dr. Garassino presented the first analysis of TERAVOLT data at the AACR virtual meeting I in April. Results were recently published in The Lancet Oncology as well. That analysis included 200 patients, 98% of whom were from Europe, and the median follow-up was 15 days.
Baseline characteristics and outcomes
Dr. Horn’s updated analysis included 400 patients with a median follow-up of 33 days from COVID-19 diagnosis. The data encompassed patients from North and South America, Europe, Africa, Asia, and Australia.
Of the 400 patients, 169 had recovered, 141 had died, and 118 were still in the hospital at the time of analysis. In all, 334 patients (78.3%) required a hospital admission, and 33 (8.3%) were admitted to the ICU. The median length of hospitalization was 10 days.
Across the three outcome groups (recovered, died, ongoing), the median age was 67-70 years. Most patients had non–small cell lung cancer (74.5%-81.9%), and most had stage IV disease (61.4%-76.8%).
A majority of patients were male (63.3%-70.2%), and most were current or former smokers (77.5%-86.9%). The median body mass index was 24-25 kg/m2, and 35%-46.4% of patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0.
Most patients (82.2%-90.7%) had COVID-19 diagnosed via real-time polymerase chain reaction, although some patients were diagnosed via clinical findings alone (3.1%-5%).
“[R]egardless of outcome, the most common presenting symptom was fever, cough, or dyspnea,” Dr. Horn noted.
As for complications of COVID-19, 71% of patients who died had pneumonitis/pneumonia, 49.6% had acute respiratory distress syndrome, 14.9% had multiorgan failure, 12.1% had sepsis, and 5.7% had coagulopathy.
Among recovered patients, 59% had pneumonitis/pneumonia, 4.1% had acute respiratory distress syndrome, 3% had coagulopathy, 0.6% had sepsis, and none had multiorgan failure.
Patients who recovered were more likely to have no comorbidities at baseline, and 31.2% of patients who died had at least one comorbidity. The most frequent comorbidities were hypertension, chronic obstructive pulmonary disease, vascular disease, diabetes, and renal insufficiencies.
Prior treatments and COVID therapy
Among patients who died, 33.4% were on ACE inhibitors or angiotensin II receptor blockers, 27% were on anticoagulants, and 23.4% were on steroids (the equivalent of at least 10 mg of prednisone per day) at the time of COVID-19 diagnosis.
Among recovered patients, 20.7% were on ACE inhibitors or angiotensin II receptor blockers, 18.3% were on anticoagulants, and 14.2% were on steroids at the time of COVID-19 diagnosis.
“When we look at cancer therapy in the last 3 months, we can see that, regardless of outcome, the majority of patients had either not been treated or were on first-line therapy at the time of their COVID-19 diagnosis,” Dr. Horn noted.
Among patients who died, 46.8% had received chemotherapy, 22% had received immunotherapy, 12.8% had received targeted therapy, and 9.2% had received radiotherapy.
Among recovered patients, 33.7% had received chemotherapy, 26.6% had received immunotherapy, 19.5% had received targeted therapy, and 14.2% had received radiotherapy.
COVID-19–directed treatments included anticoagulation, antibiotics, antivirals, antifungals, steroids, interleukin-6 inhibitors, and hydroxychloroquine. Use of these therapies was similar among patients who recovered and patients who died.
Factors associated with death
In all, 79.4% of deaths were attributed to COVID-19, 10.6% were attributed to cancer, 8.5% were attributed to cancer and COVID-19, and 1.4% of deaths had an unknown cause.
In a univariate analysis, baseline characteristics associated with an increased risk of death were age of 65 years or older (P = .0033), one or more comorbidity (P = .0351), and ECOG performance status of 1 (P < .0001). Therapies associated with an increased risk of death in a univariate analysis included steroids (P = .0186), anticoagulation (P = .0562), and either chemotherapy alone or chemotherapy plus immunotherapy (P = .0256).
In a multivariate analysis, age over 65 years (P = .018), ECOG performance status of 1 (P < .001), prior use of steroids (P = .052), and receipt of chemotherapy alone or in combination with immunotherapy (P = .025) were all associated with an increased risk of death.
“There is no impact of gender [sex], body mass index, smoking status, stage, or type of cancer on risk of death,” Dr. Horn said. “Therapy administered to treat COVID-19 is not significantly associated with outcome.”
“The impact of COVID-19 infection on cancer management and outcomes must be evaluated,” she added. “Data collection is ongoing, with additional analysis and studies planned to look at patient and provider perception of COVID-19 and the impact it has had on cancer care.”
Strengths and limitations
There are several limitations to findings from the TERAVOLT registry, according to invited discussant Giuseppe Curigliano, MD, PhD, of the University of Milan.
He said the results are limited by the differences in triage decisions between European and other centers, the fact that most patients in TERAVOLT were hospitalized, the high proportion of patients with stage IV non–small cell lung cancer, and methods of data collection and analysis.
“There is no real-time data capture, no auditing, no standardized outcome definitions, and CRFs [case report forms] had a lot of limitations,” Dr. Curigliano said. “We have multiple biases, including selection bias, recall bias, confounding by indication, and changes in practice or disease evolution.”
Dr. Curigliano noted, however, that TERAVOLT is the largest real-world dataset of patients with COVID-19 and thoracic malignancies.
Furthermore, results from TERAVOLT correspond to results from the CCC-19 registry. Data from both registries suggest that older age, the presence of comorbidities, higher ECOG performances status, and chemotherapy alone or in combination with other therapies are associated with increased mortality among patients with cancer and COVID-19.
The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer. Dr. Horn disclosed relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, and other pharmaceutical companies. Dr. Curigliano disclosed relationships with AstraZeneca, Boehringer Ingelheim, Ellipses Pharma, and other pharmaceutical companies.
SOURCE: Horn L et al. ASCO 2020, Abstract LBA111.
FROM ASCO 2020
Combo drug improves survival in older patients with high-risk/secondary AML
The use of CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin, was tied to long-term remission and survival in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML), according to final results of a phase 3 study.
As part of the American Society of Clinical Oncology virtual scientific program, Jeffrey E. Lancet, MD, of the Moffitt Cancer Center in Tampa, Fla., presented the 5-year final data from a trial comparing CPX-351 vs. the conventional 7+3 regimen of cytarabine and daunorubicin in more than 300 older adult patients (age 60-75 years) with newly diagnosed high-risk or secondary AML. Early mortality rates for CPX-351 vs. 7+3 were 6% vs. 11% at Day 30 and 14% vs. 21% at day 60, respectively.
The final 5-year follow-up results had a median follow-up of just greater than 60 months, and maintained the improved median overall survival previously observed in the trial with CPX-351 (153 patients), compared with 7+3 (155 patients), Dr. Lancet reported.
Allogeneic hematopoietic stem cell transplant was received by 35% of the patients in the CPX-351 arm and 25% of patients in the 7+3 arm. The median overall survival after transplant was not reached for the CPX-351 arm, compared with 10.3 months with the 7+3 treated patients.
Remission, either complete remission or complete remission with incomplete neutrophil or platelet recovery, was achieved by 48% of patients in the CPX-351 arm and 33% of patients in the 7+3 arm, according to the results of the 5-year follow-up. In addition, among all patients who achieved remission, median overall survival was longer with CPX-351 than with 7+3, and the Kaplan-Meier estimated survival rate was higher for CPX-351 at both 3 years and 5 years.
At 5 years of follow-up, 81% of patients in the CPX-351 arm and 93% of patients in the 7+3 arm had died, with similar causes cited in each arm. Progressive leukemia was the most common primary cause of death in both treatment arms, according to Dr. Lancet.
“The final 5-year follow-up results from this phase 3 study support the prior evidence that CPX-351 has the ability to produce or contribute to long-term remission and survival in older patients with newly diagnosed high-risk or secondary AML,” Dr. Lancet concluded.
CPX-351 (Vyxeos) has been approved by the Food and Drug Administration and the European Medicines Agency for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplastic syndrome–related changes.
The study was funded by Jazz Pharmaceuticals. Dr. Lancet disclosed that he has a consulting or advisory role for Agios, Daiichi Sankyo, Jazz Pharmaceuticals, and Pfizer.
SOURCE: Lancet JE et al. ASCO 2020, Abstract 7510.
The use of CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin, was tied to long-term remission and survival in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML), according to final results of a phase 3 study.
As part of the American Society of Clinical Oncology virtual scientific program, Jeffrey E. Lancet, MD, of the Moffitt Cancer Center in Tampa, Fla., presented the 5-year final data from a trial comparing CPX-351 vs. the conventional 7+3 regimen of cytarabine and daunorubicin in more than 300 older adult patients (age 60-75 years) with newly diagnosed high-risk or secondary AML. Early mortality rates for CPX-351 vs. 7+3 were 6% vs. 11% at Day 30 and 14% vs. 21% at day 60, respectively.
The final 5-year follow-up results had a median follow-up of just greater than 60 months, and maintained the improved median overall survival previously observed in the trial with CPX-351 (153 patients), compared with 7+3 (155 patients), Dr. Lancet reported.
Allogeneic hematopoietic stem cell transplant was received by 35% of the patients in the CPX-351 arm and 25% of patients in the 7+3 arm. The median overall survival after transplant was not reached for the CPX-351 arm, compared with 10.3 months with the 7+3 treated patients.
Remission, either complete remission or complete remission with incomplete neutrophil or platelet recovery, was achieved by 48% of patients in the CPX-351 arm and 33% of patients in the 7+3 arm, according to the results of the 5-year follow-up. In addition, among all patients who achieved remission, median overall survival was longer with CPX-351 than with 7+3, and the Kaplan-Meier estimated survival rate was higher for CPX-351 at both 3 years and 5 years.
At 5 years of follow-up, 81% of patients in the CPX-351 arm and 93% of patients in the 7+3 arm had died, with similar causes cited in each arm. Progressive leukemia was the most common primary cause of death in both treatment arms, according to Dr. Lancet.
“The final 5-year follow-up results from this phase 3 study support the prior evidence that CPX-351 has the ability to produce or contribute to long-term remission and survival in older patients with newly diagnosed high-risk or secondary AML,” Dr. Lancet concluded.
CPX-351 (Vyxeos) has been approved by the Food and Drug Administration and the European Medicines Agency for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplastic syndrome–related changes.
The study was funded by Jazz Pharmaceuticals. Dr. Lancet disclosed that he has a consulting or advisory role for Agios, Daiichi Sankyo, Jazz Pharmaceuticals, and Pfizer.
SOURCE: Lancet JE et al. ASCO 2020, Abstract 7510.
The use of CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin, was tied to long-term remission and survival in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML), according to final results of a phase 3 study.
As part of the American Society of Clinical Oncology virtual scientific program, Jeffrey E. Lancet, MD, of the Moffitt Cancer Center in Tampa, Fla., presented the 5-year final data from a trial comparing CPX-351 vs. the conventional 7+3 regimen of cytarabine and daunorubicin in more than 300 older adult patients (age 60-75 years) with newly diagnosed high-risk or secondary AML. Early mortality rates for CPX-351 vs. 7+3 were 6% vs. 11% at Day 30 and 14% vs. 21% at day 60, respectively.
The final 5-year follow-up results had a median follow-up of just greater than 60 months, and maintained the improved median overall survival previously observed in the trial with CPX-351 (153 patients), compared with 7+3 (155 patients), Dr. Lancet reported.
Allogeneic hematopoietic stem cell transplant was received by 35% of the patients in the CPX-351 arm and 25% of patients in the 7+3 arm. The median overall survival after transplant was not reached for the CPX-351 arm, compared with 10.3 months with the 7+3 treated patients.
Remission, either complete remission or complete remission with incomplete neutrophil or platelet recovery, was achieved by 48% of patients in the CPX-351 arm and 33% of patients in the 7+3 arm, according to the results of the 5-year follow-up. In addition, among all patients who achieved remission, median overall survival was longer with CPX-351 than with 7+3, and the Kaplan-Meier estimated survival rate was higher for CPX-351 at both 3 years and 5 years.
At 5 years of follow-up, 81% of patients in the CPX-351 arm and 93% of patients in the 7+3 arm had died, with similar causes cited in each arm. Progressive leukemia was the most common primary cause of death in both treatment arms, according to Dr. Lancet.
“The final 5-year follow-up results from this phase 3 study support the prior evidence that CPX-351 has the ability to produce or contribute to long-term remission and survival in older patients with newly diagnosed high-risk or secondary AML,” Dr. Lancet concluded.
CPX-351 (Vyxeos) has been approved by the Food and Drug Administration and the European Medicines Agency for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplastic syndrome–related changes.
The study was funded by Jazz Pharmaceuticals. Dr. Lancet disclosed that he has a consulting or advisory role for Agios, Daiichi Sankyo, Jazz Pharmaceuticals, and Pfizer.
SOURCE: Lancet JE et al. ASCO 2020, Abstract 7510.
FROM ASCO 2020
Will primary care physicians be COVID-19’s next victims?
In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. Those arguments resonated with Kenny Lin, MD, MPH, a family physician, professor at Georgetown University School of Medicine, and a regular contributor to Medscape. He spoke with Dr. Frieden about his concerns.
Dr. Lin: Why did you feel that it was important to write this piece focused on primary care?
Dr. Frieden: I’m glad you asked that question. Given all that is going on, one might ask, what is the importance of primary care? We’ve got this epidemic going on that requires public health and hospital systems. Why voice concern about primary care now?
It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.
Dr. Lin: I agree. In my own practice we haven’t had to furlough anyone, but we’ve put people on forced paid time off. We’ve been reallocating physicians to other parts of our health system. It is definitely a concern. A solo practitioner or someone in a rural practice would most likely be even much more heavily hit. You’ve argued that the neglect of our public health system on a national level has led to many preventable deaths from COVID-19. Do you feel that something similar has happened in primary care? How could a stronger, better-funded primary care infrastructure better prepare us for the next pandemic?
Dr. Frieden: All over the world, we see an overemphasis on hospital care and an underemphasis on primary care, outpatient care, family medicine. As a result, we pay more. We have larger risks, and we don’t prevent diseases that we could prevent. It’s fundamentally about the economic incentives of our health care system. Of course, that often reflects the political reality of different profit centers and cost centers of care. That won’t change with tweaking around the edges. It will only change if we change the way we pay for health care. Money talks. We need to start paying at least part of what we pay based on health outcomes.
Many years ago a colleague and I wrote an article, “Health Care as If Health Mattered.” If you step back and look at how we pay for health care, very little, if any, of our payment structure is based on how much health the care system delivers. Part of that can be addressed by going to capitated models, which I think do better. But you have also got to put into those capitated systems some quality and outcome measures that are both valid and not too burdensome to report on. That’s not easy. We could talk a lot about some of the information systems and payment systems, but I think the bottom line is that we need to be able to deal not only with health emergencies, but also with preventive care, care of chronic diseases, and behavioral health care in ways that maximize health.
One of the ways to do that is simple, monthly, capitated payments along with what I call a registry-based outcomes system.
I’m a tuberculosis specialist by training. In tuberculosis there really is a great information system. We track every single patient who has been diagnosed, and we hold every clinician accountable for whether or not they’ve successfully treated that patient. An optimal health care system should do the same with treatment of hypertension, diabetes, seizure disorder, and other common conditions in which treatment makes a really big difference. Preventive care, especially vaccine delivery, is another example.
I understand that physicians will point out that patients may not come in for that care, or they’re hard to deal with, or they refuse recommended treatment. We don’t expect 100%. But we should expect that, if we’re paying for health care, we should get health.
To do that, I think we need much more support for primary care, both in terms of the absolute amount of dollars going in and the administrative support. Some of our systems are so complicated that you can’t manage them without a billing department. How does a one- or two-physician practice deal with systems that will take dozens of hours a week to manage? You have to deal with the administrative complexity, the structure of the incentives, and the structure of care.
I think these are all things that we have to address. But for a minute, let’s helicopter up and look at the big picture. Without additional help from Congress, tens of thousands of primary care physicians could go out of business in the coming weeks. This is a crisis, and this will be very hard to rebuild. We don’t have a strong, resilient primary care infrastructure today, and if we’re not careful it’ll be even weaker as we try to rebuild.
It has been encouraging to see some of the care innovations that have occurred in response to the pandemic. I’m particularly encouraged by the widespread interest in and support for telemedicine. Telemedicine is a very important way of making care safer, more accessible, less expensive, more efficient. There have been a lot of restrictions on it, not just in the United States but globally, for many years. It’s really interesting to see those restrictions rapidly change. I give credit to the Centers for Medicare & Medicaid Services for quick changes in this area.
Now, telemedicine isn’t a cure-all. There are lots of things you can’t do from a distance. It’s a pale reflection of reality, compared with an in-person first visit with a patient. But it’s a whole lot better than nothing. If we look at some of the best health systems in the United States, they’ve gone to as much as 80% of clinical visits done by telemedicine. I don’t think we’re going to go back. Even if COVID is no longer the threat that it is today, if you can do things more quickly, more efficiently, and more conveniently for both patients and doctors, do them. Obviously, it won’t be all visits, but it could be a large proportion of visits and an important part of strengthening our primary care system.
My initiative, Resolve to Save Lives, which is part of the global health organization Vital Strategies, has done work in the area of public health around the world. I am really struck by how weak primary care systems are in so many countries. Strong primary care systems are the exception rather than the rule, but they’re also a best buy in health care. They’re crucially important, and they’re going to work differently in different countries, in different states, in different communities. We need to do a better job of supporting primary care, building primary care, and paying for primary care.
Dr. Lin: You’ve identified two needs. The immediate need is that primary care practices need revenue now to not have to close in the immediate aftermath or the ongoing COVID epidemic, but also there’s the long term, the percentage of health care dollars that are going to primary care in the long term. You pointed out in your article that currently 5% or less of health care spending is in primary care, which is a lot less percentage-wise than in many other countries. I think the question always comes up is that we want to increase that share, but the money has to come from somewhere. Where is that extra money going to come from? Dr. Frieden: I’m not an expert in health care finance, but one thing I’ve learned over the years is that one person’s waste, fraud, and abuse is somebody else’s profit center. It’s not going to be easy. On the one hand, we do need to think about more efficient ways to organize primary care; on the other hand, we have to figure out a way to internalize some of the savings. If you give good primary care and, therefore, someone doesn’t get hospitalized, you can actually lose money in the current system, whereas you’re saving the system a lot of money by preventing that hospitalization.
I think our health system does have significant inefficiencies in terms of the number of tests and interventions that are done that are really not proven to help patients. It has been demonstrated for decades now that the usual economic incentives don’t operate in health care. In health care, supply often generates demand. The number of gallbladder operations is proportional not to population but to the number of gallbladder surgeons. That’s a problem, and it’s a problem that we’re going to have to assess. “Gatekeeper” is an unpleasant word, but if a primary care practitioner could be the advocate for patients so that we’re not pushing for patients to get more care or to get less care but to get the right care, we have the potential to reduce costs while improving quality.
Dr. Lin: You accurately point out that the fee-for-service payment system has been the major culprit in the declining revenues of primary care practices since the start of the pandemic. But for the majority of primary care physicians, including myself, fee-for-service is all that we’ve ever known. Do you think that primary care is ready for such an abrupt financing change, particularly in a very short period of time?Dr. Frieden: You’re certainly accurate in saying that nothing about health care finance is easy. Trying to address these problems at the national or state level has been extremely difficult. I think that the pilot programs in Medicare are very important. Medicaid is a particular challenge because it’s a state-based program and many of the costs are driven by nursing home and long-term care. When you take those costs out, the actual funding per patient or per provider is quite low in most places.
It’s hard enough to reorganize if you’ve got ample resources, but to reorganize when they are insufficient is particularly hard. I would say only that there are no quick and simple answers to this question, but there is a widespread understanding that what we’re doing now doesn’t make sense. We pay top dollar and we get – despite fantastic doctors and fantastic hospitals – lousy outcomes. I’m a public health physician. I’m an internal medicine and infectious disease specialist. Fundamentally, I look at the data. If you think of our health care system as a patient, the patient is not doing well. We’re not functional to the degree we need to be, particularly when you think of what an enormous outlier our per capita expenditures are [compared with other developed countries] – almost twice the average upper-income country and 25% more than any other upper-income country.
Now, anyone who tells you that change is going to be pain-free is not leveling with you. In addition to things like telemedicine, we have to make much more use of team-based care and task sharing. There are lots of things that doctors are doing these days that they really shouldn’t.
Dr. Lin: In your recent op-ed, you noted the pivot to telehealth that primary care practices have made very quickly in response to the pandemic. That certainly was the experience for my practice. But what are some other strategies that you think are important to support the goal of better care delivery in our primary care practices?Dr. Frieden: Another really important innovation is team-based care. There are lots of things that doctors are doing today that nurses, nurse practitioners, physician assistants, and community health workers can do better and for less money. Frankly, I think that should increase the job satisfaction of physicians, to be doing work that is specific to the physician, requiring either more patient interaction or advanced reasoning or experience.
In my own field of tuberculosis control, I learned how to treat tuberculosis because the nurse at the TB clinic kept correcting me because that’s all she did. She did tuberculosis care, so she had seen everything. Even though I’d finished an infectious disease fellowship and internal medicine residency, the public health nurse knew TB a whole lot better than I did.
Similarly, as we work on hypertension control, you can protocolize most of this care and do a much better job. That’s been proven for more than 40 years, and yet we still don’t do it.
One of the big parts of being able to do more with the same or fewer resources is going to be more team-based care. That’s really a task-sharing approach. I think of that as a triple win: You get better care for lower costs with more employment. What’s not to like?
Dr. Lin: I’m hopeful, as you are, that many of these innovations that have been made by necessity will persist beyond the duration of COVID-19. As you said, the health care system has been really difficult to change, and it often takes something like this to galvanize enough consensus that things need to change.
Dr. Frieden: I think the bottom line here is that we should pay our primary health care providers to keep us healthy and ensure that we have a payment system that lets them do that without risking bankruptcy. That’s not too much to ask of our system. It’s important for our health. It’s important for our economy. It’s important for our communities.
Dr. Lin teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journal American Family Physician. Follow him on Twitter. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for MedStar Georgetown University Hospital and received income in an amount equal to or greater than $250 from UpToDate, Wiley-Blackwell, and American Academy of Family Physicians.
Dr. Frieden is a physician with advanced training in internal medicine, infectious disease, public health, and epidemiology. He has served as director of the Centers for Disease Control and Prevention and as commissioner of the New York City Health Department. Currently he is president and CEO of Resolve to Save Lives. Follow him on Twitter. Thomas R. Frieden, MD, MPH, has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. Those arguments resonated with Kenny Lin, MD, MPH, a family physician, professor at Georgetown University School of Medicine, and a regular contributor to Medscape. He spoke with Dr. Frieden about his concerns.
Dr. Lin: Why did you feel that it was important to write this piece focused on primary care?
Dr. Frieden: I’m glad you asked that question. Given all that is going on, one might ask, what is the importance of primary care? We’ve got this epidemic going on that requires public health and hospital systems. Why voice concern about primary care now?
It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.
Dr. Lin: I agree. In my own practice we haven’t had to furlough anyone, but we’ve put people on forced paid time off. We’ve been reallocating physicians to other parts of our health system. It is definitely a concern. A solo practitioner or someone in a rural practice would most likely be even much more heavily hit. You’ve argued that the neglect of our public health system on a national level has led to many preventable deaths from COVID-19. Do you feel that something similar has happened in primary care? How could a stronger, better-funded primary care infrastructure better prepare us for the next pandemic?
Dr. Frieden: All over the world, we see an overemphasis on hospital care and an underemphasis on primary care, outpatient care, family medicine. As a result, we pay more. We have larger risks, and we don’t prevent diseases that we could prevent. It’s fundamentally about the economic incentives of our health care system. Of course, that often reflects the political reality of different profit centers and cost centers of care. That won’t change with tweaking around the edges. It will only change if we change the way we pay for health care. Money talks. We need to start paying at least part of what we pay based on health outcomes.
Many years ago a colleague and I wrote an article, “Health Care as If Health Mattered.” If you step back and look at how we pay for health care, very little, if any, of our payment structure is based on how much health the care system delivers. Part of that can be addressed by going to capitated models, which I think do better. But you have also got to put into those capitated systems some quality and outcome measures that are both valid and not too burdensome to report on. That’s not easy. We could talk a lot about some of the information systems and payment systems, but I think the bottom line is that we need to be able to deal not only with health emergencies, but also with preventive care, care of chronic diseases, and behavioral health care in ways that maximize health.
One of the ways to do that is simple, monthly, capitated payments along with what I call a registry-based outcomes system.
I’m a tuberculosis specialist by training. In tuberculosis there really is a great information system. We track every single patient who has been diagnosed, and we hold every clinician accountable for whether or not they’ve successfully treated that patient. An optimal health care system should do the same with treatment of hypertension, diabetes, seizure disorder, and other common conditions in which treatment makes a really big difference. Preventive care, especially vaccine delivery, is another example.
I understand that physicians will point out that patients may not come in for that care, or they’re hard to deal with, or they refuse recommended treatment. We don’t expect 100%. But we should expect that, if we’re paying for health care, we should get health.
To do that, I think we need much more support for primary care, both in terms of the absolute amount of dollars going in and the administrative support. Some of our systems are so complicated that you can’t manage them without a billing department. How does a one- or two-physician practice deal with systems that will take dozens of hours a week to manage? You have to deal with the administrative complexity, the structure of the incentives, and the structure of care.
I think these are all things that we have to address. But for a minute, let’s helicopter up and look at the big picture. Without additional help from Congress, tens of thousands of primary care physicians could go out of business in the coming weeks. This is a crisis, and this will be very hard to rebuild. We don’t have a strong, resilient primary care infrastructure today, and if we’re not careful it’ll be even weaker as we try to rebuild.
It has been encouraging to see some of the care innovations that have occurred in response to the pandemic. I’m particularly encouraged by the widespread interest in and support for telemedicine. Telemedicine is a very important way of making care safer, more accessible, less expensive, more efficient. There have been a lot of restrictions on it, not just in the United States but globally, for many years. It’s really interesting to see those restrictions rapidly change. I give credit to the Centers for Medicare & Medicaid Services for quick changes in this area.
Now, telemedicine isn’t a cure-all. There are lots of things you can’t do from a distance. It’s a pale reflection of reality, compared with an in-person first visit with a patient. But it’s a whole lot better than nothing. If we look at some of the best health systems in the United States, they’ve gone to as much as 80% of clinical visits done by telemedicine. I don’t think we’re going to go back. Even if COVID is no longer the threat that it is today, if you can do things more quickly, more efficiently, and more conveniently for both patients and doctors, do them. Obviously, it won’t be all visits, but it could be a large proportion of visits and an important part of strengthening our primary care system.
My initiative, Resolve to Save Lives, which is part of the global health organization Vital Strategies, has done work in the area of public health around the world. I am really struck by how weak primary care systems are in so many countries. Strong primary care systems are the exception rather than the rule, but they’re also a best buy in health care. They’re crucially important, and they’re going to work differently in different countries, in different states, in different communities. We need to do a better job of supporting primary care, building primary care, and paying for primary care.
Dr. Lin: You’ve identified two needs. The immediate need is that primary care practices need revenue now to not have to close in the immediate aftermath or the ongoing COVID epidemic, but also there’s the long term, the percentage of health care dollars that are going to primary care in the long term. You pointed out in your article that currently 5% or less of health care spending is in primary care, which is a lot less percentage-wise than in many other countries. I think the question always comes up is that we want to increase that share, but the money has to come from somewhere. Where is that extra money going to come from? Dr. Frieden: I’m not an expert in health care finance, but one thing I’ve learned over the years is that one person’s waste, fraud, and abuse is somebody else’s profit center. It’s not going to be easy. On the one hand, we do need to think about more efficient ways to organize primary care; on the other hand, we have to figure out a way to internalize some of the savings. If you give good primary care and, therefore, someone doesn’t get hospitalized, you can actually lose money in the current system, whereas you’re saving the system a lot of money by preventing that hospitalization.
I think our health system does have significant inefficiencies in terms of the number of tests and interventions that are done that are really not proven to help patients. It has been demonstrated for decades now that the usual economic incentives don’t operate in health care. In health care, supply often generates demand. The number of gallbladder operations is proportional not to population but to the number of gallbladder surgeons. That’s a problem, and it’s a problem that we’re going to have to assess. “Gatekeeper” is an unpleasant word, but if a primary care practitioner could be the advocate for patients so that we’re not pushing for patients to get more care or to get less care but to get the right care, we have the potential to reduce costs while improving quality.
Dr. Lin: You accurately point out that the fee-for-service payment system has been the major culprit in the declining revenues of primary care practices since the start of the pandemic. But for the majority of primary care physicians, including myself, fee-for-service is all that we’ve ever known. Do you think that primary care is ready for such an abrupt financing change, particularly in a very short period of time?Dr. Frieden: You’re certainly accurate in saying that nothing about health care finance is easy. Trying to address these problems at the national or state level has been extremely difficult. I think that the pilot programs in Medicare are very important. Medicaid is a particular challenge because it’s a state-based program and many of the costs are driven by nursing home and long-term care. When you take those costs out, the actual funding per patient or per provider is quite low in most places.
It’s hard enough to reorganize if you’ve got ample resources, but to reorganize when they are insufficient is particularly hard. I would say only that there are no quick and simple answers to this question, but there is a widespread understanding that what we’re doing now doesn’t make sense. We pay top dollar and we get – despite fantastic doctors and fantastic hospitals – lousy outcomes. I’m a public health physician. I’m an internal medicine and infectious disease specialist. Fundamentally, I look at the data. If you think of our health care system as a patient, the patient is not doing well. We’re not functional to the degree we need to be, particularly when you think of what an enormous outlier our per capita expenditures are [compared with other developed countries] – almost twice the average upper-income country and 25% more than any other upper-income country.
Now, anyone who tells you that change is going to be pain-free is not leveling with you. In addition to things like telemedicine, we have to make much more use of team-based care and task sharing. There are lots of things that doctors are doing these days that they really shouldn’t.
Dr. Lin: In your recent op-ed, you noted the pivot to telehealth that primary care practices have made very quickly in response to the pandemic. That certainly was the experience for my practice. But what are some other strategies that you think are important to support the goal of better care delivery in our primary care practices?Dr. Frieden: Another really important innovation is team-based care. There are lots of things that doctors are doing today that nurses, nurse practitioners, physician assistants, and community health workers can do better and for less money. Frankly, I think that should increase the job satisfaction of physicians, to be doing work that is specific to the physician, requiring either more patient interaction or advanced reasoning or experience.
In my own field of tuberculosis control, I learned how to treat tuberculosis because the nurse at the TB clinic kept correcting me because that’s all she did. She did tuberculosis care, so she had seen everything. Even though I’d finished an infectious disease fellowship and internal medicine residency, the public health nurse knew TB a whole lot better than I did.
Similarly, as we work on hypertension control, you can protocolize most of this care and do a much better job. That’s been proven for more than 40 years, and yet we still don’t do it.
One of the big parts of being able to do more with the same or fewer resources is going to be more team-based care. That’s really a task-sharing approach. I think of that as a triple win: You get better care for lower costs with more employment. What’s not to like?
Dr. Lin: I’m hopeful, as you are, that many of these innovations that have been made by necessity will persist beyond the duration of COVID-19. As you said, the health care system has been really difficult to change, and it often takes something like this to galvanize enough consensus that things need to change.
Dr. Frieden: I think the bottom line here is that we should pay our primary health care providers to keep us healthy and ensure that we have a payment system that lets them do that without risking bankruptcy. That’s not too much to ask of our system. It’s important for our health. It’s important for our economy. It’s important for our communities.
Dr. Lin teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journal American Family Physician. Follow him on Twitter. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for MedStar Georgetown University Hospital and received income in an amount equal to or greater than $250 from UpToDate, Wiley-Blackwell, and American Academy of Family Physicians.
Dr. Frieden is a physician with advanced training in internal medicine, infectious disease, public health, and epidemiology. He has served as director of the Centers for Disease Control and Prevention and as commissioner of the New York City Health Department. Currently he is president and CEO of Resolve to Save Lives. Follow him on Twitter. Thomas R. Frieden, MD, MPH, has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. Those arguments resonated with Kenny Lin, MD, MPH, a family physician, professor at Georgetown University School of Medicine, and a regular contributor to Medscape. He spoke with Dr. Frieden about his concerns.
Dr. Lin: Why did you feel that it was important to write this piece focused on primary care?
Dr. Frieden: I’m glad you asked that question. Given all that is going on, one might ask, what is the importance of primary care? We’ve got this epidemic going on that requires public health and hospital systems. Why voice concern about primary care now?
It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.
Dr. Lin: I agree. In my own practice we haven’t had to furlough anyone, but we’ve put people on forced paid time off. We’ve been reallocating physicians to other parts of our health system. It is definitely a concern. A solo practitioner or someone in a rural practice would most likely be even much more heavily hit. You’ve argued that the neglect of our public health system on a national level has led to many preventable deaths from COVID-19. Do you feel that something similar has happened in primary care? How could a stronger, better-funded primary care infrastructure better prepare us for the next pandemic?
Dr. Frieden: All over the world, we see an overemphasis on hospital care and an underemphasis on primary care, outpatient care, family medicine. As a result, we pay more. We have larger risks, and we don’t prevent diseases that we could prevent. It’s fundamentally about the economic incentives of our health care system. Of course, that often reflects the political reality of different profit centers and cost centers of care. That won’t change with tweaking around the edges. It will only change if we change the way we pay for health care. Money talks. We need to start paying at least part of what we pay based on health outcomes.
Many years ago a colleague and I wrote an article, “Health Care as If Health Mattered.” If you step back and look at how we pay for health care, very little, if any, of our payment structure is based on how much health the care system delivers. Part of that can be addressed by going to capitated models, which I think do better. But you have also got to put into those capitated systems some quality and outcome measures that are both valid and not too burdensome to report on. That’s not easy. We could talk a lot about some of the information systems and payment systems, but I think the bottom line is that we need to be able to deal not only with health emergencies, but also with preventive care, care of chronic diseases, and behavioral health care in ways that maximize health.
One of the ways to do that is simple, monthly, capitated payments along with what I call a registry-based outcomes system.
I’m a tuberculosis specialist by training. In tuberculosis there really is a great information system. We track every single patient who has been diagnosed, and we hold every clinician accountable for whether or not they’ve successfully treated that patient. An optimal health care system should do the same with treatment of hypertension, diabetes, seizure disorder, and other common conditions in which treatment makes a really big difference. Preventive care, especially vaccine delivery, is another example.
I understand that physicians will point out that patients may not come in for that care, or they’re hard to deal with, or they refuse recommended treatment. We don’t expect 100%. But we should expect that, if we’re paying for health care, we should get health.
To do that, I think we need much more support for primary care, both in terms of the absolute amount of dollars going in and the administrative support. Some of our systems are so complicated that you can’t manage them without a billing department. How does a one- or two-physician practice deal with systems that will take dozens of hours a week to manage? You have to deal with the administrative complexity, the structure of the incentives, and the structure of care.
I think these are all things that we have to address. But for a minute, let’s helicopter up and look at the big picture. Without additional help from Congress, tens of thousands of primary care physicians could go out of business in the coming weeks. This is a crisis, and this will be very hard to rebuild. We don’t have a strong, resilient primary care infrastructure today, and if we’re not careful it’ll be even weaker as we try to rebuild.
It has been encouraging to see some of the care innovations that have occurred in response to the pandemic. I’m particularly encouraged by the widespread interest in and support for telemedicine. Telemedicine is a very important way of making care safer, more accessible, less expensive, more efficient. There have been a lot of restrictions on it, not just in the United States but globally, for many years. It’s really interesting to see those restrictions rapidly change. I give credit to the Centers for Medicare & Medicaid Services for quick changes in this area.
Now, telemedicine isn’t a cure-all. There are lots of things you can’t do from a distance. It’s a pale reflection of reality, compared with an in-person first visit with a patient. But it’s a whole lot better than nothing. If we look at some of the best health systems in the United States, they’ve gone to as much as 80% of clinical visits done by telemedicine. I don’t think we’re going to go back. Even if COVID is no longer the threat that it is today, if you can do things more quickly, more efficiently, and more conveniently for both patients and doctors, do them. Obviously, it won’t be all visits, but it could be a large proportion of visits and an important part of strengthening our primary care system.
My initiative, Resolve to Save Lives, which is part of the global health organization Vital Strategies, has done work in the area of public health around the world. I am really struck by how weak primary care systems are in so many countries. Strong primary care systems are the exception rather than the rule, but they’re also a best buy in health care. They’re crucially important, and they’re going to work differently in different countries, in different states, in different communities. We need to do a better job of supporting primary care, building primary care, and paying for primary care.
Dr. Lin: You’ve identified two needs. The immediate need is that primary care practices need revenue now to not have to close in the immediate aftermath or the ongoing COVID epidemic, but also there’s the long term, the percentage of health care dollars that are going to primary care in the long term. You pointed out in your article that currently 5% or less of health care spending is in primary care, which is a lot less percentage-wise than in many other countries. I think the question always comes up is that we want to increase that share, but the money has to come from somewhere. Where is that extra money going to come from? Dr. Frieden: I’m not an expert in health care finance, but one thing I’ve learned over the years is that one person’s waste, fraud, and abuse is somebody else’s profit center. It’s not going to be easy. On the one hand, we do need to think about more efficient ways to organize primary care; on the other hand, we have to figure out a way to internalize some of the savings. If you give good primary care and, therefore, someone doesn’t get hospitalized, you can actually lose money in the current system, whereas you’re saving the system a lot of money by preventing that hospitalization.
I think our health system does have significant inefficiencies in terms of the number of tests and interventions that are done that are really not proven to help patients. It has been demonstrated for decades now that the usual economic incentives don’t operate in health care. In health care, supply often generates demand. The number of gallbladder operations is proportional not to population but to the number of gallbladder surgeons. That’s a problem, and it’s a problem that we’re going to have to assess. “Gatekeeper” is an unpleasant word, but if a primary care practitioner could be the advocate for patients so that we’re not pushing for patients to get more care or to get less care but to get the right care, we have the potential to reduce costs while improving quality.
Dr. Lin: You accurately point out that the fee-for-service payment system has been the major culprit in the declining revenues of primary care practices since the start of the pandemic. But for the majority of primary care physicians, including myself, fee-for-service is all that we’ve ever known. Do you think that primary care is ready for such an abrupt financing change, particularly in a very short period of time?Dr. Frieden: You’re certainly accurate in saying that nothing about health care finance is easy. Trying to address these problems at the national or state level has been extremely difficult. I think that the pilot programs in Medicare are very important. Medicaid is a particular challenge because it’s a state-based program and many of the costs are driven by nursing home and long-term care. When you take those costs out, the actual funding per patient or per provider is quite low in most places.
It’s hard enough to reorganize if you’ve got ample resources, but to reorganize when they are insufficient is particularly hard. I would say only that there are no quick and simple answers to this question, but there is a widespread understanding that what we’re doing now doesn’t make sense. We pay top dollar and we get – despite fantastic doctors and fantastic hospitals – lousy outcomes. I’m a public health physician. I’m an internal medicine and infectious disease specialist. Fundamentally, I look at the data. If you think of our health care system as a patient, the patient is not doing well. We’re not functional to the degree we need to be, particularly when you think of what an enormous outlier our per capita expenditures are [compared with other developed countries] – almost twice the average upper-income country and 25% more than any other upper-income country.
Now, anyone who tells you that change is going to be pain-free is not leveling with you. In addition to things like telemedicine, we have to make much more use of team-based care and task sharing. There are lots of things that doctors are doing these days that they really shouldn’t.
Dr. Lin: In your recent op-ed, you noted the pivot to telehealth that primary care practices have made very quickly in response to the pandemic. That certainly was the experience for my practice. But what are some other strategies that you think are important to support the goal of better care delivery in our primary care practices?Dr. Frieden: Another really important innovation is team-based care. There are lots of things that doctors are doing today that nurses, nurse practitioners, physician assistants, and community health workers can do better and for less money. Frankly, I think that should increase the job satisfaction of physicians, to be doing work that is specific to the physician, requiring either more patient interaction or advanced reasoning or experience.
In my own field of tuberculosis control, I learned how to treat tuberculosis because the nurse at the TB clinic kept correcting me because that’s all she did. She did tuberculosis care, so she had seen everything. Even though I’d finished an infectious disease fellowship and internal medicine residency, the public health nurse knew TB a whole lot better than I did.
Similarly, as we work on hypertension control, you can protocolize most of this care and do a much better job. That’s been proven for more than 40 years, and yet we still don’t do it.
One of the big parts of being able to do more with the same or fewer resources is going to be more team-based care. That’s really a task-sharing approach. I think of that as a triple win: You get better care for lower costs with more employment. What’s not to like?
Dr. Lin: I’m hopeful, as you are, that many of these innovations that have been made by necessity will persist beyond the duration of COVID-19. As you said, the health care system has been really difficult to change, and it often takes something like this to galvanize enough consensus that things need to change.
Dr. Frieden: I think the bottom line here is that we should pay our primary health care providers to keep us healthy and ensure that we have a payment system that lets them do that without risking bankruptcy. That’s not too much to ask of our system. It’s important for our health. It’s important for our economy. It’s important for our communities.
Dr. Lin teaches family medicine, preventive medicine, and health policy at Georgetown University School of Medicine. He is deputy editor of the journal American Family Physician. Follow him on Twitter. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for MedStar Georgetown University Hospital and received income in an amount equal to or greater than $250 from UpToDate, Wiley-Blackwell, and American Academy of Family Physicians.
Dr. Frieden is a physician with advanced training in internal medicine, infectious disease, public health, and epidemiology. He has served as director of the Centers for Disease Control and Prevention and as commissioner of the New York City Health Department. Currently he is president and CEO of Resolve to Save Lives. Follow him on Twitter. Thomas R. Frieden, MD, MPH, has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
How to reboot elective CV procedures after COVID-19 lockdown
With the COVID-19 pandemic winding down in some parts of the United States, attention has turned to figuring out how to safely reboot elective cardiovascular (CV) services, which, for the most part, shut down in order to combat the virus and flatten the curve.
To aid in this effort, top cardiology societies have published a series of guidance documents. One, entitled Multimodality Cardiovascular Imaging in the Midst of the COVID-19 Pandemic: Ramping Up Safely to a New Normal, was initiated by the editors of JACC Cardiovascular Imaging and was developed in collaboration with the ACC Cardiovascular Imaging Council.
“As we enter a deceleration or indolent phase of the disease and a return to a ‘new normal’ for the foreseeable future, cardiovascular imaging laboratories will adjust to a different work flow and safety precautions for patients and staff alike,” write William Zoghbi, MD, of the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, and colleagues.
Minimize risk, maximize clinical benefit
The group outlined strategies and considerations on how to safely ramp up multimodality CV imaging laboratories in an environment of an abating but continuing pandemic.
The authors provide detailed advice on reestablishing echocardiography, transthoracic echocardiography, transesophageal echocardiography, stress testing modalities, treadmill testing, nuclear cardiology, cardiac CT, and cardiac MRI.
The advice is designed to “minimize risk, reduce resource utilization and maximize clinical benefit,” the authors wrote. They address patient and societal health; safety of healthcare professionals; choice of CV testing; and scheduling considerations.
Dr. Zoghbi and colleagues said that integrated communication among patients, referring physicians, the imaging teams, and administrative staff are key to reestablishing a more normal clinical operation.
“Recognizing that practice patterns and policies vary depending on institution and locale, the recommendations are not meant to be restrictive but rather to serve as a general framework during the COVID-19 pandemic and its recovery phase,” the writing group said.
Ultimately, the goal is to offer the necessary CV tests and information for the clinical team to provide the best care for patients, they added.
“To be successful in this new safety-driven modus operandi, innovation, coordination and adaptation among clinicians, staff and patients is necessary till herd immunity or control of COVID-19 is achieved,” they concluded.
Rebooting electrophysiology services
Uncertainty as to how to resume electrophysiology (EP) services for arrhythmia patients prompted representatives from the Heart Rhythm Society, the American Heart Association, and the ACC to develop a series of “guiding suggestions and principles” to help safely reestablish electrophysiological care.
The 28-page document is published in Circulation: Arrhythmia and Electrophysiology and the Journal of the American College of Cardiology Electrophysiology.
“Rebooting” EP services at many institutions may be more challenging than shutting down, wrote Dhanunjaya R. Lakkireddy, MD, Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kan., and colleagues.
Topics addressed by the writing group include the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication; prioritization of procedures, and development of outpatient and periprocedural care pathways.
They suggest creating an EP COVID-19 “reboot team” made up of stakeholders involved in the EP care continuum pathway that would coordinate with institutional or hospital-level COVID-19 leadership.
The reboot team may include an electrophysiologist, an EP laboratory manager, an outpatient clinic manager, an EP nurse, advanced practice providers, a device technician, an anesthesiologist, and an imaging team to provide insights into various aspects of the work flow.
“This team can clarify, interpret, iterate and disseminate policies, and also provide the necessary operational support to plan and successfully execute the reboot process as the efforts to contain COVID-19 continue,” the writing group said.
A mandatory component of the reboot plan should be planning for a second wave of the virus.
“We will have to learn to create relatively COVID-19 safe zones within the hospitals to help isolate patients from second waves and yet be able to provide regular care for non–COVID-19 patients,” the writing group said.
“Our main goal as health care professionals, whether we serve in a clinical, teaching, research, or administrative role, is to do everything we can to create a safe environment for our patients so that they receive the excellent care they deserve,” they concluded.
Defining moment for remote arrhythmia monitoring
In a separate report, an international team of heart rhythm specialists from the Latin American Heart Rhythm Society, the HRS, the European Heart Rhythm Association, the Asia Pacific Heart Rhythm Society, the AHA, and the ACC discussed how the pandemic has fueled adoption of telehealth and remote patient management across medicine, including heart rhythm monitoring.
Their report was simultaneously published in Circulation: Arrhythmia and Electrophysiology, EP Europace, the Journal of the American College of Cardiology, the Journal of Arrhythmia, and Heart Rhythm.
The COVID-19 pandemic has “catalyzed the use of wearables and digital medical tools,” and this will likely define medicine going forward, first author Niraj Varma, MD, PhD, of the Cleveland Clinic, said in an interview.
He noted that the technology has been available for some time, but the pandemic has forced people to use it. “Necessity is the mother of invention, and this has become necessary during the pandemic when we can’t see our patients,” said Dr. Varma.
He also noted that hospitals and physicians are now realizing that telehealth and remote arrhythmia monitoring “actually work, and regulatory agencies have moved very swiftly to dissolve traditional barriers and will now reimburse for it. So it’s a win-win.”
Dr. Varma and colleagues said that the time is right to “embed and grow remote services in everyday medical practice worldwide.” In their report, they offered a list of commonly used platforms for telehealth and examples of remote electrocardiogram and heart rate monitoring devices.
Development of the three reports had no commercial funding. Complete lists of disclosures for the writing groups are available in the original articles.
A version of this article originally appeared on Medscape.com.
With the COVID-19 pandemic winding down in some parts of the United States, attention has turned to figuring out how to safely reboot elective cardiovascular (CV) services, which, for the most part, shut down in order to combat the virus and flatten the curve.
To aid in this effort, top cardiology societies have published a series of guidance documents. One, entitled Multimodality Cardiovascular Imaging in the Midst of the COVID-19 Pandemic: Ramping Up Safely to a New Normal, was initiated by the editors of JACC Cardiovascular Imaging and was developed in collaboration with the ACC Cardiovascular Imaging Council.
“As we enter a deceleration or indolent phase of the disease and a return to a ‘new normal’ for the foreseeable future, cardiovascular imaging laboratories will adjust to a different work flow and safety precautions for patients and staff alike,” write William Zoghbi, MD, of the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, and colleagues.
Minimize risk, maximize clinical benefit
The group outlined strategies and considerations on how to safely ramp up multimodality CV imaging laboratories in an environment of an abating but continuing pandemic.
The authors provide detailed advice on reestablishing echocardiography, transthoracic echocardiography, transesophageal echocardiography, stress testing modalities, treadmill testing, nuclear cardiology, cardiac CT, and cardiac MRI.
The advice is designed to “minimize risk, reduce resource utilization and maximize clinical benefit,” the authors wrote. They address patient and societal health; safety of healthcare professionals; choice of CV testing; and scheduling considerations.
Dr. Zoghbi and colleagues said that integrated communication among patients, referring physicians, the imaging teams, and administrative staff are key to reestablishing a more normal clinical operation.
“Recognizing that practice patterns and policies vary depending on institution and locale, the recommendations are not meant to be restrictive but rather to serve as a general framework during the COVID-19 pandemic and its recovery phase,” the writing group said.
Ultimately, the goal is to offer the necessary CV tests and information for the clinical team to provide the best care for patients, they added.
“To be successful in this new safety-driven modus operandi, innovation, coordination and adaptation among clinicians, staff and patients is necessary till herd immunity or control of COVID-19 is achieved,” they concluded.
Rebooting electrophysiology services
Uncertainty as to how to resume electrophysiology (EP) services for arrhythmia patients prompted representatives from the Heart Rhythm Society, the American Heart Association, and the ACC to develop a series of “guiding suggestions and principles” to help safely reestablish electrophysiological care.
The 28-page document is published in Circulation: Arrhythmia and Electrophysiology and the Journal of the American College of Cardiology Electrophysiology.
“Rebooting” EP services at many institutions may be more challenging than shutting down, wrote Dhanunjaya R. Lakkireddy, MD, Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kan., and colleagues.
Topics addressed by the writing group include the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication; prioritization of procedures, and development of outpatient and periprocedural care pathways.
They suggest creating an EP COVID-19 “reboot team” made up of stakeholders involved in the EP care continuum pathway that would coordinate with institutional or hospital-level COVID-19 leadership.
The reboot team may include an electrophysiologist, an EP laboratory manager, an outpatient clinic manager, an EP nurse, advanced practice providers, a device technician, an anesthesiologist, and an imaging team to provide insights into various aspects of the work flow.
“This team can clarify, interpret, iterate and disseminate policies, and also provide the necessary operational support to plan and successfully execute the reboot process as the efforts to contain COVID-19 continue,” the writing group said.
A mandatory component of the reboot plan should be planning for a second wave of the virus.
“We will have to learn to create relatively COVID-19 safe zones within the hospitals to help isolate patients from second waves and yet be able to provide regular care for non–COVID-19 patients,” the writing group said.
“Our main goal as health care professionals, whether we serve in a clinical, teaching, research, or administrative role, is to do everything we can to create a safe environment for our patients so that they receive the excellent care they deserve,” they concluded.
Defining moment for remote arrhythmia monitoring
In a separate report, an international team of heart rhythm specialists from the Latin American Heart Rhythm Society, the HRS, the European Heart Rhythm Association, the Asia Pacific Heart Rhythm Society, the AHA, and the ACC discussed how the pandemic has fueled adoption of telehealth and remote patient management across medicine, including heart rhythm monitoring.
Their report was simultaneously published in Circulation: Arrhythmia and Electrophysiology, EP Europace, the Journal of the American College of Cardiology, the Journal of Arrhythmia, and Heart Rhythm.
The COVID-19 pandemic has “catalyzed the use of wearables and digital medical tools,” and this will likely define medicine going forward, first author Niraj Varma, MD, PhD, of the Cleveland Clinic, said in an interview.
He noted that the technology has been available for some time, but the pandemic has forced people to use it. “Necessity is the mother of invention, and this has become necessary during the pandemic when we can’t see our patients,” said Dr. Varma.
He also noted that hospitals and physicians are now realizing that telehealth and remote arrhythmia monitoring “actually work, and regulatory agencies have moved very swiftly to dissolve traditional barriers and will now reimburse for it. So it’s a win-win.”
Dr. Varma and colleagues said that the time is right to “embed and grow remote services in everyday medical practice worldwide.” In their report, they offered a list of commonly used platforms for telehealth and examples of remote electrocardiogram and heart rate monitoring devices.
Development of the three reports had no commercial funding. Complete lists of disclosures for the writing groups are available in the original articles.
A version of this article originally appeared on Medscape.com.
With the COVID-19 pandemic winding down in some parts of the United States, attention has turned to figuring out how to safely reboot elective cardiovascular (CV) services, which, for the most part, shut down in order to combat the virus and flatten the curve.
To aid in this effort, top cardiology societies have published a series of guidance documents. One, entitled Multimodality Cardiovascular Imaging in the Midst of the COVID-19 Pandemic: Ramping Up Safely to a New Normal, was initiated by the editors of JACC Cardiovascular Imaging and was developed in collaboration with the ACC Cardiovascular Imaging Council.
“As we enter a deceleration or indolent phase of the disease and a return to a ‘new normal’ for the foreseeable future, cardiovascular imaging laboratories will adjust to a different work flow and safety precautions for patients and staff alike,” write William Zoghbi, MD, of the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, and colleagues.
Minimize risk, maximize clinical benefit
The group outlined strategies and considerations on how to safely ramp up multimodality CV imaging laboratories in an environment of an abating but continuing pandemic.
The authors provide detailed advice on reestablishing echocardiography, transthoracic echocardiography, transesophageal echocardiography, stress testing modalities, treadmill testing, nuclear cardiology, cardiac CT, and cardiac MRI.
The advice is designed to “minimize risk, reduce resource utilization and maximize clinical benefit,” the authors wrote. They address patient and societal health; safety of healthcare professionals; choice of CV testing; and scheduling considerations.
Dr. Zoghbi and colleagues said that integrated communication among patients, referring physicians, the imaging teams, and administrative staff are key to reestablishing a more normal clinical operation.
“Recognizing that practice patterns and policies vary depending on institution and locale, the recommendations are not meant to be restrictive but rather to serve as a general framework during the COVID-19 pandemic and its recovery phase,” the writing group said.
Ultimately, the goal is to offer the necessary CV tests and information for the clinical team to provide the best care for patients, they added.
“To be successful in this new safety-driven modus operandi, innovation, coordination and adaptation among clinicians, staff and patients is necessary till herd immunity or control of COVID-19 is achieved,” they concluded.
Rebooting electrophysiology services
Uncertainty as to how to resume electrophysiology (EP) services for arrhythmia patients prompted representatives from the Heart Rhythm Society, the American Heart Association, and the ACC to develop a series of “guiding suggestions and principles” to help safely reestablish electrophysiological care.
The 28-page document is published in Circulation: Arrhythmia and Electrophysiology and the Journal of the American College of Cardiology Electrophysiology.
“Rebooting” EP services at many institutions may be more challenging than shutting down, wrote Dhanunjaya R. Lakkireddy, MD, Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kan., and colleagues.
Topics addressed by the writing group include the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication; prioritization of procedures, and development of outpatient and periprocedural care pathways.
They suggest creating an EP COVID-19 “reboot team” made up of stakeholders involved in the EP care continuum pathway that would coordinate with institutional or hospital-level COVID-19 leadership.
The reboot team may include an electrophysiologist, an EP laboratory manager, an outpatient clinic manager, an EP nurse, advanced practice providers, a device technician, an anesthesiologist, and an imaging team to provide insights into various aspects of the work flow.
“This team can clarify, interpret, iterate and disseminate policies, and also provide the necessary operational support to plan and successfully execute the reboot process as the efforts to contain COVID-19 continue,” the writing group said.
A mandatory component of the reboot plan should be planning for a second wave of the virus.
“We will have to learn to create relatively COVID-19 safe zones within the hospitals to help isolate patients from second waves and yet be able to provide regular care for non–COVID-19 patients,” the writing group said.
“Our main goal as health care professionals, whether we serve in a clinical, teaching, research, or administrative role, is to do everything we can to create a safe environment for our patients so that they receive the excellent care they deserve,” they concluded.
Defining moment for remote arrhythmia monitoring
In a separate report, an international team of heart rhythm specialists from the Latin American Heart Rhythm Society, the HRS, the European Heart Rhythm Association, the Asia Pacific Heart Rhythm Society, the AHA, and the ACC discussed how the pandemic has fueled adoption of telehealth and remote patient management across medicine, including heart rhythm monitoring.
Their report was simultaneously published in Circulation: Arrhythmia and Electrophysiology, EP Europace, the Journal of the American College of Cardiology, the Journal of Arrhythmia, and Heart Rhythm.
The COVID-19 pandemic has “catalyzed the use of wearables and digital medical tools,” and this will likely define medicine going forward, first author Niraj Varma, MD, PhD, of the Cleveland Clinic, said in an interview.
He noted that the technology has been available for some time, but the pandemic has forced people to use it. “Necessity is the mother of invention, and this has become necessary during the pandemic when we can’t see our patients,” said Dr. Varma.
He also noted that hospitals and physicians are now realizing that telehealth and remote arrhythmia monitoring “actually work, and regulatory agencies have moved very swiftly to dissolve traditional barriers and will now reimburse for it. So it’s a win-win.”
Dr. Varma and colleagues said that the time is right to “embed and grow remote services in everyday medical practice worldwide.” In their report, they offered a list of commonly used platforms for telehealth and examples of remote electrocardiogram and heart rate monitoring devices.
Development of the three reports had no commercial funding. Complete lists of disclosures for the writing groups are available in the original articles.
A version of this article originally appeared on Medscape.com.
Pregnant women at greater risk for severe COVID-19, CDC says
Pregnant women may be at increased risk for severe COVID-19 illness, according to a new report published online June 26 in Morbidity and Mortality Weekly Report.
Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.
Furthermore, Hispanic and non-Hispanic black pregnant women appear to be disproportionately impacted by the infection.
Sascha Ellington, PhD, of the Centers for Disease Control and Prevention’s COVID-19 Response Pregnancy and Infant Linked Outcomes Team, and colleagues said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.
“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote.
As of June 7, a total of 8,207 cases of COVID-19 in pregnant women were reported to the CDC, approximately 9% of COVID-19 cases among reproductive-aged women with known pregnancy status. The authors compared outcomes in these pregnant patients with those in 83,205 nonpregnant women with COVID-19. There was a substantially greater proportion of hospital admissions among pregnant patients (2,587; 31.5%) compared with nonpregnant patients (4,840; 5.8%) with COVID-19.
The authors cautioned that there were no data to differentiate between hospitalizations for COVID-19–related problems as opposed to those arising from pregnancy, including delivery.
For other severity measures, ICU admissions were reported for 1.5% of pregnant women compared with 0.9% for their nonpregnant counterparts, whereas mechanical ventilation was required for 0.5% compared with 0.3%, respectively. Mortality was identical, affecting 0.2% in both groups, with 16 deaths in pregnant patients with COVID-19 and 208 in nonpregnant patients.
Age had an impact as well, with hospitalization more frequent among those aged 35-44 years than among those aged 15-24, regardless of pregnancy status. When stratified by race/ethnicity, ICU admission was most frequently reported among pregnant women who were of non-Hispanic Asian lineage: 3.5% compared with 1.5% in all pregnant women.
Among pregnant women with laboratory-confirmed SARS-CoV-2 infection reporting race/ethnicity, 46% were Hispanic, 22% were black, and 23% were white, whereas among women who gave birth in 2019, 24% were Hispanic, 15% were black, and 51% were white. “Although data on race/ethnicity were missing for 20% of pregnant women in this study, these findings suggest that pregnant women who are Hispanic and black might be disproportionately affected by SARS-CoV-2 infection during pregnancy,” the authors wrote.
They noted that in a recent meta-analysis of influenza, pregnancy was similarly associated with a sevenfold risk for hospitalization, but a lower risk for ICU admission and no increased risk for death. A recent study suggested that COVID-19 severity during pregnancy may be lower than in other respiratory infections such as H1N1.
ACOG responds
In a response to the CDC findings, the American College of Obstetricians and Gynecologists (ACOG) advises calm, noting that the risk of needing the severity-associated interventions in the CDC report remains low and pregnant COVID-19 patients do not appear to have a greater risk for mortality.
Nevertheless, ACOG is reviewing all its COVID-19–related clinical and patient materials and “will make any necessary revisions to recommendations.”
In the meantime, the college advises clinicians to alert patients to the potential increased risk for severe COVID-19 illness during pregnancy. They should also stress to pregnant women and their families the need for precautions to prevent infection, paying particular attention to measures to protect those with greater occupational exposure to the virus.
ACOG also criticized the exclusion of pregnant and lactating women from clinical trials of potential coronavirus vaccines, noting that the new CDC findings underscore the importance of prioritizing pregnant patients to receive coronavirus vaccination when it becomes available.
“ACOG again urges the federal government to use its resources to ensure the safe inclusion of pregnant and lactating patients, including patients of color, in trials for vaccines and therapeutics to ensure that all populations are included in the search for ways to prevent and treat COVID-19,” the statement reads.
The CDC authors said that their report also highlights the need for more complete data to fully understand the risk for severe illness in pregnant women. To address these gaps, the CDC is collaborating with health departments in COVID-19 pregnancy surveillance for the reporting of outcomes in pregnant women with laboratory-confirmed SARS-CoV-2 infection.
A version of article originally appeared on Medscape.com.
Pregnant women may be at increased risk for severe COVID-19 illness, according to a new report published online June 26 in Morbidity and Mortality Weekly Report.
Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.
Furthermore, Hispanic and non-Hispanic black pregnant women appear to be disproportionately impacted by the infection.
Sascha Ellington, PhD, of the Centers for Disease Control and Prevention’s COVID-19 Response Pregnancy and Infant Linked Outcomes Team, and colleagues said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.
“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote.
As of June 7, a total of 8,207 cases of COVID-19 in pregnant women were reported to the CDC, approximately 9% of COVID-19 cases among reproductive-aged women with known pregnancy status. The authors compared outcomes in these pregnant patients with those in 83,205 nonpregnant women with COVID-19. There was a substantially greater proportion of hospital admissions among pregnant patients (2,587; 31.5%) compared with nonpregnant patients (4,840; 5.8%) with COVID-19.
The authors cautioned that there were no data to differentiate between hospitalizations for COVID-19–related problems as opposed to those arising from pregnancy, including delivery.
For other severity measures, ICU admissions were reported for 1.5% of pregnant women compared with 0.9% for their nonpregnant counterparts, whereas mechanical ventilation was required for 0.5% compared with 0.3%, respectively. Mortality was identical, affecting 0.2% in both groups, with 16 deaths in pregnant patients with COVID-19 and 208 in nonpregnant patients.
Age had an impact as well, with hospitalization more frequent among those aged 35-44 years than among those aged 15-24, regardless of pregnancy status. When stratified by race/ethnicity, ICU admission was most frequently reported among pregnant women who were of non-Hispanic Asian lineage: 3.5% compared with 1.5% in all pregnant women.
Among pregnant women with laboratory-confirmed SARS-CoV-2 infection reporting race/ethnicity, 46% were Hispanic, 22% were black, and 23% were white, whereas among women who gave birth in 2019, 24% were Hispanic, 15% were black, and 51% were white. “Although data on race/ethnicity were missing for 20% of pregnant women in this study, these findings suggest that pregnant women who are Hispanic and black might be disproportionately affected by SARS-CoV-2 infection during pregnancy,” the authors wrote.
They noted that in a recent meta-analysis of influenza, pregnancy was similarly associated with a sevenfold risk for hospitalization, but a lower risk for ICU admission and no increased risk for death. A recent study suggested that COVID-19 severity during pregnancy may be lower than in other respiratory infections such as H1N1.
ACOG responds
In a response to the CDC findings, the American College of Obstetricians and Gynecologists (ACOG) advises calm, noting that the risk of needing the severity-associated interventions in the CDC report remains low and pregnant COVID-19 patients do not appear to have a greater risk for mortality.
Nevertheless, ACOG is reviewing all its COVID-19–related clinical and patient materials and “will make any necessary revisions to recommendations.”
In the meantime, the college advises clinicians to alert patients to the potential increased risk for severe COVID-19 illness during pregnancy. They should also stress to pregnant women and their families the need for precautions to prevent infection, paying particular attention to measures to protect those with greater occupational exposure to the virus.
ACOG also criticized the exclusion of pregnant and lactating women from clinical trials of potential coronavirus vaccines, noting that the new CDC findings underscore the importance of prioritizing pregnant patients to receive coronavirus vaccination when it becomes available.
“ACOG again urges the federal government to use its resources to ensure the safe inclusion of pregnant and lactating patients, including patients of color, in trials for vaccines and therapeutics to ensure that all populations are included in the search for ways to prevent and treat COVID-19,” the statement reads.
The CDC authors said that their report also highlights the need for more complete data to fully understand the risk for severe illness in pregnant women. To address these gaps, the CDC is collaborating with health departments in COVID-19 pregnancy surveillance for the reporting of outcomes in pregnant women with laboratory-confirmed SARS-CoV-2 infection.
A version of article originally appeared on Medscape.com.
Pregnant women may be at increased risk for severe COVID-19 illness, according to a new report published online June 26 in Morbidity and Mortality Weekly Report.
Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.
Furthermore, Hispanic and non-Hispanic black pregnant women appear to be disproportionately impacted by the infection.
Sascha Ellington, PhD, of the Centers for Disease Control and Prevention’s COVID-19 Response Pregnancy and Infant Linked Outcomes Team, and colleagues said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.
“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote.
As of June 7, a total of 8,207 cases of COVID-19 in pregnant women were reported to the CDC, approximately 9% of COVID-19 cases among reproductive-aged women with known pregnancy status. The authors compared outcomes in these pregnant patients with those in 83,205 nonpregnant women with COVID-19. There was a substantially greater proportion of hospital admissions among pregnant patients (2,587; 31.5%) compared with nonpregnant patients (4,840; 5.8%) with COVID-19.
The authors cautioned that there were no data to differentiate between hospitalizations for COVID-19–related problems as opposed to those arising from pregnancy, including delivery.
For other severity measures, ICU admissions were reported for 1.5% of pregnant women compared with 0.9% for their nonpregnant counterparts, whereas mechanical ventilation was required for 0.5% compared with 0.3%, respectively. Mortality was identical, affecting 0.2% in both groups, with 16 deaths in pregnant patients with COVID-19 and 208 in nonpregnant patients.
Age had an impact as well, with hospitalization more frequent among those aged 35-44 years than among those aged 15-24, regardless of pregnancy status. When stratified by race/ethnicity, ICU admission was most frequently reported among pregnant women who were of non-Hispanic Asian lineage: 3.5% compared with 1.5% in all pregnant women.
Among pregnant women with laboratory-confirmed SARS-CoV-2 infection reporting race/ethnicity, 46% were Hispanic, 22% were black, and 23% were white, whereas among women who gave birth in 2019, 24% were Hispanic, 15% were black, and 51% were white. “Although data on race/ethnicity were missing for 20% of pregnant women in this study, these findings suggest that pregnant women who are Hispanic and black might be disproportionately affected by SARS-CoV-2 infection during pregnancy,” the authors wrote.
They noted that in a recent meta-analysis of influenza, pregnancy was similarly associated with a sevenfold risk for hospitalization, but a lower risk for ICU admission and no increased risk for death. A recent study suggested that COVID-19 severity during pregnancy may be lower than in other respiratory infections such as H1N1.
ACOG responds
In a response to the CDC findings, the American College of Obstetricians and Gynecologists (ACOG) advises calm, noting that the risk of needing the severity-associated interventions in the CDC report remains low and pregnant COVID-19 patients do not appear to have a greater risk for mortality.
Nevertheless, ACOG is reviewing all its COVID-19–related clinical and patient materials and “will make any necessary revisions to recommendations.”
In the meantime, the college advises clinicians to alert patients to the potential increased risk for severe COVID-19 illness during pregnancy. They should also stress to pregnant women and their families the need for precautions to prevent infection, paying particular attention to measures to protect those with greater occupational exposure to the virus.
ACOG also criticized the exclusion of pregnant and lactating women from clinical trials of potential coronavirus vaccines, noting that the new CDC findings underscore the importance of prioritizing pregnant patients to receive coronavirus vaccination when it becomes available.
“ACOG again urges the federal government to use its resources to ensure the safe inclusion of pregnant and lactating patients, including patients of color, in trials for vaccines and therapeutics to ensure that all populations are included in the search for ways to prevent and treat COVID-19,” the statement reads.
The CDC authors said that their report also highlights the need for more complete data to fully understand the risk for severe illness in pregnant women. To address these gaps, the CDC is collaborating with health departments in COVID-19 pregnancy surveillance for the reporting of outcomes in pregnant women with laboratory-confirmed SARS-CoV-2 infection.
A version of article originally appeared on Medscape.com.